Seropram Drops 40mg/Ml
Out of date information, search anotherRead all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have further questions, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects are troubling, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Cipramil Drops 40mg/ml, but will be referred to as Cipramil throughout this leaflet.
In this leaflet:
^3 What Cipramil is and what it is used for Before you take Cipramil [3 How to take Cipramil [3 Possible side effects r3 How to store Cipramil [3 Further information
^ What Cipramil is and what it is used for
How does Cipramil work?
Cipramil is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to a group of medicines known as antidepressants.
These medicines help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness.
What is Cipramil used for?
Cipramil is used for the treatment of depression and, when you feel better, to help prevent these symptoms recurring. Cipramil is also used for long-term treatment to prevent the occurrence of new episodes of depression or if you have recurrent depression.
Cipramil is also beneficial in relieving symptoms if you tend to suffer from panic attacks.
Before you take Cipramil Drops
Do not take Cipramil
* If you are allergic (hypersensitive) to citalopram, or any of the other ingredients of Cipramil (see What Cipramil contain, section 6). Consult your doctor if you think you might be.
* If you are also taking a medicine containing pimozide. Talk to your doctor.
* At the same time as taking medication known as monoamine oxidase
inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide (used for the treatment of depression), selegiline (used in the treatment of Parkinson's disease) and linezolid (an antibiotic). Even if you have finished taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine you will need to wait 2 weeks before you start taking Cipramil. One day must elapse after you have finished taking moclobemide. After stopping Cipramil you must allow 1 week before taking any MAOI.
* if you are born with or have had an episode of abnormal heart rhythm (seen at ECG; an examination to evaluate how the heart is functioning).
* if you take medicines for heart rhythm problems or that may affect the heart's rhythm (see Taking other medicines, below).
Take special care with Cipramil
Please tell your doctor if you have any medical problems, especially if you have:
* Liver disease
* Kidney disease
* Diabetes (you may need an adjustment of your antidiabetic therapy)
* Epilepsy or a history of seizures or fits
* A bleeding disorder or have ever suffered from bleeding in the stomach or intestine
* Mania or panic disorder
* Low blood levels of sodium
* ECT (electroconvulsive therapy)
* Problems with your eyes, such as certain kinds of glaucoma
* Suffered or suffer from heart problems or have recently had a heart attack.
* A low resting heart-rate and/or you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets).
* Experienced a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate.
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Some patients with manic-depressive illness may enter into a manic phase. This is characterized by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related diseases, the improvement is not achieved immediately. After the start of Cipramil treatment it may take several weeks before you experience any improvement. In the beginning of the treatment certain patients may experience increased anxiety, which will disappear during continued treatment. Therefore, it is very important that you follow exactly your doctor's orders and do not stop the treatment or change the dose without consulting your doctor.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Use in children and adolescents under 18 years of age Cipramil should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe citalopram for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Cipramil for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Cipramil. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Cipramil in this age group have not yet been demonstrated.
Taking other medicines
Medicines may affect the action of other medicines and this can sometimes cause serious adverse reactions.
Please tell your doctor or pharmacist if you are taking or have taken any other medicines (including those purchased without prescription) during the last 14 days. This includes other medicines for depression (see Do not take Cipramil above).
* The herbal remedy St John's wort (Hypericum perforatum). This should not be taken at the same time as Cipramil.
* Monoamine oxidase inhibitors (MAOIs). These should not be taken at the same time as Cipramil (see Do not take Cipramil Drops above).
Tell your doctor if you are taking any of the following medicines:
* Linezolid (an antibiotic).
* Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you feel unwell when using these medicines with Cipramil you should see your doctor.
* Lithium (used to prevent and treat mania) and tryptophan (an antidepressant)
* Pimozide (a neuroleptic). This should not be taken at the same time as Cipramil (see Do not take Cipramil above).
* Imipramine and desipramine (used to treat depression).
* Medicines containing selegiline (used to treat Parkinson's disease)
* Cimetidine (used to treat stomach ulcers).
* Mefloquine (used to treat malaria).
* Bupropion (used to treat depression).
* Medicines known to affect the blood platelets (e.g. anticoagulant drugs used to treat or prevent blood clots; aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used as painkillers and some antipsychotic drugs and tricyclic antidepressants).
* Metoprolol, a beta blocker used to treat migraine, some heart conditions and high blood pressure. The effects of either drug could be increased, decreased or altered.
* Neuroleptics (used in the treatment of schizophrenia).
Do not take Cipramil if you take medicines for heart rhythm problems or medicines that may affect the heart's rhythm, e.g. such as Class IA and III antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.
Taking Cipramil with food and drink
Cipramil can be taken with or without food (see section 3 "How to take Cipramil”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment although Cipramil has not been shown to increase the effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant, think you might be pregnant, or are trying to become pregnant, tell your doctor. Do not take Cipramil if you are pregnant unless you and your doctor have discussed the risks and benefits involved.
Make sure your midwife and/or doctor know you are on Cipramil. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Cipramil may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately. Also, if you take Cipramil during the last 3 months of your pregnancy and until the date of birth you should be aware that the following effects may be seen in your newborn: fits, being too hot or cold, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping difficulties. If your newborn baby gets any of these symptoms please contact your midwife and/or doctor immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not breast-feed your baby when taking Cipramil because small amounts of the medicine can pass into the breast milk.
Fertility
Cipramil has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machines
Cipramil does not usually affect the ability to carry out normal daily activities. However, if you feel dizzy or sleepy when you start to take this medicine, you should be careful when driving, operating machinery or performing jobs that need you to be alert until these effects wear off.
Important information about some of the ingredients of Cipramil
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg in all doses. These drops also contain the preservatives E216 and E218, which may cause allergic reactions (possibly delayed).
[3 How to take Cipramil
How much to take
It is important to take your drops as instructed by your doctor. The label will tell you how many to take and how often. If it does not, or you are not sure, ask your doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before increasing the dose to between 16 -24 mg (8 to 12 drops) per day. The dose may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose, e.g. 8-16 mg per day. Elderly patients should not usually receive more than 16 mg (8 drops) per day.
Children and adolescents (< 18 years)
Cipramil should not be given to children or adolescents under 18 years of age. For further information, please see section 2, Before you take Cipramil Drops.
Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops) per day.
If you have previously taken Cipramil tablets, you will find that the dose of your medicine in mg given as drops is a bit lower than that of tablets. This is because your body more easily absorbs the drops than the tablets, so you do not need as many mg to have the same effect.
The doses of tablets correspond to doses of drops as follows:
Tablets Drops
10 mg 8 mg (4 drops)
20 mg 16 mg (8 drops)
30 mg 24 mg (12 drops)
40 mg 32 mg (16 drops)
Patient Information Leaflet (continued)
How and when to take Cipramil
The drops are for oral use and can be taken in a drink of water, or orange or apple juice.
Cipramil is taken every day as one dose at any time of the day.
Duration of treatment
Like other medicines for depression and panic disorder these drops may take a few weeks before you feel any improvement. Continue to take Cipramil even if it takes some time before you feel any improvement in your condition.
The duration of treatment is individual, usually at least 6 months. Continue to take the drops for as long as your doctor recommends. Do not stop taking them even if you begin to feel better, unless you are told to do so by your doctor. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms may return.
Patients who have recurrent depression benefit from continued treatment, sometimes for several years, to prevent the occurrence of new depressive episodes.
Never change the dose of the medicine without talking to your doctor first.
If you take more Cipramil than you should
If you think that you or anyone else may have taken too many Cipramil drops, contact your doctor or nearest hospital emergency department immediately. Do this even if there are no signs of discomfort or poisoning. Take the Cipramil box/container with you if you go to a doctor or hospital. Some of the signs of an overdosage could be life-threatening.
Symptoms of overdosage may include:
* Irregular heart beat
* Seizures
* Changes in heart rhythm
* Feeling sick (nausea)
* Vomiting
* Sweating
* Drowsiness
* Unconsciousness
* Fast heart beats
* Tremor
* Changes in blood pressure
* Serotonin syndrome (see Section 4)
* Agitation
* Dizziness
* Enlarged eye pupils
* Bluish skin
* Breathing too quickly
If you forget to take Cipramil
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose.
Effects when treatment with Cipramil is stopped
Stopping this medicine quickly may cause symptoms such as dizziness, nausea and numbness or tingling in hands or feet, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling or being sick, sweating, feeling restless or agitated, tremor, feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). These are usually non-serious and disappear within a few days. When you have completed your course of treatment, the dose of Cipramil is usually reduced gradually over a couple of weeks.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
* Fast heart beat
* Slow heart beat
* Nettle rash
* Loss of hair
* Rash
* Sensitivity to sunlight
* Difficulties urinating
* Vaginal bleeding
* Swelling of the arms or legs
* Increased weight
Rare (likely to affect up to 1 in every 1000 people)
* Convulsions
* Involuntary movements
* Taste disturbances
* Bleeding
* Hepatitis
Some patient have reported (frequency not known)
* Thoughts of harming or killing themselves
* An increase in bleeding or bruising caused by a decrease in blood platelets
* Rash (hypersensitivity)
* Low potassium levels in the blood (hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythms
* Panic attack
* Grinding teeth
* Restlessness
* Unusual muscle movements or stiffness
* Involuntary movements of the muscles (akathisia)
* Low blood pressure
* Nosebleed
* Bleeding disorders including skin and mucosal bleeding (ecchymosis)
* Sudden swelling of skin or mucosa
* In men, painful erections
* Flow of breast milk in men or in women who are not breast-feeding (galactorrhoea)
* Abnormal liver function tests
* An increased risk of bone fractures has been observed in patients taking this type of medicines
SSRIs can, very rarely, increase the risk of bleeding, including stomach or intestinal bleeding. Let your doctor know if you vomit blood or develop black or blood stained stools.
Also let your doctor know if you continue to have other symptoms associated with your depression. This might include hallucinations, anxiety, mania or confusion.
Any side effects that do occur will usually disappear after a few days. If they are troublesome or persistent, or if you develop any other unusual side effects while taking Cipramil, please tell your doctor.
If you notice any other side effects not mentioned in this leaflet please tell your doctor or pharmacist.
^ Possible side effects
Like all medicines, Cipramil can have side effects and some people may experience unwanted effects (side effects) whilst taking Cipramil. Several of the effects listed below can also be symptoms of your illness and may disappear as you start to get better.
Serious side effects
Stop taking Cipramil and seek medical advice immediately if you have any of the following symptoms:
* Difficulty in breathing.
* Swelling of the face, lips, tongue or throat that causes difficulty in swallowing or breathing.
* Severe itching of the skin (with raised lumps).
* Fast, irregular heartbeat, fainting which could be symptoms of a life-threatening condition known as torsades de pointes.
If you notice any of the following you should contact your doctor immediately as your dose may need to be reduced or stopped:
* You start having fits for the first time or fits that you have suffered from in the past before become more frequent.
* Your behaviour changes because you feel elated or over excited.
* You experience high fever, agitation, confusion, and trembling or abrupt contractions of muscles. These may be signs of a rare condition called serotonin syndrome.
* Tiredness, confusion and twitching of your muscles. These may be signs of a low blood level of sodium.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
The following side effects are often mild and usually disappear after a few days' treatment.
Very common side effects (likely to affect more than 1 in 10 people)
* Sleepiness
* Difficulty in sleeping
* Increased sweating
* Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to clean your teeth more often than usual)
* Feeling sick (nausea)
Common side effects (likely to affect up to 1 in 10 people)
* Lack of appetite
* Agitation
* Decreased sex drive
* Anxiety
* Nervousness
* Confusion
* Abnormal dreams
* Tremor
* Tingling or numbness in the hands or feet
* Ringing in the ears (tinnitus)
* Yawning
* Diarrhoea
* Vomiting
* Constipation
* Itching
* Pain in muscles and joints
* For men, problems with ejaculation and erection
* For females, failing to reach an orgasm
* Tiredness,
* Prickling of the skin
* Loss of weight
Uncommon (likely to affect up to 1 in every 100 people)
* Bruising easily
* Increased appetite
* Aggression
* Reduced emotions, indifference
* Hallucinations
* Mania
* Fainting
* Large pupils (the dark centre of the eye)
How to store Cipramil
Do not use this medicine after the expiry date shown on the carton label. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment. Only keep this medicine if your doctor tells you to. If your medicine becomes discoloured or shows any signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Use within 16 weeks after first use.
[6 Further information
What Cipramil Drops contain
Each ml of solution contains 40mg of the active ingredient citalopram. Cipramil also contains the following inactive ingredients; methyl-parahydroxybenzoate E218, propyl-parahydroxybenzoate E216, ethyl alcohol 9% v/v, hydroxyethylcellulose, purified water.
What Cipramil Drops look like and contents of the pack
Cipramil comes in a brown glass bottle containing 15ml clear drops solution with screw cap and polyethylene dropper.
Manufacturer and Licence Holder
Cipramil is manufactured by H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby Denmark and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.
|POM| PL Number: 15184/1112
Cipramil is a registered trademark of H.Lundbeck A/S.
Leaflet revision date: 23/10/12
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have further questions, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects are troubling, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Cipramil Drops 40mg/ml, but will be referred to as Cipramil throughout this leaflet.
In this leaflet:
^3 What Cipramil is and what it is used for Before you take Cipramil [3 How to take Cipramil [3 Possible side effects r3 How to store Cipramil [3 Further information
^ What Cipramil is and what it is used for
How does Cipramil work?
Cipramil is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to a group of medicines known as antidepressants.
These medicines help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness.
What is Cipramil used for?
Cipramil is used for the treatment of depression and, when you feel better, to help prevent these symptoms recurring. Cipramil is also used for long-term treatment to prevent the occurrence of new episodes of depression or if you have recurrent depression.
Cipramil is also beneficial in relieving symptoms if you tend to suffer from panic attacks.
Before you take Cipramil
Do not take Cipramil
* If you are allergic (hypersensitive) to citalopram, or any of the other ingredients of Cipramil (see What Cipramil contain, section 6). Consult your doctor if you think you might be.
* If you are also taking a medicine containing pimozide. Talk to your doctor.
* At the same time as taking medication known as monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide (used for the treatment of depression), selegiline (used in the treatment of Parkinson's disease) and linezolid (an antibiotic). Even if you have finished taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine you will need to wait 2 weeks before you start taking Cipramil. One day must elapse after you have finished taking moclobemide. After stopping Cipramil you must allow 1 week before taking any MAOI.
* if you are born with or have had an episode of abnormal heart rhythm (seen at ECG; an examination to evaluate how the heart is functioning).
* if you take medicines for heart rhythm problems or that may affect the heart's rhythm (see Taking other medicines, below).
Take special care with Cipramil
Please tell your doctor if you have any medical problems, especially if you have:
* Liver disease
* Kidney disease
* Diabetes (you may need an adjustment of your antidiabetic therapy)
* Epilepsy or a history of seizures or fits
* A bleeding disorder or have ever suffered from bleeding in the stomach or intestine
* Mania or panic disorder
* Low blood levels of sodium
* ECT (electroconvulsive therapy)
* Problems with your eyes, such as certain kinds of glaucoma
* Suffered or suffer from heart problems or have recently had a heart attack.
* A low resting heart-rate and/or you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets).
* Experienced a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate.
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Some patients with manic-depressive illness may enter into a manic phase. This is characterized by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related diseases, the improvement is not achieved immediately. After the start of Cipramil treatment it may take several weeks before you experience any improvement. In the beginning of the treatment certain patients may experience increased anxiety, which will disappear during continued treatment. Therefore, it is very important that you follow exactly your doctor's orders and do not stop the treatment or change the dose without consulting your doctor.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Use in children and adolescents under 18 years of age Cipramil should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Cipramil for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Cipramil for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Cipramil. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Cipramil in this age group have not yet been demonstrated.
Taking other medicines
Medicines may affect the action of other medicines and this can sometimes cause serious adverse reactions.
Please tell your doctor or pharmacist if you are taking or have taken any other medicines (including those purchased without prescription) during the last 14 days. This includes other medicines for depression (see Do not take Cipramil above).
* The herbal remedy St John's wort (Hypericum perforatum). This should not be taken at the same time as Cipramil.
* Monoamine oxidase inhibitors (MAOIs). These should not be taken at the same time as Cipramil (see Do not take Cipramil above).
Tell your doctor if you are taking any of the following medicines:
* Linezolid (an antibiotic).
* Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you feel unwell when using these medicines with Cipramil you should see your doctor.
* Lithium (used to prevent and treat mania) and tryptophan (an antidepressant)
* Pimozide (a neuroleptic). This should not be taken at the same time as Cipramil (see Do not take Cipramil above).
* Imipramine and desipramine (used to treat depression).
* Medicines containing selegiline (used to treat Parkinson's disease)
* Cimetidine (used to treat stomach ulcers).
* Mefloquine (used to treat malaria).
* Bupropion (used to treat depression).
* Medicines known to affect the blood platelets (e.g. anticoagulant drugs used to treat or prevent blood clots; aspirin and non-steroidal antiinflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used as painkillers and some antipsychotic drugs and tricyclic antidepressants).
* Metoprolol, a beta blocker used to treat migraine, some heart conditions and high blood pressure. The effects of either drug could be increased, decreased or altered.
* Neuroleptics (used in the treatment of schizophrenia).
Do not take Cipramil if you take medicines for heart rhythm problems or medicines that may affect the heart's rhythm, e.g. such as Class IA and III antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.
Taking Cipramil with food and drink
Cipramil can be taken with or without food (see section 3 "How to take Cipramil”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment although Cipramil has not been shown to increase the effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant, think you might be pregnant, or are trying to become pregnant, tell your doctor. Do not take Cipramil if you are pregnant unless you and your doctor have discussed the risks and benefits involved.
Make sure your midwife and/or doctor know you are on Cipramil. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Cipramil may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately. Also, if you take Cipramil during the last 3 months of your pregnancy and until the date of birth you should be aware that the following effects may be seen in your newborn: fits, being too hot or cold, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping difficulties. If your newborn baby gets any of these symptoms please contact your midwife and/or doctor immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not breast-feed your baby when taking Cipramil because small amounts of the medicine can pass into the breast milk.
Fertility
Cipramil has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machines
Cipramil does not usually affect the ability to carry out normal daily activities. However, if you feel dizzy or sleepy when you start to take this medicine, you should be careful when driving, operating machinery or performing jobs that need you to be alert until these effects wear off.
Important information about some of the ingredients of Cipramil Drops
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg in all doses. These drops also contain the preservatives E216 and E218, which may cause allergic reactions (possibly delayed).
How to take Cipramil
How much to take
It is important to take your drops as instructed by your doctor. The label will tell you how many to take and how often. If it does not, or you are not sure, ask your doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before increasing the dose to between 16 -24 mg (8 to 12 drops) per day. The dose may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose, e.g. 8-16 mg per day. Elderly patients should not usually receive more than 16 mg (8 drops) per day.
Children and adolescents (< 18 years)
Cipramil should not be given to children or adolescents under 18 years of age. For further information, please see section 2, Before you take Cipramil.
Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops) per day.
If you have previously taken Cipramil tablets, you will find that the dose of your medicine in mg given as drops is a bit lower than that of tablets. This is because your body more easily absorbs the drops than the tablets, so you do not need as many mg to have the same effect.
The doses of tablets correspond to doses of drops as follows:
Tablets Drops
10 mg 8 mg (4 drops)
20 mg 16 mg (8 drops)
30 mg 24 mg (12 drops)
40 mg 32 mg (16 drops)
Patient Information Leaflet (continued)
How and when to take Cipramil
The drops are for oral use and can be taken in a drink of water, or orange or apple juice.
Cipramil is taken every day as one dose at any time of the day.
Duration of treatment
Like other medicines for depression and panic disorder these drops may take a few weeks before you feel any improvement. Continue to take Cipramil even if it takes some time before you feel any improvement in your condition.
The duration of treatment is individual, usually at least 6 months. Continue to take the drops for as long as your doctor recommends. Do not stop taking them even if you begin to feel better, unless you are told to do so by your doctor. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms may return.
Patients who have recurrent depression benefit from continued treatment, sometimes for several years, to prevent the occurrence of new depressive episodes.
Never change the dose of the medicine without talking to your doctor first.
If you take more Cipramil than you should
If you think that you or anyone else may have taken too many Cipramil drops, contact your doctor or nearest hospital emergency department immediately. Do this even if there are no signs of discomfort or poisoning. Take the Cipramil box/container with you if you go to a doctor or hospital. Some of the signs of an overdosage could be life-threatening.
Symptoms of overdosage may include:
* Irregular heart beat
* Seizures
* Changes in heart rhythm
* Feeling sick (nausea)
* Vomiting
* Sweating
* Drowsiness
* Unconsciousness
* Fast heart beats
* Tremor
* Changes in blood pressure
* Serotonin syndrome (see Section 4)
* Agitation
* Dizziness
* Enlarged eye pupils
* Bluish skin
* Breathing too quickly
If you forget to take Cipramil
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose.
Effects when treatment with Cipramil is stopped
Stopping this medicine quickly may cause symptoms such as dizziness, nausea and numbness or tingling in hands or feet, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling or being sick, sweating, feeling restless or agitated, tremor, feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). These are usually non-serious and disappear within a few days. When you have completed your course of treatment, the dose of Cipramil is usually reduced gradually over a couple of weeks.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
* Fast heart beat
* Slow heart beat
* Nettle rash
* Loss of hair
* Rash
* Sensitivity to sunlight
* Difficulties urinating
* Vaginal bleeding
* Swelling of the arms or legs
* Increased weight
Rare (likely to affect up to 1 in every 1000 people)
* Convulsions
* Involuntary movements
* Taste disturbances
* Bleeding
* Hepatitis
Some patient have reported (frequency not known)
* Thoughts of harming or killing themselves
* An increase in bleeding or bruising caused by a decrease in blood platelets
* Rash (hypersensitivity)
* Low potassium levels in the blood (hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythms
* Panic attack
* Grinding teeth
* Restlessness
* Unusual muscle movements or stiffness
* Involuntary movements of the muscles (akathisia)
* Low blood pressure
* Nosebleed
* Bleeding disorders including skin and mucosal bleeding (ecchymosis)
* Sudden swelling of skin or mucosa
* In men, painful erections
* Flow of breast milk in men or in women who are not breast-feeding (galactorrhoea)
* Abnormal liver function tests
* An increased risk of bone fractures has been observed in patients taking this type of medicines
SSRIs can, very rarely, increase the risk of bleeding, including stomach or intestinal bleeding. Let your doctor know if you vomit blood or develop black or blood stained stools.
Also let your doctor know if you continue to have other symptoms associated with your depression. This might include hallucinations, anxiety, mania or confusion.
Any side effects that do occur will usually disappear after a few days. If they are troublesome or persistent, or if you develop any other unusual side effects while taking Cipramil, please tell your doctor.
If you notice any other side effects not mentioned in this leaflet please tell your doctor or pharmacist.
[4 Possible side effects
Like all medicines, Cipramil can have side effects and some people may experience unwanted effects (side effects) whilst taking Cipramil. Several of the effects listed below can also be symptoms of your illness and may disappear as you start to get better.
Serious side effects
Stop taking Cipramil and seek medical advice immediately if you have any of the following symptoms:
* Difficulty in breathing.
* Swelling of the face, lips, tongue or throat that causes difficulty in swallowing or breathing.
* Severe itching of the skin (with raised lumps).
* Fast, irregular heartbeat, fainting which could be symptoms of a life-threatening condition known as torsades de pointes.
If you notice any of the following you should contact your doctor immediately as your dose may need to be reduced or stopped:
* You start having fits for the first time or fits that you have suffered from in the past before become more frequent.
* Your behaviour changes because you feel elated or over excited.
* You experience high fever, agitation, confusion, and trembling or abrupt contractions of muscles. These may be signs of a rare condition called serotonin syndrome.
* Tiredness, confusion and twitching of your muscles. These may be signs of a low blood level of sodium.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
The following side effects are often mild and usually disappear after a few days' treatment.
Very common side effects (likely to affect more than 1 in 10 people)
* Sleepiness
* Difficulty in sleeping
* Increased sweating
* Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to clean your teeth more often than usual)
* Feeling sick (nausea)
Common side effects (likely to affect up to 1 in 10 people)
* Lack of appetite
* Agitation
* Decreased sex drive
* Anxiety
* Nervousness
* Confusion
* Abnormal dreams
* Tremor
* Tingling or numbness in the hands or feet
* Ringing in the ears (tinnitus)
* Yawning
* Diarrhoea
* Vomiting
* Constipation
* Itching
* Pain in muscles and joints
* For men, problems with ejaculation and erection
* For females, failing to reach an orgasm
* Tiredness,
* Prickling of the skin
* Loss of weight
Uncommon (likely to affect up to 1 in every 100 people)
* Bruising easily
* Increased appetite
* Aggression
* Reduced emotions, indifference
* Hallucinations
* Mania
* Fainting
* Large pupils (the dark centre of the eye)
rp How to store Cipramil
Do not use this medicine after the expiry date shown on the carton label. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment. Only keep this medicine if your doctor tells you to. If your medicine becomes discoloured or shows any signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Use within 16 weeks after first use.
[p Further information
What Cipramil Drops contain
Each ml of solution contains 40mg of the active ingredient citalopram. Cipramil also contains the following inactive ingredients; methyl-parahydroxybenzoate E218, propyl-parahydroxybenzoate E216, ethyl alcohol 9% v/v, hydroxyethylcellulose, purified water.
What Cipramil Drops look like and contents of the pack
Cipramil comes in a brown glass bottle containing 15ml clear drops solution with screw cap and polyethylene dropper.
Manufacturer and Licence Holder
Cipramil is manufactured by Montefarmaco SPA, Via G. Galilei-7, 20016 Pero (MI) Italy and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.
IPOMI PL Number: 15184/1112
Cipramil is a registered trademark of H.Lundbeck A/S.
Leaflet revision date: 23/10/12
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have further questions, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects are troubling, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Citalopram Hydrochloride Drops 40mg/ml, but will be referred to as Citalopram Hydrochloride throughout this leaflet.
In this leaflet:
^3 What Citalopram Hydrochloride is and what it is used for Before you take Citalopram Hydrochloride [3 How to take Citalopram Hydrochloride [3 Possible side effects r3 How to store Citalopram Hydrochloride [3 Further information
[3 What Citalopram Hydrochloride is and what it is used for
How does Citalopram Hydrochloride work?
Citalopram Hydrochloride is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to a group of medicines known as antidepressants.
These medicines help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness.
What is Citalopram Hydrochloride used for?
Citalopram Hydrochloride is used for the treatment of depression and, when you feel better, to help prevent these symptoms recurring. Citalopram Hydrochloride is also used for long-term treatment to prevent the occurrence of new episodes of depression or if you have recurrent depression.
Citalopram Hydrochloride is also beneficial in relieving symptoms if you tend to suffer from panic attacks.
[3 Before you take Citalopram Hydrochloride Drops
Do not take Citalopram Hydrochloride
* If you are allergic (hypersensitive) to citalopram, or any of the other ingredients of Citalopram Hydrochloride (see What Citalopram Hydrochloride contain, section 6). Consult your doctor if you think you might be.
* If you are also taking a medicine containing pimozide. Talk to your doctor.
* At the same time as taking medication known as monoamine oxidase
inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide (used for the treatment of depression), selegiline (used in the treatment of Parkinson's disease) and linezolid (an antibiotic). Even if you have finished taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine you will need to wait 2 weeks before you start taking Citalopram Hydrochloride. One day must elapse after you have finished taking moclobemide. After stopping Citalopram Hydrochloride you must allow 1 week before taking any MaOI.
* if you are born with or have had an episode of abnormal heart rhythm (seen at ECG; an examination to evaluate how the heart is functioning).
* if you take medicines for heart rhythm problems or that may affect the heart's rhythm (see Taking other medicines, below).
Take special care with Citalopram Hydrochloride
Please tell your doctor if you have any medical problems, especially if you have:
* Liver disease
* Kidney disease
* Diabetes (you may need an adjustment of your antidiabetic therapy)
* Epilepsy or a history of seizures or fits
* A bleeding disorder or have ever suffered from bleeding in the stomach or intestine
* Mania or panic disorder
* Low blood levels of sodium
* ECT (electroconvulsive therapy)
* Problems with your eyes, such as certain kinds of glaucoma
* Suffered or suffer from heart problems or have recently had a heart attack.
* A low resting heart-rate and/or you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets).
* Experienced a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate.
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Some patients with manic-depressive illness may enter into a manic phase. This is characterized by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related diseases, the improvement is not achieved immediately. After the start of Citalopram Hydrochloride treatment it may take several weeks before you experience any improvement. In the beginning of the treatment certain patients may experience increased anxiety, which will disappear during continued treatment. Therefore, it is very important that you follow exactly your doctor's orders and do not stop the treatment or change the dose without consulting your doctor.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Use in children and adolescents under 18 years of age Citalopram Hydrochloride should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe citalopram for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Citalopram Hydrochloride for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Citalopram Hydrochloride. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Citalopram Hydrochloride in this age group have not yet been demonstrated.
Taking other medicines
Medicines may affect the action of other medicines and this can sometimes cause serious adverse reactions.
Please tell your doctor or pharmacist if you are taking or have taken any other medicines (including those purchased without prescription) during the last 14 days. This includes other medicines for depression (see Do not take Citalopram Hydrochloride Drops above).
* The herbal remedy St John's wort (Hypericum perforatum). This should not be taken at the same time as Citalopram Hydrochloride.
* Monoamine oxidase inhibitors (MAOIs). These should not be taken at the same time as Citalopram Hydrochloride (see Do not take Citalopram Hydrochloride above).
Tell your doctor if you are taking any of the following medicines:
* Linezolid (an antibiotic).
* Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you
feel unwell when using these medicines with Citalopram Hydrochloride you should see your doctor.
* Lithium (used to prevent and treat mania) and tryptophan (an antidepressant)
* Pimozide (a neuroleptic). This should not be taken at the same time as Citalopram Hydrochloride (see Do not take Citalopram Hydrochloride
above).
* mipramine and desipramine (used to treat depression).
* Medicines containing selegiline (used to treat Parkinson's disease)
* Cimetidine (used to treat stomach ulcers).
* Mefloquine (used to treat malaria).
* Bupropion (used to treat depression).
* Medicines known to affect the blood platelets (e.g. anticoagulant drugs used to treat or prevent blood clots; aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used as painkillers and some antipsychotic drugs and tricyclic antidepressants).
* Metoprolol, a beta blocker used to treat migraine, some heart conditions and high blood pressure. The effects of either drug could be increased, decreased or altered.
* Neuroleptics (used in the treatment of schizophrenia).
Do not take Citalopram Hydrochloride if you take medicines for heart rhythm problems or medicines that may affect the heart's rhythm, e.g. such as Class IA and III antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.
Taking Citalopram Hydrochloride with food and drink
Citalopram Hydrochloride can be taken with or without food (see section 3 "How to take Citalopram Hydrochloride”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment although Citalopram Hydrochloride has not been shown to increase the effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant, think you might be pregnant, or are trying to become pregnant, tell your doctor. Do not take Citalopram Hydrochloride if you are pregnant unless you and your doctor have discussed the risks and benefits involved.
Make sure your midwife and/or doctor know you are on Citalopram Hydrochloride. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Citalopram Hydrochloride may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately. Also, if you take Citalopram Hydrochloride during the last 3 months of your pregnancy and until the date of birth you should be aware that the following effects may be seen in your newborn: fits, being too hot or cold, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping difficulties. If your newborn baby gets any of these symptoms please contact your midwife and/or doctor immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not breast-feed your baby when taking Citalopram Hydrochloride because small amounts of the medicine can pass into the breast milk.
Fertility
Citalopram Hydrochloride has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machines
Citalopram Hydrochloride does not usually affect the ability to carry out normal daily activities. However, if you feel dizzy or sleepy when you start to take this medicine, you should be careful when driving, operating machinery or performing jobs that need you to be alert until these effects wear off.
Important information about some of the ingredients of Citalopram Hydrochloride
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg in all doses. These drops also contain the preservatives E216 and E218, which may cause allergic reactions (possibly delayed).
[3 How to take Citalopram Hydrochloride
How much to take
It is important to take your drops as instructed by your doctor. The label will tell you how many to take and how often. If it does not, or you are not sure, ask your doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before increasing the dose to between 16 -24 mg (8 to 12 drops) per day. The dose may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose, e.g. 8-16 mg per day. Elderly patients should not usually receive more than 16 mg (8 drops) per day.
Children and adolescents (< 18 years)
Citalopram Hydrochloride should not be given to children or adolescents under 18 years of age. For further information, please see section 2, Before you take Citalopram Hydrochloride Drops.
Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops) per day.
If you have previously taken Citalopram Hydrochloride tablets, you will find that the dose of your medicine in mg given as drops is a bit lower than that of tablets. This is because your body more easily absorbs the drops than the tablets, so you do not need as many mg to have the same effect.
The doses of tablets correspond to doses of drops as follows:
Tablets Drops
10 mg 8 mg (4 drops)
20 mg 16 mg (8 drops)
30 mg 24 mg (12 drops)
40 mg 32 mg (16 drops)
Patient Information Leaflet (continued)
How and when to take Citalopram Hydrochloride
The drops are for oral use and can be taken in a drink of water, or orange or apple juice.
Citalopram Hydrochloride is taken every day as one dose at any time of the day.
Duration of treatment
Like other medicines for depression and panic disorder these drops may take a few weeks before you feel any improvement. Continue to take Citalopram Hydrochloride even if it takes some time before you feel any improvement in your condition.
The duration of treatment is individual, usually at least 6 months. Continue to take the drops for as long as your doctor recommends. Do not stop taking them even if you begin to feel better, unless you are told to do so by your doctor. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms may return.
Patients who have recurrent depression benefit from continued treatment, sometimes for several years, to prevent the occurrence of new depressive episodes.
Never change the dose of the medicine without talking to your doctor first.
If you take more Citalopram Hydrochloride than you should
If you think that you or anyone else may have taken too many Citalopram Hydrochloride
drops, contact your doctor or nearest hospital emergency department immediately. Do this even if there are no signs of discomfort or poisoning. Take the Citalopram Hydrochloride box/container with you if you go to a doctor or hospital.
Some of the signs of an overdosage could be life-threatening.
Symptoms of overdosage may include:
* Irregular heart beat
* Seizures
* Changes in heart rhythm
* Feeling sick (nausea)
* Vomiting
* Sweating
* Drowsiness
* Unconsciousness
* Fast heart beats
* Tremor
* Changes in blood pressure
* Serotonin syndrome (see Section 4)
* Agitation
* Dizziness
* Enlarged eye pupils
* Bluish skin
* Breathing too quickly
If you forget to take Citalopram Hydrochloride
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose.
Effects when treatment with Citalopram Hydrochloride is stopped
Stopping this medicine quickly may cause symptoms such as dizziness, nausea and numbness or tingling in hands or feet, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling or being sick, sweating, feeling restless or agitated, tremor, feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). These are usually non-serious and disappear within a few days. When you have completed your course of treatment, the dose of Citalopram Hydrochloride is usually reduced gradually over a couple of weeks.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
* Reduced emotions, indifference
* Hallucinations
* Mania
* Fainting
* Large pupils (the dark centre of the eye)
* Fast heart beat
* Slow heart beat
* Nettle rash
* Loss of hair
* Rash
* Sensitivity to sunlight
* Difficulties urinating
* Vaginal bleeding
* Swelling of the arms or legs
* Increased weight
Rare (likely to affect up to 1 in every 1000 people)
* Convulsions
* Involuntary movements
* Taste disturbances
* Bleeding
* Hepatitis
Some patient have reported (frequency not known)
* Thoughts of harming or killing themselves
* An increase in bleeding or bruising caused by a decrease in blood platelets
* Rash (hypersensitivity)
* Low potassium levels in the blood (hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythms
* Panic attack
* Grinding teeth
* Restlessness
* Unusual muscle movements or stiffness
* Involuntary movements of the muscles (akathisia)
* Low blood pressure
* Nosebleed
* Bleeding disorders including skin and mucosal bleeding (ecchymosis)
* Sudden swelling of skin or mucosa
* In men, painful erections
* Flow of breast milk in men or in women who are not breast-feeding (galactorrhoea)
* Abnormal liver function tests
* An increased risk of bone fractures has been observed in patients taking this type of medicines
SSRIs can, very rarely, increase the risk of bleeding, including stomach or intestinal bleeding. Let your doctor know if you vomit blood or develop black or blood stained stools.
Also let your doctor know if you continue to have other symptoms associated with your depression. This might include hallucinations, anxiety, mania or confusion.
Any side effects that do occur will usually disappear after a few days. If they are troublesome or persistent, or if you develop any other unusual side effects while taking Citalopram Hydrochloride, please tell your doctor.
If you notice any other side effects not mentioned in this leaflet please tell your doctor or pharmacist.
[4 Possible side effects
Like all medicines, Citalopram Hydrochloride can have side effects and some people may experience unwanted effects (side effects) whilst taking Citalopram Hydrochloride. Several of the effects listed below can also be symptoms of your illness and may disappear as you start to get better.
Serious side effects
Stop taking Citalopram Hydrochloride and seek medical advice immediately
if you have any
of the following symptoms:
* Difficulty in breathing.
* Swelling of the face, lips, tongue or throat that causes difficulty in swallowing or breathing.
* Severe itching of the skin (with raised lumps).
* Fast, irregular heartbeat, fainting which could be symptoms of a life-threatening condition known as torsades de pointes.
If you notice any of the following you should contact your doctor immediately as your dose may need to be reduced or stopped:
* You start having fits for the first time or fits that you have suffered from in the past before become more frequent.
* Your behaviour changes because you feel elated or over excited.
* You experience high fever, agitation, confusion, and trembling or abrupt contractions of muscles. These may be signs of a rare condition called serotonin syndrome.
* Tiredness, confusion and twitching of your muscles. These may be signs of a low blood level of sodium.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
The following side effects are often mild and usually disappear after a few days' treatment.
Very common side effects (likely to affect more than 1 in 10 people)
* Sleepiness
* Difficulty in sleeping
* Increased sweating
* Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to clean your teeth more often that usual)
* Feeling sick (nausea)
Common side effects (likely to affect up to 1 in 10 people)
* Lack of appetite
* Agitation
* Decreased sex drive
* Anxiety
* Nervousness
* Confusion
* Abnormal dreams
* Tremor
* Tingling or numbness in the hands or feet
* Ringing in the ears (tinnitus)
* Yawning
* Diarrhoea
* Vomiting
* Constipation
* Itching
* Pain in muscles and joints
* For men, problems with ejaculation and erection
* For females, failing to reach an orgasm
* Tiredness,
* Prickling of the skin
* Loss of weight
Uncommon (likely to affect up to 1 in every 100 people)
* Bruising easily
* Increased appetite
* Aggression
3 How to store Citalopram Hydrochloride
Do not use this medicine after the expiry date shown on the carton label. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment. Only keep this medicine if your doctor tells you to. If your medicine becomes discoloured or shows any signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Use within 16 weeks after first use.
^ Further information
What Citalopram Hydrochloride Drops contain
Each ml of solution contains 40mg of the active ingredient citalopram. Citalopram Hydrochloride also contains the following inactive ingredients; methyl-parahydroxybenzoate E218, propyl-parahydroxybenzoate E216, ethyl alcohol 9% v/v, hydroxyethylcellulose, purified water.
What Citalopram Hydrochloride Drops look like and contents of the pack
Citalopram Hydrochloride comes in a brown glass bottle containing 15ml clear drops solution with screw cap and polyethylene dropper.
Manufacturer and Licence Holder
Citalopram Hydrochloride is manufactured by H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby Denmark and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
POM PL Number: 15184/1112 Leaflet revision date: 23/10/12
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have further questions, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects are troubling, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Citalopram Hydrochloride Drops 40mg/ml, but will be referred to as Citalopram Hydrochloride throughout this leaflet.
In this leaflet:
^3 What Citalopram Hydrochloride is and what it is used for Before you take Citalopram Hydrochloride [3 How to take Citalopram Hydrochloride [3 Possible side effects r3 How to store Citalopram Hydrochloride [3 Further information
[3 What Citalopram Hydrochloride is and what it is used for
How does Citalopram Hydrochloride work?
Citalopram Hydrochloride is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to a group of medicines known as antidepressants.
These medicines help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness.
What is Citalopram Hydrochloride used for?
Citalopram Hydrochloride is used for the treatment of depression and, when you feel better, to help prevent these symptoms recurring. Citalopram Hydrochloride is also used for long-term treatment to prevent the occurrence of new episodes of depression or if you have recurrent depression.
Citalopram Hydrochloride is also beneficial in relieving symptoms if you tend to suffer from panic attacks.
[3 Before you take Citalopram Hydrochloride
Do not take Citalopram Hydrochloride
* If you are allergic (hypersensitive) to citalopram, or any of the other ingredients of Citalopram Hydrochloride (see What Citalopram Hydrochloride contain, section 6). Consult your doctor if you think you might be.
* If you are also taking a medicine containing pimozide. Talk to your doctor.
* At the same time as taking medication known as monoamine oxidase
inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide (used for the treatment of depression), selegiline (used in the treatment of Parkinson's disease) and linezolid (an antibiotic). Even if you have finished taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine you will need to wait 2 weeks before you start taking Citalopram Hydrochloride. One day must elapse after you have finished taking moclobemide. After stopping Citalopram Hydrochloride you must allow 1 week before taking any MaOI.
* if you are born with or have had an episode of abnormal heart rhythm (seen at ECG; an examination to evaluate how the heart is functioning).
* if you take medicines for heart rhythm problems or that may affect the heart's rhythm (see Taking other medicines, below).
Take special care with Citalopram Hydrochloride
Please tell your doctor if you have any medical problems, especially if you have:
* Liver disease
* Kidney disease
* Diabetes (you may need an adjustment of your antidiabetic therapy)
* Epilepsy or a history of seizures or fits
* A bleeding disorder or have ever suffered from bleeding in the stomach or intestine
* Mania or panic disorder
* Low blood levels of sodium
* ECT (electroconvulsive therapy)
* Problems with your eyes, such as certain kinds of glaucoma
* Suffered or suffer from heart problems or have recently had a heart attack.
* A low resting heart-rate and/or you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets).
* Experienced a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate.
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Some patients with manic-depressive illness may enter into a manic phase. This is characterized by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related diseases, the improvement is not achieved immediately. After the start of Citalopram Hydrochloride treatment it may take several weeks before you experience any improvement. In the beginning of the treatment certain patients may experience increased anxiety, which will disappear during continued treatment. Therefore, it is very important that you follow exactly your doctor's orders and do not stop the treatment or change the dose without consulting your doctor.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Use in children and adolescents under 18 years of age Citalopram Hydrochloride should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe citalopram for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Citalopram Hydrochloride for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Citalopram Hydrochloride. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Citalopram Hydrochloride in this age group have not yet been demonstrated.
Taking other medicines
Medicines may affect the action of other medicines and this can sometimes cause serious adverse reactions.
Please tell your doctor or pharmacist if you are taking or have taken any other medicines (including those purchased without prescription) during the last 14 days. This includes other medicines for depression (see Do not take Citalopram Hydrochloride above).
* The herbal remedy St John's wort (Hypericum perforatum). This should not be taken at the same time as Citalopram Hydrochloride.
* Monoamine oxidase inhibitors (MAOIs). These should not be taken at the same time as Citalopram Hydrochloride (see Do not take Citalopram Hydrochloride above).
Tell your doctor if you are taking any of the following medicines:
* Linezolid (an antibiotic).
* Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you
feel unwell when using these medicines with Citalopram Hydrochloride you should see your doctor.
* Lithium (used to prevent and treat mania) and tryptophan (an antidepressant)
* Pimozide (a neuroleptic). This should not be taken at the same time as Citalopram Hydrochloride (see Do not take Citalopram Hydrochloride
above).
* mipramine and desipramine (used to treat depression).
* Medicines containing selegiline (used to treat Parkinson's disease)
* Cimetidine (used to treat stomach ulcers).
* Mefloquine (used to treat malaria).
* Bupropion (used to treat depression).
* Medicines known to affect the blood platelets (e.g. anticoagulant drugs used to treat or prevent blood clots; aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used as painkillers and some antipsychotic drugs and tricyclic antidepressants).
* Metoprolol, a beta blocker used to treat migraine, some heart conditions and high blood pressure. The effects of either drug could be increased, decreased or altered.
* Neuroleptics (used in the treatment of schizophrenia).
Do not take Citalopram Hydrochloride if you take medicines for heart rhythm problems or medicines that may affect the heart's rhythm, e.g. such as Class IA and III antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.
Taking Citalopram Hydrochloride with food and drink
Citalopram Hydrochloride can be taken with or without food (see section 3 "How to take Citalopram Hydrochloride”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment although Citalopram Hydrochloride has not been shown to increase the effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant, think you might be pregnant, or are trying to become pregnant, tell your doctor. Do not take Citalopram Hydrochloride if you are pregnant unless you and your doctor have discussed the risks and benefits involved.
Make sure your midwife and/or doctor know you are on Citalopram Hydrochloride. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Citalopram Hydrochloride may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately. Also, if you take Citalopram Hydrochloride during the last 3 months of your pregnancy and until the date of birth you should be aware that the following effects may be seen in your newborn: fits, being too hot or cold, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping difficulties. If your newborn baby gets any of these symptoms please contact your midwife and/or doctor immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not breast-feed your baby when taking Citalopram Hydrochloride because small amounts of the medicine can pass into the breast milk.
Fertility
Citalopram Hydrochloride has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machines
Citalopram Hydrochloride does not usually affect the ability to carry out normal daily activities. However, if you feel dizzy or sleepy when you start to take this medicine, you should be careful when driving, operating machinery or performing jobs that need you to be alert until these effects wear off.
Important information about some of the ingredients of Citalopram Hydrochloride
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg in all doses. These drops also contain the preservatives E216 and E218, which may cause allergic reactions (possibly delayed).
[3 How to take Citalopram Hydrochloride
How much to take
It is important to take your drops as instructed by your doctor. The label will tell you how many to take and how often. If it does not, or you are not sure, ask your doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before increasing the dose to between 16 -24 mg (8 to 12 drops) per day. The dose may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose, e.g. 8-16 mg per day. Elderly patients should not usually receive more than 16 mg (8 drops) per day.
Children and adolescents (< 18 years)
Citalopram Hydrochloride should not be given to children or adolescents under 18 years of age. For further information, please see section 2, Before you take Citalopram Hydrochloride Drops.
Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops) per day.
If you have previously taken Citalopram Hydrochloride tablets, you will find that the dose of your medicine in mg given as drops is a bit lower than that of tablets. This is because your body more easily absorbs the drops than the tablets, so you do not need as many mg to have the same effect.
Patient Information Leaflet (continued)
The doses of tablets correspond to doses of drops as follows:
Tablets Drops
10 mg 8 mg (4 drops)
20 mg 16 mg (8 drops)
30 mg 24 mg (12 drops)
40 mg 32 mg (16 drops)
How and when to take Citalopram Hydrochloride
The drops are for oral use and can be taken in a drink of water, or orange or apple juice.
Citalopram Hydrochloride is taken every day as one dose at any time of the day.
Duration of treatment
Like other medicines for depression and panic disorder these drops may take a few weeks before you feel any improvement. Continue to take Citalopram Hydrochloride even if it takes some time before you feel any improvement in your condition.
The duration of treatment is individual, usually at least 6 months. Continue to take the drops for as long as your doctor recommends. Do not stop taking them even if you begin to feel better, unless you are told to do so by your doctor. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms may return.
Patients who have recurrent depression benefit from continued treatment, sometimes for several years, to prevent the occurrence of new depressive episodes.
Never change the dose of the medicine without talking to your doctor first.
If you take more Citalopram Hydrochloride than you should
If you think that you or anyone else may have taken too many Citalopram Hydrochloride
drops, contact your doctor or nearest hospital emergency department immediately. Do this even if there are no signs of discomfort or poisoning. Take the Citalopram Hydrochloride box/container with you if you go to a doctor or hospital.
Some of the signs of an overdosage could be life-threatening.
Symptoms of overdosage may include:
* Irregular heart beat
* Seizures
* Changes in heart rhythm
* Feeling sick (nausea)
* Vomiting
* Sweating
* Drowsiness
* Unconsciousness
* Fast heart beats
* Tremor
* Changes in blood pressure
* Serotonin syndrome (see Section 4)
* Agitation
* Dizziness
* Enlarged eye pupils
* Bluish skin
* Breathing too quickly
If you forget to take Citalopram Hydrochloride
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose.
Effects when treatment with Citalopram Hydrochloride is stopped
Stopping this medicine quickly may cause symptoms such as dizziness, nausea and numbness or tingling in hands or feet, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling or being sick, sweating, feeling restless or agitated, tremor, feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). These are usually non-serious and disappear within a few days. When you have completed your course of treatment, the dose of Citalopram Hydrochloride is usually reduced gradually over a couple of weeks.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Uncommon (likely to affect up to 1 in every 100 people)
* Bruising easily
* Increased appetite
* Aggression
* Reduced emotions, indifference
* Hallucinations
* Mania
* Fainting
* Large pupils (the dark centre of the eye)
* Fast heart beat
* Slow heart beat
* Nettle rash
* Loss of hair
* Rash
* Sensitivity to sunlight
* Difficulties urinating
* Vaginal bleeding
* Swelling of the arms or legs
* Increased weight
Rare (likely to affect up to 1 in every 1000 people)
* Convulsions
* Involuntary movements
* Taste disturbances
* Bleeding
* Hepatitis
Some patient have reported (frequency not known)
* Thoughts of harming or killing themselves
* An increase in bleeding or bruising caused by a decrease in blood platelets
* Rash (hypersensitivity)
* Low potassium levels in the blood (hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythms
* Panic attack
* Grinding teeth
* Restlessness
* Unusual muscle movements or stiffness
* Involuntary movements of the muscles (akathisia)
* Low blood pressure
* Nosebleed
* Bleeding disorders including skin and mucosal bleeding (ecchymosis)
* Sudden swelling of skin or mucosa
* In men, painful erections
* Flow of breast milk in men or in women who are not breast-feeding (galactorrhoea)
* Abnormal liver function tests
* An increased risk of bone fractures has been observed in patients taking this type of medicines
SSRIs can, very rarely, increase the risk of bleeding, including stomach or intestinal bleeding. Let your doctor know if you vomit blood or develop black or blood stained stools.
Also let your doctor know if you continue to have other symptoms associated with your depression. This might include hallucinations, anxiety, mania or confusion.
Any side effects that do occur will usually disappear after a few days. If they are troublesome or persistent, or if you develop any other unusual side effects while taking Citalopram Hydrochloride, please tell your doctor.
If you notice any other side effects not mentioned in this leaflet please tell your doctor or pharmacist.
[m How to store Citalopram Hydrochloride
Do not use this medicine after the expiry date shown on the carton label. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment. Only keep this medicine if your doctor tells you to. If your medicine becomes discoloured or shows any signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Use within 16 weeks after first use.
>4 Possible side effects
Like all medicines, Citalopram Hydrochloride can have side effects and some people may experience unwanted effects (side effects) whilst taking Citalopram Hydrochloride. Several of the effects listed below can also be symptoms of your illness and may disappear as you start to get better.
Serious side effects
Stop taking Citalopram Hydrochloride and seek medical advice immediately
if you have any
of the following symptoms:
* Difficulty in breathing.
* Swelling of the face, lips, tongue or throat that causes difficulty in swallowing or breathing.
* Severe itching of the skin (with raised lumps).
* Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as torsades de pointes.
If you notice any of the following you should contact your doctor immediately as your dose may need to be reduced or stopped:
* You start having fits for the first time or fits that you have suffered from in the past before become more frequent.
* Your behaviour changes because you feel elated or over excited.
* You experience high fever, agitation, confusion, and trembling or abrupt contractions of muscles. These may be signs of a rare condition called serotonin syndrome.
* Tiredness, confusion and twitching of your muscles. These may be signs of a low blood level of sodium.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
The following side effects are often mild and usually disappear after a few days' treatment.
Very common side effects (likely to affect more than 1 in 10 people)
* Sleepiness
* Difficulty in sleeping
* Increased sweating
* Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to clean your teeth more often that usual)
* Feeling sick (nausea)
Common side effects (likely to affect up to 1 in 10 people)
* Lack of appetite
* Agitation
* Decreased sex drive
* Anxiety
* Nervousness
* Confusion
* Abnormal dreams
* Tremor
* Tingling or numbness in the hands or feet
* Ringing in the ears (tinnitus)
* Yawning
* Diarrhoea
* Vomiting
* Constipation
* Itching
* Pain in muscles and joints
* For men, problems with ejaculation and erection
* For females, failing to reach an orgasm
* Tiredness,
* Prickling of the skin
* Loss of weight
Q Further information
What Citalopram Hydrochloride Drops contain
Each ml of solution contains 40mg of the active ingredient citalopram. Citalopram Hydrochloride also contains the following inactive ingredients; methyl-parahydroxybenzoate E218, propyl-parahydroxybenzoate E216, ethyl alcohol 9% v/v, hydroxyethylcellulose, purified water.
What Citalopram Hydrochloride Drops look like and contents of the pack
Citalopram Hydrochloride comes in a brown glass bottle containing 15ml clear drops solution with screw cap and polyethylene dropper.
Manufacturer and Licence Holder
Citalopram Hydrochloride is manufactured by Montefarmaco SPA, Via G. Galilei-7, 20016 Pero (MI) Italyand is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
POM PL Number: 15184/1112 Leaflet revision date: 23/10/12
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have further questions, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects are troubling, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Seropram Drops 40mg/ml, but will be referred to as Seropram throughout this leaflet.
In this leaflet:
^3 What Seropram is and what it is used for Before you take Seropram [3 How to take Seropram [3 Possible side effects r3 How to store Seropram [3 Further information
^ What Seropram is and what it is used for
How does Seropram work?
Seropram is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to a group of medicines known as antidepressants.
These medicines help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness.
What is Seropram used for?
Seropram is used for the treatment of depression and, when you feel better, to help prevent these symptoms recurring. Seropram is also used for long-term treatment to prevent the occurrence of new episodes of depression or if you have recurrent depression.
Seropram is also beneficial in relieving symptoms if you tend to suffer from panic attacks.
Before you take Seropram
Do not take Seropram
* If you are allergic (hypersensitive) to citalopram, or any of the other ingredients of Seropram (see What Seropram contain, section 6).
Consult your doctor if you think you might be.
* If you are also taking a medicine containing pimozide. Talk to your doctor.
* At the same time as taking medication known as monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide (used for the treatment of depression), selegiline (used in the treatment of Parkinson's disease) and linezolid (an antibiotic). Even if you have finished taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine you will need to wait 2 weeks before you start taking Seropram. One day must elapse after you have finished taking moclobemide. After stopping Seropram you must allow 1 week before taking any MAOI.
* if you are born with or have had an episode of abnormal heart rhythm (seen at ECG; an examination to evaluate how the heart is functioning).
* if you take medicines for heart rhythm problems or that may affect the heart's rhythm (see Taking other medicines, below).
Take special care with Seropram
Please tell your doctor if you have any medical problems, especially if you have:
* Liver disease
* Kidney disease
* Diabetes (you may need an adjustment of your antidiabetic therapy)
* Epilepsy or a history of seizures or fits
* A bleeding disorder or have ever suffered from bleeding in the stomach or intestine
* Mania or panic disorder
* Low blood levels of sodium
* ECT (electroconvulsive therapy)
* Problems with your eyes, such as certain kinds of glaucoma
* Suffered or suffer from heart problems or have recently had a heart attack.
* A low resting heart-rate and/or you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets).
* Experienced a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate.
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Some patients with manic-depressive illness may enter into a manic phase. This is characterized by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related diseases, the improvement is not achieved immediately. After the start of Seropram treatment it may take several weeks before you experience any improvement. In the beginning of the treatment certain patients may experience increased anxiety, which will disappear during continued treatment. Therefore, it is very important that you follow exactly your doctor's orders and do not stop the treatment or change the dose without consulting your doctor.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Use in children and adolescents under 18 years of age Seropram should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe citalopram for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Seropram for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Seropram. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Seropram in this age group have not yet been demonstrated.
Taking other medicines
Medicines may affect the action of other medicines and this can sometimes cause serious adverse reactions.
Please tell your doctor or pharmacist if you are taking or have taken any other medicines (including those purchased without prescription) during the last 14 days. This includes other medicines for depression (see Do not take Seropram above).
* The herbal remedy St John's wort (Hypericum perforatum). This should not be taken at the same time as Seropram.
* Monoamine oxidase inhibitors (MAOIs). These should not be taken at the same time as Seropram (see Do not take Seropram above).
Tell your doctor if you are taking any of the following medicines:
* Linezolid (an antibiotic).
* Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you feel unwell when using these medicines with Seropram you should see your doctor.
* Lithium (used to prevent and treat mania) and tryptophan (an antidepressant)
* Pimozide (a neuroleptic). This should not be taken at the same time as Seropram (see Do not take Seropram above).
* Imipramine and desipramine (used to treat depression).
* Medicines containing selegiline (used to treat Parkinson's disease)
* Cimetidine (used to treat stomach ulcers).
* Mefloquine (used to treat malaria).
* Bupropion (used to treat depression).
* Medicines known to affect the blood platelets (e.g. anticoagulant drugs used to treat or prevent blood clots; aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used as painkillers and some antipsychotic drugs and tricyclic antidepressants).
* Metoprolol, a beta blocker used to treat migraine, some heart conditions and high blood pressure. The effects of either drug could be increased, decreased or altered.
* Neuroleptics (used in the treatment of schizophrenia).
Do not take Seropram if you take medicines for heart rhythm problems or medicines that may affect the heart's rhythm, e.g. such as Class IA and III antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.
Taking Seropram with food and drink
Seropram can be taken with or without food (see section 3 "How to take Seropram”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment although Seropram has not been shown to increase the effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant, think you might be pregnant, or are trying to become pregnant, tell your doctor. Do not take Seropram if you are pregnant unless you and your doctor have discussed the risks and benefits involved.
Make sure your midwife and/or doctor know you are on Seropram. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Seropram may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately. Also, if you take Seropram during the last 3 months of your pregnancy and until the date of birth you should be aware that the following effects may be seen in your newborn: fits, being too hot or cold, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping difficulties. If your newborn baby gets any of these symptoms please contact your midwife and/or doctor immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not breast-feed your baby when taking Seropram because small amounts of the medicine can pass into the breast milk.
Fertility
Seropram has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machines
Seropram does not usually affect the ability to carry out normal daily activities. However, if you feel dizzy or sleepy when you start to take this medicine, you should be careful when driving, operating machinery or performing jobs that need you to be alert until these effects wear off.
Important information about some of the ingredients of Seropram
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg in all doses. These drops also contain the preservatives E216 and E218, which may cause allergic reactions (possibly delayed).
[3 How to take Seropram
How much to take
It is important to take your drops as instructed by your doctor. The label will tell you how many to take and how often. If it does not, or you are not sure, ask your doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before increasing the dose to between 16 -24 mg (8 to 12 drops) per day. The dose may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose, e.g. 8-16 mg per day. Elderly patients should not usually receive more than 16 mg (8 drops) per day.
Children and adolescents (< 18 years)
Seropram should not be given to children or adolescents under 18 years of age. For further information, please see section 2, Before you take Seropram.
Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops) per day.
If you have previously taken Seropram tablets, you will find that the dose of your medicine in mg given as drops is a bit lower than that of tablets. This is because your body more easily absorbs the drops than the tablets, so you do not need as many mg to have the same effect.
The doses of tablets correspond to doses of drops as follows:
Tablets Drops
10 mg 8 mg (4 drops)
20 mg 16 mg (8 drops)
30 mg 24 mg (12 drops)
40 mg 32 mg (16 drops)
Patient Information Leaflet (continued)
How and when to take Seropram
The drops are for oral use and can be taken in a drink of water, or orange or apple juice.
Seropram is taken every day as one dose at any time of the day.
Duration of treatment
Like other medicines for depression and panic disorder these drops may take a few weeks before you feel any improvement. Continue to take Seropram even if it takes some time before you feel any improvement in your condition.
The duration of treatment is individual, usually at least 6 months. Continue to take the drops for as long as your doctor recommends. Do not stop taking them even if you begin to feel better, unless you are told to do so by your doctor. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms may return.
Patients who have recurrent depression benefit from continued treatment, sometimes for several years, to prevent the occurrence of new depressive episodes.
Never change the dose of the medicine without talking to your doctor first.
If you take more Seropram than you should
If you think that you or anyone else may have taken too many Seropram drops, contact your doctor or nearest hospital emergency department immediately. Do this even if there are no signs of discomfort or poisoning. Take the Seropram box/container with you if you go to a doctor or hospital. Some of the signs of an overdosage could be life-threatening.
Symptoms of overdosage may include:
* Irregular heart beat
* Seizures
* Changes in heart rhythm
* Feeling sick (nausea)
* Vomiting
* Sweating
* Drowsiness
* Unconsciousness
* Fast heart beats
* Tremor
* Changes in blood pressure
* Serotonin syndrome (see Section 4)
* Agitation
* Dizziness
* Enlarged eye pupils
* Bluish skin
* Breathing too quickly
If you forget to take Seropram
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose.
Effects when treatment with Seropram is stopped
Stopping this medicine quickly may cause symptoms such as dizziness, nausea and numbness or tingling in hands or feet, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling or being sick, sweating, feeling restless or agitated, tremor, feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). These are usually non-serious and disappear within a few days. When you have completed your course of treatment, the dose of Seropram is usually reduced gradually over a couple of weeks.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
* Fast heart beat
* Slow heart beat
* Nettle rash
* Loss of hair
* Rash
* Sensitivity to sunlight
* Difficulties urinating
* Vaginal bleeding
* Swelling of the arms or legs
* Increased weight
Rare (likely to affect up to 1 in every 1000 people)
* Convulsions
* Involuntary movements
* Taste disturbances
* Bleeding
* Hepatitis
Some patient have reported (frequency not known)
* Thoughts of harming or killing themselves
* An increase in bleeding or bruising caused by a decrease in blood platelets
* Rash (hypersensitivity)
* Low potassium levels in the blood (hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythms
* Panic attack
* Grinding teeth
* Restlessness
* Unusual muscle movements or stiffness
* Involuntary movements of the muscles (akathisia)
* Low blood pressure
* Nosebleed
* Bleeding disorders including skin and mucosal bleeding (ecchymosis)
* Sudden swelling of skin or mucosa
* In men, painful erections
* Flow of breast milk in men or in women who are not breast-feeding (galactorrhoea)
* Abnormal liver function tests
* An increased risk of bone fractures has been observed in patients taking this type of medicines
SSRIs can, very rarely, increase the risk of bleeding, including stomach or intestinal bleeding. Let your doctor know if you vomit blood or develop black or blood stained stools.
Also let your doctor know if you continue to have other symptoms associated with your depression. This might include hallucinations, anxiety, mania or confusion.
Any side effects that do occur will usually disappear after a few days. If they are troublesome or persistent, or if you develop any other unusual side effects while taking Seropram, please tell your doctor.
If you notice any other side effects not mentioned in this leaflet please tell your doctor or pharmacist.
3 Possible side effects
Like all medicines, Seropram can have side effects and some people may experience unwanted effects (side effects) whilst taking Seropram. Several of the effects listed below can also be symptoms of your illness and may disappear as you start to get better.
Serious side effects
Stop taking Seropram and seek medical advice immediately if you have any of the following symptoms:
* Difficulty in breathing.
* Swelling of the face, lips, tongue or throat that causes difficulty in swallowing or breathing.
* Severe itching of the skin (with raised lumps).
* Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as torsades de pointes.
If you notice any of the following you should contact your doctor immediately as your dose may need to be reduced or stopped:
* You start having fits for the first time or fits that you have suffered from in the past before become more frequent.
* Your behaviour changes because you feel elated or over excited.
* You experience high fever, agitation, confusion, and trembling or abrupt contractions of muscles. These may be signs of a rare condition called serotonin syndrome.
* Tiredness, confusion and twitching of your muscles. These may be signs of a low blood level of sodium.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
The following side effects are often mild and usually disappear after a few days' treatment.
Very common side effects (likely to affect more than 1 in 10 people)
* Sleepiness
* Difficulty in sleeping
* Increased sweating
* Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to clean your teeth more often that usual)
* Feeling sick (nausea)
Common side effects (likely to affect up to 1 in 10 people)
* Lack of appetite
* Agitation
* Decreased sex drive
* Anxiety
* Nervousness
* Confusion
* Abnormal dreams
* Tremor
* Tingling or numbness in the hands or feet
* Ringing in the ears (tinnitus)
* Yawning
* Diarrhoea
* Vomiting
* Constipation
* Itching
* Pain in muscles and joints
* For men, problems with ejaculation and erection
* For females, failing to reach an orgasm
* Tiredness,
* Prickling of the skin
* Loss of weight
Uncommon (likely to affect up to 1 in every 100 people)
* Bruising easily
* Increased appetite
* Aggression
* Reduced emotions, indifference
* Hallucinations
* Mania
* Fainting
* Large pupils (the dark centre of the eye)
3 How to store Seropram
Do not use this medicine after the expiry date shown on the carton label. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment. Only keep this medicine if your doctor tells you to. If your medicine becomes discoloured or shows any signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Use within 16 weeks after first use.
3 Further information
What Seropram Drops contain
Each ml of solution contains 40mg of the active ingredient citalopram. Seropram also contains the following inactive ingredients; methyl-parahydroxybenzoate E218, propyl-parahydroxybenzoate E216, ethyl alcohol 9% v/v, hydroxyethylcellulose, purified water.
What Seropram Drops look like and contents of the pack
Seropram comes in a brown glass bottle containing 15ml clear drops solution with screw cap and polyethylene dropper.
Manufacturer and Licence Holder
Seropram is manufactured by H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby Denmark and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.
| POM PL Number: 15184/1112 Seropram is a registered trademark of H.Lundbeck A/S.
Leaflet revision date: 23/10/12
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have further questions, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects are troubling, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Seropram Drops 40mg/ml, but will be referred to as Seropram throughout this leaflet.
In this leaflet:
^3 What Seropram is and what it is used for
^3 Before you take Seropram
[3 How to take Seropram
[3 Possible side effects
r3 How to store Seropram
[3 Further information
^ What Seropram is and what it is used for
How does Seropram work?
Seropram is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to a group of medicines known as antidepressants.
These medicines help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness.
What is Seropram used for?
Seropram is used for the treatment of depression and, when you feel better, to help prevent these symptoms recurring. Seropram is also used for long-term treatment to prevent the occurrence of new episodes of depression or if you have recurrent depression.
Seropram is also beneficial in relieving symptoms if you tend to suffer from panic attacks.
Before you take Seropram
Do not take Seropram
* If you are allergic (hypersensitive) to citalopram, or any of the other ingredients of Seropram (see What Seropram contain, section 6).
Consult your doctor if you think you might be.
* If you are also taking a medicine containing pimozide. Talk to your doctor.
* At the same time as taking medication known as monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide (used for the treatment of depression), selegiline (used in the treatment of Parkinson's disease) and linezolid (an antibiotic). Even if you have finished taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine you will need to wait 2 weeks before you start taking Seropram. One day must elapse after you have finished taking moclobemide. After stopping Seropram you must allow 1 week before taking any MAOI.
* if you are born with or have had an episode of abnormal heart rhythm (seen at ECG; an examination to evaluate how the heart is functioning).
* if you take medicines for heart rhythm problems or that may affect the heart's rhythm (see Taking other medicines, below).
Take special care with Seropram
Please tell your doctor if you have any medical problems, especially if you have:
* Liver disease
* Kidney disease
* Diabetes (you may need an adjustment of your antidiabetic therapy)
* Epilepsy or a history of seizures or fits
* A bleeding disorder or have ever suffered from bleeding in the stomach or intestine
* Mania or panic disorder
* Low blood levels of sodium
* ECT (electroconvulsive therapy)
* Problems with your eyes, such as certain kinds of glaucoma
* Suffered or suffer from heart problems or have recently had a heart attack.
* A low resting heart-rate and/or you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets).
* Experienced a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate.
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Some patients with manic-depressive illness may enter into a manic phase. This is characterized by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related diseases, the improvement is not achieved immediately. After the start of Seropram treatment it may take several weeks before you experience any improvement. In the beginning of the treatment certain patients may experience increased anxiety, which will disappear during continued treatment. Therefore, it is very important that you follow exactly your doctor's orders and do not stop the treatment or change the dose without consulting your doctor.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
* If you have previously had thoughts about killing or harming yourself.
* If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Use in children and adolescents under 18 years of age Seropram should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe citalopram for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Seropram for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Seropram. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Seropram in this age group have not yet been demonstrated.
Taking other medicines
Medicines may affect the action of other medicines and this can sometimes cause serious adverse reactions.
Please tell your doctor to pharmacist if you are taking or have taken any other medicines (including those purchased without prescription) during the last 14 days. This includes other medicines for depression (see Do not take Seropram above).
* The herbal remedy St John's wort (Hypericum perforatum). This should not be taken at the same time as Seropram.
* Monoamine oxidase inhibitors (MAOIs). These should not be taken at the same time as Seropram (see Do not take Seropram above).
Tell your doctor if you are taking any of the following medicines:
* Linezolid (an antibiotic).
* Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you feel unwell when using these medicines with Seropram you should see your doctor.
* Lithium (used to prevent and treat mania) and tryptophan (an antidepressant)
* Pimozide (a neuroleptic). This should not be taken at the same time as Seropram (see Do not take Seropram above).
* Imipramine and desipramine (used to treat depression).
* Medicines containing selegiline (used to treat Parkinson's disease)
* Cimetidine (used to treat stomach ulcers).
* Mefloquine (used to treat malaria).
* Bupropion (used to treat depression).
* Medicines known to affect the blood platelets (e.g. anticoagulant drugs used to treat or prevent blood clots; aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used as painkillers and some antipsychotic drugs and tricyclic antidepressants).
* Metoprolol, a beta blocker used to treat migraine, some heart conditions and high blood pressure. The effects of either drug could be increased, decreased or altered.
* Neuroleptics (used in the treatment of schizophrenia).
Do not take Seropram if you take medicines for heart rhythm problems or medicines that may affect the heart's rhythm, e.g. such as Class IA and III antiarrhythmics, antipsychotics (e.g. fentiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.
Taking Seropram with food and drink
Seropram can be taken with or without food (see section 3 "How to take Seropram”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment although Seropram has not been shown to increase the effects of alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant, think you might be pregnant, or are trying to become pregnant, tell your doctor. Do not take Seropram if you are pregnant unless you and your doctor have discussed the risks and benefits involved.
Make sure your midwife and/or doctor know you are on Seropram. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Seropram may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately. Also, if you take Seropram during the last 3 months of your pregnancy and until the date of birth you should be aware that the following effects may be seen in your newborn: fits, being too hot or cold, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping difficulties. If your newborn baby gets any of these symptoms please contact your midwife and/or doctor immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not breast-feed your baby when taking Seropram because small amounts of the medicine can pass into the breast milk.
Fertility
Seropram has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machines
Seropram does not usually affect the ability to carry out normal daily activities. However, if you feel dizzy or sleepy when you start to take this medicine, you should be careful when driving, operating machinery or performing jobs that need you to be alert until these effects wear off.
Important information about some of the ingredients of Seropram
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg in all doses. These drops also contain the preservatives E216 and E218, which may cause allergic reactions (possibly delayed).
[3 How to take Seropram
How much to take
It is important to take your drops as instructed by your doctor. The label will tell you how many to take and how often. If it does not, or you are not sure, ask your doctor or pharmacist.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before increasing the dose to between 16 -24 mg (8 to 12 drops) per day. The dose may be increased by your doctor to a maximum of 32 mg (16 drops) per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose, e.g. 8-16 mg per day. Elderly patients should not usually receive more than 16 mg (8 drops) per day.
Children and adolescents (< 18 years)
Seropram should not normally by used by children or adolescents under 18 years of age. For further information, please see section 2, Before you take Seropram.
Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops) per day.
If you have previously taken Seropram tablets, you will find that the dose of your medicine in mg given as drops is a bit lower than that of tablets. This is because your body more easily absorbs the drops than the tablets, so you do not need as many mg to have the same effect.
The doses of tablets correspond to doses of drops as follows:
Tablets Drops
10 mg 8 mg (4 drops)
20 mg 16 mg (8 drops)
30 mg 24 mg (12 drops)
40 mg 32 mg (16 drops)
Patient Information Leaflet (continued)
How and when to take Seropram
The drops are for oral use and can be taken in a drink of water, or orange or apple juice.
Seropram is taken every day as one dose at any time of the day.
Duration of treatment
Like other medicines for depression and panic disorder these drops may take a few weeks before you feel any improvement. Continue to take Seropram even if it takes some time before you feel any improvement in your condition.
The duration of treatment is individual, usually at least 6 months. Continue to take the drops for as long as your doctor recommends. Do not stop taking them even if you begin to feel better, unless you are told to do so by your doctor. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms may return.
Patients who have recurrent depression benefit from continued treatment, sometimes for several years, to prevent the occurrence of new depressive episodes.
Never change the dose of the medicine without talking to your doctor first.
If you take more Seropram than you should
If you think that you or anyone else may have taken too many Seropram drops, contact your doctor or nearest hospital emergency department immediately. Do this even if there are no signs of discomfort or poisoning. Take the Seropram box/container with you if you go to a doctor or hospital. Some of the signs of an overdosage could be life-threatening.
Symptoms of overdosage may include:
* Irregular heart beat
* Seizures
* Changes in heart rhythm
* Feeling sick (nausea)
* Vomiting
* Sweating
* Drowsiness
* Unconsciousness
* Fast heart beats
* Tremor
* Changes in blood pressure
* Serotonin syndrome (see Section 4)
* Agitation
* Dizziness
* Enlarged eye pupils
* Bluish skin
* Breathing too quickly
If you forget to take Seropram
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose.
Effects when treatment with Seropram is stopped
Stopping this medicine quickly may cause symptoms such as dizziness, nausea and numbness or tingling in hands or feet, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling or being sick, sweating, feeling restless or agitated, tremor, feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). These are usually non-serious and disappear within a few days. When you have completed your course of treatment, the dose of Seropram is usually reduced gradually over a couple of weeks.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
* Fast heart beat
* Slow heart beat
* Nettle rash
* Loss of hair
* Rash
* Sensitivity to sunlight
* Difficulties urinating
* Vaginal bleeding
* Swelling of the arms or legs
* Increased weight
Rare (likely to affect up to 1 in every 1000 people)
* Convulsions
* Involuntary movements
* Taste disturbances
* Bleeding
* Hepatitis
Some patient have reported (frequency not known)
* Thoughts of harming or killing themselves
* An increase in bleeding or bruising caused by a decrease in blood platelets
* Rash (hypersensitivity)
* Low potassium levels in the blood (hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythms
* Panic attack
* Grinding teeth
* Restlessness
* Unusual muscle movements or stiffness
* Involuntary movements of the muscles (akathisia)
* Low blood pressure
* Nosebleed
* Bleeding disorders including skin and mucosal bleeding (ecchymosis)
* Sudden swelling of skin or mucosa
* In men, painful erections
* Flow of breast milk in men or in women who are not breast-feeding (galactorrhoea)
* Abnormal liver function tests
* An increased risk of bone fractures has been observed in patients taking this type of medicines
SSRIs can, very rarely, increase the risk of bleeding, including stomach or intestinal bleeding. Let your doctor know if you vomit blood or develop black or blood stained stools.
Also let your doctor know if you continue to have other symptoms associated with your depression. This might include hallucinations, anxiety, mania or confusion.
Any side effects that do occur will usually disappear after a few days. If they are troublesome or persistent, or if you develop any other unusual side effects while taking Seropram, please tell your doctor.
If you notice any other side effects not mentioned in this leaflet please tell your doctor or pharmacist.
>4 Possible side effects
Like all medicines, Seropram can have side effects and some people may experience unwanted effects (side effects) whilst taking Seropram. Several of the effects listed below can also be symptoms of your illness and may disappear as you start to get better.
Serious side effects
Stop taking Seropram and seek medical advice immediately if you have any of the following symptoms:
* Difficulty in breathing.
* Swelling of the face, lips, tongue or throat that causes difficulty in swallowing or breathing.
* Severe itching of the skin (with raised lumps).
* Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as torsades de pointes.
If you notice any of the following you should contact your doctor immediately as your dose may need to be reduced or stopped:
* You start having fits for the first time or fits that you have suffered from in the past before become more frequent.
* Your behaviour changes because you feel elated or over excited.
* You experience high fever, agitation, confusion, and trembling or abrupt contractions of muscles. These may be signs of a rare condition called serotonin syndrome.
* Tiredness, confusion and twitching of your muscles. These may be signs of a low blood level of sodium.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
The following side effects are often mild and usually disappear after a few days' treatment.
Very common side effects (likely to affect more than 1 in 10 people)
* Sleepiness
* Difficulty in sleeping
* Increased sweating
* Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to clean your teeth more often that usual)
* Feeling sick (nausea)
Common side effects (likely to affect up to 1 in 10 people)
* Lack of appetite
* Agitation
* Decreased sex drive
* Anxiety
* Nervousness
* Confusion
* Abnormal dreams
* Tremor
* Tingling or numbness in the hands or feet
* Ringing in the ears (tinnitus)
* Yawning
* Diarrhoea
* Vomiting
* Constipation
* Itching
* Pain in muscles and joints
* For men, problems with ejaculation and erection
* For females, failing to reach an orgasm
* Tiredness,
* Prickling of the skin
* Loss of weight
Uncommon (likely to affect up to 1 in every 100 people)
* Bruising easily
* Increased appetite
* Aggression
* Reduced emotions, indifference
* Hallucinations
* Mania
* Fainting
* Large pupils (the dark centre of the eye)
[4 How to store Seropram
Do not use this medicine after the expiry date shown on the carton label. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment. Only keep this medicine if your doctor tells you to. If your medicine becomes discoloured or shows any signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Use within 16 weeks after first use.
[4 Further information
What Seropram Drops contain
Each ml of solution contains 40mg of the active ingredient citalopram. Seropram also contains the following inactive ingredients; methyl-parahydroxybenzoate E218, propyl-parahydroxybenzoate E216, ethyl alcohol 9% v/v, hydroxyethylcellulose, purified water.
What Seropram Drops look like and contents of the pack
Seropram comes in a brown glass bottle containing 15ml clear drops solution with screw cap and polyethylene dropper.
Manufacturer and Licence Holder
Seropram is manufactured by Montefarmaco SPA, Via G. Galilei-7, 20016 Pero (MI) Italy and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
I POM PL Number: 15184/1112 Seropram is a registered trademark of H.Lundbeck A/S.
Leaflet revision date: 23/10/12