Citalopram 40mg Tablets
1. What Citalopram Tablet is and what it is used for
Package leaflet: Information for the patient
CITALOPRAM
10 mg, 20 mg & 40 mg TABLETS
(citalopram hydrobromide)
Read all of this leaflet carefully before you start using this medicine because it contains important information for you
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Important things that you need to know about Citalopram:
• Citalopram treats depression and anxiety disorders in adults (over 18 years). Like all medicines it can have unwanted effects. It is important that you and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting treatment.
• Tell a close friend or relative that you are taking Citalopram and ask them to read this leaflet. Ask them to tell you if they are worried that you are behaving differently whilst you are taking Citalopram. It is important that you receive the right treatment and you should see your doctor again if you feel any worse.
• Citalopram will not work straight away. You may feel worse at first and it could be at least two weeks before you start to feel any better. You should be seeing your doctor reguarly and it may take several weeks to find the best dose for you.
• Some people who are depressed or anxious think of harming or killing themselves. If you start to feel worse or have thoughts of harming or killing yourself at any time, see your doctor or go to a hospital straight
away (see section 2).
• You should not change your dose or stop taking Citalopram unless your doctor tells you to. If you stop
taking Citalopram suddenly or miss a dose, you may get withdrawal effects (see section 3).
• If you are pregnant or planning to get pregnant, talk to your doctor. See section 2: Pregnancy, Breast-feeding and Fertility, inside this leaflet.
• Seek medical help at once if you have 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) or fast, irregular heart beat and fainting which could be symptoms of a life-threatening heart condition (see section 4).
• If you feel restless and feel like you cannot sit or stand still, tell your doctor. Increasing the dose of Citalopram may make these feelings worse
(see section 4).
Now read the rest of this leaflet. If you have more questions, ask your doctor or pharmacist (chemist). You may also find it helpful to contact a self-help group, or patient organisation, to find out more about your condition. Your doctor will be able to give you details.
What is in this leaflet:
1. What Citalopram Tablet is and what it is used for
2. What you need to know before you take Citalopram Tablets
3. How to take Citalopram Tablets
4. Possible side effects
5. How to store Citalopram Tablets
6. Contents of the pack and other information
Citalopram Tablets contains the active substance citalopram. Citalopram is one of a group of medicines called selective serotonin reuptake inhibitors (SSRIs). These work by bringing the level of serotonin in the brain back up to normal. Low levels of serotonin are thought to be a cause of depression and related disorders.
Citalopram is used to treat symptoms of:
• Depression (feelings of sadness, tearfulness, inability to sleep or enjoy life as you once used to) including the accompanying symptoms of anxiety;
• Panic attacks - citalopram can help relieve symptoms in people who are prone to panic attacks.
2. What you need to know before you take Citalopram Tablets
Do not take Citalopram Tablets :
• if you are allergic to citalopram or any of the other ingredients in the tablets (listed in section 6).
• if you are taking a monoamine oxidase inhibitor drug (MAOI) for depression or reversible monoamine oxidase inhibitors type A (MAOIs), since serious or even fatal reactions can occur. Examples of MAOIs include selegiline, moclobemide and linezolid. Treatment with citalopram should only be started 2 weeks after discontinuation of an irreversible MAOI.
After stopping citalopram 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 Other medicines and Citalopram Tablets).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Citalopram Tablets if you.
• are receiving ECT (electroconvulsive therapy)
• have epilepsy or fits (seizures).
• have mania now or in the past;
• suffer from diabetes, as your insulin/medication may need adjusting
• have liver or kidney problems
• have a bleeding disorder or have suffered from bleeding in the stomach or intestine
• suffer with problems with your eyes, such as certain kinds of glaucoma
• have low levels of sodium in the blood
• start to experience fever, muscle stiffness or tremor;
changes in your mental state, like confusion, irritability and extreme agitation as you may be suffering from 'serotonin syndrome' or 'neuroleptic malignant syndrome'.
• suffer or have suffered from heart problems or have recently had a heart attack.
• have 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).
• experience 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.
Please note:
Some patients with manic-depressive illness may enter into a manic phase. This is characterised by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this consult 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 this medicine
As with other medicines used to treat depression or related diseases, an improvement is not achieved immediately. After the start of treatment with Citalopram Tablets, it may take several weeks before you experience any improvement. At 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 your doctor's orders exactly and do not stop the treatment or change the dose without consulting your doctor.
Im po rta nt i nfo rmatio n a bout Citalopram Tablets and 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.
Children and adolescents
Citalopram Tablets should normally not be used for children and adolescents under 18 years. 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 Tablets 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 Tablets. Also, the longterm safety effects of this medicine concerning growth, maturation and cognitive and behavioural development of this age group, have not yet been demonstrated.
Other medicines and Citalopram Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking Citalopram Tablets at the same time as some other medications may affect the way in which they work, or enhance their side effects, and vice versa (i. e. interactions may occur)
• the herbal remedy St John's wort (Hypericum perforatum). This should not be taken at the same time as Citalopram Tablets.
• monoamine oxidase inhibitors (MAOIs). These should not be taken at the same time as Citalopram Tablets (see Do not take Citalopram Tablets).
• linezolid (an antibiotic).
• sumatriptan (used to treat migraine) or tramadol (a pain killer). If you feel unwell when using these medicines with Citalopram Tablets you should see your doctor
• lithium or tryptophan for the treatment of depression, anxiety and other mental disorders
• pimozide (a neuroleptic). This should not be taken at the same time as Citalopram Tablets
• 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.
• cimetidine used to treat heartburn and stomach
• imipramine and desipramine (used to treat depression).
• medicines containing selegiline (used to treat Parkinson's disease)
• mefloquine (used to treat malaria).
• bupropion (used to treat depression).
• neuroleptics (used in the treatment of schizophrenia). DO NOT TAKE Citalopram Tablets 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 anti-arrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxa-cin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (astem-izole, mizolastine). If you have any further questions about this you should speak to your doctor.
Citalopram Tablets with food and alcohol
Citalopram Tablets can be taken with or without food. Drinking alcohol while being treated with citalopram is not recommended.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Make sure your midwife and/or doctor know you are on Citalopram Tablets. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Citalopram Tablets 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 Tablets 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
You should not breast-feed your baby when taking Citalopram Tablets because small amounts of the medicine can pass into the breast milk.
Fertility
Citalopram 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 Tablets do not usually affect the ability to carry out normal daily activities. However, if you feel dizzy or
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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.
3. How to take Citalopram Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How and when to take Citalopram tablets:
Citalopram Tablets should be taken every day as a single dose. They should be swallowed whole with a drink of water, preferably at the same time each day. Do not crush or chew your tablets.
How much to take:
Your doctor will decide on the right starting dose for you and on any increase in the dose depending on your condition and whether you are taking any other medicines.
The label on the carton will tell you how many tablets you should take and when.
Adults:
Depression
The recommended dose is 20 mg per day. This may be increased by your doctor to a maximum of 40 mg per day. Panic disorder
The starting dose is 10 mg per day for the first week before increasing the dose to 20-30 mg per day. This dose may be increased by your doctor to a maximum of 40 mg per day.
Elderly
The starting dose should be decreased to half of the recommended dose, e.g. 10-20 mg per day.
Elderly patients should not usually receive more than 20 mg per day.
Use in children and adolescents
Citalopram Tablets are not recommended for children or adolescents. For further information, please see section 2. Patients with special risks
Patients with liver complaints should not receive more than 20 mg per day
Duration of treatment
Like other medicines for depression and panic disorder these tablets may take a few weeks before you feel any improvement. Continue to take Citalopram Tablets 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 tablets 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 Tablets than you should:
If you have accidentally taken more than your prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist immediately. Do this even if there are no signs of discomfort or poisoning. Remember to take the pack and any remaining Citalopram Tablets with you.
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 Tablets:
It is important that you take your medicine every day. If you forget to take your medicine, just take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Citalopram Tablets:
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 Tablets is usually reduced gradually over a couple of weeks. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If you get any of the following symptoms after taking these tablets, you should stop taking the tablets and contact your doctor immediately:
• Any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat
• Rash or itching (especially affecting your whole body)
• Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as Torsades de Pointes.
• You have thoughts of harming or killing yourself at any time, contact your doctor or go to the hospital
straight away
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 (convulsions) for the first time or fits that you suffered from in the past have become more
frequent
• your behaviour changes because you feel elated or over excited
• a combination of symptoms (known as 'serotonin syndrome') including unexplained fever with faster breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or sleepiness (only rarely);
Common: may affect up to 1 in 10 people
• decrease in appetite; decrease in weight
• agitation; anxiety; nervousness; confusional state; abnormal dreams
• reduced emotions, indifference (apathy)
• decrease in sex drive; impotence; ejaculation disorder; ejaculation failure; abnormal orgasm (female)
• tremor; dizziness; tingling or numbness (paraesthesia)
• migraine
• loss of memory (amnesia)
• feeling your heartbeat (palpitations)
• swelling and irritation inside the nose (rhinitis)
• ringing in the ears
• yawning; fatigue
• attention disturbance
• diarrhoea; vomiting; constipation
• indigestion
• stomach pain
• flatulence (wind)
• increase in saliva
• itching
• muscle pain (myalgia); joint pain (athralgia) Uncommon: may affect up to 1 in 100 people
• red blotches or discolouration of the skin (purpura); hives (urticaria); rash; skin sensitivity to light
• hair loss increased appetite
• aggression; vague or dreamlike state (depersonalisation); hallucination; mania
• increase in sex drive
• fainting
• unusually large pupils (the dark centre of the eye)
• slow heart beat; rapid heartbeat
• difficulty in passing urine
• excessive menstrual bleeding
• fluid retention in the body causing swelling
• increase in weight
Rare: may affect up to 1 in 1,000 people
• low blood sodium (hyponatremia)
• tonic-clonic seizures
• Involuntary movements
• coughing
• taste disturbances
• bleeding
• fever
• inflammation of the liver (hepatitis)
• feeling unwell (malaise)
Not known: frequency cannot be estimated from the available data
• QT interval prolongation on electrocardiogram.
• reduction in blood platelets which increases the risk of bleeding or bruising
• low levels of blood potassium which can cause muscle weakness, twitching or abnormal heart rhythm
• hypersensitivity reactions; allergic reactions
• panic attack; grinding of the teeth; restlessness; convulsions;
• unusual muscle movements or stiffness
• Involuntary movements of the muscles (akathisia)
• disturbed vision
• irregular heartbeat; hypotension (feeling faint or light-headed on standing)
• nosebleeds;
• bleeding disorders including skin and mucosal bleeding (ecchymosis)
• abnormal liver test
• prolonged or painful erection; production of milk unassociated with childbirth
• an increased risk of bone fractures has been observed in patients taking this type of medicine
• Irregular menstrual bleeding (metrorrhagia)
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 Tablets, please tell your doctor.
Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Citalopram Tablets
Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Citalopram Tablets contain:
The active substance is citalopram.
- Each 10 mg film-coated tablet contains citalopram 10 mg (as hydrobromide).
- Each 20 mg film-coated tablet contains citalopram 20 mg (as hydrobromide).
- Each 40 mg film-coated tablet contains citalopram 40 mg (as hydrobromide)
The other ingredients are mannitol, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, macrogol, hypromellose and titanium dioxide (E171)
What Citalopram Tablets look like and contents of the pack:
Citalopram 10 mg Tablets are white, round, film coated without a score line.
Citalopram 20 mg and 40 mg Tablets are white, round, film coated with a score line on one side.
Citalopram Tablets are available in blister packs of 28 and 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.
Manufacturer:
Cipla (EU) Limited, 20 Balderton Street, London W1K 6TL, United Kingdom.
Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium
This leaflet was last revised in 01/2016
Other side effects
The following side effects are often mild and usually disappear after a few days' treatment.
Very common: may affect more than 1 in 10 people
• sleepiness; difficulty in sleeping
• changes in your sleeping pattern
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• dry mouth
• headache
• nausea
• increased sweating
• loss of body strength, weakness