Citalopram 10 Mg Film-Coated Tablets
Package leaflet: Information for the user
Citalopram 10 mg film-coated tablets Citalopram 20 mg film-coated tablets Citalopram 40 mg film-coated tablets
Citalopram
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- 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.
What is in this leaflet:
1. What Citalopram is and what it is used for
2. What you need to know before you take Citalopram
3. How to take Citalopram
4. Possible side effects
5. How to store Citalopram tablets
6. Contents of the pack and other information
1. What Citalopram is and what it is used for
Citalopram belongs to a group of antidepressants called selective serotonin re-uptake inhibitors (SSRIs).
Citalopram is used:
- to treat depression
- to treat panic disorder.
- to treat obsessive-compulsive disorder (OCD)
2. What you need to know before you take Citalopram
Do not take Citalopram
- If you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
- If you are also taking a medicine containing pimozide.
- At the same time as taking medication known as monoamine oxidase inhibitors (also called MAOIs, for example selegiline, linezolid or moclobemide) or have taken them at any time within the last two weeks. After stopping Citalopram you must allow 1 week before taking any MAOI.
- If you are also taking a medicine containing linezolid.
- 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. Also refer to the section “Taking other medicines” below.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Citalopram.
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.
- If you suffer from a subjective sensation of inner restlessness that manifests itself with an inability to sit still or remain motionless. Do not increase dosage and contact your doctor.
- If you suffer from diabetes, treatment with Citalopram may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
- If you suffer from epilepsy, seizures are a potential risk with antidepressant drugs. Citalopram should be discontinued if there is an increase in seizure frequency.
- If you receive electro-convulsive therapy, because there is little experience caution is advisable.
- If you have a history of mania/hypomania, Citalopram should be used with caution and should be discontinued when you enter a manic phase.
- If you have a bleeding disorder, Citalopram may cause bleeding (e.g. skin and mucous bleeding). If you are using medicinal products that effect the coagulation of blood (see 'Taking other medicines').
- If you have a stomach ulcer, gynaecological bleeding or have had any bleeding in the stomach or intestine in the past.
- If you experience a so-called serotonin syndrome. A combination of symptoms, such as agitation, tremor, muscle contractions and hyperthermia may indicate the development of this condition. Treatment with Citalopram should be discontinued immediately.
- If you are psychotic with depressive episodes.
- If you have kidney or liver problems.
- If you have a decreased level of sodium in the blood (hyponatremia). Citalopram should be used with caution in patients susceptible to this condition, such as the elderly and those already taking a medicine which could lower the blood level of sodium.
- If treatment is stopped, since withdrawal reactions might occur (see “If you stop taking Citalopram”). Withdrawal reactions include: dizziness, pins and needles or numbness, headache, nausea and anxiety. Most of the withdrawal reactions are mild and self-limiting in nature. If treatment is being stopped, it is advised that the dose is gradually reduced over 1-2 week periods.
- If you suffer or have suffered from heart problems or have recently had a heart attack.
- If you 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).
- If you 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.
Children and adolescents:
Citalopram 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 attempts, 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 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. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Citalopram in this age group have not yet been demonstrated.
Other medicines and Citalopram
Tell you doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Citalopram 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. phenothiazine derivatives , pimozide, haloperidol), tricyclic antidepressants , certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarian treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor. Some medicines may influence the effect of Citalopram, and Citalopram may influence the effects of other medicines. Such medicines include:
- for antidepressant of the type called monoamine oxidase inhibitors (MAOI's), such as linezolid, phenelzine, isocarboxazid and tranylcypromine. Do not take Citalopram for fourteen days after discontinuation
of treatment with a so called irreversible MAOI. Do not take Citalopram for the time specified after discontinuation of treatment with a reversible MAOI (e.g. moclobemide), as stated in the patient information leaflet of the reversible MAOI. Do not take MAOIs for seven days after discontinuation of treatment with Citalopram. Do not use Citalopram if you are taking more than 10 mg/day of the MAO selegiline
- for depression, e.g, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, tricyclic antidepressants like nortriptyline, and the herbal remedy St. John's Wort (Hypericum perforatum)
- for migraine, e.g. sumatriptan and other triptans
- for pain, tramadol
- for pain and inflammation, non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen, ketoprofen and
diclofenac
- to prevent blood clotting, e.g. warfarin, acetylsalicylic acid, dipyridamol, ticlopidine
- for irregular heartbeat, e.g. propafenone, flecainide
- for heart failure, metoprolol
- for stomach ulcer, omeprazole, lansoprazole, ticlopidine cimetidine
- for psychiatric illness, e.g. lithium, risperidone, clomipramine, pimozide
- Other medicinal products with serotonergic effects such as antidepressants oxitriptan or tryptophan.
Please tell your doctor of pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal or alternative therapies.
Citalopram with food, drink and alcohol
Citalopram can be taken with or without food.
As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment although Citalopram 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 or think you might be pregnant, tell your doctor. Do not take Citalopram if you are pregnant unless you and your doctor have discussed the risks and benefits involved.
You should not discontinue treatment with Citalopram abruptly. If you are taking Citalopram in the last 3 months of pregnancy, let your doctor know as your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They include not being able to sleep or feed properly, trouble with breathing, a bluish skin or being too hot or cold, being sick, crying a lot, stiff or floppy muscles, lethargy, tremors, jitters or fits, sleepiness. If your baby has any of these symptoms when it is born, contact your doctor who will be able to advise you.
Make sure your midwife and/or doctor know you are on Citalopram. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Citalopram 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.
Breast-feeding
Citalopram passes into breast milk in small amounts. There is a risk of an effect on the baby. If you are taking Citalopram, talk to your doctor before you start breast-feeding.
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 may affect your ability to drive a car or use machines. Do not drive or use machines until you know how citalopram affects you. Please ask your doctor or pharmacist if you are unsure about this issue.
Citalopram contains lactose
Citalopram tablets contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Citalopram
Always take this medicine exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist if you are not sure.
Citalopram should be taken as a single dose, either in the morning or the evening. The tablets can be taken with or without food. The tablets should be swallowed whole together with water or other fluids. Citalopram does not work immediately. Usually, the effect will be perceptible after 3 to 4 weeks.
The duration of treatment is individual, usually it is for at least 4 to 6 months after you feel well again. Citalopram should be withdrawn slowly. It is advised that the dose is gradually reduced over a 1-2 week period. Do not stop taking Citalopram unless your doctor has told you to do so, even if you begin to feel better. Your doctor will tell you how long the treatment with Citalopram will last.
Never change the dose of your medicine without talking to your doctor first.
Use in children and adolescents under 18 years of age:
Citalopram should not be used in the treatment of children and adolescents under the age of 18 years (see “Take special care with Citalopram”).
The recommended dose is:
Adults:
Depression
The usual 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. The dose may be increased by your doctor to a maximum of 40 mg per day.
Obsessive-compulsive disorder (OCD)
The starting dose is 20 mg per day. This may be increased by your doctor to a maximum of 40 mg per day.
Elderly patients (> 65 years of age):
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.
Reduced liver function:
Patients with a mildly to moderately reduced liver function should receive a starting dose of 10 mg per day. Patients with liver complaints should not receive more than 20 mg per day.
Caution and extra careful dosing is advised in patients with a severely reduced liver function.
Patients with a reduced liver function should be clinically monitored.
Reduced kidney function:
The doctor may decide to prescribe a dose lower than that described above.
20 mg & 40 mg: The tablet can be divided into equal doses.
Withdrawal symptoms seen on discontinuation:
Abrupt discontinuation should be avoided. When stopping treatment with Citalopram the dose should be gradually reduced over one to two week periods in order to reduce the risk of withdrawal reactions (see sections: “If you stop taking Citalopram”).
If you have the impression that the effect of Citalopram is too strong or too weak, talk to your doctor or pharmacist.
If you take more Citalopram than you should
If you have taken more Citalopram than you should, talk to a doctor or pharmacist immediately.
If you forget to take Citalopram
Do not take a double dose to make up for a forgotten tablet. Take your next dose as usual.
If you stop taking Citalopram
Do not stop taking Citalopram unless you are told to do so by your doctor.
Since withdrawal reactions may occur when the treatment is stopped, it is advised to reduce the dose gradually at intervals of 1-2 weeks.
Withdrawal reactions include: dizziness, pins and needles or numbness, sleep disturbances (including insomnia and intense dreams), feeling or being sick, agitation or anxiety, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances. Most of the withdrawal reactions are mild and self-limiting in nature. If treatment is being stopped, it is advised that the dose is gradually reduced over 1-2 week periods.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any of the following symptoms you should stop taking Citalopram and see your doctor immediately.
- Serotonin syndrome has been reported in patients treated with these types of antidepressants (SSRIs). Tell your doctor if you experience high fever, trembling, muscle twitches and anxiety, because these symptoms may indicate the development of this condition. Treatment with Citalopram should be discontinued immediately.
- Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as Torsades de Pointes.
- You should see your doctor immediately if you experience symptoms of anaphylaxis (severe allergy) such as swollen face, tongue and/or pharynx and/or difficulty to swallow together with difficulties to breathe (angioedema).
These are very serious side effects. If you have them, you may have had a serious allergic reaction to Citalopram. You may need urgent medical attention or hospitalisation.
All of these very serious side effects are very rare.
The following side effects have been reported at the approximate frequencies shown:
Very common (affecting more than one person in 10)
Common (affecting fewer than one person in ten but more than one person in 100)
Uncommon (affecting fewer than one person in 100 but more than one person in 1,000)
Rare (affecting fewer than one person in 1,000 but more than one person in 10,000)
Not known (cannot be estimated from the available data)
Very common (affecting more than one person in 10):
- sleepiness
- difficulty sleeping
- feeling sick
- dry mouth
- increased sweating.
- headache
Common (affecting more than 1 person in 100 but less than 1 in 10):
- agitation
- nervousness
- tremor
- problems with concentration
- abnormal dreaming
- anxiety
- decreased sex drive
- reduction in weight
- loss of appetite
- confusion
- pins and needles
- dizziness
- vomiting
- diarrhoea
- constipation
- inability of women to achieve orgasm
- impotence
- problems ejaculating, ejaculation failure
- itching
- yawning
- ringing in the ears
- muscle pain
- joint pain
- feeling of weakness (lethargy).
Uncommon (affecting more than 1 person in 1,000 but less than 1 in 100):
- gain in weight
- increased appetite
- aggression
- loss of contact with your own personal reality, accompanied by feelings of unreality and strangeness
- hallucinations
- a state of optimism, cheerfulness and well-being (euphoria)
- fainting
- large pupils
- slowing of the heart beat
- fast heart rate
- hives
- hair loss
- rash
- bleeding (e.g. vaginal, skin and mucous bleeding)
- light sensitivity of the skin
- swelling of the skin or of the tissue lining internal cavities of the body (mucous membrane).
Rare (affecting more than 1 person in 10,000 but less than 1 in 1,000):
- convulsions
- impairment of voluntary movement i.e. tremors, tics
- taste abnormalities
- liver problems
- fever
- lower amount of blood sodium
- problems passing urine.
Not known (cannot be estimated from the available data):
- thoughts of suicide or suicidal behaviour during therapy or early after treatment is stopped (see section 2 under Take Special Care with Citalopram)
- shock (strong decrease of blood pressure, paleness, agitation, weak and fast pulse, clammy skin, decreased consciousness) caused by a sudden strong vascular dilatation as a result of severe hypersensitivity to certain substances (anaphylactic reactions)
- syndrome of inappropriate anti-diuretic hormone secretion (SIADH, symptoms are confusion, hallucinations, drowsiness, fits, coma and breathing difficulties).
- lower amount of blood potassium
- panic attacks
- grinding or clenching of the teeth
- restlessness
- movement disorders
- abnormal vision
- abnormality of the rhythm of the heart beat
- dizziness when suddenly standing up
- nosebleeds
- bruising
- gastrointestinal bleeding
- painful persistent erections
- abnormal milk secretion from the breast in males.
An increased risk of bone fractures has been observed in patients taking this type of medicines.
Any side effects that do occur will usually disappear after a few days.
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.
Do not use this medicine after the expiry date which is stated on the carton and container label and blister foil after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 to protect the environment.
6. Contents of the pack and other information What Citalopram tablets contains
- The active substance is citalopram hydrobromide. Each tablet contains 10mg, 20mg or 40mg of citalopram as citalopram hydrobromide.
- The other ingredients are
Tablet core: lactose monohydrate, maize starch, copovidone, croscarmellose sodium, cellulose microcrystalline, magnesium stearate,
- Tablet film-coat: Opadry White 03B58902 [hypromellose, macrogol 400 and titanium dioxide (E171)].
What Citalopram tablets looks like and contents of the pack
10 mg: White, biconvex, round shaped film-coated tablets debossed with 'A' on one side and '05' on the other side.
20 mg: White, biconvex, capsule shaped, film-coated tablets debossed with 'A' on one side and with a score line in between '0' and '6' on the other side.
The tablet can be divided into equal doses.
40 mg: White, biconvex, capsule shaped, film-coated tablets debossed with 'A' on one side and with a score line in between '0' and '7' on the other side.
The tablet can be divided into equal doses.
Pack sizes:
Blister pack: 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 112 or 120 tablets.
HDPE container pack:
10 mg & 20 mg tablets: 30, 100 and hospital packs of 200, 250, 500 and 1000 tablets.
40 mg tablets: 30, 100 and hospital packs of 200, 250, 500 tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Amneal Pharma Europe Limited 70 Sir John Rogerson's Quay,
Dublin 2,
Ireland
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000 Malta
This leaflet was last revised in: 08/2014
amneal*
PHARMACEUTICALS