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FRONT

CITALOPRAM 10 mg, 20 mg AND 40 mg FILM-COATED TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

1.    What Citalopram is and what it is used for

2.    Before you take Citalopram

3.    How to take Citalopram

4.    Possible side effects

5.    How to store Citalopram

6.    Further Information

OWHAT CITALOPRAM IS AND WHAT IT IS USED FOR

•    Citalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

•    Citalopram is used for the treatment of depression (major depressive episodes).

BEFORE YOU TAKE CITALOPRAM

Do NOT take Citalopram:

•    If you are allergic (hypersensitive) to citalopram or any of the other ingredients of Citalopram (listed in section 6 Further Information)

•    If you are taking, or have taken in the last 2 weeks an antidepressant medicine of the type called monoamine oxidase inhibitors (MAOIs) e.g. selegiline or moclobemide

•    If you are treated with linezolid (an antibiotic medicine) unless you are under close observation and monitoring of blood pressure

•    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.

Take special care with Citalopram

•    Use in children and adolescents under 18 years of age

Citalopram should not normally 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 the doctor may prescribe Citalopram for patients under 18 because he/she decides that this is in their best interest. 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.

•    Thoughts of suicide and worsening of your depression

If you are depressed 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 and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

•    During the first few weeks of treatment symptoms such as restlessness, and an inability to sit or stand still may develop in patients taking anti-depressants. In patients who develop these symptoms, increasing the dose could be harmful.

•    Citalopram should be discontinued in any patients who develop fits (epilepsy) or if their frequency of fits increase. Citalopram should be avoided in patients with unstable (uncontrolled) epilepsy. Patients with controlled epilepsy should be carefully monitored.

•    Citalopram should not be used at the same time as medicines which have a serotenergic effect including pain killers and medicines used to treat migraines (see 'Taking other medicines").

•    Citalopram should be used with caution in patients with low sodium levels.

Tell your doctor or pharmacist before you start to take this medicine if you:

•    Suffer from diabetes, treatment with Citalopram may alter control of your sugar levels

•    Suffer from epilepsy or seizures, as seizures are a potential risk with antidepressant drugs

•    Receive electro-convulsive therapy

•    Have a history of mania/hypomania, citalopram should be used with caution and should be discontinued when you enter a manic phase

•    Have kidney or liver problems. Citalopram is not recommended for use in patients with severe kidney problems

•    Have a bleeding disorder, Citalopram may cause bleeding

•    Are using medicinal products that effect the clotting of blood (see section 'Taking other medicines')

•    Have a stomach ulcer or have had any bleeding in the stomach or intestine in the past

•    Suffer from low blood potassium or magnesium levels

•    Suffer from psychosis with depressive episodes

•    Experience '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

•    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.

You should not discontinue treatment with Citalopram abruptly due to the withdrawal effects (see Section 3).

Taking other medicines DO NOT TAKE Citalopram

heart rhythm problems or medicines that may affect the heart's rhythm, e.g. 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-malarian treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.

Talk to your doctor or pharmacist if you are taking, or

have previously taken any of the following:

•    Monoamine oxidase inhibitors (MAOIs), e.g. phenelzine, isocarboxazid or tranylcypromine. Do not take Citalopram for 14 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 7 days after discontinuation of treatment with Citalopram. Do not use Citalopram if you are taking more than 10 mg/day of the MAO selegiline

•    Other medicinal products with serotonergic effects such as sumatriptan, other triptans or tryptophan (see 'Take special care with Citalopram')

•    An anticoagulant (to prevent blood clotting), e.g. warfarin, aspirin (acetylsalicylic acid), dipyridamole or ticlopidine

•    Medicines that lower the seizure threshold i.e. neuroleptics, mefloquin or bupropion

•    Herbal preparations containing St John's wort (Hypericum perforatum)

•    Pain-relief and inflammation medicines called non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, ketoprofen or diclofenac

•    Medicines used to treat pain, such as tramadol (see 'Take special care with Citalopram')

•    Medicines used to treat depression, e.g. fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine

•    Medicines used to treat migraine, e.g. sumatriptan and other triptans (see 'Take special care with Citalopram')

•    Medicines used to treat heart failure, e.g. metoprolol

•    Medicines for psychiatric illness, e.g. lithium, risperidone or chlorpromazine

•    Medicines for stomach ulcers, e.g. omeprazole, esomeprazole, lansoprazole or cimetidine

•    Medicines that decrease blood levels of potassium or magnesium as these conditions increase the risk of life-threatening heart rhythm disorder (QT prolongation, Torsades de Pointes)

•    Linezolid (an antibiotic medicine)

•    Pimozide (an antipsychotic medicine). Citalopram must not be taken together with pimozide due to the influence of this combination to the heart function.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Citalopram with food and drink

You are advised not to drink alcohol whilst taking Citalopram. Citalopram can be taken with or without food.

Pregnancy

There is only limited experience concerning the use of Citalopram during pregnancy. Do not take Citalopram if you are pregnant or planning to become pregnant, unless your doctor considers it absolutely necessary.

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.

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 blue-ish skin or being too hot or cold, being sick, crying a lot, stiff or floppy muscles, lethargy, tremors, jitters or fits. If your baby has any

of these symptoms when it is born, contact your doctor who will be able to advise you.

Ask your doctor or pharmacist for advice before taking any medicine.

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.

Ask your doctor or pharmacist for advice before taking any medicine.

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 anything.

Important information about some of the ingredients of Citalopram

This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

a HOW TO TAKE CITALOPRAM

Always take Citalopram exactly as your doctor has told you. You should 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 with a drink of water or other fluid. Citalopram does not work immediately. An antidepressant effect should not be expected for at least 2 weeks. Treatment should continue until you are free of symptoms for 4-6 months. 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 even if you begin to feel better, unless you are told to do so by the doctor. Never change the dose of your medicine without talking to your doctor first.

The usual dose is:

Adults

The usual 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.

Children and adolescents under the age of 18

Citalopram should not be used in the treatment of children and adolescents under 18 years of age (see 'Take special care with Citalopram').

Liver problems

Patients with mild to moderate liver problems should receive a starting dose of 10 mg per day. Patients with liver complaints should not receive more than 20 mg per day. Such patients should be clinically monitored. Caution and extra careful dosing is advised in patients with severe liver problems.

Kidney problems

In patients with mild to moderate kidney problems no dosage adjustment is required. The use of Citalopram in patients with severe kidney problem is not recommended as no information is available in these patients.

Withdrawal symptoms seen on discontinuation

Abrupt discontinuation should be avoided. When stopping treatment with Citalopram the dose should be gradually reduced over a 1-2 week period in order to reduce the risk of withdrawal reactions (see section 'If you stop taking Citalopram' and 'Possible side effects'). If intolerable symptoms occur following a decrease in the dose upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, your doctor may continue decreasing the dose, but at a more gradual rate.

If you take more Citalopram than you should If you have taken more Citalopram than you should, talk to a doctor or pharmacist immediately.

Symptoms of an overdose include: sleepiness, a condition of near unconsciousness with apparent mental inactivity, reduced ability to respond to stimulation or coma, seizures, ECG changes (e.g prolonged QT interval), irregular heart beat, feeling sick, vomiting, discolouration of the skin, sweating, hyperventilation. Features of serotonin syndrome may occur (see 'Possible side effects'), particularly when other substances are co-ingested.

If you forget to take Citalopram

If you miss a dose, do not take a double dose to make up for a forgotten dose.

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, electric shock sensations, numbness, sleeplessness, intense dreams, agitation, anxiety, feeling sick or being sick, shaking, confusion, sweating, headache, diarrhoea, faster heartbeat (palpitations), emotional instability, irritability and visual disturbances. Most of the withdrawal reactions are mild and self-limiting in nature but may be severe in some patients.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Citalopram can cause side effects, although not everybody gets them. A few people may develop a severe allergic reaction. This is a very rare but serious side effect. If you experience any of the following symptoms stop taking citalopram and tell your doctor immediately or go to your nearest casualty department:

•    Swelling of the lips, face and neck (allergic reaction) leading to severe difficulty in swallowing or breathing

•    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 allergy to certain substances (anaphylactic reactions)

•    Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as Torsades de Pointes.

Serotonin syndrome has been reported in patients treated with this type of antidepressant (SSRI). 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.

Cases of thoughts/behaviours of harming or killing yourself have been reported during Citalopram therapy or early after treatment has been stopped (see section 2, Take special care with Citalopram).

An increased risk of bone fractures has been observed in patients taking this type of medicines. The following side effects have been reported at the approximate frequencies shown:

Very common: affects more than 1 user in 10

•    sleepiness, difficulty sleeping, agitation, nervousness

•    headache, tremor, dizziness

•    Visual focusing problems, blurred vision

•    irregular heartbeat

•    feeling sick, dry mouth, constipation, diarrhoea

•    increased sweating

•    feeling of weakness (lethargy).

Common: affects 1 to 10 users in 100

•    reduction in weight, gain in weight

•    sleeping disorders, problems with concentration, abnormal dreaming (unusual and intense dreams), memory loss, anxiety, decreased sex drive, increased appetite, loss of appetite, absence of emotion or enthusiasm, confusion

•    migraine, pins and needles or numbness

•    abnormalities of vision, decreased eyesight

•    fast heart rate

•    dizziness when suddenly standing up, low blood pressure, high blood pressure

•    runny and itchy nose, inflammation of the sinuses (pain and pressure in your face, which is worse when you lean forwards, blocked nose, sore throat and cough, headache, fever, earache, toothache or pain in your upper jaw)

•    indigestion/heart burn, being sick, stomach pain, wind, increased saliva

•    problems passing urine, excessive production of urine

•    inability to achieve orgasm in women, menstrual pain, impotence (inability to get or maintain an erection), ejaculation failure

•    rash, itching

•    fatigue, yawning, taste abnormalities.

Uncommon: affects 1 to 10 users in 1,000

•    a state of optimism, cheerfulness and well-being (euphoria), increased sex drive

•    fits, impairment of voluntary movement, i.e. tremor, tics, changes in muscle tone, slowness of movement, involuntary and/or irregular muscle movements that occur in the facial area

•    ringing in the ears

•    slowing of the heart beat

•    coughing

•    liver problems, which can be detected by blood tests

•    sensitivity to light

•    muscle pain

•    allergic reactions, fainting, general feeling of being unwell.

Rare: affects 1 to 10 users in 10,000

•    bleeding, e.g. from the vagina, stomach, skin and mucous membranes (the lubricated inner lining of the mouth, nasal passages, vagina and urethra)

•    restlessness of the arms and legs (akathisia)

•    lower amount of blood sodium, predominantly in the elderly (which causes hallucinations, confusion, fits, lack of energy and muscle cramps or weakness).

Very Rare: affects less than 1 user in 10,000

•    hallucinations, mood disorders, loss of contact with your own personal reality, accompanied by feelings of unreality and strangeness, panic attacks

•    abnormality of the rhythm or rate of the heart beat

•    abnormal milk secretion from the breast

•    itching, swelling of the lips, face and neck (allergic reaction) leading to severe difficulty in swallowing or breathing

•    joint pain

•    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 allergy to certain substances (anaphylactic reactions)

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, electric shock sensations, numbness, sleepiness, intense dreams, agitation, anxiety, feeling sick or being sick, shaking, confusion, sweating, headache, diarrhoea, faster heartbeat (palpitations), emotional instability, irritability and visual disturbances. Most of the withdrawal reactions are mild and self limiting in nature.

Any side effects that do occur will usually disappear after a few days. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

^ HOW TO STORE CITALOPRAM

Keep Citalopram out of the reach and sight of children.

Do not use Citalopram after the expiry date shown on the outer packaging. Do not store above 25°C. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

FURTHER INFORMATION

What Citalopram contains:

•    The active ingredient is citalopram hydrobromide

•    Citalopram 10 mg Film-Coated Tablets: Each film-coated tablet contains 12.49 mg citalopram hydrobromide equivalent to 10 mg citalopram

•    Citalopram 20 mg Film-Coated Tablets: Each film-coated tablet contains 24.98 mg citalopram hydrobromide equivalent to 20 mg citalopram

•    Citalopram 40 mg Film-Coated Tablets: Each film-coated tablet contains 49.96 mg citalopram hydrobromide equivalent to 40 mg citalopram

•    The other ingredients are:

•    Core: copovidone, croscarmellose sodium (E466), glycerol (E422), lactose monohydrate, magnesium stearate (E470b), maize starch, microcrystalline cellulose (E460i)

•    Coating: hypromellose (E464), microcrystalline cellulose (E460i), macrogol stearate 40 (E431) and titanium dioxide (E171).

What Citalopram looks like and contents of the pack:

•    Citalopram 10 mg Film-Coated Tablets are round, white tablets with a diameter of 6 mm.

•    Citalopram 20 mg Film-Coated Tablets are oval, white tablets with a break-line on one side and diameter of 8 mm.

•    Citalopram 40 mg Film-Coated Tablets are oval, white tablets with a break-line on one side and diameter of 11 mm.

•    The products are available in pack sizes of 10, 14, 20, 28, 30, 50, 56, 98 and 100 tablets per box, 50x1 unit dose blister.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder is TEVA UK Limited, Eastbourne, BN22 9AG and the company responsible for manufacture is TEVA Pharmaceutical Works Company Limited, Hungary.

This leaflet was last revised: May 2012

PL 00289/0927-9

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