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PATIENT INFORMATION LEAFLET

CITALOPRAM 10mg, 20mg AND 40mg TABLETS

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 further questions, ask your doctor or your 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

6.    Contents of the pack and other information

1    . WHAT CITALOPRAM IS AND WHAT IT IS USED FOR

How does Citalopram work?

Citalopram is a SSRI (Selective Serotonin Reuptake Inhibitor) and belongs to a group of medicines called antidepressants. These medicines help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness. Depression is linked to a shortage of substances which carry messages in the brain (including serotonin and noradrenaline). Citalopram helps to relieve the shortage of these ‘brain messages’. Common signs of depression include feelings of worthlessness or deep sadness; difficulty with everyday tasks; sleeping too much or not being able to sleep; feeling anxious; and changes in appetite.

What is Citalopram used for?

Citalopram tablets are used to treat the symptoms of depression and, when you are feeling better, to help prevent these symptoms recurring. Citalopram tablets are also beneficial in relieving symptoms in patients prone to panic attacks. Treatment for depression is usually continued for at least six months and for panic disorder for at least three months.

It may take a while before you start to feel better. In general, improvement in patients starts after one week, but may only become evident from the second week of therapy. It is important to take citalopram every day and not to stop taking it unless your doctor tells you to. If you do, your symptoms may come back.

2    . WHAT YOU NEED TO KNOW BEFORE YOU TAKE

CITALOPRAM

Important information about some of the ingredients of citalopram:

Citalopram tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Do not take citalopram:

•    If you are allergic (hypersensitive) to citalopram or any of the other ingredients of this medicine (see Section 6).

•    If you are also taking a medicine containing pimozide. Talk to your doctor.

•    If you are also taking medications known as monoamine oxidase inhibitors (MAOI’s). 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 your Citalopram tablets. One day must elapse after you have finished taking moclobemide. After stopping citalopram you must allow 1 week before taking any MAOI.

•    For information on medicines that should not be taken with citalopram, see section on Taking other medicines’.

•    If you were 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 or pharmacist before taking Citalopram

Take special care with citalopram:

If you have or have had:

•    Liver disease

•    Kidney disease

•    Low blood levels of sodium

•    ECT (electroconvulsive therapy)

•    Suffered or suffer from heart problems or have recently had a heart attack

•    A low resting heart-rate

•    Mania or panic disorder

•    Salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tab lets)

•    A fast or irregular heartbeat, fainting, collapse or dizzinesson standing up which may indicate abnormal functioning of the heart rate

•    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

Problem with your eyes, such as certain kinds of glaucoma 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, contact your doctor.

Symptoms of restlessness or difficulty sitting orstanding can also occur during the first few weeks of treatment. Tell your doctor immediately if you experience these symptoms.

Alcohol

As with all antidepressants, it is advisable to avoid drinking any alcohol.

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, defiant behaviour and anger) when they take this class ofmedicines.

Despite this, your doctor may prescribe this medicine forpatients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed this medicine 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 this medicine. The long-term safety effects concerning growth, maturation and cognitive and behavioural development of this medicine in this age group have not yet been demonstrated.

Pregnancy, breast-feeding and fertility

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

Do not take this medicine if you are pregnant unless you have discussed the risks and benefits involved. If you take this group of medicines (antidepressants) during the last few months of your pregnancy and until the date of birth, you should be aware that the following effects have been seen in newborns: 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.

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 new born (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 breastfeed your baby while taking Citalopram as small amounts of the medicine can pass into the breast milk.

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 yet.

Driving and using machines

Most people do not find their ability to carry out normal daily activities affected. However, make sure your abilities are not affected before you drive or operate machinery.

Other medicines and Citalopram

Tell your doctor or pharmacist if you are taking, have recently taken or might take any othermedbines.

DO NOT take the following medicines while on citalopram:

•    Other antidepressants:

-    Monoamine Oxidase Inhibitors (MAOIs), or inthe two weeks after they have been stopped. If your doctor asks you to take a MAOI you will be asked to stop taking this medicine at least seven days before starting the MAOI.

-    If you are or were taking a RIMA (Reversible MAOI), e.g. moclobemide, consult your doctor and/or pharmacist on how long you must wait after stopping therapy before starting citalopram.

•    Medicines for heart rhythm problems or medicines thatmay affect the heart’s rhythm, such as:

-    Class IA and III antiarrhythmics

-    Anti psych otics (e.g. phenothiazine derivatives, pimozide, haloperidol

-    Tricyclic antidepressants

-    Certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malaria treatment particularly halofantrine)

-    Certain antihistamines (asternizole, mizolastine)

-    Linezolid, used in the treatment of skin infections or pneumonia

-    Medicines containing selegiline (used to treat Parkinson’s disease)

If you have any further questions about this you should speak to your doctor.

Take care when taking any of the following medicines:

•    Lithium or tryptophan - drugs for depression or mania attacks

•    Drugs to prevent blood clotting (Anticoagulants) - e.g. warfarin

•    Antiplatelet agents e.g. aspirin

•    Drugs for pain relief e.g. Non-steroidal anti-inflammatory drugs (NSAIDs), tramadol

•    Drugs for migraine - e.g. Sumatriptan

•    Medicines for depression (antidepressants) e.g. Imipramine, desipramine

•    Antimalarial drugs e.g. artemether with lumefantrine, Mefloquin

•    Buproprion -A drug used to help you stopsmoking

•    Medicines for mental health problems (Antipsychotics) e.g. Phenothiazine

•    Beta-blockers e.g. Metoprolol

•    The herbal remedy St. John’s Wort (Hypericum perforatum). If you already take a St. John’s Wort preparation stop taking the St John’s Wort and mention it to your doctor at your nextvisit.

•    Drugs that decrease the amount of acid produced in the stomach e.g. omeprazole, cimitidine.

•    Neuroleptics (used in the treatment of schizophrenia)

•    Medicinal products inducing hypokalaemia/hypomagnesaemia

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Citalopram with food and drink

Citalopram can be taken with or without food (see section 3 “How to take citalopram”)

3 ■ HOW TO TAKE CITALOPRAM

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be taken regularly according to your doctor’s instructions. The dispensing label on the pack will tell you how many to take and when to take them.

The recommended dose is:

Adults

•    Depression: The usual dose is 20mg per day. This may be increased by your doctor to a maximum of 40mg per day.

•    Panic disorder: The starting dose is 10mg per day for the first week before increasing the dose to 20-30mg per day. The dose may be increased by your doctor to a maximum of 40mg per day.

Elderly patients

The starting dose should be decreased to half of the recommended dose, e.g. 10-20mg per day. Elderly patients should not usually receive more than 20mg per day.

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Product: Citalopram 10mg,20mgand 40mg Tablets PIL

Patients with liverproblems

Patients with liver problems should not receive more than 20mg per day.

Citalopram can betaken anytime of the day with or without food. The tablets should be swallowed whole without chewing and with plenty of fluid. This medicine is not recommended for use in children or adolescents (under the age of 18).

This medicine can be taken by elderly patients. Patients with kidney or liver problems may be given a lower dose of Citalopram, between 20 and 40mg perday.

It may take several weeks before you feel any benefit from these tablets. This is normal for this type of medicine. The duration of treatment is individual, usually at least 6 months. Continue to take your 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. Never change the dose of your medicine without talking to your doctor first. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms mayreturn.

If you take more citalopram than you should

Call a doctor straight away or go immediately to the nearest casualty department, taking the remaining tablets with you. The most likely signs of overdose are convulsions, tiredness, unconsciousness, coma, feeling or being sick, tremor, enlarged eye pupils, dizziness, changes in blood pressure, hyperventilation, increased heart rate, agitation, sweating and/or turning blue.

If you forget to takecltalopram

Do not take a double dose to make up for forgotten individual doses. Just skip that dose and take your next one at the normal time.

If your stop taking citalopram

Do not suddenly stop taking citalopram even if your depression has lifted. If you stop suddenly, you may experience dizziness, tingling in hands and feet, anxiety, numbness, nausea and headaches, feeling or being sick, sleep disturbances (vivid dreams, nightmares, inability to sleep), sweating, feeling restless or agitated, tremor, feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). It is possible that some of your symptoms may come back. Once you are feeling better, talk to your doctor who will tell you how to reduce the dose gradually.

4. POSSIBLE SIDE EFFECTS

Like all medicines, citalopram can have side effects. Patients who are prone to panic attacks may actually experience a temporary period of heightened anxiety after starting treatment. This generally resolves during the first 1-2 weeks.

STOP taking Citalopram tablets 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

•    Hepatitis (inflammation of the liver) - may cause yellowing of the skin and whites of the eyes

If you notice any of the following symptoms 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 become more frequent

•    Your behaviour changes because you feel elated orover excited

•    You experience high fever, agitation, confusion, 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 or potassium

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 likethis:

•    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 straightaway.

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.

The following side effects are often mild and usually disappear after a few days’ treatment.

Very Common (likely to affect more than 1 in 10 people)

•    Feeling sick (nausea)

•    Dry mouth (a dry mouth increases the risk of toothdecay, so be sure to clean your teeth more often than usual)

•    Increased sweating

•    Sleepiness

•    Difficulty in sleeping

•    Headache

•    Weakness

Common (likely to affect up to 1 in 10 people)

•    Lack of appetite, loss ofweight

•    Tremor

•    Anxiety, nervousness, problems with concentration, confusion, agitation

•Abnormal dreams

•    Tiredness, constantly yawning, exhaustion

•    Reduced libido (decreased sex drive)

•    For women, problems with reaching orgasm, abnormal orgasm

•Tingling (pins and needles)

•    Dizziness

•    Ringing in the ears (tinnitus)

•    Diarrhoea, vomiting, constipation

•    Itching

•    Muscle or joint pain

•    For men, problems with ejaculation and erection

•    Migraine,

•    Amnesia

•    Palpitations

•    blocked or runny nose

•    Abnormal pain

•    Flatulence (wind)

•    Heartburn/indigestion

•    Increased saliva production

•    Reduced emotions,indifference (apathy)

Uncommon (likely to affect up to 1 in every 100 people)

•    Increase in appetite, weight gain •Aggression, hallucination

•    Mania

•    Depersonalisation (having ‘out of body’ experiences)

•    tteeJLoa fairt.o.rJjght. headed,, [osjncj consciousness.............

•    Fast heart rate

•    Slow heart rate

•    Large pupils (the dark centre of theeye)

•    Rash

•    Hives

•    Hair loss

•    Sensitivity to sunlight

•    Difficulty passing urine

•    Heavy menstrual periods

•    Swelling of the arms and legs

•    Libido increased (increased sexdrive)

Rare (likely to affect up to 1 in every 1000 people)

•    Taste disturbances

•    Convulsions

•    Hepatitis

•    Bleeding

•    Fever

•    Malaise

•    Coughing

•    Low blood sodium level

•    Difficulty in controlling voluntary movements, i.e. walking and increased involuntary movements

Frequency not known

•    A reduction in blood platelets which increase the risk of bleeding or bruising

•    Convulsions,

•    Abnormal heart rhythm

•    Thoughts of harming or killing themselves

•    Panic attacks, restlessness, grinding of teeth or clenching of jaws

•    Abnormal movements or jerky movements, inability to sit still

•    Disturbed vision

•A fall in blood pressure on standing up which causes dizziness, light-headed ness orfainting

•    Nose bleeds

•    Rash (hypersensitivity)

•    Unusual bleeding from the stomach and back passage

•    Bleeding between menstrual periods

•    Bruising/skin discolouration due to bleeding (ruptured blood vessels), skin swelling

•    In men, painful/prolonged erection

•    Secretion of breast milk in men or women who are not breast feeding

•Abnormal liverfunctiontests

•    Low potassium levels in the blood (hypokalaemia)

•An increased risk of bone fractures has been observed in patients taking this type of medicines

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can