PACKAGE LEAFLET: INFORMATION FOR THE USER

Citalopram 10 mg Tablets Citalopram 20 mg Tablets Citalopram 40 mg Tablets

Citalopram

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ASANDOZ

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 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 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

Citalopram is one of a group of medicines called “selective serotonin reuptake inhibitors” (SSRIs) which are antidepressants. Everyone has a substance called serotonin in their brain. People who are depressed have lower levels of serotonin than others. It is not fully understood how Citalopram and other SSRIs work but they may help by increasing the level of serotonin in the brain. This medicine is used to treat:

• Depressive illness (major depressive episodes).

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 taking or have recently taken medicines called monoamine oxidase inhibitors (MAOIs; amongst others used to treat depression). Before starting with Citalopram, you must talk to your doctor, because you may have to wait for up to 14 days after quitting the use of a MAOI (see also “Other medicines and Citalopram”). The MAOI selegiline (used to treat Parkinson's disease) may be used, but not in doses exceeding 10 mg per day. When changing from Citalopram, you have to wait for at least seven days before you start taking MAOIs.

•    if you are taking linezolid (an antibiotic medicine)

•    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 “Other medicines and Citalopram” below)

Warnings and precautions:

Talk to your doctor before taking Citalopram.

Children and adolescents under 18 years of age

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 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 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 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.

Talk to your doctor before taking Citalopram if you have, or ever had:

•    kidney or liver disease

•    diabetes: treatment with Citalopram may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted

•    a history of mania/hypomania: Citalopram should be used with caution and should be discontinued when you enter a manic phase.

•    psychosis with depressive episodes

•    panic disorders

•    seizures or fits (epilepsy): seizures are a potential risk with antidepressant drugs

•    bleeding problems or if you are taking medicines which prevent blood clotting (see section “Other medicines and Citalopram” below): Citalopram may cause bleedings (e.g. skin and mucous bleeding)

•    electro-convulsive therapy (ECT), because there is limited clinical experience; caution is advisable.

•    a low level of sodium in your blood

•    you suffer or have suffered from heart problems or have recently had a heart attack

•    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)

•    you experience a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate.

•    you have problems with your eyes, such as certain kinds of glaucoma.

Other medicines and Citalopram:

•    Tell your doctor if you are taking or have recently taken or might take any other medicines. Some medicines can cause problems if you take them with this medicine.

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. 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.

•    if you take or have recently taken MAO-inhibitors (likewise medicinal products against depression or Parkinson's disease). Citalopram must not be administered until 14 days after an irreversible MAO inhibitor was discontinued.

After discontinuation of a reversible MAO inhibitor (RIMA), the time prescribed in the relevant expert information of the RIMA must be complied with. Therapy with MAO inhibitors may be initiated 7 days at the earliest after discontinuation of citalopram. Please ask your doctor regarding this.

•    if you take linezolid (an antibiotic medicine).

Take care with the following medicines:

Talk to your doctor before taking Citalopram if you are taking any of these other medicines:

•    medicines which increase the serotonin levels, such as, oxitriptan, or tryptophan (a dietary supplement)

•    for depression, such as other SSRIs (e.g. fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine), bupropion, and St John's Wort (a herbal remedy)

•    for migraine called triptans, such as sumatriptan

•    for pain, such as tramadol

•    for mental illness, such as lithium, risperidone,

•    for high blood pressure or heart failure, such as metoprolol

•    for irregular heartbeat, e.g. propafenone, flecainide

•    to prevent blood clotting, such as warfarin, dipyridamol, ticlopidine (called anticoagulants)

•    for pain and inflammation, such as acetylsalicylic acid or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) like ibuprofen, diclofenac and celecoxib

•    for stomach ulcers, such as omeprazole, lansoprazole, esomeprazole or cimetidine

•    for malaria prophylaxis, such as mefloquine

Citalopram with food, drink and alcohol:

Do not drink alcohol while you are taking Citalopram. Alcohol may make your symptoms or side effects worse. Citalopram can be taken with or without food.

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.

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 breath 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 of yet.

Driving and using machines:

This medicine may cause side effects (such as feeling dizzy, sleepy, or confused) that affect how well you concentrate and how quickly you can react. If you get these side effects, do not drive or use machines, or do anything else where you need to be alert and concentrate.

3. How to take Citalopram

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

Your doctor will decide your dose and will adjust it individually for you. It will take at least two weeks before you start feeling better. If you do not start to feel better after this time, talk to your doctor, who will advise you. Your doctor may decide to increase your dosage gradually, up to a maximum daily dose. This depends on how you respond to the treatment.

The recommended starting dose for adults is 20 mg per day.

If necessary, the dose can be increased up to a maximum of 40 mg per day.

Elderly patients (above 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.

Hepatic impairment

If you have liver disease your doctor will prescribe a starting dose of 10 mg. The maximum dose of Citalopram is 20 mg per day.

Renal impairment

If you suffer from severe kidney disease use of citalopram is not recommended, as no information is available on use in these patients. If you have mild or moderate kidney disease, you can use the normal dose of Citalopram.

Take your tablets once a day- either in the morning or in the evening with or without food. Swallow them with sufficient fluid (e.g. a glass of water). Do not chew the tablets.

Treatment should continue until you are free of symptoms for 4-6 months.

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 you will need to keep taking your tablets.

If you take more Citalopram than you should:

If you take too many of these tablets, talk to your doctor or go to a hospital straight away, and show them the pack of tablets. The most likely signs of taking too many tablets (overdose) are: feeling dizzy or drowsy, having a fit, feeling sick (nausea) having fast heartbeats, fast breathing, sweating.

If you forget to take Citalopram:

If you forget to take your dose of this medicine, simply carry on with the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Citalopram:

Do not stop taking this medicine without talking to your doctor first, even if you feel better.

If you stop suddenly after taking this medicine for a long time, you may feel dizzy, have sensory disturbances (numbness or ‘pins and needles', called paresthesia), feeling sick (nausea), headaches, feeling anxious. These symptoms are generally mild to moderate and go away on their own within two weeks. However, in some patients these symptoms may be more severe, or go on for longer. They usually happen in the first few days after stopping the medicine.

When stopping Citalopram, your doctor will help you to lower your dose slowly over a number of weeks or months. This should help lower the chance of withdrawal effects. If you get severe withdrawal effects in spite of this, please see your doctor. He or shemay ask you to start taking your tablets again and come off them more slowly.

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.

If you get any of the following symptoms you should stop taking Citalopram and see your doctor immediately

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

Following side-effects are rare (may affect up to 1 in 1000 people):

•    Unusual bruising or bleeding, including vomiting blood or passing blood in your stools

•    Feeling tired, weak or confused and having muscles which ache, and are stiff or clumsy (uncoordinated). This may be because your blood is low in sodium.

Following side-effects are very rare (may affect up to 1 in 10,000 people) or it is not known (frequency cannot be estimated from the available data):

•    Fits (seizures or convulsions)

•    Allergic reactions: If you develop swelling of the eyelids, face, lips, mouth or tongue, start to itch or have difficulty breathing or swallowing, you may have an allergic reaction

•    Feeling restless and like you cannot sit or stand still (doctors call this akathisia). Increasing your dose of Citalopram may make these feelings worse

•    Serotonin syndrome: If you have some or all of the following symptoms you may have something called “serotonin syndrome”. The symptoms include: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat

•    Cases of people developing thoughts of harming or killing themselves, or showing such behaviour have been reported during the use of citalopram or shortly after stopping treatment.

Other possible side-effects during treatment:

Very common (may affect more than 1 in 10 people ):

•    not sleeping well (insomnia) or feeling sleepy,

•    fluttering or pounding heartbeat (palpitations)

•    feeling sick (nausea), , dry mouth

•    headache,

•    increased sweating

•    abnormal eye-accomodation

•    feeling of weakness (asthenia)

Common (may affect up to 1 in 10 people):

•    agitation, nervousness

•    lack of concentration, loss of memory, sleep disorder, nightmares, vivid dreams, feeling anxious

•    lack of motivation or interests, feeling confused, anorexia

•    migraine, numbness or ‘pins and needles' (doctors call this paresthesia)

•    feeling dizzy or shaky (tremors)

•    lack of appetite

•    increased or decreased blood pressure

•    diarrhoea, constipation, digestion disturbances, vomiting, abdominal pain, flatulence, increased salivation

•    weight loss

•    sinusitis, runny nose

•    decreased sex drive. Lack of orgasm in women and in men, Men may experience problems with ejaculation and erection, impotence; painful menstrual periods

•    itching

•    yawning, fatigue

•    ringing in the ear (tinnitus)

•    muscle pain

•    pain in your joints

•    urination problems or need to urinate more often

•    tiredness

Uncommon (may affect up to 1 in 100 people):

•    more appetite

•    weight gain

•    mania (feeling elated, or emotionally ‘high')

•    feeling euphoric

•    feeling detached from yourself (depersonalisation)

•    hallucinations

•    increased sex drive

•    aggression

•    slow heartbeat, fast heartbeat

•    heavy and prolonged menstrual period

•    coughing

•    sensitivity to sunlight,

•    malaise, fainting.

•    skin rashes

•    difficulties urinating

•    loss of hair

•    swelling of arms and legs

•    large pupils (the dark centre of the eye)

•    hives

•    bleeding disorders including skin and mucosal bleeding (purpura)

Rare (may affect up to 1 in 1,000 people)

•    hepatitis

•    fever

•    taste disturbances

•    dyskinesia

•    convulsions

Not known (frequency cannot be estimated from the available data):

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

•    a fall in blood pressure/ fainting when you suddenly stand up.

•    movement disorders such as stiffness, shaking or abnormal involuntary movements in the mouth and tongue (extrapyramidal disorders) and other movement disorders

•    panic attacks, restlessness

•    grinding one's teeth

•    blurred vision

•    abnormal production of breast milk in men and women

•    hypokalaemia

•    nosebleed

•    abnormal bleeding that occurs between periods or that is not associated with menstruation painful erections

•    sudden swelling of skin or mucosa

•    abnormal liver function test

•    an increase in bleeding or bruising caused by a decrease in blood platelets

•    bleeding disorders including skin and mucosal bleeding (ecchymosis)

•    disturbed ADH secretion (a hormone which influences renal water retention)

•    gastrointestinal bleeding

Possible withdrawal effects when stopping treatment

•    feeling dizzy

•    feelings like pins and needles, burning sensations and electric shock sensations

•    sleep disturbances (vivid dreams, nightmares, inability to sleep)

•    feeling anxious

•    feeling restless or agitated

•    tremor (shakiness)

•    feeling confused or disorientated

•    feeling emotional or irritable

•    headaches

•    feeling sick (nausea)

•    diarrhoea

•    sweating

•    visual disturbances

•    fluttering or pounding heartbeat (palpitations)

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 also report side effects directly via Yellow Card Scheme: 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

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 or blister/tablet container after EXP. The expiry date refers to the last day of that month.

This medicine 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 protect the environment.

6. Contents of the pack and other information

What Citalopram contains

The active substance is citalopram

•    Each film-coated tablet contains citalopram hydrobromide, equivalent to 10, 20 and 40 mg citalopram.

•    The other ingredients are: mannitol, microcrystalline cellulose, colloidal silica anhydrous, magnesium stearate, hypromellose, macrogol 6000 and titanium dioxide(E171)

What Citalopram looks like and contents of the pack

Citalopram 10 mg film-coated tablets are round, white film-coated tablets with a diameter of 6 mm.

Citalopram 20 mg film-coated tablets are round, white tablets with a break-line and diameter of 8 mm. The tablet can be divided into equal doses.

Citalopram 40 mg film-coated tablets are round, white film-coated tablets with a break-line and diameter of 10 mm.

The tablet can be divided into equal doses.

Citalopram 10 mg, 20 mg and 40 mg film-coated tablets, packed in PVC/PVDC/Al blisters are available in pack sizes of 10, 14,

20, 28, 30, 50, 56, 98 or 100 film-coated tablets per box,

100x1 unit dose blister HDPE tablet container with a LDPE tamper evident cap containing 250 or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder:

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

The manufacturer:

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,39179 Barleben, Germany or

Salutas Pharma GmbH,

Dieselstrasse 5, 70839 Gerlingen, Germany.

or

Lek Pharmaceuticals d.d., Verovskova ulica 57, 1526 Ljubljana, Slovenia

This leaflet was last revised in 07/2016.

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