PACKAGE LEAFLET: INFORMATION FOR THE USER SZ90410LT01B

Citalopram 20 mg and 40 mg 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 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 you get any side effects, talk to your doctor or pharmacist.

This includes any side effects not listed in this leaflet.

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

What Citalopram is and what it is used for

Citalopram belongs to the group of so-called SSRIs (selective serotonin re-uptake inhibitors) and is used to treat depressive illnesses (episodes of major depression). People who are depressed have lower levels of the substance serotonin in their brain than others. Citalopram may help by increasing the level of serotonin.

What you need to know before you take Citalopram

Do not take Citalopram

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

•    If you are taking MAO (monoamine oxidase) inhibitors (medicines used for treatment of depression or Parkinson's disease). The MAO-inhibitor selegiline may be used in combination with citalopram, albeit not more than 10mg per day

•    If you have recently taken MAO-inhibitors. Depending on the type of MAO-inhibitor you used to use, you may have to wait for up to 14 days after stopping the MAO-inhibitor before starting with Citalopram (see also “Other medicines and Citalopram”). If you stop taking Citalopram and want to start using MAO-inhibitors, you have to wait for at least 7 days.

•    If you are taking pimozide (an antipsychotic 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. (see also “Other medicines and Citalopram)

Warnings and precautions

Talk to your doctor before taking Citalopram.

Use in children and adolescents under 18 years

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

If you are depressed you can sometimes have thoughts of harming or killing yourself. These may be increased when you 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 young 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.

Check with your doctor if:

•    you have diabetes, because your doctor may need to adjust the dosage of insulin or other medicine used to lower your blood sugar.

•    you have had seizures or have epilepsy. You will be carefully monitored by your doctor. Treatment with Citalopram should be stopped if seizures occur or if there is an increase in the seizure frequency.

•    you are receiving electro-convulsive treatment.

•    you have or have had episodes of mania (overactive behaviour or thoughts).

•    you have a history of bleeding disorders or are using medicines that influence blood coagulation or increase the bleeding risk (see “Other medicines and citalopram”).

•    you have so-called psychosis with depressive episodes, because the psychotic symptoms may increase.

•    you are taking herbal products containing

St. John's wort (Hypericum perforatum see also “Other medicines and citalopram”).

•    you are taking sumatriptan or other triptans, tramadol, oxitriptan or tryptophan (see also “Other medicines and citalopram”).

•    you have reduced liver or kidney function, because it may be necessary to prescribe a lower dose for you.

•    you are susceptible for deviation of heart rhythm (QT-interval prolongation) or have suspected congenital long QT-syndrome or suffer from low blood levels of potassium or magnesium (hypokalaemia/hypomagnesaemia).

•    you start feeling sick and unwell with weak muscles or confused while being treated with Citalopram.

•    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.

twitching and fever occur during treatment, this may be a first sign of so-called serotonin syndrome. Please inform your doctor without delay; he/she will discontinue treatment with Citalopram immediately.

If you start feeling restless and are no longer able to stand or sit still, please inform your doctor, since you may be suffering from a side-affect called akathisia.

At the initiation of treatment, sleeplessness and intense excitation can occur. In this case, the doctor may adjust the dose accordingly.

Other medicines and Citalopram

Tell your doctor or pharmacist if you are taking or 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. fentiazine derviatives, 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.

The following medicinal products can influence the effect of Citalopram or can be influenced in their effect.

•    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.

•    Pimozide (an antipsychotic medicine). Concomitant treatment with citalopram and pimozide is contra-indicated due to the influence of thiscombination to the heart function.

It is especially important that you ask your doctor for advice if you are taking

•    Sumatriptan or other triptans (medicinal products to treat migraine), oxitryptan or tryptophan (substances that may influence the level of serotonin in the brain)

•    Other medicine for depression: tricyclic antidepressants, other serotonin re-uptake inhibitors or medicines containing lithium

•    Tramadol (medicinal product to treat severe pain)

•    Herbal remedy St. John's Wort (Hypericum perforatum).

Concomitant use of above mentioned medicinal products may lead to “serotonin syndrome” by potentiating serotonergic effects of Citalopram (see “Warnings and precautions”).

•    Desipramine (medicine to treat depression).

The blood level of desipramin may be increased and a reduction of the desipramin dose may be needed

•    Blood-thinning medicine (warfarin or any other oral anticoagulant)

•    Medicinal products influencing thrombocyte function (e.g. non-steroidal antirheumatics, acetylsalicylic acid, dipyridamol and ticlopidine, atypical antipsychotics, phenothiazines).

Concomitant use of above mentioned medicinal

products may lead to increased/prolonged bleeding

(see “Warnings and precautions”)

•    Cimetidine, a medicinal product to reduce gastric acid and other medicinal products to treat stomach ulcers, e.g. omeprazole, esomeprazole, lansoprazole or fluvoxamine (other medicine to treat depression).

Combination with citalopram may cause a rise in the blood level of citalopram

•    neuroleptics (used to treat schizophrenia). Concomitant use can cause seizures

•    Metoprolol (medicine to treat high blood pressure or heart failure), flecainide and propafenone (to treat irregular heartbeat), other medicines to treat depression (clomipramine, nortriptyline) or medicines to treat psychoses (risperidone, thioridazine, haloperidol). An increase in the blood level of these

medicines has been reported or may be possible

•    Medicines that have an influence on heart rhythm (QT-interval prolongation) or decrease blood levels of potassium or magnesium because citalopram also has this effect

•    Medicines lowering the seizure threshold, e.g. other antidepressants (tricyclics, SSRI's), antipsychotic medicines (e. g. phenothiazines, butyrophenones), tramadol (pain killer).

Citalopram with food, drink and alcohol

When taking Citalopram, you should not consume any alcohol.

The film-coated tablets may be taken with or without food.

Pregnancy and breast-feeding

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.

You should not discontinue treatment with Citalopram abruptly.

Make sure your midwife and/or doctor know you are on Citalopram.

If you are taking Citalopram in the last 3 months of pregnancy 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 blueish 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 midwife and/or doctor immediately who will be able to advise you.

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.

If signs such as intense excitation, trembling, muscular

Continued on next page >>

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 can influence the ability to drive and to use machines. As with all medicinal products acting on the psyche, the ability to judge and react may be impaired in emergency situations.

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.

Citalopram 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.

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.

Take the film-coated tablets together with sufficient liquid once daily in the morning or in the evening.

The tablets may be taken with or without food.

The recommended dose for adults is

The starting dose is 20 mg citalopram once daily.

If necessary, the dose may be increased gradually according to the doctors orders to 40 mg citalopram once daily.

Elderly patients (aged over 65 years)

The dose should be reduced to half the normal dose for adults, e.g. 10-20 mg citalopram per day. Depending on your individual response, the dose may be increased by the doctor. The maximum dose for elderly patients is 20 mg citalopram per day.

Patients with impaired hepatic function

Patients with impaired hepatic function should receive an initial dose of 10 mg citalopram per day. The dose must not exceed 20 mg citalopram per day. Your doctor will closely monitor your liver function, while on treatment with citalopram.

Patients with impaired renal function

If you suffer from a mild to moderate decrease in renal function, you can use the normal dose for adults. If you suffer from severe renal impairment, use of citalopram is not recommended since no information is available on use in these patients.

How long should you take Citalopram?

Your doctor decides on the duration of treatment.

An improvement in the depressive symptoms cannot be expected before at least 2 weeks have passed after initiation of treatment.

After the depressive symptoms have subsided, therapy should be continued for at least 4-6 months.

If you take more Citalopram than you should

If you have taken too much Citalopram a doctor is to be informed immediately.

Depending on the dose ingested, overdosages with citalopram manifest themselves as complaints such as nausea, vomiting, sweating, sleepiness, coma, seizures, accelerated pulse rate, disturbances of muscle tone, hyperventilation (accelerated and increased exhalation), increased body temperature and rare ECG alterations.

If you forget to take Citalopram

Do not take a double dose to make up for a forgotten dose. If you have forgotten to take a dose of Citalopram, take it as soon as possible. However, if it nearly time for the next dose, skip the missed dose and continue intake of Citalopram as prescribed by your doctor. In case of doubt, always consult your doctor or pharmacist.

If you stop taking Citalopram

Do not stop taking Citalopram until your doctor tells you to, even if you feel better.

If you stop suddenly after taking this medicine for a long time you can experience withdrawal effects; you may feel dizzy, have sensory disturbances (numbness or ‘pins and needles', called paresthesia), sleep disturbances (including insomnia and intense dreams), feeling sick (nausea), sweating, headaches, tremor, feeling agitated or 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.

Citalopram should be withdrawn slowly when terminating treatment. It is recommended to reduce the dose gradually over a period of at least 1-2 weeks.

If you get severe withdrawal effects when you stop taking Citalopram, please see your doctor. He or she may 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 product, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happens, stop taking Citalopram and tell your doctor immediately or go to your nearest hospital:

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

•    Serotonin syndrome has been reported. Symptoms may include restlessness, confusion, sweating, hallucinations, exaggeration of reflexes, muscle cramps, shivering, rapid heart rate and tremor

•    Severe hypersensitivity reactions which may result in a strong decrease in blood pressure, paleness, anxiety, a fast weak pulse rate, a clammy skin, decreased consciousness, tremor, breathing difficulties and sudden swelling of the skin and mucosa.

The following additional side effects have been reported:

Very common: may affect more than 1 in 10 people

•    sleepiness, sleeplessness, intense excitation, nervosity

•    headache, trembling, dizziness

•    palpitations

•    nausea, dry mouth, constipation, diarrhoea

•    increased sweating

•    accommodation disorders of eyes

•    debility (asthenia).

Common: may affect up to 1 in 10 people

•    sleep disturbances, impaired concentration, abnormal dreaming, memory defects, anxiety, decreased libido, increased appetite, loss of appetite, apathy, confusion

•    migraine, spontaneously experiencing feelings like tickling, itching or tingling (paraesthesia)

•    accelerated pulse rate, drop in blood pressure when changing posture (orthostatic hypotension), increased blood pressure, lowered blood pressure

•    digestive disorders (dyspepsia), vomiting, abdominal pain, flatulence, increased salivation

•    urination disorders, abnormally high urine production (polyuria)

•    weight loss or gain

•    rhinitis, sinusitis

•    disturbed ejaculation, orgasmic impairment

in the woman, menstrual complaints, impotence

•    rash, itching

•    visual disturbances

•    fatigue, yawning, taste alterations.

Uncommon: may affect up to 1 in 100 people

•    euphoria, increased libido

•    disturbances of the motor system (extrapyramidal disorders), seizures

•    decelerated pulse rate

•    increase in liver enzymes

•    cough

•    hypersensitivity to light

•    noise in the ear (tinnitus)

•    muscle pain (myalgia)

•    allergic reactions, short-term unconsciousness (syncope), general malaise.

Rare: may affect up to 1 in 1,000 people

•    inability to sit or stand still (restlessness/akathisia)

•    bleeding (gynaecological bleeding, gastrointestinal bleeding and bleeding soft skin or mucosa), serotonin syndrome, reduced sodium level in the blood (hyponatraemia), predominantly in elderly patients and sometimes due to syndrome of inappropriate anti-diuretic hormone secretion (SIADH) with symptoms like feeling sick and unwell with weak muscles or confused.

Not known: frequency cannot be estimated from the

available data

•    seeing or hearing things that are not real (hallucinations), overactive behaviour or thoughts (mania), feeling detached from yourself (depersonalisation), panic attacks (these symptoms may be associated with the underlying disease)

•    Cases of suicidal ideation and suicidal behaviours have been reported during citalopram therapy or early after treatment discontinuation (see section 2 “Warnings and precautions”)

•    secretion of milk from the mammary glands (galactorrhoea)

•    angioedema has been reported which can present itself as sudden swelling of the skin and mucosa due to fluid retention (e.g. of the throat and tongue), breathing difficulties and/or itching and rash

•    joint pain (arthralgia), increased risk of bone fractures (observed for all medicines belonging to certain groups of antidepressants)

•    Withdrawal symptoms when treatment is terminated may occur (see also “If you stop taking Citalopram”).

If you get any of the side effects talk to your doctor

or pharmacist. This includes any side effects not

listed in this leaflet.

5 How to store Citalopram

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton/tablet container and the blister after EXP.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away dispose of medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other infomation

What Citalopram contains

The active substance is citalopram hydrobromide. Each Citalopram 20 mg and 40 mg tablet contains citalopram hydrobromide, equivalent to respectively 20 and 40 mg citalopram.

The other ingredients are: microcrystalline cellulose, glycerol 85%, magnesium stearate, maize starch, lactose monohydrate, copovidone, sodium starch glycollate (type A).

Coating: Macrogol 6000, hypromellose, talc and titanium dioxide (E171).

What Citalopram looks like and contents of the pack

Citalopram 20 mg Tablets are white, oblong biconvex film-coated tablet with a one sided notch and the embossment C20.

Citalopram 40 mg Tablets are white, oblong biconvex film-coated tablet with a one sided notch and the embossment C40.

The tablets can be divided in two equal halves.

Citalopram 20 mg Tablets, packed in PVC/PVDC/Al blisters are available in pack sizes of 12, 14, 20, 28, 30, 50, 50 x 1,56, 98, 100 and 250 tablets.

HDPE tablet container containing 250 tablets.

Citalopram 40 mg Tablets, packed in PVC/PVDC/Al blisters are available in pack sizes of 10, 14, 20, 28, 30, 50, 56, 98 and 100 tablets.

HDPE tablet container containing 250 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

LEK S.A, Ul. Podlipie 16, 95-010 Stryk6w, Poland or

LEK S.A, Ul. Domaniewska 50 C, PL-02-672 Warszawa, Poland

This leaflet was last revised in 02/2016.

draft: 44028147, 44030800 laetus code: 13635 mat.no.: 46171737

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