PACKAGE LEAFLET: INFORMATION FOR THE USER

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Citalopram 10 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 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

What 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:

•    Depressive illnesses (major depressive episodes)

•    Panic disorder with or without agoraphobia

(e.g. strong fear of leaving the house, entering shops, or fear of public places).

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 MAO (monoamine oxidase) inhibitors:

-    e.g. the antidepressant moclobemide or

-    you are treated with the non-selective MAO-inhibitor linezolid (an antibiotic medicine) unless you are under close observation and monitoring of blood pressure.

-    The irreversible MAO-inhibitor selegiline (medicine for Parkinson’s disease) may be used in combination with citalopram in daily doses not exceeding 10 mg selegiline per day (see “Other medicines and Citalopram”).

-    If you have taken irreversible MAO-inhibitors within the last two weeks or if you have taken a reversible MAO-inhibitor (RIMA) within the time prescribed in the relevant patient information leaflet of the RIMA (see “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 (see “Other medicines and Citalopram”).

•    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.

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.

Restlessness/difficulties to sit or stand still

Symptoms such as restlessness, for example, you cannot sit or stand still (akathisia), can occur during the first weeks of treatment. Tell your doctor immediately if you experience these symptoms. Then a dosage adjustment may be helpful.

•    You are at risk of a decreased sodium level in the blood (hyponatraemia) e.g. from concomitant medications and cirrhosis. Hyponatraemia associated with the syndrome of inappropriate anti-diuretic hormone secretion (SIADH) has been reported rarely during treatment with Citalopram, predominantly in the elderly.

•    You have diabetes. The dosage of your antidiabetic medication may possibly have to be adjusted.

•    You have epilepsy. In the event of seizures the treatment should be discontinued. Contact your doctor.

•    You have bleeding disorders, e.g. gynaecological

or gastric bleeding or if you are using medicines that influence blood coagulation or increase the bleeding risk (see “Taking other medicines”), because use of Citalopram may increase the risk of bleeding.

•    At the beginning of the treatment you develop difficulty sleeping or excitement. Your doctor may adjust the dose.

•    You are to have electro-convulsive therapy.

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

•    You have or had panic disorders.

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

Oher medicines and Citalopram

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 IAand III antiarrhythmics, antipsychotics (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 (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.

Some other medicines can affect or be affected by Citalopram. Some of these medicines are listed below:

•    Desipramine (for depression). The blood level of desipramine may be increased and a reduction of the desipramine dose may be necessary.

•    Metoprolol (for e.g. heart disease), 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.

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

•    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).

•    Medicines lowering the seizure threshold, e.g. other antidepressants (SSRI’s), antipsychotic medicines (e.g. butyrophenones, thioxanthenes), mefloquin, bupropion and tramadol (pain killer).

The following medicines can enhance the serotonergic

effects of Citalopram and may cause increased side

effects:

•    MAO inhibitors (for depression or Parkinson’s disease) (e.g. moclobemide and selegiline or linezolid, an antibiotic medicine). With exception of selegilin not exceeding 10 mg/dayyou must not use Citalopram concomitantly with MAO inhibitors as serious or even fatal reactions (serotonin syndrome) can occur. There must be a pause between the treatments (see section “Do not take Citalopram”). Ask your doctor.

•    Oxitriptan and tryptophan (serotonin precursors)

•    Lithium (for mental disorders)

•    Sumatriptan and other triptans (for migraine)

•    Tramadol (for severe pain)

•    St. John’s wort (Hypericum perforatum)

•    Cimetidine (stomach medicine) and other medicinal products to treat stomach ulcers, e.g. omeprazole, esomeprazole, lansoprazole, ticlopidine or fluvoxamine (other medicine to treat depression). Combination with citalopram may cause a rise in the blood level of citalopram.

Increased anxiety

In the treatment of panic disorder it usually takes 2-4 weeks before any improvement is seen. In the beginning of the treatment certain patients may experience increased anxiety, which will disappear during the continued treatment. Therefore, it is very important that you follow exactly your doctor’s orders and do not stop the treatment or change the dose without consulting your doctor.

Mania (overactive behaviour or thoughts)

If you go into a manic phase characterised by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity, please contact your doctor.

Withdrawal symptoms seen on discontinuation of a selective serotonin reuptake inhibitor (SSRI)

When you stop taking Citalopram, especially if it is abruptly, you may feel discontinuation symptoms (see “How to take Citalopram ” and “Possible side effects”). These are common when treatment is stopped. The risk is higher, when Citalopram has been used for a long time or in high doses or when the dose is reduced too quickly. Most people find that the symptoms are mild and go away on their own within two weeks. However, in some patients they may be severe in intensity or they may be prolonged (2-3 months or more).

If you get severe discontinuation symptoms when you stop taking Citalopram, please contact your doctor. He or she may ask you to start taking your tablets again and come off them more slowly.

Children and adolescents under 18 years of age:

Antidepressants 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 medicinal products. Despite this, your doctor may prescribe Citalopram for patients under 18 because he/she decides that it 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.

Check with your doctor if:

•    You start to develop fever, muscle stiffness or tremor and extreme agitation; you may suffer from so called serotonin syndrome. Although this syndrome occurs rarely it may result in potentially life threatening conditions, contact your doctor immediately, the use of Citalopram might need to be discontinued.

•    You are taking herbal products containing

St. John’s wort (Hypericum perforatum, see “Taking other medicines”).

•    You are taking serotonergic medicines such as sumatriptan or other triptans, tramadol, oxitriptan and tryptophan (see “Taking other medicines”).

•    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 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.

The following medicines increase the risk of bleeding:

•    Warfarin and other blood-thinning medicines

•    Acetylsalicylic acid and other pain-relieving medicines of the NSAID type (non-steroidal anti-inflammatory drugs) (e.g. ibuprofen)

•    Dipyridamole and ticlopidine (heart medicines)

•    Phenothiazines and atypical antipsychotics (for mental disorders)

•    Tricyclic antidepressants (for depression)

(e.g. imipramine).

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

Citalopram with food and drink

Food does not have any influence on the effect of Citalopram.

Simultaneous consumption of alcohol is not recommended.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Citalopram if you are pregnant or planning to have a baby, unless you and your doctor have discussed the risks and benefits involved.

You should not stop treatment with Citalopram abruptly during pregnancy. Contact your doctor if you wish to pause or stop the treatment.

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.

If you are taking Citalopram during the last 3 months of your pregnancy and until the date of birth, your newborn child may experience serious side effects or abstinences, such as breathing difficulties, bluish skin/lips, irregular breathing with breathing pauses, temperature fluctuations, seizures, lethargy, sleeping difficulties, difficulty in feeding, vomiting, low level of sugar in the blood, stiff or floppy muscles, abnormally increased reflexes, tremor, extreme nervousness or nervous shaking, irritability, constant crying and somnolence.

If your baby has any of these symptoms when it is born, contact your doctor immediately who will be able to advise you.

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.

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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 has minor to moderate influence on the ability to drive and use machines. Do not drive or use machines until you know how you are affected by the medicinal product. Citalopram does not usually affect the ability to carry out normal daily activities. However, if you feel dizzy or sleepy when you start to take this medicine, you should be careful when driving, operating machinery or performing jobs that need you to be alert until these effects wear off.

If you are not sure consult your doctor whether you can carry out the above mentioned activities.

Citalopram contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Citalopram.

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How to take Citalopram

Be aware that it may take 2-4 weeks before you notice an improvement. The treatment should continue until you have been free of symptoms for 4-6 months. When the treatment with Citalopram is to cease, the dose should be reduced gradually over a period of at least 1-2 weeks.

Citalopram should be taken once daily, either in the morning or the evening.

Drink a glass of water together with the medicine; it may be taken with or without food.

For doses not feasible with this strength, other appropriate strengths of this medicinal product are available.

How much to take

ADULTS:

Depression:

The recommended 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. Full therapeutic response may take up to 3 months to develop.

ELDERLY PATIENTS (ABOVE 65 YEARS OF AGE): Depression and panic disorder:

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.

USE IN CHILDREN AND ADOLESCENTS BELOW 18 YEARS OF AGE:

Citalopram should normally not be used in children and adolescents below 18 years of age (see “Warnings and precautions”).

IMPAIRED LIVER FUNCTION:

The usual starting dose is 10 mg once daily. Patients with liver complaints should not receive more than 20 mg per day.

IMPAIRED KIDNEY FUNCTION:

It may be necessary to adjust the dose. Follow the doctor’s instructions.

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

If you take more Citalopram than you should

Contact your doctor, accident and emergency department or pharmacy if you have taken more Citalopram than is indicated in this leaflet or more than the doctor has prescribed. Some of the signs of an overdosage could be life-threatening.

Depending on the dose ingested, overdosages with Citalopram manifest themselves as complaints such as irregular heartbeat, seizures, changes in heart rhythm (faster or slower heartbeat), feeling sick (nausea), vomiting, sweating, drowsiness, unconsciousness, tremor, changes in blood pressure (may be increased or decreased), serotonin syndrome (see Section 4), agitation, dizziness, enlarged eye pupils, bluish skin, breathing too quickly, cardiac arrest, coma.

If you forget to take Citalopram

Do not take a double dose to make up for a forgotten dose.

If you stop taking Citalopram

Abrupt discontinuation should be avoided.

When you stop treatment with Citalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions.

If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, your physician may continue decreasing the dose, but at a more gradual rate.

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

•    Dry mouth which may increase the risk of

caries - you should therefore brush your teeth more often than usual while taking Citalopram.

•    Nausea, constipation.

•    Headache.

Common side effects (may affect up to 1 in 10 people)

•    Decreased appetite, weight loss, increased appetite, taste disturbance.

•    Diarrhoea, vomiting, gastric discomfort (including acid reflux, heartburn), stomach pain, flatulence, increased salivation.

•    High blood pressure. Talk to your doctor. High blood pressure should be treated. Severely raised blood pressure is serious.

•    Dizziness and possibly fainting (possibly only when you stand up) due to low blood pressure.

•    Low blood pressure.

•    Fever

•    Prickling, tingling sensations or numbness in your skin.

•    Tiredness, sleeping difficulties, abnormal dreams.

•    Migraine, ringing in the ears (tinnitus).

•    Visual disturbance.

•    Runny nose, sinusitis, yawning.

•    Difficulties urinating.

•    Itching, rash.

•    Muscle pain, joint pain.

•    Ejaculation problems, impotence (erectile dysfunction).

•    Menstrual pain, orgasm difficulties.

•    Reduced libido.

•    Anxiety, confusion, indifference.

•    Impaired concentration, disturbance in attention, abnormal dreams, memory loss.

•    Excessive secretion of urine (polyuria)

Uncommon side effects (may affect up to 1 in 100 people)

•    Hallucinations. Could be serious. Contact your doctor or emergency.

•    Fainting.

•    Seizures.

•    Movement disorders and involuntary movements.

•    Enlarged pupils.

•    Cough.

•    Difficulties urinating, possibly urinary retention.

This can be or become serious. Talk to your doctor.

•    Oedema (fluid retention).

•    Hair loss.

•    Nettle rash, itchy rash, rash, increased sensitivity of the skin to light (photosensitivity).

•    Unusually heavy menstrual bleeding.

•    Aggression (threatening, possibly violent behaviour), feeling of unreality or of strangeness to your own person.

•    Pathological elation (mania).

•    Elation (euphoria).

•    Increased libido.

•    Anorexia

•    Malaise

•    Weight increase

•    Slower heart beat.

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

•    Involuntary movements.

•    Bleeding.

•    Inability to sit still. Restless legs.

Very rare side effects (may affect up to 1 in 10,000 people)

•    Flow of breast milk.

Side effects with frequency not known (frequency cannot be estimated from the available data)

•    Weakness, reduced muscle power, quivering and abnormal heart rhythm due to low potassium levels in the blood (hypokalaemia). In some patients it may develop into a serious side effect. Talk to your doctor.

•    Nose bleeding.

•    Blood spots under the skin.

•    Irregular, heavy menstrual bleeding.

•    Persistent, painful erection. Contact you doctor or emergency department as soon as possible.

•    Panic attack.

•    Teeth grinding.

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

Besides, Citalopram may cause side effects that you will usually not notice. It concerns changes in certain laboratory test results, such as liver counts, which normalise once treatment is stopped.

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 (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

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How to store Citalopram

4

Possible side effects

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

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

The expiry date refers to the last day of that month.

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.

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

The side effects usually disappear after a few weeks of treatment.

Several of the effects listed below can also be symptoms of your illness and may disappear as you start to get better.

If you get one or more of the following side effects, you should stop taking Citalopram and immediately contact your doctor or emergency department.

Common side effects (may affect up to 1 in 10 people)

•    Serious heart rhythm disturbances with rapid, irregular pulse.

Uncommon side effects (may affect up to 1 in 100 people)

•    Severe itching of the skin (with raised lumps).

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

•    Nausea, muscle weakness, confusion, tiredness and muscle twitching due to low levels of sodium in your blood. In some patients this can develop into a serious side effect. Talk to your doctor.

•    Hepatitis, jaundice.

•    Fits that you have suffered from in the past become more frequent.

Very rare side effects (may affect up to 1 in 10,000 people)

•    Sudden allergic reaction (within minutes to hours), e.g. rash, breathing difficulties, dizziness and fainting (anaphylactic reaction).

•    Rash (hives) and swellings. Cases involving swelling of the face, lips and tongue may be life-threatening (angioedema).

Side effects with frequency not known (frequency cannot be estimated from the available data)

•    Suicidal thoughts, suicidal behaviours. Cases of suicidal thoughts and suicidal behaviour have been reported during treatment with citalopram or shortly after withdrawal of treatment (see “Warnings and precautions”). Contact your doctor or emergency department.

•    High fever, shivering and sudden muscle twitching, confusion, pathological elation and agitation.

•    Reduced platelet count, leading to an increased risk of bleeding and bruising.

•    Unusual bleedings, including gastrointestinal bleedings (bloody vomit and/or black stools due to bleeding in stomach and intestine), and bleeding from the uterus.

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

•    You start having fits for the first time.

The following side effects have also been reported:

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

•    Palpitations, shaking, increased sweating.

•    Lethargy (urge to sleep), sleepiness, weakness and frailty.

•    Difficulty in sleeping.

•    Restless agitation, nervousness.

•    Dizziness.

•    Blurred vision (difficulties reading small print).

Contents of the pack and further information

What Citalopram contains

The active substance is citalopram.

Each film-coated tablet contains 10 mg citalopram (as citalopram hydrobromide).

The other ingredients are:

Core: Microcrystalline cellulose, glycerol 85 %, magnesium stearate, maize starch, lactose monohydrate, copovidone, sodium starch glycollate (type A)

Film-coating: Macrogol 6000, hypromellose, talc, titanium dioxide (E171).

What Citalopram looks like and contents of the pack

Citalopram 10 mg film-coated tablets are white, round, film-coated tablets without a score line Packages containing 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 film-coated tablets in blister;

100, 105 and 250 film-coated tablets in HDPE-bottle.*

* only for dose-dispensing and hospitals

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Sandoz Ltd, Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Salutas Pharma GmbH, Otto-Von-Guericke-Allee 1, 39179 Barleben, Germany or Salutas Pharma GmbH, Dieselstrasse 5, ,70839 Gerlingen, Germany or Lek S.A., ul. Domaniewska 50 C,02-672 Warszawa, Poland or Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia orTillomed Laboratories Ltd., 3 Howard Road, St. Neots, Cambridgeshire PE19 8ET, United Kingdom or Rowa Pharmaceuticals Ltd., Newtown, Bantry, Co. Cork, Ireland.

This leaflet was last revised in 12/2014.

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