Citalopram 10 A, filmomhulde tabletten

Citalopram Tablets belongs to a group of medicines called Selective Serotonin Reuptake Inhibitors (SSRI’s).

Citalopram Tablets are used to treat depression (major depressive episodes).

This medicine acts on the serotonin-system in the brain by increasing the serotonin level. Disturbances in the serotonin-system are considered an important factor in the development of depression and related diseases.

Do not take Citalopram Film-Coated Tablets

• if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
• if you are currently 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 10 mg per day.
• if you have recently taken MAO-inhibitors. Depending on the type of MAO-inhibitor you were using, 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 Film-Coated Tablets”). 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 a medicine called linezolid (used to treat infections). If your doctor decides that you can take Citalopram Tablets at the same time as taking linezolid, they will have to check your blood pressure regularly.
• 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 Film-Coated Tablets”).

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Warning and precautions

Talk to your doctor before taking Citalopram Tablets if any of the following apply to you:

• if you suffer from impaired liver or kidney function. Your doctor may need to adjust your dosage.
• if you are a diabetic. Citalopram may alter blood sugar control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
• if you suffer or have suffered from heart problems or have recently had a heart attack.
• if 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).
• if you suffer from epilepsy or have a history of seizures or fits. Treatment with citalopram should be stopped if seizures occur or if there is an increase in the seizures frequency.
• if you suffer or have suffered from a bleeding disorder which includes tendency to bleed including the occurrence of bruises without an apparent cause (ecchymosis), gastrointestinal bleeding, bleeding under the skin, abnormal periods in females or if you use medicines which possibly increase tendency to bleed, such as warfarin (see section “Other Medicines and Citalopram Film-Coated Tablets”).
• if you are having electro-convulsive therapy (ECT).
• if you have a history of overactive behaviour or thoughts (mania) . If a new manic episode occurs, your doctor may ask you to stop taking citalopram.
• if you suffer from hallucinations or delusions (psychosis). Treatment with citalopram may increase these symptoms.
• if you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) or have a history of glaucoma.

Check with your doctor:

• if you start to develop fever, muscle stiffness or tremor and extreme agitation; you may suffer from the 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.
• if you start feeling sick and unwell with weak muscles or confused while being treated with citalopram. You may have a decreased level of sodium in the blood.
• if you experience a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate.
• if you experience sleeplessness and agitation at the beginning of the treatment. Your doctor may adjust your dosage.

Other important information you should know before taking this medicine

Thoughts of suicide and worsening of your depression

If you are depressed you can sometimes have thoughts of harming or killingyourself. These may be increased when first startingantidepressants 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 adultsaged less than 25 yearswith 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 friendthat 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, of if they are worried about changes in your behaviour.

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Use in 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 attempts, suicidal thoughts and hostility (predominately 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 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 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.

Restlessness/difficulty to sit or stand still (acathisia)

Symptoms such as restlessness or difficulty to sit or stand still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.

Withdrawal symptoms seen on discontinuation

Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation of Citalopram is abrupt. The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction. Dizziness, sensory disturbances (including

paraesthesia), sleep disturbances (including insomnia and	intense dreams), agitation or anxiety, nausea
and/or vomiting, tremor, confusion, sweating, headache,	diarrhoea, palpitations, emotional instability,
irritability, and visual disturbances are the most commonly reported reactions. Generally these symptoms are

mild to moderate; however, in some patients they may be severe in intensity. They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose. Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in someindividuals they may be prolonged (23- months or more). It is therefore advised that Citalopram should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to your needs.

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.

Other medicines and Citalopram Film-Coated Tablets

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

DO NOT TAKE CITALOPRAM FILM-COATED TABLETS

• 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. phenothiazine 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.
• if you take irreversible non-selective “monoamine oxidase inhibitors” (MAOIs) (e.g. phenelzine, iproniazid, isocarboxazid or tranylcypromine). You should not start taking citalopram for 14 days after finishing treatment with your previous medicine.
• if you take “Reversible, selective MAO-A inhibitors” (e.g. moclobemide used to treat depression). You may have to wait for one or more days before you can start using citalopram.
• if you take more than 10 mg per day of the “Irreversible MAO-B inhibitor” selegiline (used to treat Parkinson’s disease).

Tell your doctor if you are taking any of the following medicines:

• Sumatriptan and similar medicines (used to treat migraine).
• Tramadol (used against severe pain).
• Tryptophan or oxitriptan (substances that may increase serotonin levels).
• St John's Wort (hypericum perforatum) - a herbal remedy used for depression.

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• Lithium (used in the treatment of manic-depressive disorder).

Concomitant use of citalopram and the medicines mentioned above may increase the risk of severe side effects like the so-called serotonin-syndrome (see section 4 “Possible side effects”).

• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood, so called anti-coagulant).
• Warfarin, dypiridamol and ticlopedine (medicines used to thin the blood, so called anti-coagulants).
• Atypical antipsychotics such as risperidone, clozapine, olanzapine, quetiapine and paliperidone.
• Phenohiazines such as chlorpromazine, thioridazine, promazine, levomepromazine, fluphenazine and prochlorperazine (medicines used to treat psychosis).
• Tricyclic antidepressants such as clomipramine, nortriptyline and amitryptiline.

Concomitant use of citalopram and the medicines mentioned above may increase the risk of bleeding.

• Metoprolol (used in cardio-vascular diseases).
• Haloperidol (antipsychotic).
• Imipramine and desipramine (to treat depression).
• Cimetidine (used to treat stomach ulcers).

Your doctor may need to adjust the dosage when citalopram is used together with the above mentioned medicines.

• Neuroleptics (medicines to treat schizophrenia, psychosis).

Citalopram Film-Coated Tablets with food, drink and alcohol

These tablets should be swallowed with water and can be taken with or without food. Do not crush or chew your tablets.

The effect of alcohol is unknown and should be avoided while you are taking these tablets.

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

Do not take citalopram if you are pregnant unless you and your doctor have discussed the risks and benefits involved.

You should not discontinue treatment with Citalopram Tablets abruptly.

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.

When used during the last 3 months of your pregnancy and until the date of birth you should be aware that the following effects may also be seen in your newborn: 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.

Breastfeeding

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

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If you are breast-feeding, ask your doctor for advice.

You should not breastfeed when taking citalopram because small amounts of the medicine can pass into the breast milk.

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 cause side effects which may affect your ability to make judgments or react to emergencies. If you suffer from any of these side effects, do NOT drive, operate machinery or perform tasks that require you to be alert.

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

How much to take

Adults

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

Elderly patients (over 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 18 years of age

Citalopram should not normally be used for children and adolescents under 18 years.

Patients with special risks

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

Citalopram should be taken daily as a single dose. Your tablets can be taken with or without food and should be swallowed with a drink of water. Do not crush or chew your tablets.

The effect of citalopram is not felt straight away. It will take at least two weeks before you notice any improvement. After you are free of symptoms, citalopram should be taken for another 4-6 months.

If you take more Citalopram Film-Coated Tablets than you should you may experience drowsiness, coma, absence of spontaneous movement, reduced responses to stimulation, and usually impaired consciousness, sweating, fits, your heart may beat faster than normal, nausea, vomiting, bluish or purplish discolouration of the skin and excessive rate and depth of breathing. You should contact your doctor immediately or go to the nearest hospital casualty department. Remember to take the pack and any remaining tablets with you.

If you forget to take Citalopram Film-Coated Tablets

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Citalopram Film-Coated Tablets

Do not stop taking Citalopram Tablets until your doctor tells you to do so. When you have completed your course of treatment, your doctor will advise on how to reduce the dose of citalopram gradually over a couple of weeks.

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When you stop taking Citalopram Tablets, especially if it is abruptly, you may feel withdrawal symptoms (see ‘Withdrawal symptoms seen on discontinuation’). These are common when treatment with citalopram 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 withdrawal 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.

Withdrawal symptoms include: dizziness, sensation of pricking or tingling, sleep disturbances (including inadequate sleep, vivid dreams), agitation or anxiety, feeling sick (nausea) and/or vomitting, tremor (shakiness), confusion, sweating, diarrhoea, palpitations, emotional instability, irritability, visual disturbances and headache.

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

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. Please be aware that some of the effects may also be symptoms of your illness and therefore will improve when you start to get better.

Contact your doctor or go to a hospital straight away if you:

• have an allergic reaction after taking Citalopram Tablets. Signs of an allergic reaction include red and lumpy skin rash; swelling of the eyelids, face, lips, mouth or tongue; itchy skin; difficulty in breathing or swallowing. This is rare and may affect up to 1 in 1,000 people.
• experience seizures (fits). This is rare and may affect up to 1 in 1,000 people.
• have unusual bruising or bleeding. This is rare and may affect up to 1 in 1,000 people.
• vomit blood or pass blood in your stools. It is not known how common this side effect is.

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

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

Contact your doctor if you:

• experience a reaction called “serotonin syndrome”. Signs of this include: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heart beat. It is not known how common this side effect is.
• feel tired, weak or confused and have achy, stiff or uncoordinated muscles this may be because your blood is low in sodium. This is rare and may affect up to 1 in 1,000 people.

The following side effects have also been reported:

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

• Drowsiness.
• Trouble sleeping or getting inadequate sleep (insomnia).
• Headache.
• Palpitation (awareness of your heart beat).
• Feeling sick (nausea).
• Dry mouth.
• Increased sweating.
• Feeling weak

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

• Decreased appetite or weight loss.

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• Agitation, anxiety, confusion or nervousness.
• Apathy (a feeling of indifference).
• Sleep disorders such as vivid or abnormal dreams.
• Sexual disturbances (decreased sex drive, ejaculation failure, problems with erection, women may experience difficulties achieving orgasm or have abnormal orgasms).
• Tremor.
• Pins and needles.
• Dizziness.
• Changes in ability to concentrate.
• Migraine.
• Loss of memory.
• Changes in taste.
• Unusual noises or ringing in the ears (tinnitus).
• Runny nose, sinusitis, yawning.
• Vomiting, stomach ache, diarrhoea or constipation, flatulence (wind), increased saliva flow.
• Itchy skin (pruritis).
• Painful muscles or joints.
• Passing water (urine) less or more frequently than usual.
• Painful periods.
• Tiredness (fatigue).

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

• Increased appetite or weight gain.
• Aggression.
• Feeling detached from yourself (depersonalisation).
• Hallucination.
• Feeling very excited, with rushed thoughts and actions (mania).
• Feeling overly optimistic or cheerful (euphoria).
• Increased sex drive.
• Fainting or feeling faint.
• Abnormally large or dilated eye pupil.
• An unusually fast or slow heartbeat.
• Coughing.
• Small areas of red, swollen and itchy skin (urticaria).
• Hair loss.
• Rash.
• Purple spots or patches on the skin.
• Skin sensitivity to light.
• Difficulty in passing water (urine).
• Unusually heavy or long menstrual periods.
• Swelling of the feet and ankles.
• Generally feeling out-of-sorts or unwell.

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

• Low levels of sodium in the blood. Signs of this include feeling weak, being sick (vomiting) or cramps.
• Seizures (fits).
• Involuntary movements or twitching.
• Unusual bruising or bleeding, including vomiting blood or passing blood in your stools.
• Liver disorder.
• Fever.

Some patients have reported (frequency cannot be estimated from the available data):

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• Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
• Allergic reactions or allergic-like reactions.
• Increased or decreased levels of Antidiuretic Hormone (ADH) in the blood. This would show up on blood test results and be explained to you be your doctor.
• Low levels of potassium in the blood. Signs of this include feeling weak, painful muscles, cramps, or constipation.
• Panic attack.
• Clenching or grinding of the teeth during sleep.
• Restlessness.
• Suicidal thoughts or suicidal behaviour (e.g. thoughts of killing or harming yourself). See also section 2.
• Convulsions.
• A condition called “serotonin syndrome”. Signs of this include feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heart beat.
• Movement disorders resulting in an inability to sit or stand still (akathisia) or tics.
• Disturbances of vision.
• Low or high blood pressure.
• Bleeding from the nose.
• Bleeding in your stomach or gut.
• Abnormal liver test results. These will be explained by your doctor.
• Red or bluish-black discolouration just under the skin.
• Large areas of red, swollen and itchy skin (angioedema).
• Bleeding from the uterus (womb) that is not due to menstrual period.
• Persistent, painful erection (men).
• Discharge from the nipples (men).

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

Do not be concerned by this list of possible side effects. You may not get any of them.

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 <to be completed nationally>. By reporting side effects you can help provide more information on the safety of this medicine.

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 outer carton and blister after Exp. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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

What Citalopram Film-Coated Tablets contain

• The active substance is citalopram (as hydrobromide). Each tablet contains citalopram hydrobromide, equivalent to 10/ 20/ 40mg citalopram.

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• The other ingredients in the tablet core are, mannitol, microcrystalline cellulose, silica colloidal anhydrous and magnesium stearate; in the tablet coating hypromellose, titanium dioxide (E171) and macrogol.

What Citalopram Film-Coated Tablets look like and contents of the pack

Citalopram 10mg Film-Coated Tablets

A white, round coated tablet with ‘CT10’ on one side and blank on the other side

Citalopram 20mg Film-coated Tablets

A white, round coated tablet with ‘CT20’ on one side and a breakline on the other side.

Citalopram 40mg Film-coated Tablets

A white, round coated tablet with ‘CT40’ on one side and a breakline on the other side

Citalopram Tablets are available in blister packs of 10, 14, 20, 28, 30, 50, 56, 98, 100 & 100x1 tablets and tablet containers of 250 & 500 tablets.

Not all pack size may be marketed.

Citalopram 10 A, filmomhulde tabletten, is ingeschreven in het register onder nummer RVG 27621. Citalopram 20 A, filmomhulde tabletten, is ingeschreven in het register onder nummer RVG 27622. Citalopram 40 A, filmomhulde tabletten, is ingeschreven in het register onder nummer RVG 27623.

Marketing Authorisation Holder:

Arrow Generics Limited,

Unit 2, Eastman Way, Stevenage, Hertfordshire SG1 4SZ, Verenigd Koninkrijk

Manufacturer:

Arrow Pharm (Malta) Ltd. , HF 62, Hal Far Industrial Estate, Hal Far Malta

Arrow Generics, Unit 4 Willsborough Cluster, Clonshaugh Industrial Estate, Dublin 17, Ierland

Arrow Generics Limited, Eastman Way, Stevenage, Hertfordshire SG1 4SZ, Verenigd Koninkrijk

This medicinal product	the Member States of the EEA under the following
names:
NL: Citalopram 10A, 20A and	tabletten 10mg, 20mg and 40mg

UK: Citalopram 10mg, 20mg and 40mg Tablets

BE: Doc Citalopram 10mg, 20mg and 40mg filmomhulde tabletten

DE: Citalo-Q 10mg, 20mg and 40mg Film tabletten

DK/FI: Citalopram Arrow 10mg, 20mg and 40mg film-coated tablet

SE: Citalopram Arrow 10 mg, 20 mg and 40 mg filmdragerade tabletter

This leaflet was last revised in augustus 2013.

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