PACKAGE LEAFLET: INFORMATION FOR THE USER

ESCITALOPRAM 5 MG, 10 MG AND 20 MG FILM-COATED TABLETS

Eight important things you need to know about Escitalopram

Please read all of the leaflet. It includes a lot of additional important information about this medicine.

*    Escitalopram treats depression. Like all medicines it can have unwanted effects.

It is therefore important that you and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting treatment.

*    Escitalopram is not for use in children and adolescents under 18. See section 2, Use in children and adolescents under 18 years of age, inside this leaflet.

*    Escitalopram won’t work straight away. Some people taking antidepressants feel worse before feeling better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you haven’t started feeling better. See section 3, How to take escitalopram, inside this leaflet.

*    Some people who are depressed think of harming or killing themselves. If you start to feel worse, or think of harming or killing yourself, see your doctor or go to a hospital straight away. See section 2 Thoughts of suicide and worsening of your depression, inside this leaflet.

*    Don’t stop taking escitalopram without talking to your doctor. If you stop taking escitalopram suddenly or miss a dose, you may get withdrawal effects. See section 4, Stopping escitalopram, inside this leaflet.

*    If you feel restless and feel like you can’t sit or stand still, tell your doctor. Increasing the dose of escitalopram may make these feelings worse. See section 5, Possible side effects, inside this leaflet.

*    Taking some other medicines with escitalopram can cause problems. You may need to talk to your doctor. See section 2 Other medicines and escitalopram, inside this leaflet.

*    If you are pregnant or planning to get pregnant, talk to your doctor. See section 2 Pregnancy, breastfeeding and fertility, inside this leaflet.

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 escitalopram is and what it is used for

2.    What you need to know before you take escitalopram

3.    How to take escitalopram

4.    Stopping escitalopram

5.    Possible side effects

6.    How to store escitalopram

7.    Contents of the pack and other information

1. WHAT ESCITALOPRAM IS AND WHAT IT IS USED FOR

The name of your medicine is Escitalopram 5mg, 10mg and 20mg film-coated tablets (called escitalopram throughout this leaflet). It contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines act 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.

Escitalopram is a medicine for the treatment of depression (major depressive episodes).

It may take a couple of weeks before you start to feel better. Continue to take escitalopram even if it takes some time before you feel any improvement in your condition.

You must talk to a doctor if you do not feel better or if you feel worse.

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2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESCITALOPRAM

Do not take escitalopram

*    if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in the section 6).

*    if you are taking medicines called monoamine oxidase inhibitors (MAOIs), including moclobemide, selegiline and linezolid.

*    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 section 2 “Other medicines and escitalopram”).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine. Please tell your doctor if you have any other condition or illness, as your doctor may need to take this into consideration. In particular, tell your doctor:

*    if you have epilepsy. Treatment with escitalopram should be stopped if seizures occur for the first time, or if there is an increase in the seizure frequency (see also section 4 “Possible side effects").

*    if you suffer from impaired liver or kidney function. Your doctor may need to adjust your dosage.

*    if you have diabetes. Treatment with escitalopram may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.

*    if you have a decreased level of sodium in the blood.

*    if you have a tendency to easily develop bleedings or bruises.

*    if you are receiving electroconvulsive treatment.

*    if you have coronary heart disease.

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

*    if you have or have previously had eye problems, such as certain kinds of glaucoma (increased pressure in the eye). Please note

Some patients with manic-depressive illness may enter into a manic phase. This is characterized by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.

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

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 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 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.

Use in children and adolescents under 18 years of age

Escitalopram 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 escitalopram for patients under 18 because he/she decides that this is in their best interest. If your doctor has prescribed escitalopram 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 escitalopram. Also, the long term safety effects concerning growth, maturation and cognitive and behavioural development of escitalopram in this age group have not yet been demonstrated.

Other medicines and escitalopram

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

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

*    Monoamine oxidase inhibitors (MAOIs), containing phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, moclobemide, selegiline and the antibiotic linezolid. If you have taken any of these medicines you will need to wait 14 days before you start taking escitalopram. After stopping escitalopram you must allow 7 days before taking any of these medicines.

*    Lithium (used in the treatment of manic-depressive disorder) and tryptophan.

*    Imipramine and desipramine (both used to treat depression).

*    Sumatriptan and similar medicines (used to treat migraine) and tramadol (used against severe pain). These increase the risk of side effects.

*    Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of escitalopram.

*    St. John's Wort (hypericum perforatum) - a herbal remedy used for depression.

*    Acetylsalicyclic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood, so called anti-coagulant). These may increase bleeding tendency.

*    Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so called anti-coagulant). Your doctor will probably check the coagulation time of your blood when starting and discontinuing escitalopram in order to check that your dose of anti-coagulant is still adequate.

*    Mefloquin (used to treat Malaria), bupropion (used to treat depression) and tramadol (used to treat severe pain) due to a possible risk of a lowered threshold for seizures.

*    Neuroleptics (medicines to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to a possible risk of a lowered threshold for seizures, and antidepressants.

*    Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine, and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of escitalopram may need to be adjusted.

*    Medicines that decrease blood levels of potassium or magnesium, as these conditions increase the risk of life threatening heart rhythm disorders.

Do not take escitalopram if you take medicines for heart rhythm problems or medicines that may affect the heart’s rhythm, such as Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment, particularly halofantrine), certain antihistamines (e.g.astemizole, mizolastine).

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

Escitalopram with food, drink and alcohol

Escitalopram can be taken with or without food (see section 3 “How to take escitalopram”).

As with many medicines, combining escitalopram with alcohol is not advisable, although escitalopram is not expected to interact with alcohol.

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. Do not take escitalopram if you are pregnant or breast-feeding, unless you and your doctor have discussed the risks and benefits involved.

If you take escitalopram during the last 3 months of your pregnancy you should be aware that the following effects may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties. If your newborn baby has any of these symptoms, please contact your doctor immediately.

Make sure your midwife and/or doctor know you are on escitalopram. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like escitalopram 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 used during pregnancy escitalopram should never be stopped abruptly.

It is expected that escitalopram will be excreted into breast milk.

Citalopram, a medicine like escitalopram, 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

You are advised not to drive a car or operate machinery until you know how escitalopram affects you.

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3. HOW TO TAKE ESCITALOPRAM

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

Unless otherwise prescribed by the doctor, the recommended dose for adults is:

10 mg of escitalopram once daily. If necessary, your doctor can increase the dose. The maximum recommended dose is 20 mg of escitalopram once daily.

Swallow the tablet whole with some water. You can take the tablet with or without food.

Escitalopram 10mg/ 20mg Film-coated Tablets can be divided into equal doses.

Elderly patients (above 65 years of age)

The recommended starting dose of escitalopram is 5 mg taken as one daily dose. The dose may be increased by your doctor to 10 mg per day.

Children and adolescents (below 18 years of age)

Escitalopram should not normally be given to children and adolescents. For further information please see section 2 “What you need to know before you take escitalopram”.

Patients with liver function disorders

The recommended daily dose for patients with liver function disorders is 5 mg of escitalopram once daily. After 2 weeks your doctor may increase the dose to 10 mg of escitalopram once daily.

Patients with mild to moderate kidney function disorders

No dose adjustment is necessary if you suffer from mild or moderate kidney function disorders.

Patients with severe kjdnev function disorders

Patients with severe kidney function disorders should only take escitalopram after consulting their doctor.

How long should you continue to take escitalopram

Your doctor will determine how long you should continue to take escitalopram. As with other medicines for the treatment of depression, it may take some weeks until you start to feel better. Continue to take the tablets even if it takes a while until you feel better.

In any event you should speak to your doctor in advance before you make any changes to the dose.

Duration of treatment varies. Continue to take the film-coated tablets as your doctor has prescribed, even if you are already feeling better. If you stop taking the tablets too early, your symptoms may return. Therefore, treatment should be continued for at least six months after your symptoms have subsided.

If you take more escitalopram than you should

If you take more than the prescribed dose of escitalopram, contact your doctor or nearest hospital emergency department immediately. Do this even if there are no signs of discomfort. Some of the signs of an overdose could be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, change in heart rhythm, decreased blood pressure and change in body fluid/salt balance. Take the escitalopram box/container with you when you go to the doctor or hospital.

If you forget to take escitalopram

Do not take a double dose to make up for forgotten doses. If you do forget to take a dose, and you remember before you go to bed, take it straight away. Carry on as usual the next day. If you only remember during the night, or the next day, leave out the missed dose and carry on as usual.

4. STOPPING ESCITALOPRAM

You should speak to your doctor in advance before you stop taking escitalopram. Please inform your doctor if you wish to stop treatment early.

Do not stop taking escitalopram until your doctor tells you to do so. When you have completed your course of treatment, it is generally advised that the dose of escitalopram is gradually reduced over a number of weeks. When you stop taking escitalopram, especially if it is abruptly, you may feel discontinuation symptoms. These are common when treatment with escitalopram is stopped. The risk is higher, when escitalopram 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 escitalopram, please contact your doctor. He or she may ask you to start taking your tablets again and reduce the dose more slowly.

Discontinuation symptoms include: Feeling dizzy (unsteady or off-balance), feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling sick (nausea), sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations).

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

5. POSSIBLE SIDE EFFECTS

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

Stop taking escitalopram and see a doctor or go to a hospital straight away if you get:

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

•    unusual bleeds, including gastrointestinal bleeds Rare (may affect up to 1 in 1000 people):

•    swelling of skin, tongue, lips, or face, or have difficulties breathing or swallowing (allergic reaction).

•    a high fever, agitation, confusion, trembling and abrupt contractions of muscles. These may be signs of a rare condition called serotonin syndrome.

Talk to a doctor straightaway if you notice any of the following side effects (frequency not known):

•    Difficulties urinating

•    Seizures (fits), see also section 2 “Warnings and precautions”

•    Yellowing of the skin and the white in the eyes (signs of liver function impairment/hepatitis)

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

•    Thoughts of harming yourself or thoughts of killing yourself (see also section 2 “What you need to know before you take escitalopram”).

In addition to the above, the following side effects have been reported:

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

•    Feeling sick (nausea)

•    Headache

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

•    Blocked or runny nose (sinusitis)

•    Decreased or increased appetite

•    Anxiety, restlessness, abnormal dreams, difficulties falling asleep, feeling sleepy, dizziness, yawning, tremors, prickling of the skin

•    Diarrhoea, constipation, vomiting, dry mouth

•    Increased sweating

•    Pain in muscle and joints (arthralgia and myalgia)

•    Sexual disturbances (delayed ejaculation, problems with erection, decreased sexual drive and women may experience difficulties achieving orgasm)

•    Fatigue, fever

•    Increased weight

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

•    Nettle rash (urticaria), rash, itching (pruritus)

•    Grinding one’s teeth, agitation, nervousness, panic attack, confusion

•    Disturbed sleep, taste disturbance, fainting (syncope)

•    Enlarged pupils (mydriasis), visual disturbance, ringing in the ears (tinnitus)

•    Loss of hair

•    Vaginal bleeding

•    Decreased weight

•    Fast heart beat

•    Swelling of the arms or legs

•    Nose bleeds

Rare (may affect up to 1 in 1000 people):

•    Aggression, depersonalisation, hallucination

•    Slow heart beat

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

•    Decreased levels of sodium in the blood (the symptoms are feeling sick and unwell with weak muscles or confused)

•    Dizziness when you stand up due to low blood pressure (orthostatic hypotension)

•    Abnormal liver function tests (increased amounts of liver enzymes in the blood)

•    Movement disorders (involuntary movements of the muscles)

•    Painful erections (priapism)

•    Bleeding disorders including skin and mucous bleeding (bruising) and low level of blood platelets (thrombycytopenia)

•    Sudden swelling of skin or mucosa (angioedemas)

•    Increase in the amount of urine excreted (inappropriate ADH secretion)

•    Flow of milk in men and women that are not nursing

•    Mania

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

•    Alteration of the heart rhythm (called “prolongation of QT interval”, seen on ECG, electrical activity of the heart)

In addition, a number of side effects are known to occur with drugs that work in a similar way to escitalopram (the active ingredient of Escitalopram film-coated tablets). These are:

•    Motor restlessness (akathisia)

•    Loss of appetite

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 at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

6. HOW TO STORE ESCITALOPRAM

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 the blister (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.

7. CONTENTS OF THE PACK AND OTHER INFORMATION

What Escitalopram 5mg, 10mg and 20mg film-coated tablets contains

The active substance is escitalopram.

One film-coated tablet contains 5 mg, 10 mg or 20 mg escitalopram (as escitalopram oxalate).

The other ingredients are:

•    Tablet core: Microcrystalline cellulose (E460), croscarmellose sodium (E468), silica, colloidal anhydrous, magnesium stearate (E470b).

•    Tablet film coating: Hypromellose (E464), titanium dioxide (E171), macrogol 400.

What Escitalopram 5mg, 10mg and 20mg film-coated tablets look like and contents of the pack

Escitalopram 5 mg film-coated tablets are white to off-white, round, biconvex, film-coated tablets.

Escitalopram 10mg and 20mg film-coated tablets are white to off-white, oval shaped film-coated tablets with a break line on one side.

Escitalopram are available in packs of 7, 10, 14, 20, 28, 30, 50, 56, 98, 100 (blister packs) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Manufacturer

HBM Pharma s.r.o., Sklabinska 30, 03680 Martin, Slovakia.

This leaflet was last revised in 07/2014

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Brand: ESCITALOPRAM 5MG, 10MG AND 20MG FILM-COATED TABLETS

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Artwork Approval

Reason for Circulation:

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Signature:

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