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PACKAGE LEAFLET: INFORMATION FOR THE USER

Escitalopram 5 mg film-coated tablets Escitalopram 10 mg film-coated tablets Escitalopram 15 mg film-coated tablets Escitalopram 20 mg film-coated tablets

Escitalopram

Read all of this leaflet carefully before you start

taking this medicine.

—    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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Escitalopram is and what it is used for

2.    Before you take Escitalopram

3.    How to take Escitalopram

4.    Possible side effects

5.    How to store Escitalopram

6.    Further information

1. WHAT ESCITALOPRAM IS AND WHAT IT IS USED FOR

Escitalopram film-coated tablets contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia which is fear of being in places where help might not be available, social anxiety disorder, generalised anxiety disorder and obsessive-compulsive disorder).

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.

2. BEFORE YOU TAKE ESCITALOPRAM

Do not take Escitalopram film-coated tablets

•    if you are allergic (hypersensitive) to escitalopram or any of the other ingredients of Escitalopram film-coated-tablets (see section 6 “Further information”).

•    if you take other medicines which belong to a group called MAO inhibitors, including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic).

•    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 “Taking other medicines”

Take special care with Escitalopram film-coated tablets

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 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 (the level of sugar in the blood). 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 (treatment by electroshock).

•    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

As with other medicines used to treat depression or related diseases, the improvement is not achieved immediately. After the start of escitalopram treatment it may take several weeks before you experience any improvement. 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.

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

Sometimes you may be unaware of the above-mentioned symptoms and therefore you may find it helpful to ask a friend or relative to help you to observe the possible signs of change in your behaviour.

Tell your doctor immediately or contact the nearest hospital if you have distressing thoughts or experiences or if any of the above-mentioned symptoms occurs during the treatment.

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 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 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.

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.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

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

•    ”Non-selective monoamine oxidase inhibitors (MAOIs)”, containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medicines you will need to wait 14 days before you start taking Escitalopram film-coated tablets. After stopping Escitalopram film-coated tablets you must allow 7 days before taking any of these medicines.

•    “Reversible, selective MAO-A inhibitors”, containing moclobemide (used to treat depression).

•    “Irreversible MAO-B inhibitors”, containing selegiline (used to treat Parkinson’s disease). These increase the risk of side effects.

•    The antibiotic linezolid.

•    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 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.

•    Acetylsalicylic acid (aspirin) and non-steroidal antiinflammatory drugs (medicines used for pain relief or to thin the blood, so called anti-coagulant).

•    Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so called anticoagulant). Your doctor will probably check the coagulation time of your blood when starting and discontinuing Escitalopram in order to verify 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) 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 film-coated tablets 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. phenophiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarian treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to you doctor.

Taking Escitalopram film coated- with food and drink

Escitalopram film-coated tablets 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 and breast-feeding Inform your doctor if you are pregnant or planning to become pregnant. Do not Escitalopram film-coated-tablets if you are pregnant 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 new-born 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 new-born baby has any of these symptoms, please contact your doctor immediately.

Make sure your midwife and/or doctor know you are on Escitalopram film-coated tablets. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Escitalopram film-coated tablets may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new-born (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.

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

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.

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

Driving and using machines

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

3. HOW TO TAKE ESCITALOPRAM

Always Escitalopram film-coated tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

Depression

The normally recommended dose of Escitalopram film-coated tablets is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.

Panic disorder

The starting dose of Escitalopram film-coated tablets is 5 mg as one daily dose for the first week before increasing the dose to 10 mg per day. The dose may be further increased by your doctor to a maximum of 20 mg per day.

Social anxiety disorder

The normally recommended dose of Escitalopram film-coated tablets is 10 mg taken as one daily dose. Your doctor can either decrease your dose to 5 mg per day or increase the dose to a maximum of 20 mg per day, depending on how you respond to the medicine. Generalised anxiety disorder

The normally recommended dose of Escitalopram film-coated tablets is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.

Obsessive-compulsive disorder

The normally recommended dose of Escitalopram film-coated tablets is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.

Elderly patients (above 65 years of age)

The recommended starting dose of Escitalopram film-coated tablets 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 film-coated tablets should not normally be given to children and adolescents. For further information please see section 2 “Before you take Escitalopram”.

You can take Escitalopram film-coated tablets with or without food. Swallow the tablet with some water. Do not chew them, as the taste is bitter.

If necessary, you can divide the tablets by firstly placing the tablet on a flat surface with the score facing upwards. The tablets may then be broken by pressing down on each end of the tablet, using both forefingers.

Duration of treatment

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

Do not change the dose of your medicine without talking to your doctor first.

Continue to take Escitalopram film-coated tablets for as long as your doctor recommends. If you stop your treatment too soon, your symptoms may return. It is recommended that treatment should be continued for at least 6 months after you feel well again.

If you take more Escitalopram than you should If you take more than the prescribed dose of Escitalopram film-coated tablets, 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 film-coated tablets box/container with you when you go to the doctor or hospital.

If you forget to take Escitalopram film-coated tablets

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.

If you stop taking Escitalopram film-coated tablets

Do not stop taking Escitalopram film-coated tablets 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 film-coated tablets 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 film-coated tablets, please contact your doctor. He or she may ask you to start taking your tablets again and come off them 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Escitalopram film-coated tablets 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.

See your doctor if you get any of the following side effects during treatment:

Uncommon (affects 1 to 10 users in 1,000):

•    Unusual bleeds, including gastrointestinal bleeds Rare (affects 1 to 10 users in 10,000):

•    If you experience swelling of skin, tongue, lips, or face, or have difficulties breathing or swallowing (allergic reaction), contact your doctor or go to a hospital straight away.

•    If you have a high fever, agitation, confusion, trembling and abrupt contractions of muscles these may be signs of a rare condition called serotonin syndrome. If you feel like this, contact your doctor.

If you experience the following side affects you should contact your doctor or go to the hospital straight away:

•    Difficulties urinating

•    Seizures (fits), see also section Take special care with Escitalopram film-coated tablets

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

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

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

Very common (affects more than 1 user in 10):

•    Feeling sick (nausea)

•    Headache

Common (affects 1 to 10 users in 100):

•    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 (affects 1 to 10 users in 1,000):

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

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

•    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

•    Nosebleeds

Rare (affects 1 to 10 users in 10,000):

•    Aggression, depersonalisation, hallucination

•    Slow heart beat

•    Suicide-related events, see also section “Take special care with Escitalopram“

Some patients have reported (frequency not known):

•    Thoughts of harming yourself or thoughts of killing yourself (cases of suicidal ideation and suicidal behaviours) have been reported during escitalopram (the active ingredient of Escitalopram film-coated tablets) therapy or early treatment discontinuation, see also section “Take special care with Escitalopram”)

•    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 test (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 (ecchymosis) and low level of blood platelets (thrombocytopenia)

•    Sudden swelling of skin or mucosa (angioedemas)

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

•    Flow of milk in women that are not nursing

•    Mania

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

•    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)

•    Anorexia

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE ESCITALOPRAM

Keep out of the reach and sight of children.

Do not use Escitalopram film-coated tablets after the expiry date, which is stated on the blister or carton after EXP. The expiry date refers to the last day of the month. This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Escitalopram film-coated tablets contains

The active substance is escitalopram. Each Escitalopram film-coated tablet contains 5 mg, 10 mg, 15 mg or 20 mg escitalopram (as oxalate).

The other ingredients are:

Tablet core:

Cellulose, microcrystalline (E460), Croscarmellose sodium (E468), Magnesium Stearate (E572), Colloidal Anhydrous Silica and Talc Tablet coating:

Hypromellose (E464), Titanium dioxide (E171), Macrogol 400

What Escitalopram film-coated tablets looks like and contents of the pack

Escitalopram film-coated tablets is presented as 5 mg, 10 mg, 15 mg and 20 mg film-coated tablets.

The tablets are described below.

5 mg: White to off-white, circular, biconvex, film coated tablets with ‘E 1’ debossed on one side and plain on the other side.

10 mg: White to off-white, oval, biconvex, film coated tablets with ‘E 2’ debossed on one side and scoreline on the other side. The tablet can be divided into equal halves.

15 mg: White to off-white, oval, biconvex, film coated tablets with ‘E 3’ debossed on one side and scoreline on the other side. The tablet can be divided into equal halves.

20 mg: White to off-white, oval, biconvex, film coated tablets with “E 4” debossed on one side and scoreline on the other side. The tablet can be divided into equal halves.

The tablets are packed in either plain Aluminium/ Aluminium blisters or clear PVC-Aclar/Aluminium blisters

Escitalopram film-coated tablets is available in the following pack sizes:

5 mg film-coated tablets Blister: 14, 20, 28, 50 and 100 10 mg film-coated tablets Blister: 14,20, 28, 50 and 100 15 mg film-coated tablets Blister: 20, 28, 50 and 100 20 mg film-coated tablets Blister: 14, 20, 28, 50 and 100 Not all pack sizes may be marketed

Marketing Authorisation Holder

Glenmark Pharmaceuticals Europe Limited Laxmi House, 2 B Draycott Avenue,

Kenton, Middlesex HA3 0BU,

United Kingdom

Manufacturer

Glenmark Pharmaceuticals Europe Limited.

Building 2, Croxley Green Business Park,

Croxley Green Hertfordshire, WD18 8YA United Kingdom

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b, 140 78 Prague 4,

Czech Republic

Tillomed Laboratories Limited 3 Howard Road, Eaton Socon,

St. Neots, Cambridgeshire, PE19 8ET United Kingdom

This leaflet was last approved in April 2014

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