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This PIL has been prepared by Victor Design on behalf of RESOLUTION Chemicals, United Kingdom. The text has been revsed (27.02.2013). Fonts and dimensions remain as previous

Colours for 10 mg is PANTONE 1795

Please refer to this leaflet as ESCITALOPRAM 10 MG Proposed PLPI PIL V1

170 mm

-

PACKAGE LEAFLET: INFORMATION FOR THE USER

Escitalopram 10 mg film-coated tablets

(Escitalopram oxalate)

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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

The name of your medicine is Escitalopram 10 mg

film-coated tablets but will be referred to as

Escitalopram throughout this leaflet.

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.    Possible side effects

5.    How to store Escitalopram

6.    Contents of the pack and other information

1 WHAT ESCITALOPRAM IS AND WHAT IT IS USED FOR

Escitalopram is a selective serotonin reuptake inhibitor (SSRIs) and belongs to a group of medicines known as antidepressants. These medicines help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness.

Escitalopram film-coated tablets contains Escitalopram and are used for the treatment of depression and when you feel better, to help prevent these symptoms recurring.

y WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESCITALOPRAM

Do not take Escitalopram

•    if you are allergic (hypersensitive) to escitalopram or any of the other ingredients of this medicine (see section 6 of this leaflet). Consult your doctor if you think you might be.

•    if you are also taking a medicine containing pimozide. Talk to your doctor.

•    at the same time as taking medication known as monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide (used for the treatment of depression), selegiline (used in the treatment of Parkinson's disease) and linezolid (an antibiotic). Even if you have finished taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine you will need to wait 2 weeks before you start taking your Escitalopram tablets. One day must elapse after you have finished taking moclobemide. After stopping Escitalopram you must allow 1 week before taking any MAOI.

Warnings and precautions

Talk to your doctor or pharmacist before taking Escitalopram if you have:

•    Liver disease

•    Kidney disease.

•    Diabetes (you may need an adjustment of your antidiabetic therapy).

•    Epilepsy or history seizures or fits.

•    A bleeding disorder or have ever suffered from bleeding in the stomach or intestine.

•    Mania (rapidly changing ideas, exaggerated moods or behaviour) or panic disorder.

•    Low blood levels of sodium

•    Electroconvulsive therapy (ECT)

•    Problems with your eyes, such as certain kinds of glaucoma.

Please consult your doctor, even if these statements were applicable to you at any time in the past.

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.

Special information relating to your disease

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. n the beginning of the treatment certain patients may experience increased anxiety, which will disappear during 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.

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 (less than 25 years old) 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 not be used for children and adolescents under 18 years. Also, you should know that patients under the age of 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Escitalopram for patients under 18 because he/she decides that this is in their best interests. 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 of the symptoms listed above develop or worsen when patients under 18 are taking escitalopram tablets. Also the long-term safety effects concerning growth, maturation and cognitve and behavioural development of escitalopram in this age group have not yet been demonstrated.

Other medicines and Escitalopram

Medicines may affect the action of other medicines and this can sometimes cause serious adverse reactions. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription during the last 14 days. This includes other medicines for depression (see Do not take Escitalopram above).

•    The herbal remedy St John's wort (Hypericum perforatum). This should not be taken at the same time as Escitalopram.

•    "Monoamine oxidase inhibitors (MAOIs)" used to treat e.g. depression. These should not be taken at the same time as Escitalopram

(see "Do not take Escitalopram").

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

•    Linezolid (an antibiotic).

•    Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you feel unwell when using these medicines with Escitalopram you should see your doctor.

•    Lithium (used to prevent and treat mania) and tryptophan (an anti-depressant)

•    Pimozide (a neuroleptic). This should not be taken at the same time as Escitalopram (see Do not take Escitalopram above).

•    Imipramine and desipramine (used to treat depression).

•    Medicines containing selegiline (used to treat Parkinson's disease).

•    Cimetidine (used to treat stomach ulcers).

•    Mefloquine (used for the treatment and prevention of malaria)

•    Bupropion (used to treat depression).

•    Medicines known to affect the blood platelets (e.g. anticoagulant drugs used to treat or prevent blood clots; acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used as pain killers and some antipsychotic drugs and tricyclic antidepressants).

•    Metoprolol, a beta-blocker used to treat migraine, some heart conditions and high blood pressure. The effects of either drug could be increased, decreased or altered.

•    Neuroleptics (used in the treatment of schizophrenia).

Taking Escitalopram with food and drink

Escitalopram can be taken with or without food. As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment although Escitalopram has not been shown to increase the effects of alcohol.

Fertility, pregnancy and breast-feeding Fertility

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.

Pregnancy

Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant, think you might be pregnant, or are trying to become pregnant, tell your doctor. Do not take Escitalopram if you are pregnant unless you and your doctor have discussed the risks and benefits involved.

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. Also, if you take Escitalopram during the last 3 months of your pregnancy and until the date of birth you should be aware that the following effects may 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.

Breast-feeding

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

If you are breast-feeding, ask your doctor for advice. You should not breast-feed your baby when taking Escitalopram because small amounts of the medicine can pass into the breast milk.

Driving and using machines

Escitalopram 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.

HOW TO TAKE ESCITALOPRAM

Always take Escitalopram exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. It might be several weeks before you start to feel better. Do not stop taking your medicine or change your dose without talking to your doctor first. You should keep taking your tablets for as long as your doctor tells you to, even if you start to feel better. If you don't start to feel better after a couple of weeks, go back to your doctor. He/she may decide to increase your dose gradually, up to the maximum daily dose of 20 mg. The safety of daily doses above 20 mg has not been shown.

The usual dose of escitalopram is given below. Your doctor will tell you how long you need to take your tablets for. This could be several months or longer.

You can take your tablets with or without food. Take your medicine once each day. Swallow the tablets with a drink of water. The tablet can be divided into equal halves. Do not chew them.

...continued overleaf

170 mm

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The usual daily dose is 10 mg. The dose may be increased by your doctor up to a maximum of 20 mg.

Elderly people

Treatment should start with half the usual dose and the maximum daily dose might be less than 20 mg.

Children and adolescents under 18 years

Escitalopram should not be used in the treatment of children and adolescents under the age of 18 years. See section 2 of this leaflet, Use in children and adolescents under 18 years of age.

Patients with liver disease

If you have liver disease, your doctor might decide that you need a lower starting dose of escitalopram than usual (e.g. 5 mg of escitalopram). The maximum daily dose is 10 mg.

Patients with kidney disease

If you suffer from severe kidney disease use of escitalopram is not recommended. If you have mild or moderate kidney disease, you can use the normal dose of escitalopram.

Duration of treatment

Like other medicines for depression and panic disorder these tablets may take a few weeks before you feel any improvement. Continue to take Escitalopram even if it takes some time before you feel any improvement in your condition.

The duration of treatment is individual, usually at least 6 months. Continue to take the tablets for as long as your doctor recommends. Do not stop taking them even if you begin to feel better, unless you are told to do so by your doctor. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms may return.

Patients who have recurrent depression benefit from continued treatment, sometimes for several years, to prevent the occurrence of new depressive episodes.

Never change the dose of the medicine without talking to your doctor first.

If you take more Escitalopram than you should

If you think that you or anyone else may have taken too many Escitalopram tablets contact your doctor or nearest hospital emergency department immediately. Do this even if there are no signs of discomfort or poisoning. Take the Escitalopram carton with you if you go to a doctor or hospital. Some of the signs of an overdosage could be life-threatening.

Symptoms of overdosage may include:

Irregular heart beat Seizures

Changes in heart rhythm Feeling sick (nausea)

Vomiting

Sweating

Drowsiness

Unconsciousness

Fast heart beats

Tremor

Changes in blood pressure Serotonin syndrome (see Section 4)

Agitation

Dizziness

Enlarged eye pupils Bluish skin Breathing too quickly

If you forget to take Escitalopram

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

Effects when treatment with Escitalopram is stopped

Stopping this medicine quickly may cause symptoms such as dizziness, nausea and numbness or tingling in hands or feet, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling or being sick, sweating, feeling restless or agitated, tremor, feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). These are usually non-serious and disappear within a few days. When you have completed your course of treatment, the dose of Escitalopram is usually reduced gradually over a couple of weeks.

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

POSSIBLE SIDE EFFECTS

Like all medicines, escitalopram can have side effects and some people may experience unwanted effects (side effects) whilst taking Escitalopram. Several of the effects listed below can also be symptoms of your illness and may disappear as you start to get better.

Serious side effects

Stop taking Escitalopram and seek medical advice immediately if you have any of the following allergic reactions (frequency of this side effect cannot be estimated from the available data):

•    Difficulty in breathing.

•    Swelling of the face, lips, tongue or throat that causes difficulty in swallowing or breathing.

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

If you notice any of the following you should contact your doctor or go to nearest hospital immediately as your dose may need to be reduced or stopped:

You start having fits for the first time or fits that you have suffered from in the past become more frequent (the frequency of this side effect cannot be estimated from the available data).

Your behaviour changes because you feel elated or over excited (the frequency of this side effect cannot be estimated from the available data).

You experience high fever, agitation, confusion, trembling or abrupt contractions of muscles. These may be signs of a rare condition called serotonin syndrome (the frequency of this side effect cannot be estimated from the available data). Tiredness, confusion and twitching of your muscles. These may be signs of a low blood level of sodium (this side effect may affect up to 1 in 1,000 people).

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

The following side effects are often mild and usually disappear after a few days' treatment.

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

•    Sleepiness

•    Difficulty in sleeping

•    Increased sweating

•    Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to clean your teeth more often that usual)

•    Feeling sick (nausea)

Common side effects may affect up to 1 in 10 people:

•    Lack of appetite

•    Agitation

•    Decreased sex drive

•    Anxiety

•    Nervousness

•    Confusion

•    Abnormal dreams

•    Tremor

•    Tingling or numbness in the hands or feet

•    Ringing in the ears (tinnitus)

•    Yawning

•    Diarrhoea

•    Vomiting

•    Constipation

•    Itching

•    Pain in muscles and joints

•    For men, problems with ejaculation and erection

•    For females, failing to reach an orgasm

•    Tiredness

•    Prickling of the skin

•    Loss of weight

•    Sinusitis (blocked or running nose)

Uncommon side effects may affect up to 1 in 100 people:

•    Bruising easily

•    Increased appetite

•    Aggression

•    Reduced emotions, indifference

•    Hallucinations

•    Mania

•    Fainting

•    Large pupils (the dark centre of the eye)

•    Fast heart beat

•    Slow heart beat

•    Nettle rash

•    Loss of hair

•    Rash

•    Sensitivity to sunlight

•    Difficulties urinating

•    Vaginal bleeding

•    Swelling of the arms or legs

•    Increased weight

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

•    Convulsions

•    Involuntary movements

•    Taste disturbances

•    Bleeding

•    Hepatitis

Some patient have reported (frequency can not

be estimated from the available data)

•    Thoughts of harming or killing themselves

•    An increase in bleeding or bruising caused by a decrease in blood platelets

•    Rash (hypersensitivity)

•    Low potassium levels in the blood (hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythms

•    Panic attack

•    Grinding teeth

•    Restlessness

•    Unusual muscle movements or stiffness

•    Involuntary movements of the muscles (akathisia)

•    Low blood pressure

•    Nosebleed

•    Bleeding disorders including skin and mucosal bleeding (ecchymosis)

•    Sudden swelling of skin or mucosa

•    In men, painful erections

•    Flow of breast milk in men or in women who are not breast-feeding (galactorrhoea)

•    Abnormal liver function tests

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

SSRIs can, very rarely, increase the risk of bleeding, including stomach or intestinal bleeding. Let your doctor know if you vomit blood or develop black or blood stained stools.

Also let your doctor know if you continue to have other symptoms associated with your depression. This might include hallucinations, anxiety, mania or confusion.

Any side effects that do occur will usually disappear after a few days. If they are troublesome or persistent, or if you develop any other unusual side effects while taking Escitalopram, please tell your doctor.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

©HOW TO STORE ESCITALOPRAM TABLETS

Keep out of the sight and reach of children.

Do not store above 30°C. Store in the original package.

Do not use Escitalopram after the expiry date which is printed on the blister and carton after EXP. If your tablets become discoloured or show any other signs of deterioration, please seek advice from your pharmacist.

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.

©CONTENTS OF THE PACK AND OTHER INFORMATION

What Escitalopram contains

The active ingredient is escitalopram.

Each tablet contains 10 mg escitalopram (as oxalate).

The other ingredients in the tablet core are microcrystalline cellulose, colloidal silica anhydrous, croscarmellose sodium, stearic acid, magnesium stearate.

The tablet cores are covered with a white film-coating, Opadry-Y-1-7000H white, containing hypromellose (E464), titanium dioxide (E171) and macrogol 400.

What Escitalopram looks like and contents of the pack

Escitalopram 10mg film-coated tablets are round, white, scored, film-coated tablets marked with "9" and "3" on each side of the score on one side of the tablet and debossed with"7462" on the other side of the tablet.

The tablet can be divided into equal halves.

Each carton contains 28 tablets.

POM

PL 10321/0201

This product is manufactured by TEVA Operations Poland Sp. zo.o., ul. Sienkiewicza 25, 99-300 Kutno, Poland and is procured from within the EU and repackaged by the Product Licence Holder:

Resolution Chemicals Ltd.,

Stevenage, Herts., SG1 4QT, UK

This leaflet was last revised 27th February 2013

RESOLUTION