Auteur: Teva


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1. WHAT FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

<product name>film-coated tablets belong 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.

<product name>film-coated tablets contain escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalised anxiety disorder and obsessive-compulsive disorder).

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2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE

Do not take <product name>film-coated tablets

  • if you are allergic (hypersensitive) to escitalopram or any of the other ingredients of <product name>film-coated tablets (see section 6 “ Contents of the pack and other information”).
  • If you take other medicines that belongs 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 “Other medicines and<product name>”)

Warnings and preacutions

Talk to your doctor or pharmacist before taking<product name>:

  • if you have epilepsy. Treatment with <product name>film-coated tablets 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 <product name >film-coated tablets 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

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 to sit or stand 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 or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourselves. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

  • If you have previously had thoughts about killing or harming yourself.
  • If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were

treated with an antidepressant.

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

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Use in children and adolescents under 18 years of age

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

Other medicines and <product name>

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

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 <product name> film- coated tablets. After stopping <product name> 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 <product name> film-coated tablets.
  • St. John's Wort (hypericum perforatum) - a herbal remedy used for depression.
  • Acetylsalicylic acid 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 <product name> film-coated tablets 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 cardio-vascular diseases) clomipramine, and

nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of <product name> film-coated tablets may need to be adjusted.

Do note take <Product name> film-coated tablets 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-malarian treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.

Taking <product name> film-coated tablets with food and drink

<product name> film-coated tablets can be taken with or without food (see section 3 “How to take <product name> film-coated tablets”).

As with many medicines, combining <product name> film-coated tablets with alcohol is not advisable, although <product name> ra film-coated tablets is not expected to interact with alcohol.

Fertility, pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take <product name> film-coated tablets if

you are pregnant or 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.

If you take <product name> film-coated tablets 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, blue- ish 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 <product name> film-coated tablets. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like <product name> film-coated tablets 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 <product name> film-coated tablets should never be stopped abruptly.

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 <product name> film- coated tablets affects you.

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3. HOW YOU TAKE FILM-COATED TABLETS

Always take <product name> 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 <product name> 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 <product name> 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 <product name> 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 <product name> 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 <product name> 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 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)

<product name> film-coated tablets should not normally be given to children and adolescents. For further information please see section 2 “Before you take <product name> film-coated tablets”.

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

<PRODUCT NAME>10 mg film-coated tablets, <PRODUCT NAME>20 mg film-coated tablets 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 as shown in the drawing.

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue to take <product name> 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 <product name> 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 <product name>film-coated tablets than you should

If you take more than the prescribed dose of <product name> 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 <product name> film-coated tablets box/container with you when you go to the doctor or hospital.

If you forget to take <product name>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 <product name>film-coated tablets

Do not stop taking <product name> 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 <product name> film- coated tablets is gradually reduced over a number of weeks.

When you stop taking <product name> film-coated tablets, especially if it is abruptly, you may feel discontinuation symptoms. These are common when treatment with <product name> film-coated tablets is stopped. The risk is higher, when <product name> film-coated tablets 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 <product name> 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.

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Like all medicines, <product name> 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.

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

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

  • Unusual bleeds, including gastrointestinal bleeds

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

  • 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.

Some patients have reported (frequency can not be estimated from the available data )

  • Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as Torsades de Pointes .
  • Difficulties urinating
  • Seizures (fits), see also section Warnings and precautions
  • Yellowing of the skin and the white in the eyes are signs of liver function impairment/hepatitis

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

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

  • Feeling sick (nausea)

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

  • Aggression, depersonalisation, hallucination
  • Slow heart beat

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

  • Thoughts of harming yourself or thoughts of killing yourself, see also section “Take special care with <product name>film-coated tablets”
  • 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 (thrombycytopenia)
  • 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 medicines.
  • Alteration of the heart rhrythm (called “pronlongation 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 <product name>film-coated tablets). These are:

  • Motor restlessness (akathisia)
  • Anorexia

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

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5. HOW TO STORE

<product name>film-coated tablets should be kept out of the sight and reach of children. Do not store above 25°C. Store in the original package in order to protect from moisture. Do not use the drug after the expiry date which is printed on the blister and carton after the abbreviation EXP.

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What <product name>film-coated tablets contain

The active substance is Escitalopram. Each <product name>tablet contains 5 mg, 10 mg, 15 mg or 20 mg escitalopram (as oxalate).

  • The other ingredients are:

Core: microcrystalline cellulose, colloidal silica anhydrous, croscarmellose sodium, stearic acid and magnesium stearate.

Coating: hypromellose (E464), macrogol 400, and titanium dioxide (E171) .

What <product name>looks like and contents of the pack

<product name>5 mg is a white, film-coated tablet, marked “93” on one side and “7414” on the other.

<product name>10 mg is a white, film-coated tablet, scored on one side and marked “9” on one side and “3” on the other. The other side of the tablet is marked“7462”.The tablet can be divided into equal halves.

<product name>15 mg is a white, film-coated tablet, scored on one side and marked “S” on one side and “C” on the other. The other side of the tablet is marked “15”.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

<product name>20 mg is a white, film-coated tablet, scored on one side and marked “9” on one side and “3” on the other. The other side of the tablet is marked “7463”.

The tablet can be divided into equal halves.

<product name>comes in blister packs of 7, 14, 20, 28, 30, 49, 50, 56, 60, 90, 98, 100, 200 and 500 filmcoated tablets and perforated unit dose blister 49x1, 50x1, 100x1 and 500x1 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

{Name and address to be completed nationally}

This leaflet was last revised in

[ ] The changes highlighted in yellow are pending as part of the submitted variation HU/H/0179/001-004/IB/009/G

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