Package leaflet: Information for the patient

Distesap 20 mg/ml oral drops, solution Escitalopram

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.

What is in this leaflet

1.    What Distesap is and what it is used for

2.    What you need to know before you take Distesap

3.    How to take Distesap

4.    Possible side effects

5.    How to store Distesap

6.    Contents of the pack and other information

1. What Distesap is and what it is used for

Distesap belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). SSRIs 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.

Distesap contain escitalopram which is used to treat:

•    depression (major depressive episodes)

•    anxiety disorders (such as panic disorder with or without agoraphobia (fear of crowds/bridges/the outdoors), social anxiety disorder, generalised anxiety disorder and obsessive-compulsive disorder).

2. What you need to know before you take Distesap Do not take Distesap:

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

•    if you take other medicines that belong to a group called monoamine oxidase inhibitor (MAO inhibitors), including selegiline (treatment of Parkinson's disease), moclobemide (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”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Distesap. Please tell your doctor if you have any of the following conditions or illness, as your doctor may need to take this into consideration:

•    if you have epilepsy. Distesap 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 have any thoughts of suicide or self harm. Please see the sub-heading below; ‘Thoughts of suicide and worsening of your depression or anxiety disorder’

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

•    if you have diabetes. Treatment with Distesap 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 are under the age of 18 years

•    if you have a history of mania or manic depression

•    if you have a tendency to easily develop bleedings or bruises

•    if you are taking any other medication including herbal medications. Please see sub-heading below; ‘Other medicines and Distesap’

•    if you are receiving electroconvulsive treatment (ECT)

•    if you suffer from angle-closure glaucoma or have a history of glaucoma.

•    if you have a coronary heart disease

•    if you are pregnant or breastfeeding

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

The sensations of restlessness or difficulty in sitting or standing still (akathisia) can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.

If you have a panic disorder you may experience increased anxiety symptoms at the beginning of your 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 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

•    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 immediately.

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.

Children and adolescents

Distesap 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 (predominantly aggression, oppositional behaviour and anger) when they take this type of medicines. Despite this, your doctor may prescribe Distesap for patients under 18 because he/she decides that this is in their best interest. If your doctor has prescribed Distesap 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 Distesap. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Distesap in this age group have not yet been demonstrated.

Other medicines and Distesap

Tell your doctor if you are taking or have recently taken or might take any other medicines. 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 Distesap. After stopping Distesap you must allow 7 days before taking any of these medicines.

•    Reversible selective MAO-A inhibitors containing moclobemide (used in the treatment of depression).

•    Irreversible MAO-B inhibitors containing selegiline (used in the treatment of Parkinson’s disease). These increase the risk of side effects.

•    The antibiotic linezolid.

•    Lithium (used in the treatment of manic-depressive disorder) and tryptophan (amino acid).

•    Other medications used in the treatment of depression such as tricyclic antidepressants or other selective serotonin reuptake inhibitors (SSRI’s) such as Imipramine desipramine and fluvoxamine.

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

•    Cimetidine and omeprazole (used to treat stomach ulcers or dyspepsia (indigestion)) and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of Distesap.

•    St. John's Wort (Hypericum perforatum), a herbal remedy used for depression.

•    Aspirin and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood, so called anticoagulants). Warfarin, dipyridamole and phenprocoumon (medicines used to thin the blood, so called anticoagulants). Your doctor will probably check the coagulation time of your blood when starting and discontinuing Distesap in order to verify that your dose of anticoagulant is still adequate.

•    Mefloquin (used to treat malaria), tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRI’s), bupropion (used to treat depression), tramadol (used to treat severe pain) and Neuroleptics (medicines to treat schizophrenia, psychosis) due to a possible risk of a lowered threshold for seizures.

•    Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine, and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of Distesap 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 Distesap 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 (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.

Distesap with food and drink and alcohol

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

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

Pregnancy, breast-feeding and fertility

Inform your doctor if you are pregnant or planning to become pregnant. Do not take Distesap if you are pregnant or breast-feeding, unless you and your doctor have discussed the risks and benefits involved.

If you take Distesap 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, blueish 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 Distesap. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Distesap 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 Distesap should never be stopped abruptly.

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 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.

Driving and using machines

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

Distesap contains ethanol

This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 20 drops. Each drop contains 4.8 mg ethanol (alcohol).

3. How to take Distesap

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

Count the required number of drops into your drink (water, orange or apple juice), stir it briefly and then drink all of it.

Do not mix the Distesap with liquids other than water, orange or apple juice and do not mix them with other medicinal products.

Adults

Depression

The recommended dose of Distesap is 10 mg (10 drops) taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg (20 drops) per day.

Panic disorder

The starting dose of Distesap is 5 mg (5 drops) per day for the first week before increasing the dose to 10 mg (10 drops) per day. Your doctor may increase the dose to a maximum of 20 mg (20 drops) per day.

Social anxiety disorder

The recommended dose of Distesap is 10 mg (10 drops) taken as one daily dose. Your doctor may decrease your dose to 5 mg (5 drops) per day or increase the dose to a maximum of 20 mg (20 drops) per day, depending on how you respond to the medicine.

Generalised anxiety disorder

The recommended dose of Distesap is 10 mg (10 drops) taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg (20 drops) per day.

Obsessive-compulsive disorder

The recommended dose of Distesap is 10 mg (10 drops) taken as one daily dose. Your doctor may increase by your dose to a maximum of 20 mg (20 drops) per day.

Elderly patients (above 65 years of age)

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

Use in children and adolescents

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

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue to take Distesap 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 Distesap 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.

If you take more Distesap than you should

If you take more than the prescribed dose of Distesap contact your doctor or nearest hospital emergency department immediately. Do this even if there are no signs of discomfort. Possible 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 Distesap box/container with you when you go to the doctor or hospital.

If you forget to take Distesap

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 Distesap

Do not stop taking Distesap until your doctor tells you to do so. When you have completed your course of treatment, it is generally advised that the dose of Distesap is gradually reduced over a number of weeks.

When you stop taking Distesap, especially if it is abruptly, you may feel the following symptoms:

• 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).

These are common when treatment with Distesap is stopped. The risk is higher when Distesap 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 Distesap, please contact your doctor. He or she may ask you to start taking your drops again and come off them more slowly.

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

4. 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.

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

•    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.

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

Uncommon (may affect up to 1 in 100 people}:.

•    Unusual bleeds, including gastrointestinal bleeds and rectal 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).

•    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.

In addition to 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)

•    altered appetite, weight increase

•    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)

•    feeling tired (fatigue), fever

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

•    altered vaginal bleeding

•    weight loss

•    fast heart beat (tachycardia)

•    swelling of the arms or legs

•    nosebleeds.

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

•    aggression, depersonalisation, seeing or hearing things that are not real (hallucination)

•    slow heart beat (bradycardia).

Not Known (frequency cannot be estimated from the available data):

•    thoughts of harming yourself or thoughts of killing yourself, see also section “Warnings and precautions”

•    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) and ECG (electrocardiogram) readings

•    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 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 Distesap). These are:

•    motor restlessness the urge or need to move to stop an unpleasant sensation (akathisia)

•    poor appetite (anorexia)

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

5.    How to store Distesap

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 label or carton after EXP. The expiry date refers to the last day of that month.

After first opening, the drops should be used within 8 weeks, do not store above 25°C.

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

6.    Contents of the pack and other information What Distesap contains

The active substance is escitalopram. Each ml Distesap contains 20 mg escitalopram (as 25.55 mg escitalopram oxalate).

1 drop contains 1 mg escitalopram.

The other ingredients are propyl gallate, anhydrous citric acid, ethanol 96%, sodium hydroxide, purified water.

What Distesap looks like and contents of the pack

Distesap oral drops solution is a clear, nearly colourless to yellow solution presented in a brown glass bottle containing 15 ml, with a dropper applicator.

Marketing Authorisation Holder:

Pharmacare S.r.l.,

Via Marghera, 29 20149 Milan Italy

Manufacturer:

Doppel Farmaceutici S.r.l.

Via Martiri delle Foibe,1 29016 Cortemaggiore (PC)

Italy

This medicinal product is authorised in the Member States of the EEA under the following names

United Kingdom:    Distesap 20 mg/ml oral drops, solution

Italy:    Escitalopram Mylan Generics

This leaflet was last revised in 04/2013

- 8 -