Exopex® contains the active substance escitalopram.

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

medicines act on the serotonin-system in the brain by increasing the serotonin level. Disturbances in the serotonin-system are considered an important factor in the development of depression and related diseases.

Exopex® is used to treat

-Depression (major depressive episodes).

-Anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder and obsessive -compulsive disorder).
It may take a couple of weeks before you start to feel better.
Continue to take Exopex®, even if it takes some

time before you feel any improvement in your condition.

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

feel worse.

a. Do not take Exopex®

•If you are allergic to Escitalopram or any of the other ingredients of Exopex®.

•If you take other medicines that belongs to a group called monoamine oxidase inhibitors (MAOIs), including selegiline (used in the treatment of Parkinsons 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.

b. Take special care with Exopex®

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 Exopex® should be stopped if seizures occur for the first time, or if there is an increase in the seizure frequency.

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

•If you have diabetes. Treatment with Exopex® may alter glycemic control. Insulin and/or oral hypoglycemic dosage may need to be adjusted.

•If you have a decreased level of sodium in the blood.

•If you have 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 diarrhea 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. 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 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 behavior 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 behavior.

Use in children and adolescents under 18 years of age

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 behavior and anger) when they take this class of medicines. Despite this, your doctor may

prescribe for patients under 18 because he/she decides that this is in their best interest. If your doctor has prescribed Exopex® for a patient fewer than 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 Exopex®. Also, the long term safety effects of Exopex® concerning growth, maturation and cognitive and behavioral development in this age group have not yet been demonstrated.

c. Taking other medicines, herbal or dietary supplements

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
This includes medicines that you can buy without a prescription, including herbal 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 Exopex® .
After stopping Exopex® 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). This may cause increased blood levels of Exopex® .

•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 bleedingtendency.

•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 Exopex® 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 Exopex® may need to be adjusted.

Do not take Exopex®
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 (phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (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.

d. Taking with food and drink

Exopex® can be taken with or without food.

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

e. Pregnancy and breast-feeding

Inform your doctor if you are pregnant or planning to become pregnant. Do not take if you are pregnant or breast-feeding, unless you and your doctor have discussed the risks and benefits involved.
If you take Exopex® during the last 3 months of your pregnancy you should be aware that the following effects may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties. If your newborn baby has any of these symptoms, please contact your doctor immediately. Make sure your midwife and/or doctor know you are on Exopex®.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Exopex® 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 Exopex® should never be stopped abruptly.

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

f. Driving and using machines

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

3.How to take Exopex®

Always take Exopex® 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 Exopex® 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 Exopex® 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 Exopex® 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 Exopex® 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 Exopex® 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 Exopex® 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)

Exopex® should not normally be given to children and adolescents.

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue to take Exopex® 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 Exopex® 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 Exopex® than you should

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

doctor or hospital.

If you forget to take Exopex®

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 Exopex®

Do not stop taking Exopex® until your doctor tells you to do so. When you have completed your course of treatment, it is generally advised that the dose of Exopex® is gradually reduced over a number of weeks. When you stop taking Exopex®, especially if it is abruptly, you may feel discontinuation symptoms. These are common when treatment with Exopex® is stopped. The risk is higher, when 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 Exopex®, 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, diarrhea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). If you have any further questions on the use of thisproduct, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, Exopex® 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 1000):

•Unusual bleeds, including gastrointestinal bleeds.

Rare (affects 1 to 10 users in 10000):

•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).

•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 Torsade de Pointes.

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

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

•Feeling sick (nausea)

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.

•Diarrhea, 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 1000):

•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 heartbeat.

•Swelling of the arms or legs.

•Nosebleeds.

Rare (affects 1 to 10 users in 10000):

•Aggression, depersonalisation, hallucination.

•Slow heart beat.

Some patients have reported (frequency

cannot be estimated from the available data):

•Thoughts of harming yourself or thoughts of killing yourself.

•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 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.
These are:

•Motor restlessness (akathisia).

•Anorexia.

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.

How to store Exopex®

-Keep this medicine out of the sight and reach of children.

-Do not store above 30°C.

-Do not use Exopex® after the expiry date, which is stated on the label or carton after EXP.

-The expiry date refers to the last day of the month.

-This medicine does not require any special storage conditions.

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