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Escitalopram 5mg Film-coated Tablets Escitalopram 10mg Film-coated Tablets Escitalopram 15mg Film-coated Tablets Escitalopram 20mg Film-coated Tablets

Active substance: Escitalopram

What is in this leaflet:

1.    What Escitalopram is and what it is used for

2.    What you need to know before you take Escitalopram Tablets

3.    How to take Escitalopram Tablets

4.    Possible side effects

5.    How to store Escitalopram Tablets

6.    Contents of the pack and other information

1.    What Escitlaopram is and what it is used for

Escitalopram is an antidepressant which belongs to the ‘SSRI’ group (selective serotonin reuptake inhibitors). 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.

Escitalopram is used to treat:

-    Depressive disorders (episodes of a major depression)

-    Panic disorder with or without agoraphobia (e.g. fear of leaving the house, entering shops, being in crowds and in public places)

2.    What you need to know before you take Escitalopram Tablets Do not take Escitalopram

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

-    if you are taking 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) at the same time (see “Other medicines and Escitalopram”).

-    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 Escitalopram”)

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Escitalopram

Please tell your doctor if you:

-    have kidney diseases.

-    have heart problems (coronary heart disease).

-    suffer from impaired liver function. Your doctor may need to adjust your dosage.

-    have diabetes, treatment with Escitalopram can change the blood sugar levels. The dose of insulin or of oral antidiabetic agents might have to be adjusted.

-    have epilepsy or have had seizures or fits in the past. If seizures occur during treatment, or if seizures become more frequent the medicine should be discontinued.

-    have a previous history of mania/hypomania (pathologically elevated mood). A manic phase is characterised by profuse and rapidly changing ideas, exaggerated gaiety and excessive physical activity. If you think you may have entered a manic phase, it is important to contact your doctor.

-    have had episodes of psychosis (delusions, hallucinations, severe thought disturbances, abnormal changes in mood or abnormal behaviour).

-    have a decreased level of sodium in the blood.

-    are receiving electroconvulsive treatment.

-    have a tendency to easily develop bleedings or bruises or are at the same time taking medicines which affect the clotting of the blood such as acetylsalicylic acid (painkillers), non-steroidal anti- inflammatory medicines (painkillers), some antipsychotic agents (atypical antipsychotic agents and phenothiazines) or most tricyclic antidepressants. The risk is also increased if ticlopidine, dipyridamole (both medicines to reduce the risk of thrombosis) or oral anticoagulants (medicines to inhibit blood clotting) are being taken concurrently.

-    suffer or have suffered from heart problems or have recently had a heart attack

-    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)

-    experience a fast or irregular heartbeat, fainting, collapse or dizziness on standing up, which may indicate abnormal functioning of the heart rate

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.

Symptoms such as restlessness or difficulty to sit or stand still can occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.

Caution is indicated if Escitalopram is taken concurrently with medicines with a serotonergic effect, such as sumatriptan, other triptans, tramadol or tryptophan. In rare cases, a serotonin syndrome can occur not only in combination with other serotonergic medicines but has also been reported rarely in patients using SSRIs. If you have symptomes such as high fever, muscular twitching, feeling confused, restless, shaking, or shivering with this combination, please consult your doctor. If these symptoms occur, the treatment with Escitalopram and the serotonergic medication should be discontinued immediately and a doctor called to start symptomatic treatment.

The administration of Escitalopram concurrently with St. John’s Wort preparations (Hypericum perforatum) should be avoided, because of the increased danger of side effects (see “Taking other medicines”).

If the treatment with Escitalopram is being discontinued, the dose should be tapered off gradually over one to two weeks to avoid any possible withdrawal symptoms (see “How to take Escitalopram Tablets”).

Children and adolescents

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 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 in this leaflet 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.

Other medicines and Escitalopram

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

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. 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.

The following medicines can influence the effect of Escitalopram, or their effects can be influenced by it. Please tell your doctor if you are taking any of the following medicines:

-    Irreversible, non-selective monoamine oxidase inhibitors (MAOIs) medicines to treat for example depression, must not be taken with Escitalopram as this combination can lead to serious side effects, including the serotonin syndrome (see “Do not take Escitalopram, and Possible side effects”). If you have taken any of these medicines you will need to wait at least 14 days before you start taking Escitalopram. After stopping Escitalopram you must wait at least 7 days before you start taking any of these medicines.

-    Reversible, selective MAO-A inhibitors, containing moclobemide (used to treat depression) must not be taken with Escitalopram (see “Do not take Escitalopram”).

-    Linezolid, a antibiotic, must not be taken with Escitalopram (see “Do not take Escitalopram”).

-    Irreversible MAO-B inhibitors, containing selegiline (used to treat Parkinson’s disease) must not be taken with Escitalopram. These increase the risk of side effects such as serotonin syndrome (see “Do not take Escitalopram”).

-    Sumatriptan (a medicine to treat migraine), other triptans or tramadol (painkiller) can increase the risk of side effects such as serotonin syndrome.

-    Antidepressants (tricyclics, SSRIs), neuroleptics (antipsychotic medicines such as phenothiazines, thioxanthenes and butyrophenone), mefloquine (antimalarial medicine), bupropion (a medicine to help you quit smoking) and tramadol (a pain killer) due to a possible risk of a lowered threshold for seizures.

-    Lithium (for the treatment of bipolar disorder or manic depression) and tryptophan (a dietary supplement which is converted to serotonin during metabolism).

-    St. John’s Wort (Hypericumperforatum) a herbal remedy used for depression can increase the risk of side effects (see ‘Warnings and precautions’).

-    Medicines which affect the clotting of the blood such as acetylsalicylic acid (painkillers), non-steroidal anti-inflammatory medicines (painkillers), some antipsychotic agents (atypical antipsychotic agents and phenothiazines) or most tricyclic antidepressants. The risk is also increased if ticlopidine, dipyridamole (both medicines to reduce the risk of thrombosis) or oral anticoagulants (medicines to inhibit blood clotting) are being taken concurrently._Your doctor will probably check the coagulation time of your blood when starting and discontinuing Escitalopram in order to verify that your dose of anticoagulant is still adequate.

-    Cimetidine, omeprazole, esomeprazole and lansoprazole (used to treat stomach ulcers), fluvoxamine (antidepressant) and ticlopidine (a blood clotting medicine). These may cause increased blood levels of Escitalopram. The dosage of Escitalopram may need to be adjusted.

-    The dosage of Escitalopram may need to be adjusted if given at the same time as flecainide, propafenone and metoprolol (medicine for high blood pressure and heart disease), desipramine, clomipramine, nortryptiline (antidepressants) and risperidone, thioridazine and haloperidol (antipsychotic).

Escitalopram with food, drink and alcohol

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

As with other similar medicines, combining Escitalopram with alcohol is not advisable, although escitalopram is not expected to interact with alcohol.

Pregnancy, breast-feeding and fertility

Pregnancy

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.

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.

You should not discontinue treatment with Escitalopram abruptly. If you are taking Escitalopram in the last 3 months of pregnancy, let your doctor know as your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They might include not being able to sleep or feed properly, trouble with breathing, a blue-ish skin or being too hot or cold, being sick, crying a lot, vomiting, low blood sugar, stiff or floppy muscles, irritability, lethargy, tremors, jitters or fits. If your baby has any of these symptoms when it is born, talk to your doctor immediately who will be able to advise you.

Breast-feeding

Escitalopram is likely to pass into breast milk. There is a risk of an effect on the baby. It is therefore recommended that you do not breastfeed if you are having treatment with Escitalopram. Discuss with your doctor the risks and benefits involved.

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.

Driving and using machines

Do not drive or operate machinery until you know how Escitalopram affects you. Do not work without secure support.

3. How to take Escitalopram Tablets

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

Unless the doctor has prescribed otherwise, the usual dose is:

To treat depression

The recommended daily dose is 10 mg taken as one daily dose. Depending on your response, the dose can be adjusted by your doctor up to a maximum of 20 mg per day.

To treat panic disorders, with or without agoraphobia

The recommended daily dose in the first week of treatment is 5 mg and later on 10 mg per day.

Depending on your response, the dose can be adjusted by your doctor up 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.

Use in 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 special risk factors

The initial dose for patients with impaired liver function should not exceed 5 mg daily in the first 14 days. The doctor giving treatment can then raise the daily dose, depending on the patient’s individual response, up to 10 mg daily. Caution and an especially careful dose titration are indicated in patients with severely impaired liver function.

With mild to moderate impairment of kidney function, no dose adjustment is required. Caution is indicated with severely impaired kidney function (creatinine clearance below 30 ml/min).

Patients who are known to have a reduced metabolic conversion via CYP2C19 (specific liver enzyme) should be treated with an initial daily dose of 5 mg in the first two weeks. Depending on the patient’s individual response, the dose can be raised to 10 mg daily.

How and when to take Escitalopram Escitalopram 5mg Film-coated Tablets:

Please take the film-coated tablets once daily, swallowed whole with sufficient fluid (preferably a glass of water). Escitalopram may be taken with or without food.

Escitalopram 10, 15 and 20mg Film-coated Tablets:

Please take the film-coated tablets once daily, swallowed whole with sufficient fluid (preferably a glass of water). Escitalopram may be taken with or without food.

If necessary, tablets may be broken 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.

How long to take Escitalopram

As with all medicines to treat depression and panic disorder, it can take few weeks (2 - 4 weeks) before you notice an improvement. Therefore, you should continue taking Escitalopram even if it takes some time before you see your condition improving.

Never alter the dosage without first discussing it with your doctor.

In treating panic disorder, with or without agoraphobia, the maximum effect is achieved after about 3 months.

The total duration of treatment varies greatly from one individual to another and is determined by your doctor. Please keep to this period even if you are already feeling better or free from symptoms, in order to avoid another deterioration or the recurrence of the illness. Therefore, the recommendation is to continue treating the depression for at least 6 months after the symptoms have regressed.

The treatment of panic disorder lasts several months.

Please talk to your doctor or pharmacist if you have the impression that the effect of Escitalopram is too strong or too weak.

If you take more Escitalopram than you should

If you have taken more Escitalopram than you should, or if someone else has taken your medicine by mistake, inform your doctor or go to a hospital straight away. Do this even if you still feel well. Take any remaining tablets as well as the box/container with you, even if this is empty.

Symptoms of overdose might include dizziness, shaking, restlessness, feeling sleepy, falling unconscious, change in heart rhythm, fits, hypoventilation, muscle weakness, tenderness or pain and feeling unwell or have a high temperature (rhabdomyolysis), change in body fluid/salt balance, vomiting and being sick.

If you forget to take Escitalopram

If you forget to take a dose of Escitalopram, just take Escitalopram as usual the next time and do not take double the prescribed dose.

If you stop taking Escitalopram

If you want to interrupt the treatment, please discuss this with your doctor beforehand. He might need to take appropriate measures. Do not stop taking the medicine on your own initiative without discussing this with your doctor. When stopping treatment with Escitalopram, your doctor will gradually reduce your dose over a number of weeks or months. This should help reduce the possibility of withdrawal effects.

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, 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 and/or vomiting), 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 medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency of the side effects listed below is defined using the following convention:

very common: more than 1 user in 10

common:    1    to    10 users in    100

uncommon:    1    to    10 users in    1,000

rare:    1    to    10 users in    10,000

very rare:    less than 1 user in 10,000

not known: frequency cannot be estimated from the available data

Side effects most commonly occur in the first or second week of treatment, and normally become less severe and less frequent as treatment continues.

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

Uncommon:

-    Unusual bleeds, including bleeding in the stomach and intestine Rare:

-    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.

If you experience the following side effects 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 heart beat, 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:

-    feeling sick (nausea)

Common:

-    Anxiety, restlessness, abnormal dreams, difficulty in sleeping, sleepiness, dizziness, a skin sensation, such as burning, prickling, itching, or tingling, with no apparent physical cause, tremor, yawning.

-    Decreased libido, women may fail to orgasm, men may experience_reduction in sexual interest, delayed ejaculation and erection_problems.

-    Diarrhoea, constipation, vomiting, dry mouth.

-    Blocked or runny nose (sinusitis),

-    Increased sweating.

-    Fatigue, fever

-    Joint and muscle pain.

-    Increased weight, decreased or increased appetite.

Uncommon:

-    Involuntary grinding or clenching of the teeth, agitation, nervousness, panic attack, confusion state.

-    Taste disturbance, sleep disorder, fainting.

-    Nosebleed.

-    Bleeding from the uterus that is not associated with menstruation, abnormally heavy or extended menstrual flow.

-    Nettle rash (urticaria), rash, itching (pruritus).

-    Hair loss.

-    Swelling of the arms or legs

-    Enlarged pupils (mydriasis), blurred vision, ringing in the ears (tinnitus).

-    Fast heart beat.

-    Decreased weight

Rare:

Aggression, depersonalisation, hallucination.

Slow heart beat

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

Mania

-    Thoughts of harming yourself or thoughts of killing yourself (See also section ‘Warnings and precautions’)

-    Movement disorders (involuntary movements of the muscles)

" Inability to sit still or remain motionless, feeling of restlessness associated with increased movement

-    Flow of milk in women that are not nursing

-    Painful erection of the penis.

-    Bleeding disorders including skin and mucous bleeding (ecchymosis) and low level of

-    blood platelets (thrombocytopenia)

-    Drop in blood pressure on sudden change of position from lying down to standing.

-    Decreased levels of sodium in the blood (the symptoms are feeling sick and unwell with weak muscles or confused)

" Loss of appetite

-    Change in the amount of urine excreted (inappropriate ADH secretion)

-    Abnormal liver function test (increased amounts of liver enzymes in the blood)

-    Sudden swelling of skin or mucosa (angioedemas)

-    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)

These side effects have been reported for the therapeutic class of SSRIs

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

5.    How to store Escitlopram Tablets

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 blister / tablet container and carton after Expiry date. The expiry date refers to the last day of that month.

Blister pack (PVC/PVDC/aluminium): Do not store above 25 °C.

Blister pack (Aluminium/Aluminium): This medicinal product does not require any special storage conditions.

Tablet container: Do not store above 30 °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 Escitalopram Tablets contains:

The active substance is escitalopram. Each film-coated tablet contains escitalopram oxalate equivalent to 5 mg, 10 mg, 15 mg or 20mg escitalopram.

The other ingredients are: tablet core: microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, talc, magnesium stearate; coating: hypromellose 6cP, titanium dioxide (E 171), macrogol 6000.

What Escitalopram Tablets look like and contents of the pack:

Escitalopram 5mg: Round, biconvex, white film-coated tablet (diameter 6 mm) with ‘E’ engraved on one face.

Escitalopram 10mg: Oval, biconvex, white film-coated tablet (6.4 x 9.25 mm) with ‘E’ engraved on one face, a score on the other face and side scores. The tablet can be divided into equal halves.

Escitalopram 15mg: Oval, biconvex, white film-coated tablet (7.3 x 10.6 mm) with ‘E’ engraved on one face, a score on the other face and side scores. The tablet can be divided into equal halves.

Escitalopram 20mg: Oval, biconvex, white film-coated tablet (8 x 11.7 mm) with ‘E’ engraved on one face, a score on the other face and side scores. The tablet can be divided into equal halves.

Escitalopram Tablets are available in PVC/PVDC/aluminium or aluminium/aluminium blister in packs of 14, 20, 28, 30,50, 56, 60, 100, 200 tablets and polyethylene tablet container with a polyethylene cap with 100 tablets (5, 10, 15 and 20 mg) and 200 tablets (only 5 mg and 10 mg).

Marketing Authorisation Holder

Actavis Group PTC ehf Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland

Manufacturer

Actavis hf.

Reykjavikurvegur 78 220 Hafnafjordur Iceland

Actavis Ltd.

B16 Bulebel Industrial Estate

Zejtun ZTN 08

Malta

This leaflet was last revised in January 2013

If you would like a leaflet with larger text, please contact 01271 311257.

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Actavis, Barnstaple, EX32 8NS, UK

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