Escitalopram 5 mg film-coated tablets

• 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 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. See section 4.

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

• if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
• if you take 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).
• 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 film-coated tablets”

Talk to your doctor or pharmacist before taking Escitalopram film-coated tablets.

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 escitalopram 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 escitalopram may alter glycaemic control (the level of sugar in the blood). 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 (treatment by electroshock).
• 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.
• if you have or have previously had eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
• if you have history of bleeding disorders, or if you are pregnant (see Pregnancy, breast-feeding and fertility)

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.

Medicines like Escitalopram film-coated tablets (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

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.

Use in 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 attempts, suicidal thoughts and hostility (predominately 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 interest. 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 symptoms listed above 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.

Tell your doctor or pharmacist if you are taking, 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 Escitalopram film-coated tablets. After stopping Escitalopram 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.
• Buprenorphine (a type of opioid medicine). These medicines may interact with Escitalopram film-coated tablets and increase the risk of serotonin syndrome, a potentially life-threatening condition. You may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
• Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of escitalopram.
• St. John's Wort (Hypericum perforatum) - a herbal remedy used for depression.
• Acetylsalicylic acid (aspirin) 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 Escitalopram in order to verify that your dose of anti-coagulant is still adequate.
• Mefloquine (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) and antidepressants (tricyclic antidepressants and SSRIs) 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 Escitalopram film-coated tablets 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 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 (e.g.astemizole, hydroxyzine, mizolastine). If you have any further questions about this you should speak to you doctor.

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

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

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. Do not take Escitalopram film-coated-tablets if you are pregnant or breast-feeding unless you and your doctor have discussed the risks and benefits involved.

If you take Escitalopram during the last 3 months of your pregnancy you should be aware that the following effects may be seen in your new-born 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 new-born baby has any of these symptoms, please contact your doctor immediately.

Make sure your midwife and/or doctor know you are on Escitalopram film-coated tablets. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Escitalopram film- coated tablets may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new-born (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 you take Escitalopram film-coated tablets near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Escitalopram film-coated tablets so they can advise you.

If used during pregnancy escitalopram should never be stopped abruptly.

It is expected that Escitalopram film-coated tablets will be excreted into breast milk.

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

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

Escitalopram film-coated tablets contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

Depression

The normally recommended dose of Escitalopram 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 Escitalopram 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 Escitalopram 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 Escitalopram 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 Escitalopram 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.

The recommended starting dose of Escitalopram film-coated tablets is 5 mg taken as one daily dose. The dose may be increased by your doctor to 10 mg per day.

Escitalopram film-coated tablets should not normally be given to children and adolescents. For further information please see section 2 “Warnings and precautions”.

Reduced kidney function

Caution is advised in patients with severely reduced renal function. Take as prescribed by your doctor.

Reduced liver function

Patients with liver complaints should not receive more than 10 mg per day. Take as prescribed by your doctor.

Patients known to be poor metabolisers of the enzyme CYP2C19

Patients with this known genotype should not receive more than 10 mg per day. Take as prescribed by your doctor.

How to take Escitalopram film-coated tablets

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

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.

It may take a couple of weeks before you start to feel better. Continue to take Escitalopram 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 Escitalopram 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 than the prescribed dose of Escitalopram 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 Escitalopram film-coated tablets box/container with you when you go to the doctor or hospital.

Do not take a double dose to make up for a 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.

Do not stop taking Escitalopram 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 Escitalopram film-coated tablets is gradually reduced over a number of weeks.

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 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 get any side effects, talk to you doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is escitalopram. Each Escitalopram film-coated tablet contains 5 mg, 10 mg or 20 mg escitalopram (as oxalate).

The other ingredients are:

Tablet core:

Cellulose, microcrystalline (E460), Croscarmellose sodium (E468), Magnesium Stearate (E572), Colloidal Anhydrous Silica and Talc

Tablet coating:

Hypromellose (E464), Titanium dioxide (E171), Macrogol 400

Escitalopram film-coated tablets is presented as 5 mg, 10 mg and 20 mg film-coated tablets.

The tablets are described below.

5 mg: White to off-white, circular, biconvex, film coated tablets with ‘E 1’ debossed on one side and plain on the other side.

10 mg: White to off-white, oval, biconvex, film coated tablets with ‘E 2’ debossed on one side and scoreline on the other side. The tablet can be divided into equal halves.

20 mg: White to off-white, oval, biconvex, film coated tablets with “E 4” debossed on one side and scoreline on the other side. The tablet can be divided into equal halves.

The tablets are packed in either plain Aluminium/Aluminium blisters or clear PVC-Aclar/Aluminium blisters

Escitalopram film-coated tablets is available in the following pack sizes:

5 mg film-coated tablets

Blister: 14, 20, 28, 50, 100 and 200

10 mg film-coated tablets

Blister: 14, 20, 28, 50, 56, 100 and 200

20 mg film-coated tablets

Blister: 14, 20, 28, 50, 56, 100 and 200

Not all pack sizes may be marketed