Escitalopram Simphar

Package Leaflet: Information for the User

Escitalopram Symphar, 5 mg, film-coated tablets

Escitalopram Symphar, 10 mg, film-coated tablets

Escitalopram Symphar, 20 mg, film-coated tablets

Escitalopram

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• You should 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. See section 4.

Contents of the pack

• 1. What Escitalopram Symphar is and what it is used for
• 2. What you need to know before you take Escitalopram Symphar
• 3. How to take Escitalopram Symphar
• 4. Possible side effects
• 5. How to store Escitalopram Symphar
• 6. Contents of the pack and other information

1. What Escitalopram Symphar is and what it is used for

Escitalopram Symphar contains the active substance escitalopram. Escitalopram Symphar belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines work by increasing the levels of serotonin in the brain. Escitalopram Symphar is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder). It may take a few weeks before you start to feel better. You should continue to take Escitalopram Symphar even if you start to feel better. If you do not feel better or if your condition worsens, you should tell your doctor.

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

Do not take Escitalopram Symphar

• 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 that belong to a group called MAOIs (including selegiline, moclobemide, and linezolid);
• if you are born with or have had a heart condition that affects your heart rhythm;
• if you take medicines that affect your heart rhythm.

Warnings and precautions

Before you start taking Escitalopram Symphar, tell your doctor if you have:

• epilepsy or have had seizures in the past;
• liver or kidney disease;
• diabetes;
• low sodium levels in your blood;
• a tendency to bleed easily or if you are taking medicines that thin your blood;
• if you are pregnant or breast-feeding (see section "Pregnancy, breast-feeding, and fertility");
• if you are treated with electroconvulsive therapy;
• if you have coronary heart disease or have had a heart attack;
• if you have had heart problems or have had a heart attack recently;
• if you have a slow heart rate or if you have a condition that affects your heart rhythm;
• if you have a condition that affects your heart rhythm, such as irregular heartbeat, fainting, collapse, or dizziness when standing up;
• if you have eye problems, such as certain types of glaucoma.

Special warnings

Some patients with bipolar disorder (manic-depressive illness) may enter into an manic phase when taking antidepressants. This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If you experience these symptoms, you should contact your doctor immediately.

In the first few weeks of treatment, you may experience anxiety or difficulty sitting or standing still. If you experience these symptoms, you should contact your doctor immediately.

Medicines like Escitalopram Symphar (SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety

Patients with depression or anxiety may sometimes have thoughts of harming themselves or committing suicide. These thoughts may be more frequent when first taking antidepressants, as these medicines start to work usually after 2 weeks, and sometimes later. These thoughts are more likely to occur:

• if you have had thoughts of harming yourself or committing suicide before;
• 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 experience any of these symptoms, you should contact your doctor immediately.

It may be 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 can 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.

Children and adolescents

Escitalopram Symphar should not be given to children and adolescents under the age of 18. Also, be aware that patients under 18 are at increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (especially aggression, oppositional behavior, and anger) when they take this class of medicines.

Escitalopram Symphar with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You should also tell your doctor if you are taking any of the following medicines:

• non-selective MAOIs (including phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine);
• reversible MAOIs (such as moclobemide);
• irreversible MAOIs type B (such as selegiline);
• antibiotics (such as linezolid);
• lithium (used to treat bipolar disorder) and tryptophan;
• imipramine and desipramine (used to treat depression);
• sumatriptan and similar medicines (used to treat migraine) and tramadol (used to treat severe pain). These medicines may increase the risk of side effects;
• cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce blood clotting). These medicines may increase the levels of escitalopram in your blood;
• St. John's Wort (a herbal remedy used to treat depression);
• aspirin and non-steroidal anti-inflammatory drugs (used to treat pain or inflammation);
• warfarin, dipyridamole, and phenprocoumon (used to thin the blood);
• mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the risk of lowering the seizure threshold;
• antipsychotics (used to treat schizophrenia) and antidepressants (tricyclic antidepressants and SSRIs) due to the risk of lowering the seizure threshold;
• flecainide, propafenone, and metoprolol (used to treat heart conditions), clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Escitalopram Symphar may be necessary;
• medicines that lower potassium or magnesium levels in the blood, due to the increased risk of life-threatening heart rhythm disorders.

Do not take Escitalopram Symphar with medicines that affect your heart rhythm, such as:

• anti-arrhythmic drugs (class IA and III), antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, and certain antibiotics (such as sparfloxacin, moxifloxacin, erythromycin given intravenously, pentamidine, antimalarial drugs, especially halofantrine).

Escitalopram Symphar with food, drink, and alcohol

Escitalopram Symphar can be taken with or without food (see section 3). As with many medicines, it is recommended to avoid taking Escitalopram Symphar with alcohol, although no special precautions are required.

Pregnancy, breast-feeding, and fertility

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. You should not take Escitalopram Symphar if you are pregnant or breast-feeding unless you have discussed this with your doctor. If you take Escitalopram Symphar during the last 3 months of your pregnancy, your newborn baby might have some problems, such as difficulty breathing, bluish skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness, increased reflexes, tremors, jitteriness, irritability, lethargy, and constant crying. If your baby has any of these symptoms, you should contact your doctor. You should tell your doctor if you are taking Escitalopram Symphar and become pregnant or are planning to have a baby. Taking Escitalopram Symphar, especially in the last 3 months of pregnancy, may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and may turn blue. These symptoms usually occur in the first 24 hours after the baby is born. If your baby has any of these symptoms, you should contact your doctor. Taking Escitalopram Symphar at the end of pregnancy may increase the risk of heavy bleeding in the mother after delivery, especially if the mother has a history of bleeding disorders. If you take Escitalopram Symphar, you should tell your doctor or midwife. It is thought that Escitalopram Symphar passes into breast milk. Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces the quality of sperm. This could affect fertility, although this has not been observed in humans yet.

Driving and using machines

You should not drive or use machines until you know how Escitalopram Symphar affects you.

Escitalopram Symphar contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Escitalopram Symphar

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

Depression

The recommended dose of Escitalopram Symphar is 10 mg per day. The dose may be increased by your doctor to a maximum of 20 mg per day.

Panic disorder

The initial dose of Escitalopram Symphar is 5 mg per day for the first week, then increased to 10 mg per day. The dose may be increased by your doctor to a maximum of 20 mg per day.

Social anxiety disorder

The recommended dose of Escitalopram Symphar is 10 mg per day. Your doctor may reduce the dose to 5 mg per day or increase it to a maximum of 20 mg per day, depending on your response to the medicine.

Generalized anxiety disorder

The recommended dose of Escitalopram Symphar is 10 mg per day. The dose may be increased by your doctor to a maximum of 20 mg per day.

Obsessive-compulsive disorder

The recommended dose of Escitalopram Symphar is 10 mg per day. The dose may be increased by your doctor to a maximum of 20 mg per day.

Elderly patients (over 65 years)

The recommended initial dose of Escitalopram Symphar is 5 mg per day. Your doctor may increase the dose to 10 mg per day.

Children and adolescents

Escitalopram Symphar should not be given to children and adolescents under the age of 18. See section 2 for additional information.

Renal impairment

Caution should be exercised when treating patients with severe renal impairment. The medicine should be used with caution and under the supervision of your doctor.

Hepatic impairment

Patients with hepatic impairment should not take more than 10 mg per day. The medicine should be used with caution and under the supervision of your doctor.

Poor metabolizers of CYP2C19

Patients with a known CYP2C19 genotype should not take more than 10 mg per day. The medicine should be used with caution and under the supervision of your doctor.

How to take Escitalopram Symphar

Escitalopram Symphar can be taken with or without food. The tablets should be swallowed with water. Do not chew them as they have a bitter taste. The 10 mg and 20 mg tablets can be divided into two equal doses. To do this, place the tablet on a flat surface with the score line facing upwards, then press down on both sides of the score line with your index fingers.

Duration of treatment

You may start to feel better after a few weeks. You should continue to take Escitalopram Symphar even if you start to feel better. Do not change your dose without talking to your doctor. You should take Escitalopram Symphar for as long as your doctor recommends. If you stop taking Escitalopram Symphar too soon, your symptoms may return. It is recommended to continue treatment for at least 6 months after you feel better.

Overdose

If you take more Escitalopram Symphar than you should, you should contact your doctor or go to the nearest hospital immediately. Take the medicine pack with you. Symptoms of overdose include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, and changes in heart rhythm.

Missed dose

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose and remember before going to bed, take the missed dose as soon as you remember. Take the next dose at the usual time. If you remember the missed dose during the night or the next day, skip the missed dose and take the next dose as usual.

Stopping treatment

Do not stop taking Escitalopram Symphar without talking to your doctor. When you stop taking Escitalopram Symphar, your doctor will gradually reduce your dose over a few weeks. If you stop taking Escitalopram Symphar suddenly, you may experience withdrawal symptoms. These symptoms are common, especially when Escitalopram Symphar is stopped suddenly. The risk is higher if Escitalopram Symphar has been taken for a long time, in high doses, or if the dose is reduced too quickly. Most people find the symptoms mild and they disappear within two weeks. However, in some patients, they can be more severe or longer-lasting (2-3 months or longer). If you experience severe withdrawal symptoms after stopping Escitalopram Symphar, you should contact your doctor. Your doctor may recommend that you start taking Escitalopram Symphar again and gradually reduce the dose.

Withdrawal symptoms include dizziness (unstable balance or loss of balance), tingling sensation, sensation of electric shock, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea, sweating (including night sweats), agitation or excitement, tremors, confusion or disorientation, mood swings or irritability, diarrhea (loose stools), visual disturbances, palpitations or irregular heartbeat.

4. Possible side effects

Like all medicines, Escitalopram Symphar can cause side effects, although not everybody gets them. Side effects usually disappear after a few weeks of treatment. You should remember that some of these side effects may also be symptoms of your illness and will disappear as you get better.

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

• nausea;
• headache.

Common (may affect up to 1 in 10 people):

• blocked nose or sinusitis (inflammation of the sinuses);
• decreased or increased appetite;
• restlessness, agitation, vivid dreams, difficulty sleeping, sleepiness, dizziness, yawning, tremors, tingling sensation;
• diarrhea, constipation, vomiting, dry mouth;
• increased sweating;
• muscle and joint pain;
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women);
• feeling tired, fever;
• weight gain.

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

• hives, rash, itching;
• teeth grinding, agitation, nervousness, panic attacks, confusion;
• sleep disturbances, taste disturbances, fainting (syncope);
• dilated pupils, vision disturbances, ringing in the ears (tinnitus);
• hair loss;
• heavy menstrual bleeding;
• irregular menstrual periods;
• weight loss;
• rapid heartbeat;
• swelling of the arms or legs;
• nosebleeds.

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

• aggression, depersonalization, hallucinations;
• slow heartbeat.

Frequency not known (cannot be estimated from the available data):

• low sodium levels in the blood (which can cause tiredness, confusion, muscle weakness, or convulsions);
• dizziness when standing up due to low blood pressure (orthostatic hypotension);
• abnormal liver function tests (increased liver enzymes in the blood);
• movement disorders (involuntary movements of the muscles);
• painful erection (priapism);
• unusual bleeding in the skin and mucous membranes (ecchymoses);
• increased secretion of antidiuretic hormone (ADH), leading to water retention in the body, dilutional hyponatremia, and decreased sodium levels;
• galactorrhoea (milk secretion) in men and women who are not breast-feeding;
• mania;
• increased risk of bone fractures in patients taking this class of medicines;
• changes in heart rhythm (prolonged QT interval visible on ECG, a test that measures the heart's activity);
• severe bleeding after delivery (postpartum hemorrhage), see additional information in section "Pregnancy, breast-feeding, and fertility";

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Further information" section.

5. How to store Escitalopram Symphar

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 and carton after EXP. The expiry date refers to the last day of that month. Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Escitalopram Symphar contains

• The active substance is escitalopram. Each tablet contains 5 mg, 10 mg, or 20 mg of escitalopram (as escitalopram oxalate).
• The other ingredients are: Tablet core: microcrystalline cellulose, croscarmellose sodium, hypromellose, talc, colloidal anhydrous silica, magnesium stearate. Coating: hypromellose, macrogol 400, titanium dioxide (E171).

What Escitalopram Symphar looks like and contents of the pack

Escitalopram Symphar 5 mg: white to off-white, round, biconvex, film-coated tablets, smooth on both sides.

Escitalopram Symphar 10 mg: white to off-white, oval, biconvex, film-coated tablets, with a score line and "1" and "0" on either side of the score line on one side and smooth on the other side. The 10 mg tablets can be divided into two equal doses.

Escitalopram Symphar 20 mg: white to off-white, oval, biconvex, film-coated tablets, with a score line on one side and smooth on the other side. The 20 mg tablets can be divided into two equal doses.

Escitalopram Symphar is available in the following packs:

PVC/PE/PVDC/Aluminum blister in a cardboard box

14, 28, 56, 98 film-coated tablets.

OPA/Aluminum/PVC/Aluminum blister in a cardboard box

14, 28, 56, 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Symphar Sp. z o.o.

ul. Koszykowa 65

00-667 Warszawa

tel.: +48 22 822 93 06

e-mail: symphar@symphar.com

Manufacturer/Importer

Symphar Sp. z o.o.

ul. Chełmżyńska 249

04-458 Warszawa

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland: Escitalopram Symphar

Date of last revision of the leaflet: