Package leaflet: Information for the user

Escitalopram Zentiva 10 mg film-coated tablets, 20 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Escitalopram Zentiva is and what it is used for
What you need to know before taking Escitalopram Zentiva
How to take Escitalopram Zentiva
Possible side effects
How to store Escitalopram Zentiva
Contents of the pack and other information

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

Escitalopram Zentiva contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, which is the fear of being in places where help may not be available, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).
Escitalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain by increasing the level of serotonin. Changes in the serotonin system are considered an important factor in the development of depression and related conditions.
It may take two weeks before you start to feel better. Continue taking Escitalopram Zentiva even if it takes some time for your condition to improve.
You should speak with your doctor if you do not feel better or if your condition worsens.

2. What you need to know before taking Escitalopram Zentiva

Do not take Escitalopram Zentiva:

If you are allergic to escitalopram or to any of the other ingredients of this medicine (listed in section 6).
If you are taking other medicines belonging to a group called MAO inhibitors, including selegiline (used for the treatment of Parkinson’s disease), moclobemide (used for the treatment of depression), or linezolid (an antibiotic).
If you were born with or have experienced an episode of abnormal heart rhythm (visible on ECG (electrocardiogram), a test to assess how the heart functions).
If you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm (see section 2 “Other medicines and Escitalopram Zentiva”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Escitalopram Zentiva.
Inform your doctor if you have any other condition or illness, as this may need to be taken into account. In particular, inform your doctor:

If you suffer from epilepsy. Treatment with Escitalopram Zentiva must be discontinued if you experience seizures for the first time or if the frequency of epileptic seizures increases (see also section 4 “Possible side effects”);
If you have impaired liver or kidney function. Your doctor may need to adjust your dose;
If you have diabetes. Treatment with Escitalopram Zentiva may alter glycaemic control. It may be necessary to adjust the dose of insulin and/or oral hypoglycaemic agents;
If you have low sodium levels in the blood;
If you have a tendency to bleed or bruise easily;
If you are undergoing electroconvulsive therapy;
If you have coronary heart disease;
If you have or have had heart problems or recently suffered a heart attack;
If you have a slow resting heart rate and/or if you know your body may have lost salts due to severe and prolonged diarrhoea or vomiting, or due to the use of diuretics (water tablets);
If you experience fast or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate an abnormal heart rhythm;
If you have eye problems, such as certain types of glaucoma (increased pressure in the eyes);
If you are taking this medicine together with buprenorphine. This combination may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Escitalopram Zentiva”).
- If you have a history of bleeding disorders or if you are pregnant (see “Pregnancy”).

Please note
As with other antidepressants used to treat depression or related conditions, improvement is not immediate. Several weeks may pass after starting treatment before any improvement is seen. In the treatment of panic disorders, improvement usually occurs after 2–4 weeks. At the beginning of treatment, some patients may experience increased anxiety, which subsides with continued treatment. It is therefore very important to follow your doctor’s instructions carefully and not to stop treatment or change the dose without consulting your doctor.
Medicines such as Escitalopram Zentiva (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
If you suffer from depression and/or anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may be more frequent at the beginning of treatment with antidepressants, as these medicines take time to work—usually about two weeks, but sometimes longer.
You are more likely to have these thoughts:

If you have previously had thoughts of suicide or self-harm.
If you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If at any time you have thoughts of harming yourself or committing suicide, contact your doctor or go to the hospital immediately.
It may be helpful to inform a relative or close friend that you suffer from depression or an anxiety disorder, and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is worsening, or if they are concerned about any changes in your behaviour.
Some patients with bipolar disorder may enter a manic phase. This is characterised by unusual and rapidly changing thoughts, inappropriate happiness, and excessive physical activity. If you experience these feelings, contact your doctor.
Symptoms such as restlessness or difficulty sitting or standing still may also occur during the first few weeks of treatment. If you experience these symptoms, speak to your doctor immediately.
Sometimes you may not be aware that you are experiencing the symptoms listed above, so it may be helpful to discuss them with a friend or relative and ask them to watch for possible signs of changes in your behaviour.
Contact your doctor immediately or go to the nearest emergency room if you experience distressing thoughts or any of the symptoms listed above during treatment.
Children and adolescents under 18 years of age
Escitalopram Zentiva is generally not intended for use in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age taking this class of medicines have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger). Nevertheless, your doctor may prescribe Escitalopram Zentiva to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Escitalopram Zentiva for a patient under 18 years of age and you would like more information, contact your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen during treatment with Escitalopram Zentiva in patients under 18 years of age. In addition, the long-term safety effects of Escitalopram Zentiva on growth, maturation, and cognitive and behavioural development have not been established in this age group.

Other medicines and Escitalopram Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:

“Non-selective monoamine oxidase inhibitors (MAOIs)” containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active ingredients. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Zentiva. After stopping Escitalopram Zentiva, you must wait 7 days before taking any of these medicines;
“Reversible selective MAO-A inhibitors” containing moclobemide (used for the treatment of depression);
“Irreversible MAO-B inhibitors” containing selegiline (used for the treatment of Parkinson’s disease). These medicines increase the risk of adverse effects;
The antibiotic linezolid;
Lithium (used for the treatment of bipolar disorder) and tryptophan;
Imipramine and desipramine (both used for the treatment of depression);
Sumatriptan and similar medicines (used for the treatment of migraine) and tramadol (used for severe pain). These medicines increase the risk of adverse effects;
Buprenorphine (a strong painkiller). This combination may cause serotonin syndrome (see section “Warnings and precautions”), and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.
Cimetidine, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the levels of Escitalopram Zentiva in the blood;
St. John’s wort (Hypericum perforatum)—a herbal preparation used for depression;
Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or thin the blood, known as anticoagulants). These may increase the tendency to bleed;
Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, known as anticoagulants). Your doctor will likely monitor your blood clotting time at the start and after stopping treatment with Escitalopram Zentiva to ensure your anticoagulant dose remains appropriate;
Mefloquine (used for the treatment of malaria), bupropion (used for the treatment of depression), and tramadol (used for the treatment of severe pain), due to the possible risk of lowered seizure threshold;
Neuroleptics (medicines for the treatment of schizophrenia, psychosis) due to the possible risk of lowered seizure threshold, and antidepressants;
Flecainide, propafenone, and metoprolol (used for cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dose adjustment of Escitalopram Zentiva may be necessary;
Medicines that reduce blood levels of potassium or magnesium, as these conditions increase the risk of life-threatening heart rhythm disturbances.

DO NOT TAKE Escitalopram Zentiva if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), or certain antihistamines (astemizole, mizolastine).
If you have any further doubts, contact your doctor.
Escitalopram Zentiva with food, drinks, and alcohol
Escitalopram Zentiva can be taken with or without food (see section 3 “How to take Escitalopram Zentiva”).
As with many medicines, combining Escitalopram Zentiva with alcohol is not recommended, although interactions between Escitalopram Zentiva and alcohol are not expected.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Do not take Escitalopram Zentiva if you are pregnant or breastfeeding unless your doctor has discussed the risks and benefits of treatment with you.
If you take Escitalopram Zentiva during the last 3 months of pregnancy, you should be aware that the following adverse effects may occur in the newborn: breathing difficulties, bluish skin colour, seizures, unstable body temperature, feeding difficulties, vomiting, low blood sugar levels, muscle stiffness or floppiness, overactive reflexes, tremor, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep difficulties. If the newborn shows any of these symptoms, contact your doctor immediately.
Ensure that your midwife and/or doctor know that you are taking Escitalopram Zentiva.
When taken during pregnancy, particularly during the last 3 months, medicines such as Escitalopram Zentiva may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually appear within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If you take Escitalopram Zentiva towards the end of pregnancy, there may be an increased risk of severe vaginal bleeding immediately after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking Escitalopram Zentiva so they can provide appropriate advice.
Escitalopram Zentiva should never be stopped abruptly if taken during pregnancy.
Escitalopram Zentiva is excreted in breast milk.
Citalopram, a medicine similar to escitalopram, has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but no effect on human fertility has been observed.
Driving and using machines
You are advised not to drive or operate machinery until you know how Escitalopram Zentiva affects you.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Escitalopram Zentiva

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults

Depression
The usual recommended dose of Escitalopram Zentiva is 10 mg once daily as a single dose. Your doctor may increase the dose up to a maximum of 20 mg daily.

Panic disorder
The initial dose of Escitalopram Zentiva for the first week of treatment is 5 mg once daily as a single dose, which is then increased to 10 mg daily. Your doctor may further increase the dose up to a maximum of 20 mg daily.

Social anxiety disorder
The usual recommended dose of Escitalopram Zentiva is 10 mg taken once daily as a single dose. Your doctor may reduce the dose to 5 mg daily or increase it up to a maximum of 20 mg daily, depending on your individual response to the medicine.

Generalised anxiety disorder
The usual recommended dose of Escitalopram Zentiva is 10 mg once daily as a single dose. Your doctor may increase the dose up to a maximum of 20 mg daily.

Obsessive-compulsive disorder
The usual recommended dose of Escitalopram Zentiva is 10 mg once daily as a single dose. Your doctor may increase the dose up to a maximum of 20 mg daily.

Elderly (over 65 years of age)
The recommended starting dose of Escitalopram Zentiva is 5 mg once daily as a single dose. Your doctor may increase the dose up to 10 mg daily.

Children and adolescents (under 18 years of age)
Escitalopram Zentiva should normally not be taken by children and adolescents. For further information, see section 2 “What you need to know before taking Escitalopram Zentiva”.

You may take Escitalopram Zentiva with or without food. Swallow the tablets with a little water. Do not chew the tablets as they have a bitter taste.

If necessary, you may split the tablet by placing it on a flat surface with the scored side facing upwards. The tablets can be broken by applying pressure from one end to the other using both index fingers.

Duration of treatment
It may take a few weeks before you start to feel better. Continue taking Escitalopram Zentiva even if you do not notice an immediate improvement in your condition.
Do not change the dose of this medicine without first consulting your doctor.
Continue taking Escitalopram Zentiva for as long as your doctor has recommended. If treatment is stopped too early, symptoms may return. It is recommended that treatment continues for at least six months after symptoms have resolved.

If you take more Escitalopram Zentiva than you should
If you have taken more Escitalopram Zentiva than prescribed, contact your doctor or go immediately to the nearest hospital emergency department. Do this even if you do not feel unwell. Some signs of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, low blood pressure, and disturbances in electrolyte balance. Take the Escitalopram Zentiva pack with you when you go to see your doctor or to hospital.

If you forget to take Escitalopram Zentiva
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 it immediately and continue your treatment as usual the next day. If you remember only during the night or the following day, skip the missed dose and continue with your normal dosing schedule.

If you stop taking Escitalopram Zentiva
Do not stop taking Escitalopram Zentiva unless your doctor tells you to. When your treatment is complete, it is generally recommended that the dose of Escitalopram Zentiva be gradually reduced over several weeks.

When you stop taking Escitalopram Zentiva, especially if stopped suddenly, you may experience withdrawal symptoms. These are common when stopping treatment with Escitalopram Zentiva. The risk is greater if you have taken Escitalopram Zentiva for a long time or at high doses, or if the dose is reduced too quickly. Most patients find that these symptoms are mild and resolve spontaneously within a couple of weeks. However, in some patients, withdrawal symptoms may be severe or may persist for a longer time (2–3 months or more). If you experience severe withdrawal symptoms when stopping treatment with Escitalopram Zentiva, inform your doctor, who may advise you to restart the tablets and then reduce the dose more gradually.

Withdrawal symptoms include: dizziness (feeling unsteady or off balance), sensations of pins and needles or electric shocks (less commonly), including in the head, sleep disturbances (vivid dreams, nightmares, difficulty sleeping), feeling anxious, headache, malaise (nausea), sweating (including night sweats), restlessness or agitation, tremor (shaking), confusion or disorientation, emotional lability or irritability, diarrhoea (loose stools), visual disturbances, and disturbances in heart rhythm (palpitations).

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects usually disappear after a few weeks of treatment. Please note that many of the side effects may also be symptoms of your illness and therefore decrease as you start to feel better.
If you experience any of the following side effects during treatment, see your doctor:
Uncommon (may affect up to 1 in 100 people):

Abnormal bleeding, including gastrointestinal bleeding.

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

If you experience swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction), contact your doctor or go to hospital immediately.
If you develop high fever, agitation, confusion, tremor, and sudden muscle contractions, which may be signs of a rare condition called serotonin syndrome. If you feel this way, contact your doctor.

If you experience any of the following side effects, contact your doctor immediately or go to hospital:

Difficulty urinating
Seizures (epileptic fits), see also section “Warnings and precautions”
Yellowing of the skin or whites of the eyes, signs of liver dysfunction/hepatitis
Rapid or irregular heartbeat, feeling faint, which may be symptoms of a life-threatening condition known as Torsade de Pointes.
Thoughts of harming yourself or of suicide, see section “Warnings and precautions”.

The following side effects have also been reported in addition to those listed above:
Very common (may affect more than 1 in 10 people):

Feeling unwell (nausea)
Headache.

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

Stuffy nose or nasal discharge (sinusitis)
Decreased or increased appetite
Anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin tingling
Diarrhoea, constipation, vomiting, dry mouth
Increased sweating
Muscle and joint pain (arthralgia and myalgia)
Sexual disorders (delayed ejaculation, erection problems, decreased sexual drive, and women may have difficulty achieving orgasm)
Fatigue, fever
Weight gain.

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

Hives, skin rash (pruritus)
Teeth grinding, agitation, nervousness, panic attacks, confusion
Disturbed sleep, taste disturbances, fainting (syncope)
Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
Hair loss
Vaginal bleeding
Weight loss
Rapid heartbeat
Swelling of arms or legs
Nosebleeds

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

Aggression, depersonalisation, hallucinations
Slowed heart rate.

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

Decreased sodium levels in the blood (symptoms include feeling unwell with muscle weakness or confusion)
Dizziness upon standing due to a drop in blood pressure (orthostatic hypotension)
Abnormal liver function tests (increased liver enzyme values in blood)
Movement disorders (involuntary muscle movements)
Painful erections (priapism)
Abnormal bleeding, including bleeding of the skin and mucous membranes (bruising) and low platelet counts in the blood (thrombocytopenia)
Sudden swelling of the skin or mucous membranes (angioedema)
Increased urine volume (inappropriate ADH secretion)
Milk production in women who are not breastfeeding
Mania
Changes in heart rhythm (called “QT interval prolongation”, detected by ECG measuring the heart's electrical activity)
Severe vaginal bleeding shortly after childbirth (postpartum haemorrhage), see "Pregnancy" in section 2 for further information.

In addition, a number of side effects are known to occur with medicines that act like escitalopram (the active substance in Escitalopram Zentiva). These include:

Motor restlessness (akathisia)
Anorexia.

An increased risk of bone fractures has been observed in patients taking this type of medicine.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Escitalopram Zentiva

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Escitalopram Zentiva contains
The active substance is escitalopram. Each tablet of Escitalopram Zentiva contains 10 or 20 mg of
escitalopram (as oxalate).
The other components are:
Core: microcrystalline cellulose (E460), sodium croscarmellose (E468), colloidal anhydrous silica,
magnesium stearate (E470b).
Coating: hypromellose (E464), titanium dioxide (E171), and macrogol 400.
Description of the appearance of Escitalopram Zentiva and package contents
Escitalopram Zentiva is available as 10 mg and 20 mg film-coated tablets. The tablets are described as follows:
Escitalopram Zentiva 10 mg are white, oval film-coated tablets (approximately 8.1 x 5.6 mm) with a break line on one side. The tablets can be divided into two equal doses.
Escitalopram Zentiva 20 mg are white, oval film-coated tablets (approximately 11.6 x 7.1 mm) with a break line on one side. The tablets can be divided into two equal doses.
Escitalopram Zentiva is available in the following pack sizes:
10, 14, 20, 28, 50, 98, 90 and 100 tablets (blister packs).
Not all pack sizes may be marketed.
Marketing Authorization Holder
Zentiva Italia Srl,
Viale L. Bodio, 37/B
20158 Milan, Italy
Responsible manufacturers for batch release
HBM Pharma s.r.o.
Sklabinská 30, Martin
Slovak Republic, 036 80
This medicinal product is authorized in the European Economic Area countries under the following
names:
Germany, France, Italy: Escitalopram Zentiva