Escitalopram Grindeks

Leaflet accompanying the packaging: information for the user

Escitalopram Grindeks, 5 mg, film-coated tablets

Escitalopram Grindeks, 10 mg, film-coated tablets

Escitalopram Grindeks, 20 mg, film-coated tablets

Escitalopram

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Escitalopram Grindeks and what is it used for
• 2. Important information before taking Escitalopram Grindeks
• 3. How to take Escitalopram Grindeks
• 4. Possible side effects
• 5. How to store Escitalopram Grindeks
• 6. Contents of the packaging and other information

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

Escitalopram Grindeks contains the active substance escitalopram. Escitalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain by increasing the level of serotonin.
Escitalopram Grindeks 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).
Improvement in symptoms may take several weeks. You should continue to take Escitalopram Grindeks even if it takes some time before you feel better.
If you do not feel better or if your condition worsens, you should contact your doctor.

2. Important information before taking Escitalopram Grindeks

When not to take Escitalopram Grindeks

• 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 monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• if you have been born with a heart condition that affects your heart rhythm or if you have had a heart condition that affects your heart rhythm (seen on an ECG; a test that measures the activity of the heart).
• if you are taking medicines that affect your heart rhythm or medicines that may affect your heart rhythm (see "Escitalopram Grindeks with other medicines").

Warnings and precautions

Before starting to take Escitalopram Grindeks, you should discuss this with your doctor or pharmacist. You should tell your doctor if you have other disorders or diseases, as your doctor should take this into account. In particular, you should inform your doctor:

• if you have epilepsy. If you experience a seizure for the first time or if the frequency of seizures increases, you should stop taking Escitalopram Grindeks (see also section 4 "Possible side effects");
• if you have liver or kidney disease. A dose adjustment may be required by your doctor;
• if you have diabetes. Treatment with Escitalopram Grindeks may affect blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic medicines;
• if you have low sodium levels in the blood;
• if you have a tendency to bleed easily or bruise, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility");
• if you are being treated with electroconvulsive therapy;
• if you have coronary heart disease;
• if you have or have had heart problems or if you have recently had a heart attack;
• if you have a slow resting heart rate and/or if you have a low level of salts in the blood due to prolonged severe diarrhea, vomiting, or use of diuretics (water tablets);
• if you experience fast or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may indicate an abnormal heart rhythm;
• if you have or have had eye diseases, such as certain types of glaucoma (increased pressure in the eye).

Caution

In some patients with bipolar affective disorder, a manic phase may occur. This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, you should contact your doctor.
In the first few weeks of treatment, you may also experience symptoms such as restlessness or difficulty sitting or standing still. If you experience these symptoms, you should contact your doctor immediately.
Medicines like Escitalopram Grindeks (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. These thoughts may be more likely to occur at the start of treatment with antidepressant medicines, as their effect takes time, usually about two weeks, but sometimes longer.
These thoughts are more likely to occur:

• If you have had thoughts of suicide or self-harm before.
• If you are a young adult. Clinical trials have shown an increased risk of suicidal behavior in young adults (less than 25 years old) with mental disorders who were treated with antidepressant medicines.

If at any time you have thoughts of self-harm or suicide, you should contact your doctor or go to hospital 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 Grindeks should not normally be used for children and adolescents under 18 years. You should also be aware that patients under 18 have an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (especially aggression, oppositional behavior, and anger) when they take this type of medicine.
However, your doctor may prescribe Escitalopram Grindeks to patients under 18 if they think it is in their best interests. If your doctor has prescribed Escitalopram Grindeks for a patient under 18 and you want to discuss this, you should contact your doctor. If these symptoms occur in patients under 18, you should contact your doctor. Additionally, it has not been demonstrated that escitalopram has a long-term effect on growth, maturation, and cognitive and behavioral development in this age group.

Escitalopram Grindeks with other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.
You should inform your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you are taking any of these medicines, you should wait 14 days before starting to take Escitalopram Grindeks. After stopping Escitalopram Grindeks, you should wait 7 days before taking any of these medicines.
• Reversible, selective monoamine oxidase inhibitors (MAOIs) containing moclobemide (used to treat depression).
• Irreversible monoamine oxidase inhibitors type B (MAO-B) containing selegiline (used to treat Parkinson's disease). They increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used to treat manic-depressive psychosis) and tryptophan.
• Imipramine and desipramine (used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol and similar medicines (opioids, used to treat severe pain). They increase the risk of side effects.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). They may cause an increase in the level of escitalopram in the blood.
• St. John's Wort (Hypericum perforatum), a herbal remedy used to treat depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory medicines (used to treat pain or to thin the blood, known as anticoagulant medicines). They may increase the risk of bleeding.
• Warfarin, dipyridamole, and phenprocoumon (used to thin the blood, known as anticoagulant medicines). Your doctor will probably check your blood clotting when starting and stopping Escitalopram Grindeks to make sure that the dose of anticoagulant medicine is still appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Antipsychotic medicines (used to treat schizophrenia, psychosis) and antidepressant medicines (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used to treat heart conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotic medicines). A dose adjustment of Escitalopram Grindeks may be required.
• Medicines that lower the level of potassium or magnesium in the blood, as they increase the risk of life-threatening heart rhythm disorders.

You should not take Escitalopram Grindeks if you are taking medicines used to treat heart rhythm disorders or medicines that may affect your heart rhythm, such as anti-arrhythmic medicines class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines, especially halofantrine), certain antihistamines (astemizole, hydroxyzine, mizolastine), etc. If you have any further questions, you should contact your doctor.

Escitalopram Grindeks with food, drink, and alcohol

Escitalopram Grindeks can be taken with or without food (see section 3 "How to take Escitalopram Grindeks").
As with many medicines, it is not recommended to take Escitalopram Grindeks with alcohol, although no interaction is expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine. You should not take Escitalopram Grindeks if you are pregnant or breastfeeding, unless your doctor has discussed the risks and benefits with you.
If you take Escitalopram Grindeks during the last 3 months of pregnancy, you should be aware that the newborn may experience the following symptoms: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness of the muscles, increased reflexes, tremors, restlessness, irritability, lethargy, constant crying, and sleep disturbances. If the newborn experiences any of these symptoms, you should contact your doctor immediately.
You should make sure that the midwife and/or doctor knows that you are taking Escitalopram Grindeks.
Medicines like Escitalopram Grindeks taken during pregnancy, especially during the last 3 months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually appear within the first 24 hours after birth. If such symptoms occur in the newborn, you should contact the midwife and/or doctor immediately.
Taking Escitalopram Grindeks at the end of pregnancy may increase the risk of heavy bleeding from the vagina, occurring shortly after delivery, especially if you have had bleeding disorders in the past. Your doctor or midwife should be aware that you are taking Escitalopram Grindeks, so they can advise you.
You should not stop taking Escitalopram Grindeks abruptly during pregnancy.
It is assumed that escitalopram passes into breast milk.
In animal studies, it has been shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

You should not drive or operate machinery until you know how Escitalopram Grindeks affects you.

Escitalopram Grindeks contains sodium

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

3. How to take Escitalopram Grindeks

This medicine should always be taken as directed by your doctor. If you are unsure, you should ask your doctor or pharmacist.
Adults
Depression
The recommended dose of Escitalopram Grindeks is 10 mg, taken once daily. The dose may be increased by your doctor to a maximum of 20 mg per day.
Panic disorder
The initial dose of Escitalopram Grindeks is 5 mg, taken once daily for the first week of treatment, before increasing the dose to 10 mg per day. The dose may then be increased by your doctor to a maximum of 20 mg per day.
Social anxiety disorder
The recommended dose of Escitalopram Grindeks is 10 mg, taken once daily. Your doctor may reduce the dose to 5 mg per day or increase the dose to a maximum of 20 mg per day, depending on your response to the medicine.
Generalized anxiety disorder
The recommended dose of Escitalopram Grindeks is 10 mg, taken once daily. The dose may be increased by your doctor to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The recommended dose of Escitalopram Grindeks is 10 mg, taken once daily. The dose may be increased by your doctor to a maximum of 20 mg per day.
Patient over 65 years
The recommended initial dose of Escitalopram Grindeks is 5 mg, taken once daily. Your doctor may increase the dose to 10 mg per day.

Use in children and adolescents

Escitalopram Grindeks should not normally be given to children and adolescents. For more information, see section 2 "Warnings and precautions".
Kidney problems
Caution should be exercised in patients with severe kidney problems. The medicine should be taken as directed by your doctor.
Liver problems
Patients with liver problems should not take more than 10 mg per day. The medicine should be taken as directed by your doctor.
Poor metabolizers of medicines that are metabolized by the CYP2C19 enzyme
Patients with this known genotype should not receive more than 10 mg per day. The medicine should be taken as directed by your doctor.

How to take the tablets

Escitalopram Grindeks can be taken with or without food. The tablets should be swallowed with water. They should not be chewed, as they have a bitter taste.
If necessary, the tablets can be divided by placing them on a flat surface with the score line facing upwards. The tablets can then be broken by pressing on each end of the tablet with your index fingers, as shown in the picture.
Only the 10 mg and 20 mg tablets can be divided into equal doses.

Duration of treatment

You may start to feel better after a few weeks of treatment. You should continue to take Escitalopram Grindeks, even if it takes some time before you feel better.
You should not change the dose of the medicine without consulting your doctor.
You should continue to take Escitalopram Grindeks for as long as your doctor recommends. Stopping treatment too early may cause your symptoms to return. It is recommended to continue treatment for at least 6 months after you have recovered.

Taking a higher dose of Escitalopram Grindeks than recommended

If you have taken a higher dose of Escitalopram Grindeks than recommended, you should contact your doctor or the nearest hospital emergency department immediately. You should do this even if you do not feel any symptoms. Some of the symptoms of overdose may include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte disturbances.
You should take the packaging of Escitalopram Grindeks with you to the doctor or hospital.

Missing a dose of Escitalopram Grindeks

You should not take a double dose to make up for a missed dose. If you forget to take a dose and remember before going to bed, you should take it immediately.
The next day, you should continue to take the medicine as usual. If you remember that you have missed a dose in the night or the next day, you should skip the missed dose and take the next dose as usual.

Stopping treatment with Escitalopram Grindeks

You should not stop taking Escitalopram Grindeks unless your doctor tells you to. When stopping treatment, it is usually recommended to gradually reduce the dose of Escitalopram Grindeks over a few weeks.
After stopping treatment with Escitalopram Grindeks, especially if it is stopped abruptly, you may experience withdrawal symptoms. These are common when stopping treatment with Escitalopram Grindeks. The risk is higher if Escitalopram Grindeks has been used for a long time, in high doses, or if the dose has been reduced too quickly. In most people, the symptoms are mild and disappear on their own within two weeks. However, in some patients, they may be more severe or longer-lasting (2-3 months or longer). If you experience severe withdrawal symptoms after stopping Escitalopram Grindeks, you should contact your doctor. Your doctor may recommend restarting the tablets and reducing the dose more slowly.
Withdrawal symptoms include: dizziness (unsteady gait, balance disorders), tingling sensation, burning sensation, and (less commonly) a sensation like an electric shock, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headache, nausea (feeling sick), sweating (including night sweats), restlessness or agitation, tremors (shakiness), disorientation or confusion, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or rapid heartbeat (palpitations).

4. Possible side effects

Like all medicines, Escitalopram Grindeks 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 recover.

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

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

• Unusual bleeding, including bleeding from the digestive tract. Rare (may affect up to 1 in 1,000 people):
• Swelling of the skin, tongue, lips, throat, or face, hives, or difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which may be symptoms of a rare disorder called serotonin syndrome. Frequency not known (frequency cannot be estimated from the available data):
• Difficulty urinating.
• Seizures, see also section "Warnings and precautions".
• Yellowing of the skin and whites of the eyes, which may be a sign of liver damage or hepatitis.
• Fast or irregular heartbeat, fainting, which may be a sign of a life-threatening condition called torsades de pointes.
• Thoughts of self-harm or suicide, see also section "Warnings and precautions".
• Sudden swelling of the skin or mucous membranes (angioedema).

The following side effects have also been reported:

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

• Nausea (feeling sick).
• Headache.

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

• Nasal congestion or sinusitis (inflammation of the sinuses).
• Decreased or increased appetite.
• Anxiety, restlessness, unusual dreams, difficulty sleeping, sleepiness, dizziness, yawning, tremors, tingling sensation of the skin.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain.
• Sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty reaching orgasm in women).
• Feeling tired, fever.
• Weight gain.

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

• Hives, rash, itching (itching).
• Teeth grinding, agitation, nervousness, panic attacks, disorientation.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Dilated pupils (enlarged pupils), vision disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Heavy menstrual bleeding.
• Irregular menstrual periods.
• Weight loss.
• Fast 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 (frequency cannot be estimated from the available data):

• Decreased sodium levels in the blood (symptoms include nausea and malaise with muscle weakness or confusion).
• Dizziness when standing up due to low blood pressure (orthostatic hypotension).
• Abnormal liver function test results (increased liver enzyme activity in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erection of the penis (priapism).
• Symptoms of unusual bleeding in the skin and mucous membranes (ecchymoses).
• Increased secretion of antidiuretic hormone (ADH), leading to water retention in the body and dilutional hyponatremia (SIADH).
• Milk secretion in men and in women who are not breastfeeding.
• Mania.
• In patients taking this type of medicine, an increased risk of bone fractures has been observed.
• Change in heart rhythm (called "QT prolongation", visible on an ECG, in the electrical activity of the heart).
• Severe bleeding from the vagina, occurring shortly after delivery (postpartum hemorrhage), see also "Pregnancy, breastfeeding, and fertility" in section 2.

In addition, the following side effects are known to occur with medicines that have a similar mechanism of action to escitalopram (the active substance of Escitalopram Grindeks):

• Psychomotor restlessness (akathisia).
• Loss of appetite.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Escitalopram Grindeks

The medicine should be stored out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging and blister after "EXP".
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

The active substance is escitalopram. Each film-coated tablet contains escitalopram oxalate, equivalent to 5, 10, or 20 mg of escitalopram.
The other ingredients are:
Core: microcrystalline cellulose (E460), croscarmellose sodium (E468), hypromellose (E464), talc (553b), colloidal anhydrous silica (E551), magnesium stearate (E470b).
Coating: hypromellose (E464), macrogol, and titanium dioxide (E171).

What Escitalopram Grindeks looks like and contents of the pack

Escitalopram Grindeks 5 mg is a white to off-white, round, approximately 6 mm in diameter, biconvex film-coated tablet.
Escitalopram Grindeks 10 mg is a white to off-white, oval, approximately 8 mm x 6 mm, biconvex film-coated tablet with a score line on one side.
Escitalopram Grindeks 20 mg is a white to off-white, oval, approximately 12 mm x 7 mm, biconvex film-coated tablet with a score line on one side.
Escitalopram Grindeks is available in PVC/PE/PVdC//Aluminum or OPA/Aluminum/PVC//Aluminum blisters containing 14, 28, 30, 56, 98, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

AS GRINDEKS.
Krustpils iela 53, Rīga, LV-1057, Latvia
tel.: +371 67083205
fax: +371 67083505
e-mail: [email protected]

Manufacturer/Importer

HBM Pharma s.r.o.
Sklabinská 30, 036 80 Martin
Slovakia
AS GRINDEKS.
Krustpils iela 53, Rīga, LV-1057, Latvia
tel.: +371 67083205
fax: +371 67083505
e-mail: [email protected]

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

Austria

Escitalopram Grindeks 5 mg, 10 mg, 20 mg Filmtabletten

Belgium

Escitalopram Grindeks 5 mg, 10 mg, 20 mg comprimés pelliculés

Bulgaria

Есциталопрам Гриндекс 5 mg, 10 mg, 20 mg филмирани таблетки

Escitalopram Grindeks 5 mg, 10 mg, 20 mg film-coated tablets

Croatia

Escitalopram Grindeks 5 mg, 10 mg, 20 mg filmom obložene tablete

Czech Republic

Escitalopram Grindeks

Estonia

Escitalopram Grindeks

France

ESCITALOPRAM GRINDEKS 5 mg, comprimé pelliculé

ESCITALOPRAM GRINDEKS 10 mg, comprimé pelliculé sécable

ESCITALOPRAM GRINDEKS 20 mg, comprimé pelliculé sécable

Greece

Escitalopram/Grindeks 5 mg, 10 mg, 20 mg επικαλυμμένα με λεπτό υμένιο δισκία

Spain

Escitalopram Grindeks 5 mg, 10 mg, 20 mg comprimidos recubiertos con película

Netherlands

Escitalopram Grindeks 5 mg filmomhulde tabletten

Escitalopram Grindeks 10 mg filmomhulde tabletten

Escitalopram Grindeks 20 mg filmomhulde tabletten

Ireland

Escitalopram Grindeks 5 mg, 10 mg, 20 mg film-coated tablets

Lithuania

Escitalopram Grindeks 5 mg plėvele dengtos tabletės

Escitalopram Grindeks 10 mg plėvele dengtos tabletės

Escitalopram Grindeks 20 mg plėvele dengtos tabletės

Luxembourg

Escitalopram Grindeks 5 mg, 10 mg, 20 mg filmbeschichtete Pëllen

Latvia

Escitalopram Grindeks 5 mg, 10 mg, 20 mg apvalkotās tabletes

Germany

Escitalopram Grindeks 5 mg, 10 mg, 20 mg Filmtabletten

Norway

Escitalopram Grindeks

Poland

Escitalopram Grindeks

Portugal

Escitalopram Grindeks 5 mg, 10 mg, 20 mg comprimidos revestidos por película

Romania

Escitalopram Grindeks 5 mg, 10 mg, 20 mg comprimate filmate

Slovakia

Escitalopram Grindeks 5 mg, 10 mg, 20 mg filmom obalené tablety

Slovenia

Escitalopram Grindeks 5 mg, 10 mg, 20 mg filmsko obložene tablete

Sweden

Escitalopram Grindeks

Hungary

Escitalopram Grindeks 5, 10 és 20 mg filmtabletta

Italy

Escitalopram Grindeks

Date of last revision of the leaflet: