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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 phobia, generalized anxiety disorder, and obsessive-compulsive disorder).
Improvement in symptoms may take a few weeks. You should continue to take Escitalopram Grindeks even if it takes some time before you feel better.
If there is no improvement 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 rhythm disorder or if you have had a heart rhythm disorder (visible on an ECG; a test that assesses heart function).
• If you are taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see "Escitalopram Grindeks and other medicines").

Warnings and precautions

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

• If you have epilepsy. If you experience seizures for the first time or if their frequency increases, you should stop taking Escitalopram Grindeks (see also section 4 "Possible side effects");
• If you have liver or kidney problems. 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 agents;
• If you have low sodium levels in your 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 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 due to prolonged severe diarrhea, vomiting, or use of diuretics (medicines that increase urine production);
• If you experience rapid or irregular heartbeats, fainting, collapse, or dizziness when standing up, which may indicate an abnormal heart rhythm;
• If you have had eye diseases, such as certain types of glaucoma (increased pressure inside the eyeball).

Caution

In some patients with bipolar affective disorder, a manic phase may occur. It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, you should consult your doctor.
In the first few weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If such symptoms appear, you should immediately inform your doctor.
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

People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. They may become more pronounced when starting to take antidepressant medicines, as their effect takes time, usually about two weeks, but sometimes longer.
Such thoughts are more likely:

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

If at any time you have thoughts of self-harm or suicide, you should contact your doctor or go to the hospital immediately.It may be helpful to tell a relative or close friend about your depression or anxiety disorder and ask them to read this leaflet. You may want to ask them to remind you to take your medicine and to tell you if they notice any changes in your behavior.

Children and adolescents

Escitalopram Grindeks should not normally be used in children and adolescents under 18 years of age. You should also be aware that in the case of taking medicines of this class, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and anger).
However, your doctor may prescribe Escitalopram Grindeks to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Escitalopram Grindeks to a patient under 18 years of age and there is a need to discuss this, you should contact your doctor. If the above symptoms develop or worsen in patients under 18 years of age, you should contact your doctor. Additionally, the long-term effects of escitalopram on growth, maturation, and cognitive and behavioral development in this age group have not been established.

Escitalopram Grindeks and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as 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 A inhibitors (MAO-A) containing moclobemide (used to treat depression).
• Irreversible monoamine oxidase B inhibitors (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 migraines) 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 escitalopram levels in the blood.
• St. John's Wort (Hypericum perforatum) - a herbal medicine 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 (medicines used to thin the blood, known as anticoagulant medicines). Your doctor will probably check your blood clotting time when starting and stopping Escitalopram Grindeks to ensure 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.
• Antipsychotics (medicines used to treat schizophrenia, psychosis) and antidepressants (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 potassium or magnesium levels 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 heart rhythm, such as antiarrhythmic medicines of 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 doubts, you should consult 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 combine Escitalopram Grindeks with alcohol, although no interaction between Escitalopram Grindeks and alcohol is expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist 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: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or flaccidity, increased reflexes, tremors, restlessness, irritability, lethargy, constant crying, and sleep disturbances. If the newborn experiences any of these symptoms, you should immediately contact your doctor.
You should ensure that your midwife and/or doctor are aware that you are taking Escitalopram Grindeks.
Medicines like Escitalopram Grindeks taken during pregnancy, especially during the last 3 months of pregnancy, 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 immediately contact your midwife and/or doctor.
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 that they can advise you.
You should not stop taking Escitalopram Grindeks abruptly if you are pregnant.
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 means it is essentially "sodium-free".

3. How to take Escitalopram Grindeks

This medicine should always be taken exactly as your doctor has told you. If you are not sure, 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 phobia
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.
Elderly patients (over 65 years of age)
The recommended initial dose of Escitalopram Grindeks is 5 mg, taken once daily. Your doctor may recommend increasing 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.
Patients who are poor metabolizers of medicines involving 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 each end of the tablet with your index fingers, as shown in the picture.
Only 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 first.
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 disturbances, 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 have forgotten 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 period of several 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 taken 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 persist for longer (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 them more slowly.
Withdrawal symptoms include: dizziness (unsteady gait, balance disturbances), 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 (nausea), sweating (including night sweats), restlessness or agitation, tremors (shakiness), disorientation or confusion, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or arrhythmias (palpitations).
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 the disease and will disappear as your condition improves.

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

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

• Unusual bleeding, including bleeding from the gastrointestinal 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 is a symptom of liver dysfunction/liver inflammation.
• Rapid or irregular heartbeat, fainting, which may be symptoms 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 (nausea).
• Headache.

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

• Nasal congestion or sinusitis (sinusitis).
• Decreased or increased appetite.
• Anxiety, restlessness, unusual dreams, sleep disturbances, drowsiness, 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 (itching).
• Teeth grinding, agitation, nervousness, panic attacks, disorientation.
• 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 (frequency cannot be estimated from the available data):

• Decreased sodium levels in the blood (manifested by 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 dilution of the blood, decreased sodium levels (inappropriate ADH secretion).
• 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 interval 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 with 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 any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported 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.
Side effects can also be reported 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 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), sodium croscarmellose (E468), hypromellose (E464), talc (553b), colloidal silicon dioxide, anhydrous (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 blisters of PVC/PE/PVdC//Aluminum or OPA/Aluminum/PVC//Aluminum, 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: grindeks@grindeks.lv

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: grindeks@grindeks.lv

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 film-coated tablets
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 film-coated tablets
Czech Republic
Escitalopram Grindeks
Estonia
Escitalopram Grindeks
France
ESCITALOPRAM GRINDEKS 5 mg, film-coated tablet
ESCITALOPRAM GRINDEKS 10 mg, film-coated tablet, scored
ESCITALOPRAM GRINDEKS 20 mg, film-coated tablet, scored
Greece
Escitalopram/Grindeks 5 mg, 10 mg, 20 mg επικαλυμμένα με λεπτό υμένιο δισκία
Spain
Escitalopram Grindeks 5 mg, 10 mg, 20 mg film-coated tablets
Netherlands
Escitalopram Grindeks 5 mg film-coated tablets
Escitalopram Grindeks 10 mg film-coated tablets
Escitalopram Grindeks 20 mg film-coated tablets
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 film-coated tablets
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 film-coated tablets
Romania
Escitalopram Grindeks 5 mg, 10 mg, 20 mg film-coated tablets
Slovakia
Escitalopram Grindeks 5 mg, 10 mg, 20 mg film-coated tablets
Slovenia
Escitalopram Grindeks 5 mg, 10 mg, 20 mg film-coated tablets
Sweden
Escitalopram Grindeks
Hungary
Escitalopram Grindeks 5, 10, and 20 mg film-coated tablets
Italy
Escitalopram Grindeks

Date of last revision of the leaflet: