Escitalopram grindeks

Package leaflet: 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
Escitalopramum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Escitalopram Grindeks is and what it is 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 pack and other information

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

Escitalopram Grindeks contains the active substance escitalopram. Escitalopram belongs to a group of antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonergic 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 well-being may take several weeks. You should continue taking Escitalopram Grindeks even if it takes some time before your health improves.
If there is no improvement or if your condition worsens, contact your doctor.

2. Important information before taking Escitalopram Grindeks

When not to take Escitalopram Grindeks

• if the patient is allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking other medicines belonging to a group called MAO inhibitors, containing selegiline (used in the treatment of Parkinson's disease), moklobemide (used in the treatment of depression), or linezolid (an antibiotic);
• if the patient was born with congenital abnormal heart rhythm or if the patient has experienced an episode of abnormal heart rhythm (visible on ECG; a test assessing heart function);
• if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section "Escitalopram Grindeks and other medicines").

Warnings and precautions
Before starting treatment with Escitalopram Grindeks, discuss this with your doctor or
pharmacist. You should tell your doctor if you have any other disorders or diseases,
as your doctor should take such information into account. In particular, inform your
doctor:

• if you have epilepsy. If seizures occur for the first time or increase in frequency, treatment with Escitalopram Grindeks should be discontinued (see also section 4 "Possible side effects");
• if you have impaired liver or kidney function. Your doctor may need to adjust the dose;
• if you have diabetes. Treatment with Escitalopram Grindeks may affect blood glucose control. Adjustment of insulin and/or oral glucose-lowering medicines may be necessary;
• if you have low sodium levels in the blood;
• if you have a tendency to bleed easily or develop bruises, or if you are pregnant (see "Pregnancy, breastfeeding and fertility");
• if you are receiving electroconvulsive therapy;
• if you have ischemic heart disease;
• if you have heart problems or have recently had a heart attack;
• if you have a slow resting heart rate and/or if you have salt deficiency due to prolonged severe diarrhoea, vomiting, or use of diuretics (water tablets);
• if you experience rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm;
• if you have or have previously had eye disorders, such as certain types of glaucoma (increased pressure inside the eyeball).

Note
In some patients with bipolar affective disorder, a manic phase may occur. It is characterised by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, consult your doctor.
During the first weeks of treatment, symptoms such as motor restlessness or difficulty sitting or standing still may also occur. If such symptoms appear, inform your doctor immediately.
Medicines such as Escitalopram Grindeks (so-called SSRIs or SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persisted after discontinuation of 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. These may worsen at the beginning of treatment with antidepressants, as their effect takes time, usually about two weeks, but sometimes longer.
Such thoughts are more likely:

• If the patient previously had thoughts of suicide or self-harm.

• If the patient is a young adult. Clinical trial data show an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders who were treated with antidepressants. If at any time the patient experiences thoughts of self-harm or suicide, seek immediate medical advice from a doctor or go to hospital. It may be helpful to inform a relative or close friend about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them
  to inform him/her if they notice worsening of depression or anxiety or if they are concerned about changes
  in the patient's behaviour.
  Children and adolescents
  Escitalopram Grindeks is generally not recommended for use in children and adolescents under 18 years of age.
  It should also be noted that when taking medicines of this class, patients under 18 years of age are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger).
  Nevertheless, 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 for a patient under 18 years of age and you wish to discuss this, contact your doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age, contact your doctor. Furthermore, the long-term effect of escitalopram on growth, maturation, and cognitive and behavioural development in this age group has not yet been established.
  Escitalopram Grindeks and other medicines
  Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
  Inform your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAO inhibitors) containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine. If you are taking any of these medicines, wait 14 days before starting Escitalopram Grindeks. After stopping Escitalopram Grindeks, wait 7 days before taking any of these medicines.

• Reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moklobemide (used in the treatment of depression).

• Irreversible monoamine oxidase B (MAO-B) inhibitors containing selegiline (used in the treatment of Parkinson's disease). These increase the risk of adverse effects.

• The antibiotic linezolid.

• Lithium (used in the treatment of manic-depressive psychosis) and tryptophan.

• Imipramine and desipramine (used in the treatment of depression).

• Sumatriptan and similar medicines (used in the treatment of migraine) and tramadol and similar medicines (opioids, used for severe pain). These increase the risk of adverse effects.

• Cimetidine, lansoprazole, and omeprazole (used in the treatment of stomach ulcers), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase escitalopram blood levels.

• St. John's wort (Hypericum perforatum) – a herbal remedy used for depression.

• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (painkillers or blood-thinning medicines, known as anticoagulants). These may increase the tendency to bleed.

• Warfarin, dipyridamole, and phenprocoumon (blood-thinning medicines, known as anticoagulants). Your doctor will likely check your blood clotting time when starting and stopping Escitalopram Grindeks to ensure your anticoagulant dose remains appropriate.

• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to possible risk of lowering the seizure threshold.

• Neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to possible risk of lowering the seizure threshold.

• Flecainide, propafenone, and metoprolol (used in cardiovascular disorders), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). 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 disturbances.

Do not take Escitalopram Grindeks if you are taking medicines used for heart rhythm disorders or medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarials, particularly halofantrine), certain antihistamines (astemizole, hydroxyzine, mizolastine), etc. If you have any further doubts, 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 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 are planning to have a baby, consult your doctor or pharmacist before using this medicine. Do 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, be aware that the newborn may experience the following symptoms: breathing difficulties, blue skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or floppiness, increased reflex excitability, tremors, shivering, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, seek immediate medical advice.
Ensure that your midwife and/or doctor are aware that you are taking Escitalopram Grindeks.
Medicines such as Escitalopram Grindeks taken during pregnancy, particularly 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, contact your midwife and/or doctor immediately.
Taking Escitalopram Grindeks towards the end of pregnancy may increase the risk of heavy vaginal bleeding shortly after delivery, especially if you have previously had blood clotting disorders. Your doctor or midwife should be aware that you are taking Escitalopram Grindeks so they can provide appropriate advice.
If you are taking Escitalopram Grindeks during pregnancy, never stop it suddenly.
Escitalopram is expected to pass into breast milk.
Animal studies have 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 operating machinery
Patients are advised not to drive or operate machinery until they know how Escitalopram Grindeks affects them.
Escitalopram Grindeks contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to take Escitalopram Grindeks

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Adults

Depression
The usual recommended dose of Escitalopram Grindeks is 10 mg taken once daily. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Panic disorder
The initial dose of Escitalopram Grindeks is 5 mg taken once daily during the first week of treatment, before increasing the dose to 10 mg per day. The dose may then be increased by your doctor up to a maximum of 20 mg per day.

Social phobia
The usual recommended dose of Escitalopram Grindeks is 10 mg taken once daily. Your doctor may reduce the dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on your response to the medicine.

Generalised anxiety disorder
The usual recommended dose of Escitalopram Grindeks is 10 mg taken once daily. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The usual recommended dose of Escitalopram Grindeks is 10 mg taken once daily. The dose may be increased by your doctor up to a maximum of 20 mg per day.

Elderly patients (over 65 years)
The recommended starting 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 generally not be given to children and adolescents. For more information, see section 2 "Warnings and precautions".

Renal impairment
Caution is required in patients with severe renal impairment. The medicine should be used according to your doctor's instructions.

Hepatic impairment
Patients with impaired liver function should not take more than 10 mg per day. The medicine should be taken according to your doctor's instructions.

Patients who are poor metabolisers of drugs via the CYP2C19 isoenzyme
Patients with this known genotype should not receive more than 10 mg per day. The medicine should be taken according to your doctor's instructions.

How to take the tablets
Escitalopram Grindeks tablets can be taken with or without food. Swallow the tablets with water. Do not chew them, as they have a bitter taste.

If necessary, the tablets may be divided by first placing them on a flat surface with the score line facing upwards. The tablets can then be broken by pressing each end with both index fingers, as shown in the illustration.

Only the 10 mg and 20 mg tablets can be divided into equal doses.

Duration of treatment
You may not start feeling better until several weeks after starting treatment. Continue taking Escitalopram Grindeks even if it takes some time before you feel improvement. Do not change the dose without first consulting your doctor.

Continue taking Escitalopram Grindeks for as long as your doctor recommends. Stopping treatment too early may lead to a recurrence of symptoms. It is recommended to continue treatment for at least 6 months after regaining good well-being.

Taking more than the recommended dose of Escitalopram Grindeks
If you have taken more than the recommended dose of Escitalopram Grindeks, contact your doctor or the nearest hospital emergency department immediately. This should be done even if you do not feel unwell. Symptoms of overdose may include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, irregular heartbeat, low blood pressure, and disturbances in water and electrolyte balance.

Bring the medicine pack/container of Escitalopram Grindeks with you to the doctor's visit or hospital.

If you miss a dose of Escitalopram Grindeks
Do not take a double dose to make up for a missed dose. If you forget to take a dose and remember before going to sleep, take it immediately. The next day, continue taking the medicine as usual. If you remember about the missed dose during the night or the next day, skip the missed dose and take the next dose at the usual time.

Stopping treatment with Escitalopram Grindeks
Do not stop taking Escitalopram Grindeks unless your doctor advises you to do so. At the end of treatment, a gradual reduction of the dose of Escitalopram Grindeks over several weeks is usually recommended.

After stopping Escitalopram Grindeks, especially if stopped abruptly, you may experience withdrawal symptoms. These are common when stopping treatment with Escitalopram Grindeks. The risk is greater if Escitalopram Grindeks has been taken for a long time, at high doses, or if the dose was reduced too quickly. In most people, symptoms are mild and resolve spontaneously within two weeks. However, in some patients, they may be more severe or last longer (2–3 months or more). If you experience severe withdrawal symptoms after stopping Escitalopram Grindeks, contact your doctor. Your doctor may recommend restarting the tablets and tapering them more slowly.

Withdrawal symptoms include: dizziness (unsteady gait, balance disturbances), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, including in the head; sleep disturbances (vivid dreams, nightmares, insomnia); feelings of anxiety; headache; nausea; sweating (including night sweats); feelings of restlessness or agitation; tremors (shakiness); feelings of disorientation or confusion; emotional instability or irritability; diarrhoea (loose stools); visual disturbances; palpitations (awareness of heartbeats).

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions usually resolve within a few weeks of treatment. It should be remembered that some
of these reactions may also be symptoms of the underlying illness and will resolve as the patient's condition improves.
If any of these adverse reactions occur during treatment, you should
contact your doctor or go immediately to hospital:
Uncommon (may occur in 1 out of 100 people):

• Unusual bleeding, including gastrointestinal bleeding. Rare (may occur in 1 out of 1000 people):
• Swelling of the skin, tongue, lips, larynx or face, urticaria, or difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which may be symptoms of a rare condition called serotonin syndrome. Frequency unknown (frequency cannot be estimated from available data):
• Difficulty in passing urine.
• Seizures, see also section "Warnings and precautions".
• Yellowing of the skin and whites of the eyes, indicating impaired liver function/hepatitis.
• Rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsade de pointes.
• Thoughts of harming yourself or of suicide, see also section "Warnings and precautions".
• Sudden swelling of the skin or mucous membranes (angioedema).

In addition to those listed above, the following adverse reactions have also been reported:
Very common (may occur in more than 1 out of 10 people):

• Nausea.
• Headache.

Common (may occur in up to 1 out of 10 people):

• Nasal congestion or cold (sinusitis).
• Decreased or increased appetite.
• Anxiety, restlessness, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, tingling sensation in the skin.
• Diarrhoea, constipation, vomiting, dry mouth.
• Excessive sweating.
• Muscle and joint pain.
• Sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women).
• Feeling of fatigue, fever.
• Weight gain.

Uncommon (may occur in up to 1 out of 100 people):

• Urticaria, rash, itching (pruritus).
• Teeth grinding, agitation, nervousness, panic attack, disorientation.
• Sleep disturbances, taste disturbances, fainting (syncope).
• Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Heavy menstrual bleeding.
• Irregular menstruation.
• Weight loss.
• Rapid heartbeat.
• Swelling of the upper or lower limbs.
• Nosebleeds.

Rare (may occur in up to 1 out of 1000 people):

• Aggression, depersonalization, hallucinations.
• Slow heartbeat.

Frequency unknown (frequency cannot be estimated from available data):

• Low sodium levels in the blood (manifesting as nausea, malaise, muscle weakness, or confusion).
• Dizziness upon standing due to low blood pressure (orthostatic hypotension).
• Abnormal liver function tests (increased liver enzyme activity in blood).
• Movement disorders (involuntary muscle movements).
• Prolonged and painful erection (priapism).
• Signs of unusual bleeding under the skin or mucous membranes (petechiae).
• Increased secretion of antidiuretic hormone (ADH), leading to water retention and blood dilution, resulting in low sodium levels (syndrome of inappropriate secretion of ADH).
• Galactorrhea (milk production) in men and in women who are not breastfeeding.
• Mania.
• In patients taking medicines of this type, an increased risk of bone fractures has been observed.
• Changes in heart rhythm (known as "QT interval prolongation", visible on ECG as changes in the heart's electrical activity).
• Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage); for more information, see section 2 "Pregnancy, breastfeeding and fertility".

Additionally, adverse reactions known to occur with medicines having a similar mechanism of action to escitalopram (the active substance in Escitalopram Grindeks) include:

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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.
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Escitalopram Grindeks

Keep this medicine 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 carton and blister pack following "EXP".
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

The active substance is escitalopram. Each film-coated tablet contains escitalopram oxalate, corresponding to 5, 10 or 20 mg of escitalopram.
The other ingredients are:
Core: microcrystalline cellulose (E460), sodium croscarmellose (E468), hypromellose (E464), talc (E553b), colloidal anhydrous silica (E551), magnesium stearate (E470b).
Coating: hypromellose (E464), macrogol, titanium dioxide (E171).
What Escitalopram Grindeks looks like and contents of the pack
Escitalopram Grindeks 5 mg is a white to off-white, round, film-coated tablet, approximately 6 mm in diameter, biconvex.
Escitalopram Grindeks 10 mg is a white to off-white, oval, film-coated tablet, approximately 8 mm by 6 mm, biconvex, with the numbers "1" and "0" on either side of a breakline on one side.
Escitalopram Grindeks 20 mg is a white to off-white, oval, film-coated tablet, approximately 12 mm by 7 mm, biconvex, with a breakline on one side.
Escitalopram Grindeks is available in blisters made of PVC/PE/PVdC//Aluminum or in blisters made of OPA/Aluminum/PVC//Aluminum, containing 14, 28, 30, 56, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries 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