Escitalopram grindeks: detailed information

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 you.

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 them even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Escitalopram Grindeks is and what it is used for
What you need to know before taking Escitalopram Grindeks
How to take Escitalopram Grindeks
Possible side effects
How to store Escitalopram Grindeks
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 called selective serotonin reuptake inhibitors (SSRIs). These medicines act 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 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 the group called MAO inhibitors, containing selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic).
if the patient was born with a 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 to take 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 the patient has 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 the patient has impaired liver or kidney function. Dose adjustment by the doctor may be required;
if the patient has diabetes. Treatment with Escitalopram Grindeks may affect blood glucose control. Adjustment of insulin and (or) oral glucose-lowering medicines may be necessary;
if the patient has low sodium levels in the blood;
if the patient has a tendency to bleed easily or develop bruises, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility");
if the patient is undergoing electroconvulsive therapy;
if the patient has ischemic heart disease;
if the patient has heart problems or has recently suffered a heart attack;
if the patient has a slow resting heart rate and (or) if the patient has salt deficiency due to prolonged severe diarrhoea, vomiting, or use of diuretics (water tablets);
if the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate an abnormal heart rate;
if the patient has had or currently has 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 a 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 about 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 treated with antidepressants. If at any time the patient experiences thoughts of self-harm or suicide, seek immediate medical advice 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 reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger).
Nevertheless, a doctor may prescribe Escitalopram Grindeks to patients under 18 years of age if he/she considers 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, 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 as active substances. If 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 moclobemide (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, lanzoprazole, and omeprazole (used in the treatment of stomach ulcers), fluconazole (a medicine used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase the blood concentration of escitalopram.
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 (medicines used to thin the blood, known as anticoagulants). Your doctor will likely check your blood clotting time when starting and stopping Escitalopram Grindeks to ensure the anticoagulant dose remains appropriate.
Mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used in the treatment of severe pain) due to possible risk of lowering the seizure threshold.
Neuroleptics (medicines used in the treatment of 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). Dose adjustment of Escitalopram Grindeks may be required.
Medicines that lower blood potassium or magnesium levels, as they increase the risk of life-threatening heart rhythm disturbances.

Do not take Escitalopram Grindeks if the patient is taking medicines used for
heart rhythm disorders or medicines that may affect heart rhythm, such as class IA and III antiarrhythmic agents, 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 in doubt, 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a
child, she should consult her doctor or pharmacist before using this medicine. Do not
take Escitalopram Grindeks if the patient is pregnant or breastfeeding unless her doctor has discussed the associated risks and benefits with her.
If the patient takes Escitalopram Grindeks during the last 3 months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, blue skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose, muscle stiffness or floppiness, increased reflex excitability, tremors, shakiness, irritability, lethargy, constant crying, sleepiness, and difficulty falling asleep. If any of these symptoms occur in the newborn, seek immediate medical attention.
Ensure that the midwife and (or) doctor are aware of the use of Escitalopram Grindeks.
Medicines such as Escitalopram Grindeks taken during pregnancy, particularly in 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 occur within the first 24 hours after birth. If such symptoms occur in the newborn, contact the 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 the patient previously had blood clotting disorders. The doctor or midwife should be informed about the use of Escitalopram Grindeks so they can provide advice.
If Escitalopram Grindeks is taken during pregnancy, it should never be stopped abruptly.
Escitalopram is expected to pass into breast milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.
Driving and operating machinery
It is recommended that the patient does not 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 as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults

Depression
The usual recommended dose of Escitalopram Grindeks is 10 mg taken once daily. Your doctor may increase the dose 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. Your doctor may increase the dose 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. Your doctor may increase the dose 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 advised in patients with severe renal impairment. This 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 as directed by your doctor.

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 as directed by your doctor.

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 can be divided by first placing them on a flat surface with the score line facing upwards. The tablets can then be split 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.

Two hands pointing with index fingers at a small, round tablet lying on a flat surface

Duration of treatment
You may not start to feel better until several weeks after starting treatment. Continue taking Escitalopram Grindeks as prescribed, even if it takes some time before you notice an improvement in your condition. 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 Escitalopram Grindeks than prescribed
If you have taken more Escitalopram Grindeks than prescribed, contact your doctor or the nearest hospital emergency department immediately. This should be done even if you do not feel unwell. Some symptoms of overdose may include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and disturbances in water and electrolyte balance.

Take the medicine pack/container with you when visiting the doctor 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 following day, skip the missed dose and take the next dose as scheduled.

Stopping Escitalopram Grindeks
Do not stop taking Escitalopram Grindeks unless your doctor advises you to do so. After completing treatment, a gradual reduction in 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 higher 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, symptoms 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 reducing the dose 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 (heart fluttering or pounding).

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 after a few weeks of treatment. It should be remembered that some
of these reactions may also be symptoms of the underlying illness and will subside as the patient's condition improves.
If any of the following adverse reactions occur during treatment, you should
contact your doctor or go to hospital immediately:
Uncommon (may occur in 1 out of 100 people):

Unusual bleeding, including gastrointestinal bleeding.
Swelling of the skin, tongue, lips, larynx or face, urticaria (hives), or difficulty breathing or swallowing (severe allergic reaction).
High fever, agitation, confusion, tremors, and violent muscle contractions, which may be symptoms of a rare condition called serotonin syndrome.
Difficulty in passing urine.
Seizures, see also section “Warnings and precautions”.
Yellowing of the skin and whites of the eyes, indicating liver dysfunction/hepatitis.
Rapid or irregular heartbeat, fainting – may be symptoms of a life-threatening condition called torsade de pointes.
Thoughts about harming yourself or committing suicide – see also section “Warnings and precautions”.
Sudden swelling of the skin or mucous membranes (angioedema).

In addition to the reactions 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 runny nose (sinusitis).
Decreased or increased appetite.
Anxiety, restlessness, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, tingling sensations 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 (hives), rash, itching (pruritus).
Teeth grinding, agitation, nervousness, panic attacks, disorientation.
Sleep disturbances, taste disturbances, fainting (syncope).
Pupil dilation (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, depersonalisation, hallucinations.
Slow heartbeat.

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

Decreased sodium concentration in blood (manifesting as nausea and malaise, with 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).
Painful penile erection (priapism).
Symptoms of unusual bleeding under the skin or mucous membranes (petechiae).
Increased secretion of antidiuretic hormone (ADH), leading to water retention and blood dilution, and reduced sodium levels (syndrome of inappropriate antidiuretic hormone secretion – SIADH).
Galactorrhoea (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 (called “QT interval prolongation”, visible on ECG, in the electrical activity of the heart).
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 adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorisation 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 at temperatures 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 equivalent 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), polyethylene glycol, 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 characters "1" and "0" on either side of the 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 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