ESCITALOPRAM GRINDEKS 5 mg FILM-COATED TABLETS

2. What you need to know before you take Escitalopram Grindeks

Do not 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 problem or have had episodes of abnormal heart rhythm (detected on an ECG).
• if you are taking medicines that can affect the heart rhythm (see the section "Other medicines and Escitalopram Grindeks" in section 2).

Warnings and precautions

Consult your doctor or pharmacist before taking escitalopram. Inform your doctor if you have any other condition or disease, as your doctor may need to take this into account. In particular, consult your doctor:

• If you have epilepsy. Treatment with escitalopram should be discontinued if you experience seizures for the first time or if there is an increase in seizure frequency (see also section 4).
• If you have liver or kidney disease. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with escitalopram may affect blood sugar control. Your doctor may need to adjust your insulin or oral hypoglycemic dose.
• If you have low sodium levels in the blood.
• If you are prone to bleeding or bruising or if you are pregnant (see the section "Pregnancy, breast-feeding, and fertility").
• If you are receiving electroconvulsive therapy.
• If you have coronary heart disease.
• If you have had heart problems or have recently had a heart attack.
• If you have a low resting heart rate or if you may have low sodium levels due to prolonged diarrhea and vomiting or the use of diuretics.
• If you experience a fast or irregular heartbeat, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm.
• If you have had eye problems, such as certain types of glaucoma (increased eye pressure).

Be aware that

Some patients with manic-depressive illness may enter a manic phase, characterized by unusual and rapid changes in ideas, euphoria, and excessive physical activity. If you experience these symptoms, contact your doctor.

Symptoms such as restlessness or difficulty sitting or standing may persist during the first few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Medicines like escitalopram (also called SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety

If you are depressed or have anxiety disorders, you may sometimes think about harming or killing yourself. These thoughts may increase when you first start taking antidepressant treatment, as all these medicines take time to work, usually about two weeks or longer.

You may be more likely to have these thoughts if:

• You have had suicidal thoughts before.
• You are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric conditions who were treated with antidepressants.

If at any time you have thoughts of harming or killing yourself, contact your doctor or go to the hospital immediately.

It may be helpful to tell a relative or close friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You might 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 is not usually recommended for children and adolescents under 18 years of age. You should also know that patients under 18 years of age are at increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger) when they take this type of medicine. However, your doctor may prescribe escitalopram to patients under 18 years of age if they decide it is the best treatment for them. If your doctor has prescribed Escitalopram Grindeks to a patient under 18 years of age and you want to discuss this, contact your doctor again. You should inform your doctor if the patient under 18 years of age who is taking escitalopram experiences any of the above symptoms or if they get worse. Additionally, the long-term safety effects of escitalopram on growth, maturity, and cognitive and behavioral development in this age group have not yet been demonstrated.

Other medicines and Escitalopram Grindeks

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) that contain the active substances phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, you should wait 14 days before starting to take escitalopram. After stopping treatment with Escitalopram Grindeks, you should wait 7 days before taking any of these medicines.
• Reversible MAO-A inhibitors that contain moclobemide (used to treat depression).
• Irreversible MAO-B inhibitors that contain selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects.

• The antibiotic linezolid.
• Lithium (used to treat manic-depressive illness) and tryptophan.
• Imipramine and desipramine (used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol and similar medicines (used to relieve acute pain). These medicines increase the risk of side effects.

• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the levels of escitalopram in the blood.
• St. John's Wort (Hypericum perforatum), a herbal remedy used to treat depression.
• Aspirin and non-steroidal anti-inflammatory drugs (used to relieve pain or as anticoagulants). These medicines may increase the risk of bleeding.
• Warfarin, dipyridamole, and phenprocoumon (anticoagulant medicines). Your doctor will probably check your blood clotting time when you start taking Escitalopram Grindeks and when you stop treatment to ensure that your anticoagulant dose is still appropriate.

• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat acute pain), due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used to treat schizophrenia and psychosis) and antidepressants (tricyclic antidepressants and SSRIs), due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used to treat cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Your doctor may need to adjust the dose of Escitalopram Grindeks.
• Medicines that lower the levels of potassium or magnesium in the blood, as these disorders increase the risk of potentially fatal heart rhythm disorders.

Do not take escitalopram if you are taking medicines for heart rhythm problems or medicines that may affect the heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazines, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial treatment, especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). If you have any further questions on the use of this medicine, ask your doctor.

Taking Escitalopram Grindeks with food, drinks, and alcohol

Escitalopram Grindeks can be taken with or without food (see section 3).

As with many other medicines, it is not recommended to take escitalopram with alcohol, although it is not expected that escitalopram will interact with alcohol.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take escitalopram if you are pregnant or breast-feeding, unless you and your doctor have discussed the risks and benefits.

If you take Escitalopram Grindeks during the last 3 months of pregnancy, you should be aware that your baby may experience the following effects: difficulty breathing, blue-colored skin, seizures, inadequate temperature regulation, feeding difficulties, vomiting, low blood sugar, muscle stiffness or weakness, increased reflexes, tremors, nervousness, irritability, lethargy, persistent crying, and sleep disturbances. If your baby experiences any of these symptoms, contact your doctor immediately.

Make sure to inform your midwife or doctor that you are taking escitalopram. Taking medicines like escitalopram, especially in the last 3 months of pregnancy, may increase the risk of your baby experiencing a serious condition called "persistent pulmonary hypertension in the newborn" (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start in the first 24 hours of life. If your baby experiences these symptoms, you should contact your midwife or doctor immediately.

If you take escitalopram at the end of pregnancy, there may be an increased risk of bleeding in the vagina after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking escitalopram so they can advise you.

If escitalopram is used during pregnancy, treatment should never be stopped abruptly.

It is expected that escitalopram will be excreted in breast milk.

Studies in animals with citalopram, a medicine like escitalopram, have shown a reduction in sperm quality. This could affect fertility, although its effect on human fertility has not been observed yet.

Driving and using machines

During treatment with Escitalopram Grindeks, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with escitalopram affects you.

Escitalopram Grindeks contains sodium.

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

3. How to take Escitalopram Grindeks

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

Depression

The recommended dose of escitalopram is usually 10 mg in a single dose per day. Your doctor may increase the dose up to a maximum of 20 mg per day.

Anxiety Disorder

The starting dose of escitalopram is a single dose of 5 mg per day for the first week, before increasing the dose to 10 mg per day. Your doctor may increase the dose later up to a maximum of 20 mg per day.

Social Anxiety Disorder

The recommended dose of escitalopram is usually 10 mg in a single dose per day. Your doctor may decrease the dose to 5 mg per day or increase the dose up to a maximum of 20 mg per day, depending on the response you show to the medication.

Generalized Anxiety Disorder

The recommended dose of escitalopram is usually 10 mg in a single dose per day. Your doctor may increase the dose up to a maximum of 20 mg per day.

Obsessive-Compulsive Disorder

The recommended dose of escitalopram is usually 10 mg in a single dose per day. Your doctor may increase the dose up to a maximum of 20 mg per day.

Elderly patients (over 65 years old)

The recommended starting dose of escitalopram is usually 5 mg in a single dose per day. Your doctor may increase the dose up to 10 mg per day.

Use in children and adolescents

Escitalopram should not be administered to children or adolescents. If you want more information, consult the "Warnings and precautions" section of section 2.

Renal impairment

Caution is advised in patients with severely decreased renal activity. Follow exactly the administration instructions of the medication indicated by your doctor.

Hepatic impairment

Patients with hepatic disorder should not receive more than 10 mg per day. Follow exactly the administration instructions of the medication indicated by your doctor.

Poor metabolizers of the CYP2C19 enzyme

Patients with this genotype should not receive more than 10 mg per day. Follow exactly the administration instructions of the medication indicated by your doctor.

How to take the tablets

You can take escitalopram with or without food. Swallow the tablets with a little water. Do not chew the tablets, they have a bitter taste.

If necessary, you can divide the tablets into equal doses; to do this, place the tablet on a flat surface with the scored side of the tablet facing up. Then you can divide the tablets, pressing with your thumbs on each end, as shown in the figure.

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

Duration of treatment

It may take two weeks before you start to feel better. Continue taking escitalopram, even if it takes some time before you experience any improvement in the disease you are suffering from.

Do not change the dose of your medication without talking to your doctor first.

Continue taking escitalopram for the time your doctor has recommended. If you interrupt your treatment too early, the symptoms may come back. It is recommended to continue treatment for at least 6 months after you feel better again.

If you take more Escitalopram Grindeks than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested, even if you do not experience signs of discomfort. Some signs of overdose may be: dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, alteration of heart rhythm, decrease in blood pressure, and variation of hydroelectrolytic balance. When you go to the doctor or hospital, take the box or packaging of Escitalopram Grindeks with you.

If you forget to take Escitalopram Grindeks

Do not take a double dose to make up for forgotten doses. If you forget to take a dose and remember before going to bed, take it immediately and continue taking the medication at your usual time the next day. If you remember during the night or the next day, do not take the forgotten dose and continue your usual dosing schedule.

If you stop treatment with Escitalopram Grindeks

Do not stop taking escitalopram until your doctor tells you to. When you finish your treatment cycle, it is generally recommended that the dose of escitalopram be gradually reduced over several weeks.

When you stop taking escitalopram, especially if you do so abruptly, you may experience withdrawal symptoms. These symptoms are common when treatment with escitalopram is discontinued. The risk is greater when treatment with escitalopram has been prolonged, high doses have been taken, or when the dose is decreased too quickly. Most people experience mild symptoms that go away on their own within two weeks. However, the intensity of these symptoms can be severe in some patients or may be more prolonged (2-3 months or more). If you experience severe withdrawal symptoms when stopping treatment with escitalopram, contact your doctor. They may ask you to start taking the tablets again to reduce the dose more slowly.

The symptoms of the withdrawal syndrome include: dizziness (instability or loss of balance), feeling of muscle aches, burning sensation, and (less frequently) sensations of electric discharge, even in the head, sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headache, feeling of dizziness (nausea), sweating (including night sweats), restlessness or agitation, tremors (agitation), confusion or disorientation, emotional instability or irritability, diarrhea (loose stools), visual disturbances, fluttering or strong heartbeat (palpitations).

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects usually subside within a few weeks of treatment. You should keep in mind that many of the effects can also be symptoms of the disease you are suffering from and, therefore, will improve when you start to feel better.

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

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• Swelling of the skin, tongue, lips, pharynx, or face, hives, or difficulty breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which can be signs of a rare disorder called serotonin syndrome.

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

• Difficulty urinating.
• Seizures (epileptic crises); see also the "Warnings and precautions" section.
• Yellowing of the skin and whites of the eyes are signs of liver failure or hepatitis.
• Rapid and irregular heartbeat and fainting, which can be symptoms of a potentially fatal disease known as Torsades de Pointes.
• Suicidal thoughts or behaviors; see also the "Warnings and precautions" section.
• Sudden swelling of the skin or mucous membranes (angioedema).

In addition to the above side effects, the following have also been reported:

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

• Feeling of dizziness (nausea)
• Headache

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

• Nasal congestion or runny nose (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal thoughts, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin itching
• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthralgia and myalgia)
• Sexual dysfunction (delayed ejaculation, erection problems, decreased libido, and in women, difficulty reaching orgasm)
• Fatigue, fever
• Weight gain

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

• Hives (urticaria), rash, itching (pruritus)
• Teeth grinding, agitation, nervousness, panic attacks, confusion
• Sleep disturbances, altered taste, fainting (syncope)
• Increased pupil size (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Excessive menstrual bleeding
• Irregular menstrual period
• Weight loss
• Rapid heartbeat
• Inflammation of the arms or legs
• Nosebleeds

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

• Aggression, depersonalization, hallucinations
• Slow heartbeat

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

• Decrease in sodium levels in the blood (symptoms are dizziness and general malaise, accompanied by muscle weakness or confusion).
• Dizziness when standing up due to low blood pressure (orthostatic hypotension)
• Alteration of liver function tests (increase in liver enzyme levels in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erections (priapism)
• Signs of abnormal bleeding, such as, e.g., skin or mucous membrane bleeding (ecchymosis)
• Increased secretion of a hormone called ADH, which causes the body to retain fluids and dilute the blood, reducing the amount of sodium (inadequate ADH secretion)
• Milk secretion in men and non-lactating women
• Mania
• An increased risk of bone fractures has been observed in patients taking this type of medication
• Alteration of heart rhythm (called QT interval prolongationand observed in the ECG [heart electrical activity]).
• Acute vaginal bleeding shortly after childbirth (postpartum hemorrhage); for more information, see the "Pregnancy, breastfeeding, and fertility" section of section 2.

It is also known that certain side effects can occur with drugs that work similarly to escitalopram (the active ingredient of Escitalopram Grindeks). These are:

• Motor restlessness (akathisia)
• Lack of appetite

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Escitalopram Grindeks

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the box and blister after "EXP". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy or in any other Medication Waste Collection System. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Escitalopram Grindeks

The active ingredient is escitalopram. Each film-coated tablet contains escitalopram oxalate, equivalent to 5 mg, 10 mg, or 20 mg of escitalopram.

The other ingredients are:

Core:microcrystalline cellulose (E-460), sodium croscarmellose (E-468), hypromellose (E-464), talc (E-553b), anhydrous colloidal silica (E-551), and magnesium stearate (E-470b).

Coating:hypromellose (E-464), macrogol, and titanium dioxide (E-171).

Appearance of the product and package contents

Escitalopram Grindeks 5 mg is a film-coated tablet, white to off-white, round, biconvex, and approximately 6 mm in diameter.

Escitalopram Grindeks 10 mg is a film-coated tablet, white to off-white, oval, biconvex, approximately 8 mm x 6 mm, with the inscription 1 and 0 engraved on each side of the score line on one face.

Escitalopram Grindeks 20 mg is a film-coated tablet, white to off-white, oval, biconvex, approximately 12 mm x 7 mm, with a score line on one face.

Escitalopram Grindeks is available in PVC/PE/PVDC//Al or OPA/Al/PVC//Al blisters of 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, Riga, LV-1057, Latvia

Tel: +371 67083205

E-mail: [email protected]

Manufacturer

AS GRINDEKS.

Krustpils iela 53, Riga, LV-1057, Latvia

HBM Pharma s.r.o.

Sklabinská 30

Martin, 03680

Slovakia

You can request more information about this medication by contacting the local representative of the marketing authorization holder

Grindeks Kalceks España, S.L.

C/ José Abascal, 58 – 2º Dcha.

Madrid, 28003, Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Date of the last revision of this leaflet: May 2023.

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)