Escitalopram Genoptim

Package Leaflet: Information for the User

Escitalopram Genoptim, 10 mg, film-coated tablets

Escitalopram Genoptim, 20 mg, film-coated tablets

Escitalopram

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

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

Escitalopram Genoptim contains the active substance escitalopram. Escitalopram Genoptim 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. Disturbances in the serotonin system in the brain are believed to play a key role in the development of depression and related disorders.

Escitalopram Genoptim contains the active substance escitalopram and is used to treat depression (major depressive episodes), anxiety disorders (such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder). It may take a few weeks of treatment before you start to feel better. You should continue to take Escitalopram Genoptim even if you feel better, as long as your doctor has prescribed it. If you do not feel better or feel worse, you should consult your doctor.

2. Important information before taking Escitalopram Genoptim

When not to take Escitalopram Genoptim:

• 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 MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic);
• if you were born with a heart rhythm disorder or if you have had an episode of abnormal heart rhythm (visible on an ECG, a test that evaluates heart function);

heart.

• if you are taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section 2 "Escitalopram Genoptim and other medicines").

Warnings and precautions

Before starting treatment with Escitalopram Genoptim, you should discuss it with your doctor. 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 Genoptim (see also section 4 "Possible side effects");

if you have liver or kidney problems. Your doctor may need to adjust the dose;

if you have diabetes. Taking Escitalopram Genoptim may affect blood sugar control. You may need to adjust your insulin dose and/or oral hypoglycemic medications;

if you have low sodium levels in your blood;

if you have an increased tendency to bleed or bruise;

if you are undergoing electroconvulsive therapy;

if you have coronary heart disease;

if you have or have had heart problems or if you have recently had a heart attack;

if you have a slow resting heart rate and/or low levels of electrolytes due to prolonged severe diarrhea, vomiting, or use of diuretics (water pills);

if you experience rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm;

if you have or have had eye problems, such as certain types of glaucoma (increased pressure inside the eyeball);

if you are pregnant (see "Pregnancy, breastfeeding, and fertility"). Medicines like Escitalopram Genoptim (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

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.

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 symptoms or behaviors may worsen at the beginning of treatment with antidepressant medicines, as they usually start to work after about 2 weeks, sometimes later.

These symptoms are more likely to occur in:

• patients who have had suicidal thoughts or self-harm in the past;
• young adults. Clinical trial data show an increased risk of suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressant medicines.

If you experience thoughts of self-harm or suicide, you should immediately contact your doctor or go to the hospital.It may be helpful to inform your relatives or close friends about your depression or anxiety disorder and ask them to read this leaflet.You may ask them to tell you if they notice that your depression or anxiety has worsened or if you have any worrying changes in your behavior.

Children and adolescents

Escitalopram Genoptim should not be used in children and adolescents under 18 years of age. It should also be noted 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 expressions of anger). Nevertheless, your doctor may prescribe Escitalopram Genoptim to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Escitalopram Genoptim to a patient under 18 years of age, and you have any doubts, please contact the doctor. If the above symptoms develop or worsen in patients under 18 years of age taking Escitalopram Genoptim, you should inform your doctor. Additionally, as of now, there is a lack of data on the long-term safety of using Escitalopram Genoptim in this age group regarding growth, maturation, and cognitive and behavioral development.

Escitalopram Genoptim and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, 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 active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, you should wait 14 days before starting to take Escitalopram Genoptim. After stopping treatment with Escitalopram Genoptim, 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). These medicines increase the risk of side effects; the antibiotic linezolid; lithium (used to treat bipolar affective disorder) and tryptophan; imipramine and desipramine (used to treat depression); sumatriptan and similar medicines (used to treat migraine) and tramadol (used to treat severe pain). They may increase the risk of side effects; cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (a medicine used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in escitalopram levels in the blood; St. John's Wort (Hypericum perforatum) - a herbal medicine used in depression; acetylsalicylic acid and non-steroidal anti-inflammatory medicines (medicines used to relieve pain or thin the blood, known as anticoagulants). They may increase the risk of bleeding; warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, known as anticoagulants). Your doctor may order a blood clotting test at the start and after stopping treatment with Escitalopram Genoptim to determine if the dose of the 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; neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressant medicines (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold; flecainide, propafenone, and metoprolol (used to treat heart conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotic medicines). A dose adjustment of Escitalopram Genoptim may be required; medicines that lower potassium or magnesium levels in the blood increase the risk of life-threatening heart rhythm disorders. You should not take Escitalopram Genoptim at the same time as medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm, such as anti-arrhythmic medicines class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines - especially halofantrine), some antihistamines (astemizole, mizolastine), etc. You should consult your doctor if you have any further questions.

Escitalopram Genoptim with food, drinks, and alcohol

Escitalopram Genoptim can be taken with or without food (see section 3 "How to take Escitalopram Genoptim"). As with many medicines, it is not recommended to take Escitalopram Genoptim and drink alcohol at the same time, although interactions between Escitalopram Genoptim and alcohol are not 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 before taking this medicine. You should not take Escitalopram Genoptim during pregnancy or breastfeeding, unless you have discussed the risks and benefits of treatment with your doctor. If you take Escitalopram Genoptim during the last 3 months of pregnancy, you should be aware that the following symptoms may occur in the newborn: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty sucking, vomiting, low blood sugar, muscle stiffness or flaccidity, increased reflex excitability, tremors, tremors, irritability, lethargy, constant crying, and difficulty sleeping. If the newborn experiences any of these symptoms, you should immediately consult a doctor. You should inform your doctor and/or midwife about taking Escitalopram Genoptim. Taking medicines like Escitalopram Genoptim, especially in the last three months of pregnancy, may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN). It is characterized by rapid breathing and blue skin. These symptoms usually appear within the first day of life. If such symptoms occur in the newborn, you should immediately contact a doctor and/or midwife. You should not stop taking Escitalopram Genoptim during pregnancy unless your doctor advises you to do so. Stopping treatment with Escitalopram Genoptim during the last part of pregnancy may increase the risk of severe bleeding from the uterus, occurring shortly after delivery, especially if you have a history of bleeding disorders. If you take Escitalopram Genoptim, you should inform your doctor or midwife so that they can give you appropriate advice. It is assumed that Escitalopram Genoptim 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 Genoptim affects you.

3. How to take Escitalopram Genoptim

You should always take Escitalopram Genoptim 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 Genoptim is 10 mg, taken as a single dose once daily. The dose may be increased by your doctor to a maximum of 20 mg per day.

Panic disorder with agoraphobia

The initial dose of Escitalopram Genoptim is 5 mg once daily for the first week of treatment, then the dose is increased 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 Genoptim is 10 mg, taken as a single dose once daily. The dose may then be decreased by your doctor to 5 mg per day or increased to a maximum of 20 mg per day, depending on your response to the medicine.

Generalized anxiety disorder

The recommended dose of Escitalopram Genoptim is 10 mg, taken as a single dose 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 Genoptim is 10 mg, taken as a single dose once daily. The dose may be increased by your doctor to a maximum of 20 mg per day.

Elderly patients (>65 years)

The recommended initial dose of Escitalopram Genoptim is 5 mg, taken as a single dose once daily. Your doctor may recommend increasing the dose to 10 mg per day.

Use in children and adolescents

Escitalopram Genoptim should not normally be used in children and adolescents. Additional information is provided in section 2 "Important information before taking Escitalopram Genoptim". Escitalopram Genoptim can be taken with or without food. The tablets should be swallowed with water. Do not chew them, as they have a bitter taste. If necessary, the tablets can be broken into two halves. To do this, place the tablet on a flat surface with the score line facing up, then break it in half by pressing each end down with your index fingers, as shown in the picture.

Duration of treatment

You may start to feel better after a few weeks of treatment. You should continue to take Escitalopram Genoptim even if you feel better, as long as your doctor has prescribed it. Do not change the dose without consulting your doctor. You should take the medicine for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. It is recommended to continue treatment for at least 6 months after you have recovered.

Taking a higher dose of Escitalopram Genoptim than recommended

If you have taken more than the prescribed dose of Escitalopram Genoptim, you should immediately contact your doctor or go to the emergency room. You should do this even if you do not feel any discomfort. Symptoms of overdose include dizziness, tremors, restlessness, seizures, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and electrolyte disturbances. When visiting your doctor or going to the hospital, you should bring the packaging of Escitalopram Genoptim with you.

Missing a dose of Escitalopram Genoptim

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 bedtime, you should take the missed dose immediately. You should take the next dose at the usual time the next day. 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 Genoptim

You should not stop taking Escitalopram Genoptim unless your doctor advises you to do so. When you stop treatment, it is usually recommended to gradually reduce the dose of Escitalopram Genoptim over a period of several weeks. After stopping treatment with Escitalopram Genoptim, especially if it is stopped abruptly, you may experience withdrawal symptoms. These symptoms are common when treatment with Escitalopram Genoptim is stopped. The risk is higher if Escitalopram Genoptim has been taken for a long time, in high doses, or if the dose has been reduced too quickly. In most patients, the symptoms are mild and resolve on their own within two weeks. In some patients, however, they may be more severe or persist for longer (2-3 months or longer). If you experience severe withdrawal symptoms after stopping treatment with Escitalopram Genoptim, you should contact your doctor. Your doctor may recommend restarting treatment with Escitalopram Genoptim and reducing the dose more slowly. Withdrawal symptoms include dizziness (unsteady gait, balance disturbances), tingling sensation, burning sensation, and (less commonly) electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea (nausea), sweating (including night sweats), restlessness or agitation, tremors, disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or arrhythmias. If you have any doubts about taking the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Escitalopram Genoptim can cause side effects, although not everybody gets them. Side effects usually resolve after a few weeks of treatment. You should remember that some of these side effects may also be symptoms of the underlying disease and will resolve as your condition improves. You should contact your doctor or go to the hospital if you experience any of the following side effects during treatment:

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, or face, or difficulty breathing or swallowing (allergic reaction)

high fever, restlessness, confusion (disorientation), tremors, and sudden muscle contractions, which may be symptoms of a rare disorder called serotonin syndrome

Unknown frequency (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 sign of liver dysfunction/hepatitis

rapid, irregular heartbeat, fainting, which may be a sign of a life-threatening condition called torsades de pointes

suicidal thoughts and behaviors, see also section "Warnings and precautions"

severe postpartum hemorrhage, see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2

Other side effects reported

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

nausea

headache

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

nasal congestion or sinusitis (sinus infection)

decreased or increased appetite

anxiety, restlessness, abnormal dreams, difficulty sleeping, drowsiness, dizziness, yawning, tremors, tingling sensation

diarrhea, constipation, vomiting, dry mouth

increased sweating

muscle and joint pain

sexual disturbances (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women)

fatigue, fever

weight gain

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

hives, rash, itching

teeth grinding, restlessness, nervousness, panic attacks, confusion (disorientation)

sleep disturbances, taste disturbances, fainting (syncope)

pupil dilation, vision disturbances, ringing in the ears (tinnitus)

hair loss

heavy menstrual bleeding

irregular menstrual periods

weight loss

rapid heartbeat

swelling of the upper or lower limbs

nosebleeds

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

aggression, depersonalization (feeling of loss of one's own identity, feeling of not being oneself), hallucinations

slow heartbeat

Unknown frequency (frequency cannot be estimated from the available data):

low sodium levels in the blood (manifested by nausea and malaise with muscle weakness or disorientation)

dizziness when standing up due to low blood pressure (orthostatic hypotension)

abnormal liver function test results (elevated liver enzyme activity in the blood)

movement disorders (involuntary muscle movements)

painful erection (priapism)

symptoms of unusual bleeding in the skin and mucous membranes (ecchymoses)

sudden swelling of the skin or mucous membranes (angioedema)

increased urine production (inappropriate secretion of antidiuretic hormone - vasopressin)

galactorrhea in men and women who are not breastfeeding

mania

patients taking medicines of this class have been observed to have an increased risk of fractures

change in heart rhythm (called "QT interval prolongation", visible on an ECG, a test that evaluates heart function)

Additionally, side effects of medicines with a similar mechanism of action to escitalopram (the active substance of Escitalopram Genoptim) are known. These include:

psychomotor restlessness (akathisia)

loss of appetite.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform 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

Phone: +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 Genoptim

The medicine should be stored out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label or carton. The expiry date refers to the last day of the month stated. There are no special storage precautions. 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 pack and other information

What Escitalopram Genoptim contains

The active substance of Escitalopram Genoptim is escitalopram. Each film-coated tablet of Escitalopram Genoptim contains 10 mg or 20 mg of escitalopram (as escitalopram oxalate). The other ingredients of the medicine are:

Tablet core: croscarmellose sodium, butylhydroxytoluene (E321), butylhydroxyanisole (E320), microcrystalline cellulose (PH-102), siliconized microcrystalline cellulose, colloidal anhydrous silica, talc, magnesium stearate.

Tablet coating: hypromellose (5 cP), macrogol 400, titanium dioxide (E 171).

What Escitalopram Genoptim looks like and contents of the pack

Escitalopram Genoptim is a film-coated tablet containing 10 mg or 20 mg of the active substance. Below is a description of the tablets.

Escitalopram Genoptim is available in the following packs:

Blister pack in a carton box

10 mg tablets: 28, 30, 56, 60, 90 film-coated tablets

20 mg tablets: 28, 30 film-coated tablets

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.

ul. Krakowiaków 65

02-255 Warsaw

Importer

APL Swift Services (Malta) Ltd.

HF 26, Hal Far Industrial Estate

Hal Far, Birzebbugia, BBG 3000

Malta

Date of last revision of the leaflet: October 2022