Escitalopram Genoptim

Leaflet accompanying the packaging: information for the user

Escitalopram Genoptim, 10 mg, coated tablets

Escitalopram

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Escitalopram 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 packaging 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 levels 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 it takes some time before you feel better.

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 have been born with a heart rhythm disorder or if you have had an episode of irregular heart rhythm (visible on an ECG, a test that assesses heart function).
• if you are taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see 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 therapy with Escitalopram Genoptim (see also section 4 "Possible side effects");

if you have liver or kidney problems. A dose adjustment may be required by your doctor;

if you have diabetes. Taking Escitalopram Genoptim may affect blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agents;

if you have low sodium levels in your blood;

if you have an increased tendency to bleeding and bruising;

if you are being treated with 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 slow resting heart rate and/or if you have 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 irregular heart rhythm;

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

if you are pregnant (see "Pregnancy, breastfeeding, and fertility");

if you are taking serotoninergic medicines, as taking these medicines with Escitalopram Genoptim may lead to a life-threatening condition called serotonin syndrome (see section "Escitalopram Genoptim and other medicines").

Medicines like Escitalopram Genoptim (so-called SSRIs or SNRIs) may cause 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 anxiety 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. Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start working after about 2 weeks, sometimes later.

These symptoms are more likely to occur in:

• patients who have had suicidal thoughts or attempts in the past;
• young adult patients. Clinical trial data have shown an increased risk of suicidal behavior in people under 25 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 can ask them to monitor you and inform you if your depression or anxiety worsens or if you experience 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 adverse reactions, 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 your 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 medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Some medicines may increase the side effects of Escitalopram Genoptim, and sometimes cause serious reactions. While taking Escitalopram Genoptim, you should not take other medicines without first consulting your doctor, and in particular, you should inform your doctor if you are taking any of the following medicines:

non-selective monoamine oxidase inhibitors (MAOIs) containing 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);

imipramine and desipramine (used to treat depression);

cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in escitalopram levels in the blood;

St. John's Wort (Hypericum perforatum) - a herbal medicine used to treat depression;

acetylsalicylic acid and non-steroidal anti-inflammatory drugs (used as painkillers or to thin the blood, known as anticoagulants). They may increase the risk of bleeding;

warfarin, dipyridamole, and phenprocoumon (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 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 (used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold;

flecainide, propafenone, and metoprolol (used to treat heart conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dose adjustment of Escitalopram Genoptim may be required;

medicines that lower potassium or magnesium levels in the blood, increasing the risk of life-threatening heart rhythm disorders.

sumatriptan and similar medicines (used to treat migraines), tramadol (used to treat severe pain), tryptophan, buprenorphine (used to treat pain and opioid addiction), and naloxone (used to diagnose and treat opioid overdose). These medicines may increase the risk of side effects and interact with Escitalopram Genoptim, causing symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, body temperature above 38 °C. If you experience such symptoms (serotonin syndrome), you should contact your doctor.

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 of class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines - especially halofantrine), and certain antihistamines (astemizole, mizolastine), etc. You should consult your doctor if you have any further questions.

Escitalopram Genoptim with food, drink, 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 at the same time as drinking alcohol, although interactions (effects) of Escitalopram Genoptim with 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 while breastfeeding, unless you have discussed the risks and benefits 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, fluctuations in body temperature, difficulty sucking, vomiting, low blood sugar, stiffness or flaccidity of the muscles, increased reflexes, tremors, tremors, irritability, lethargy, constant crying, and difficulty sleeping. If the newborn experiences any of these symptoms, you should immediately contact your doctor.

You should inform your doctor and/or midwife about taking Escitalopram Genoptim.

Taking medicines like Escitalopram Genoptim during pregnancy, especially in the last three months, 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 discoloration. These symptoms usually appear within the first day of life. If such symptoms occur in the newborn, you should immediately contact your doctor and/or midwife.

You should not stop taking Escitalopram Genoptim during pregnancy unless your doctor advises you to do so.

Taking Escitalopram Genoptim at the end of pregnancy may increase the risk of severe vaginal bleeding 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 provide you with 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.

Escitalopram Genoptim contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Escitalopram Genoptim

Escitalopram Genoptim should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

Adults:

Depression

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

Panic disorder

The initial dose of Escitalopram Genoptim is 5 mg once a day 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 a day. 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 a day. 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 a day. 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 a day. 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. They should not be chewed, 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 groove facing up, and 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 therefore continue to take Escitalopram Genoptim, even if it takes some time before you feel better.

You should not change the dose without consulting your doctor.

The medicine should be taken for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. It is therefore 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 a higher dose of Escitalopram Genoptim than prescribed, you should immediately contact your doctor or go to the emergency room at your nearest hospital.

You should do this even if you do not feel any discomfort. The symptoms of overdose include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and disturbances in water and electrolyte balance. When visiting your doctor or the hospital, you should take 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 going to bed, 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 disappear on their own within two weeks. In some patients, however, they may be more severe or last 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 the medicine and tapering it off more slowly.

The withdrawal symptoms include dizziness (unsteady gait, balance disturbances), tingling sensation, burning sensation, and (less commonly) a sensation of electric shock, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea (nausea), sweating (including night sweats), psychomotor 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 disappear after a few weeks of treatment. You should remember that some of these side effects may also be symptoms of the disease being treated and will disappear as you recover.

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, agitation, 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/liver inflammation

rapid or 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 vaginal bleeding shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2

In addition to the above, the following side effects have also been 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 dysfunction (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, agitation, 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 arms or legs

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):

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

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

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

movement disorders (involuntary muscle movements)

painful erection of the penis (priapism)

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

sudden swelling of the skin or mucous membranes (angioedema)

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

lactation in men and women who are not breastfeeding

mania

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

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

In addition, the following side effects are known for medicines with a similar mechanism of action to escitalopram (the active substance of Escitalopram Genoptim):

psychomotor restlessness (akathisia)

loss of appetite

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse.

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:

Jerozolimskie Avenue 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 the medicine.

5. How to store Escitalopram Genoptim

The medicine should be stored out of 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.

There are no special precautions for storage.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Escitalopram Genoptim contains

The active substance of Escitalopram Genoptim is escitalopram. Each coated tablet of Escitalopram Genoptim contains 10 mg of escitalopram (in the form of oxalate).

The other ingredients of the medicine are:

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

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

What Escitalopram Genoptim looks like and contents of the pack

Escitalopram Genoptim has the form of coated tablets containing 10 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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.

Krakowiaków 65

02-255 Warsaw

Importer

APL Swift Services (Malta) Ltd.

HF 26, Hal Far Industrial Estate

Hal Far, Birzebbugia, BBG 3000

Malta

To obtain more detailed information about this medicine, you should contact the marketing authorization holder:

Synoptis Pharma Sp. z o.o.

Phone: +48 22 32 16 240

Date of last revision of the leaflet: