Escitalopram genoptim

Package leaflet: Information for the user

Escitalopram Genoptim, 10 mg, film-coated tablets
Escitalopramum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Contents of the leaflet:

1. What Escitalopram Genoptim is and what it is used for
2. What you need to know 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 Escitalopram Genoptim is and what it is 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 act on the serotonin system in the brain by increasing serotonin levels.
Disturbances in the function of the brain's serotonin system 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) and anxiety disorders (such as panic disorder with or
without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive
disorder).
It may take several weeks of treatment before improvement begins. You should continue
taking Escitalopram Genoptim even if it takes some time before your condition improves.
If there is no improvement or if you feel worse, consult your doctor.

2. Important information before using Escitalopram Genoptim

When not to use Escitalopram Genoptim:

• if the patient is allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
• if the patient is taking other medicines belonging to a group called MAO inhibitors, containing selegiline (used in the treatment of Parkinson's disease), 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 2 "Escitalopram Genoptim and other medicines").

Warnings and precautions
Before starting treatment with Escitalopram Genoptim, discuss this with your doctor.
Inform your doctor if the patient has any other disorders or diseases,
as the doctor should take such information into account. In particular, inform the doctor:
if the patient has epilepsy. If seizures occur for the first time or increase in frequency,
treatment with Escitalopram Genoptim 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 Genoptim 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 an increased tendency to bleed or bruise;
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 low electrolyte levels 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 abnormal heart rhythm;
if the patient has or has had eye problems, such as certain types of glaucoma (increased pressure inside the eyeball);
if the patient is pregnant (see "Pregnancy, breastfeeding and fertility");
if the patient is taking serotonergic medicines, as using these together with Escitalopram Genoptim may lead to serotonin syndrome, a potentially life-threatening condition (see section "Escitalopram Genoptim and other medicines").
Medicines such as Escitalopram Genoptim (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Note
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, consult a doctor.
During the first weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If such symptoms appear, inform the doctor immediately.
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 behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working.
These symptoms are more likely in:

• patients who previously had thoughts of self-harm or suicide;
• young adult patients. Clinical trial data show an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders treated with antidepressant medicines.
  If the patient experiences thoughts of self-harm or suicide, seek immediate medical help
  by contacting a doctor or going to hospital.
  It may be helpful to inform relatives or close friends 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 concerning changes in behaviour.
  Children and adolescents
  Escitalopram Genoptim should not be used in children and adolescents under 18 years of age. It should also be emphasized 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 (especially aggression, oppositional behaviour, and anger). Nevertheless, a doctor may prescribe Escitalopram Genoptim to patients under 18 years of age if he/she considers 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-mentioned symptoms develop or worsen in patients under 18 years of age taking Escitalopram Genoptim, inform your doctor.
  Furthermore, there are currently no data on the long-term safety of Escitalopram Genoptim in this age group regarding growth, maturation, and cognitive and behavioural development.
  Escitalopram Genoptim and other medicines
  Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
  Some medicines may increase the side effects of Escitalopram Genoptim and sometimes cause severe reactions. During treatment with Escitalopram Genoptim, do not take other medicines without prior consultation with a doctor, and particularly inform the doctor if the patient is taking any of the following medicines:
  non-selective monoamine oxidase inhibitors (MAO) containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, a 14-day interval should be observed before starting Escitalopram Genoptim. After stopping Escitalopram Genoptim, 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 medicines increase the risk of adverse effects;
  the antibiotic linezolid;
  lithium (used in the treatment of bipolar affective disorder);
  imipramine and desipramine (used in the treatment of depression);
  cimetidine, lanzoprazole, and omeprazole (used in the treatment of stomach ulcers), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase escitalopram blood levels;
  St. John's wort (Hypericum perforatum) – a herbal medicine used for depression;
  acetylsalicylic acid and non-steroidal anti-inflammatory drugs (painkillers or blood-thinning medicines known as anticoagulants). These may increase the risk of bleeding;
  warfarin, dipyridamole, and phenprocoumon (blood-thinning medicines known as anticoagulants). The doctor may order blood clotting tests at the beginning and after stopping Escitalopram Genoptim to ensure the anticoagulant dose remains appropriate;
  mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used for severe pain) due to possible risk of lowering the seizure threshold;
  neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to possible risk of lowering the seizure threshold;
  flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Escitalopram Genoptim may be required;
  medicines that reduce potassium or magnesium levels in the blood increase the risk of life-threatening heart rhythm disturbances.
  sumatriptan and similar medicines (used to treat migraine), tramadol (used for severe pain), tryptophan, buprenorphine (used to treat pain and opioid addiction), and naloxone (used to diagnose and reverse opioid poisoning, treat opioid addiction). These medicines may increase the risk of adverse effects and interact with Escitalopram Genoptim, causing symptoms such as involuntary rhythmic muscle contractions, including eye movement muscles, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, body temperature above 38°C. If the patient experiences such symptoms (serotonin syndrome), contact a doctor.
  Do not take Escitalopram Genoptim together with medicines used for heart rhythm disorders or medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarials – especially halofantrine), certain antihistamines (astemizole, mizolastine), etc. Consult a doctor if you have further questions.
  Escitalopram Genoptim with food, drink, and alcohol
  Escitalopram Genoptim can be taken with or without food (see section 3 "How to use Escitalopram Genoptim").
  As with many medicines, it is not recommended to consume alcohol while taking Escitalopram Genoptim, although interactions (effects) between Escitalopram Genoptim and alcohol are not 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 a doctor before using this medicine. The patient should not use Escitalopram Genoptim during pregnancy or breastfeeding without first discussing the risks and benefits of treatment with her doctor.
  If the patient takes Escitalopram Genoptim during the last 3 months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose, muscle stiffness or floppiness, increased reflex excitability, tremors, jitteriness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, seek medical help immediately.
  Inform the doctor and/or midwife about the use of Escitalopram Genoptim.
  Taking medicines such as Escitalopram Genoptim during pregnancy, especially during the last 3 months, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). It is characterized by rapid breathing and cyanosis. Symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, contact a doctor and/or midwife immediately.
  Do not abruptly stop taking Escitalopram Genoptim during pregnancy.
  Taking Escitalopram Genoptim towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Escitalopram Genoptim, she should inform her doctor or midwife so they can provide appropriate advice.
  Escitalopram Genoptim is expected to pass into human milk.
  Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality. This could theoretically affect fertility, although no effect on fertility has been observed in humans to date.
  Driving and operating machinery
  The patient should not drive or operate machinery until it is known how Escitalopram Genoptim affects them.
  Escitalopram Genoptim contains sodium
  The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Escitalopram Genoptim

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

Adults:

Depression
The usual recommended dose of Escitalopram Genoptim is 10 mg taken once daily as a single dose. Your doctor may increase the dose up to a maximum of 20 mg per day.

Panic disorder
The initial dose of Escitalopram Genoptim is 5 mg once daily during the first week of treatment. The dose is then increased to 10 mg per day. Your doctor may further increase the dose up to a maximum of 20 mg per day.

Social phobia
The usual recommended dose of Escitalopram Genoptim is 10 mg taken once daily as a single dose. Depending on the patient's response to the medicine, your doctor may reduce the dose to 5 mg per day or increase it up to a maximum of 20 mg per day.

Generalised anxiety disorder
The usual recommended dose of Escitalopram Genoptim is 10 mg taken once daily as a single dose. Your doctor may increase the dose up to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The usual recommended dose of Escitalopram Genoptim is 10 mg taken once daily as a single dose. Your doctor may increase the dose up to a maximum of 20 mg per day.

Elderly patients (>65 years)
The recommended initial dose of Escitalopram Genoptim is 5 mg taken once daily as a single dose. Your doctor may recommend increasing the dose to 10 mg per day.

Use in children and adolescents
Escitalopram Genoptim should generally not be used in children and adolescents. Additional information is provided in section 2, "Important information before taking Escitalopram Genoptim".

Escitalopram Genoptim may be taken with or without food. Swallow the tablets with water. Do not chew the tablets, as they have a bitter taste.

If necessary, tablets may be split in half. To do this, place the tablet on a flat surface with the groove facing upwards, then press down with the index fingers of both hands on each end to break it in half, as shown in the illustration.

Duration of treatment
You may not start to feel better until after several weeks of treatment. Therefore, continue taking Escitalopram Genoptim as prescribed, even if it takes some time before you feel improvement.

Do not change the dose without first consulting your doctor.

Continue taking the medicine for as long as your doctor recommends. If you stop treatment too early, symptoms may return. Therefore, it is recommended to continue treatment for at least 6 months after recovery.

Taking more Escitalopram Genoptim than prescribed
If you take more Escitalopram Genoptim than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. This should be done even if you do not feel unwell. Symptoms of overdose may include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, irregular heartbeat, low blood pressure, and disturbances in water and electrolyte balance. Take the medicine packaging with you when visiting the doctor or hospital.

If you miss a dose of Escitalopram Genoptim
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 the missed dose immediately. Take the next dose at the usual time the following day. If you remember during the night or the next day, skip the missed dose and take the next dose at the usual time.

Stopping Escitalopram Genoptim
Do not stop taking Escitalopram Genoptim unless your doctor tells you to. When stopping treatment, your doctor will usually recommend gradually reducing the dose of Escitalopram Genoptim over several weeks.

After stopping Escitalopram Genoptim, especially if stopped abruptly, you may experience withdrawal symptoms. These symptoms are common when treatment with Escitalopram Genoptim is discontinued. The risk is higher if Escitalopram Genoptim has been taken for a long time, at high doses, or if the dose was reduced too quickly. In most patients, 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 Genoptim, contact your doctor. Your doctor may recommend restarting the medicine and tapering it more slowly.

Withdrawal symptoms may 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), psychomotor agitation or restlessness, tremors, feelings of disorientation, emotional instability or irritability, diarrhoea (loose stools), visual disturbances, palpitations or rapid heartbeat.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects usually resolve within a few weeks of treatment. It is important to remember that some of these effects may also be symptoms of the condition being treated and will subside as your general well-being improves.
You should contact your doctor or go to hospital if any of the following adverse effects occur during treatment:
Not common (may affect up to 1 in 100 patients):
unusual bleeding, including gastrointestinal bleeding

Rare (may affect up to 1 in 1000 patients):
swelling of the skin, tongue, lips or face, or difficulty breathing or swallowing (allergic reaction)
high fever, agitation, confusion (disorientation), tremors and violent muscle contractions, which may be symptoms of a rare condition called serotonin syndrome

Frequency unknown (frequency cannot be estimated from available data):
difficulty 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, which may be symptoms of a life-threatening condition called torsade de pointes
suicidal thoughts and behaviour, see also section “Warnings and precautions”
severe vaginal bleeding shortly after childbirth (postpartum haemorrhage), see additional information in subsection “Pregnancy, breastfeeding and fertility” in section 2

In addition to the above, the following adverse effects have also been reported:
Very common (may affect more than 1 in 10 patients):
nausea
headache

Common (may affect up to 1 in 10 patients):
nasal congestion or cold-like symptoms (sinusitis)
decreased or increased appetite
anxiety, psychomotor agitation, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, tingling sensation in the skin
diarrhoea, constipation, vomiting, dry mouth
excessive sweating
muscle and joint pain
sexual disorders (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women)
feeling of fatigue, fever
weight gain

Not common (may affect up to 1 in 100 patients):
urticaria, rash, itching
teeth grinding, agitation, nervousness, panic attack, confusion (disorientation)
sleep disturbances, taste disturbances, fainting (syncope)
pupil dilation, visual disturbances, ringing in the ears (tinnitus)
hair loss
heavy menstrual bleeding
irregular menstruation
weight loss
fast heartbeat
swelling of the upper or lower limbs
nosebleeds

Rare (may affect up to 1 in 1000 patients):
aggression, depersonalisation (feeling of loss of self-identity, feeling detached from oneself), hallucinations
slow heartbeat

Frequency unknown (frequency cannot be estimated from available data):
reduced sodium levels in the blood (manifesting as nausea, malaise, muscle weakness or confusion)
dizziness upon standing due to low blood pressure (orthostatic hypotension)
abnormal liver function tests (increased liver enzyme activity in blood)
movement disorders (involuntary muscle movements)
painful penile erection (priapism)
symptoms of unusual bleeding in the skin and mucous membranes (purpura)
sudden swelling of the skin or mucous membranes (angioedema)
increased urine output (inappropriate antidiuretic hormone [vasopressin] secretion)
galactorrhoea in men and in women who are not breastfeeding
mania
in patients taking medicines of this class, an increased risk of bone fractures has been observed
change in heart rhythm (called “QT interval prolongation”, visible on ECG, a test assessing heart function)

In addition, adverse effects associated with medicines having a similar mechanism of action to escitalopram (the active substance in Escitalopram Genoptim) are known. These include:
psychomotor restlessness (akathisia)
loss of appetite.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Escitalopram Genoptim

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or the cardboard package.
The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Escitalopram Genoptim contains
The active substance is escitalopram. Each film-coated tablet of Escitalopram Genoptim contains 10 mg of escitalopram (as oxalate).
The other ingredients are:
Tablet core: sodium croscarmellose, butylhydroxytoluene (E321), butylhydroxyanisole (E320), microcrystalline cellulose (PH-102), microcrystalline cellulose siliconated, 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 of the active substance. The description of the tablets is provided below.

The medicine Escitalopram Genoptim is available in the following pack sizes:
Blister in a cardboard box
Tablets 10 mg: 28, 30, 56, 60, 90 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Importer
APL Swift Services (Malta) Ltd.
HF 26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta
For more detailed information about this medicine, please contact the Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
Tel: +48 22 32 16 240