Patient Information Leaflet

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

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

Leaflet Contents:

What Escitalopram Medreg is and what it is used for
What you need to know before taking Escitalopram Medreg
How to take Escitalopram Medreg
Possible side effects
How to store Escitalopram Medreg
Contents of the pack and other information

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

Escitalopram Medreg contains the active substance escitalopram. Escitalopram Medreg 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.
Escitalopram Medreg 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 Medreg even if it takes some time for your condition to improve.
If no improvement occurs or if you feel worse, consult your doctor.

2. Important information before using Escitalopram Medreg

When not to use Escitalopram Medreg

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 monoamine oxidase inhibitors (MAOIs), 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 Medreg and other medicines").

Warnings and precautions
Before starting treatment with Escitalopram Medreg, discuss this with your doctor or
pharmacist.
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 Medreg should be discontinued (see also section 4 "Possible side effects").
If the patient has impaired liver or kidney function. The doctor may need to adjust the dose.
If the patient has diabetes. Treatment with Escitalopram Medreg may affect blood glucose control. Adjustment of insulin dose 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 easily, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility").
If the patient is undergoing electroconvulsive therapy.
If the patient has ischemic heart disease.
If the patient has heart problems or has recently suffered a myocardial infarction.
If the patient has a slow resting heart rate and/or if electrolyte imbalances may occur 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 rate.
If the patient has or has had eye disorders, such as certain types of glaucoma (increased pressure inside the eyeball).

Note
In some patients with bipolar affective disorder, a manic phase may occur. This is characterised by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, consult a doctor.
In 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.
Medicines such as Escitalopram Medreg (so-called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
Patients 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 start to work only after about 2 weeks, sometimes later.
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 who were treated with antidepressant medicines. If the patient develops thoughts of self-harm or suicide, seek immediate medical advice from a doctor or go to hospital. It may be helpful to inform family members 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 depression or anxiety or concerning changes in behaviour.

Children and adolescents
Escitalopram Medreg should not usually be used in children and adolescents under 18 years of age. It should also be noted that patients under 18 years of age taking medicines of this class are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviours, and manifestations of anger). Nevertheless, a doctor may prescribe Escitalopram Medreg to patients under 18 years of age if he/she considers it to be in their best interest. If the doctor has prescribed Escitalopram Medreg to a patient under 18 years of age and the patient has any doubts, contact the doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Escitalopram Medreg, inform the doctor. Furthermore, there are currently no data on the long-term safety of Escitalopram Medreg in this age group regarding growth, maturation, cognitive development, and behavioural development.
Escitalopram Medreg and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking any of the following medicines:

"Non-selective monoamine oxidase inhibitors (MAOIs)" 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 Medreg. After stopping Escitalopram Medreg, wait 7 days before taking any of these medicines.
"Reversible, selective monoamine oxidase A inhibitors (MAO-A)" containing moclobemide (used in the treatment of depression).
"Irreversible monoamine oxidase B inhibitors (MAO-B)" 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) and tryptophan.
Imipramine and desipramine (both used in the treatment of depression).
Sumatriptan and similar medicines (used in the treatment of migraine) and tramadol and similar medicines (opioids, used for severe pain). These may increase the risk of adverse effects.
Cimetidine, lansoprazole, and omeprazole (used in the treatment of gastric ulcers), fluconazole (used in the treatment of fungal infections), 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 in the treatment of depression.
Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (painkillers or blood thinners, known as anticoagulants). These may increase the tendency to bleed.
Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, known as anticoagulants). The doctor may order blood clotting tests at the beginning and after stopping Escitalopram Medreg to determine whether the anticoagulant dose remains appropriate.
Mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used for severe pain) due to possible risk of lowering the seizure threshold.
Neuroleptics (medicines used in the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to possible risk of lowering the seizure threshold.
Flecainide, propafenone, and metoprolol (used in cardiovascular disorders), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Escitalopram Medreg may be required.
Medicines that lower potassium or magnesium levels in the blood, as they increase the risk of life-threatening heart rhythm disturbances.

Do not take Escitalopram Medreg simultaneously with medicines used for heart rhythm disorders or medicines that may affect heart rhythm, such as antiarrhythmic class IA and III agents, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). Consult your doctor if you have any further questions.
Escitalopram Medreg with food, drink and alcohol
Escitalopram Medreg can be taken with or without food (see section 3 "How to take Escitalopram Medreg").
As with many medicines, it is not recommended to take Escitalopram Medreg with alcohol, although interactions between Escitalopram Medreg and alcohol are not expected.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The patient should not take Escitalopram Medreg during pregnancy or while breastfeeding unless she has discussed the risks and benefits of treatment with her doctor.
If the patient takes Escitalopram Medreg 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, shakiness, irritability, lethargy, persistent crying, drowsiness, and difficulty sleeping. If such symptoms occur in the newborn, contact a doctor and/or midwife immediately.
Inform the midwife and/or doctor about the use of Escitalopram Medreg. Taking medicines such as Escitalopram Medreg 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 characterised by rapid breathing and cyanosis. Symptoms usually appear within the first 24 hours after birth. If such symptoms occur in the newborn, contact the midwife and/or doctor immediately.
If Escitalopram Medreg is taken towards the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Escitalopram Medreg, she should inform her doctor or midwife so they can provide appropriate advice.
During pregnancy, do not abruptly stop taking Escitalopram Medreg.
Escitalopram is expected to pass into human breast milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality. This may theoretically affect fertility, although no effect on fertility in humans has been observed to date.
Driving and operating machinery
Do not drive or operate machinery until the patient knows how Escitalopram Medreg affects him/her.
Escitalopram Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Escitalopram Medreg

This medicine 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 Medreg is 10 mg taken as a single dose once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

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

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

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

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

Use in children and adolescents
Escitalopram Medreg should generally not be used in children and adolescents. Additional information is provided in section 2 "Warnings and precautions".

Patients with renal impairment
Caution should be exercised in patients with severe renal impairment. This medicine should be used according to the doctor's instructions.

Patients with hepatic impairment
Patients with impaired liver function should not take doses exceeding 10 mg per day. This medicine should be used according to the doctor's instructions.

Patients who are poor metabolizers via the CYP2C19 isoenzyme
Patients with this known genotype should not take doses exceeding 10 mg per day. This medicine should be used according to the doctor's instructions.

Method of administration
Escitalopram Medreg can be taken with or without food. Tablets should be swallowed whole with water. Do not chew the tablets, as they have a bitter taste. The tablet may be divided into equal doses.

Duration of treatment
Improvement in symptoms may take several weeks. Continue taking Escitalopram Medreg as prescribed, even if it takes some time before you start feeling better.
Do not change the dose without consulting your doctor.
Continue taking Escitalopram Medreg for as long as your doctor recommends. If treatment is stopped too early, symptoms may return. Therefore, it is recommended to continue treatment for at least 6 months after recovery of well-being.

Taking more than the recommended dose of Escitalopram Medreg
If you have taken more than the prescribed dose of Escitalopram Medreg, 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, cardiac arrhythmias, low blood pressure, and disturbances in water and electrolyte balance. Bring the medicine pack or blister with you when visiting the doctor or hospital.

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

Stopping treatment with Escitalopram Medreg
Do not stop taking Escitalopram Medreg unless your doctor advises you to do so. When discontinuing treatment, your doctor will usually recommend gradually reducing the dose of Escitalopram Medreg over several weeks.

After stopping Escitalopram Medreg, especially if stopped abruptly, you may experience withdrawal symptoms. These symptoms are common when stopping treatment with Escitalopram Medreg. The risk is higher if the medicine 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 Medreg, contact your doctor. Your doctor may recommend restarting the medicine and tapering it more slowly.

Withdrawal symptoms include: dizziness (unsteadiness or loss of balance), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), feelings of anxiety, headache, nausea, sweating (including night sweats), psychomotor agitation or restlessness, tremors, confusion or disorientation, emotional instability or irritability, diarrhoea (loose stools), visual disturbances, palpitations or rapid heartbeat.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone experiences them.
Adverse effects usually resolve within a few weeks of treatment. It should be remembered that some
of these effects may also be symptoms of the illness itself and will resolve as the patient's condition improves.
If any of the following adverse effects occur during treatment,
contact a doctor or go to hospital immediately:
Uncommon (may affect up to 1 in 100 patients):

unusual bleeding, including gastrointestinal bleeding.

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

swelling of the skin, tongue, lips, larynx or face, urticaria, or difficulty breathing or swallowing (severe allergic reaction)
high fever, agitation, confusion, tremors, and sudden muscle contractions, which may be symptoms of a rare condition called serotonin syndrome.

Frequency unknown (frequency cannot be determined from available data):

difficulty in passing urine
seizures, see also section “Warnings and precautions”
yellowing of the skin and whites of the eyes, indicating impaired liver function or hepatitis
rapid, 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”
sudden swelling of the skin or mucous membranes (angioedema).

In addition to those listed above, the following adverse effects have 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 (sinusitis)
decreased or increased appetite
anxiety, psychomotor agitation, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, skin tingling
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.

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

urticaria, rash, itching
teeth grinding, agitation, nervousness, panic attack, confusion
sleep disturbances, taste disturbances, fainting (syncope)
pupil dilation, visual disturbances, ringing in the ears (tinnitus)
hair loss
heavy menstrual bleeding
irregular menstruation
weight loss
rapid heartbeat
swelling of upper or lower limbs
nosebleeds.

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

aggression, depersonalization, hallucinations
slow heartbeat.

Frequency unknown (frequency cannot be determined from available data):

decreased sodium concentration in blood (manifested by 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)
signs of unusual bleeding, e.g. from skin and mucous membranes (petechiae), and low platelet count (thrombocytopenia)
increased secretion of antidiuretic hormone (ADH), causing water retention, blood dilution, and reduced sodium levels (syndrome of inappropriate ADH secretion)
increased prolactin levels in blood
galactorrhea 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)
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); more information, see section 2 “Pregnancy, breastfeeding and fertility”.

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

psychomotor agitation (akathisia)
loss of appetite.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can
be reported directly to the Department of Monitoring of Adverse Drug Reactions,
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 can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Escitalopram Medreg

Keep the medicine out of the sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Escitalopram Medreg contains

The active substance is escitalopram. Each film-coated tablet contains 10 mg of escitalopram (as oxalate).
Other ingredients are: tablet core: microcrystalline cellulose, sodium croscarmellose, talc, colloidal anhydrous silica, magnesium stearate.
film coating: hypromellose (E 464), titanium dioxide (E 171), talc, macrogol (PEG-400).

What Escitalopram Medreg looks like and contents of the pack
White or almost white, oval, approximately 7.8 x 5.3 - 8.2 x 5.7 mm, biconvex film-coated tablets with an embossed mark "C4" on one side and a score line on the other side.
The tablet can be divided into equal doses.
Pack sizes: 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer/Importer:
Medis International a.s.
Výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Slovakia: Escitalopram Medreg
Czech Republic: Escitalopram Medreg
Poland: Escitalopram Medreg
Romania: Escitalopram Gemax Pharma 10 mg film-coated tablets
Italy: Escitalopram Medreg

Escitalopram medreg