Escitalopram Medreg

Leaflet accompanying the packaging: patient information

Escitalopram Medreg, 10 mg, film-coated tablets

Escitalopram

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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 Medreg and what is it used for
• 2. Important information before taking Escitalopram Medreg
• 3. How to take Escitalopram Medreg
• 4. Possible side effects
• 5. How to store Escitalopram Medreg
• 6. Contents of the packaging and other information

1. What is Escitalopram Medreg and what is it 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 work on the serotonin system in the brain by increasing serotonin levels.
Escitalopram Medreg 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 several weeks of treatment before improvement occurs. The patient should continue taking Escitalopram Medreg, even if it takes some time before their condition improves.
If there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Escitalopram Medreg

When not to take 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 that belong to a group called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• if the patient was born with a heart rhythm disorder or if the patient has had an episode of irregular heart rhythm (visible on an ECG, a test that assesses 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, the patient should discuss it with their doctor or pharmacist.
The patient should tell their doctor if they have other disorders or diseases, as the doctor should take this information into account. In particular, the patient should inform their doctor:

• if they have epilepsy. If they experience seizures for the first time or if the frequency of seizures increases, treatment with Escitalopram Medreg should be discontinued (see also section 4 "Possible side effects").
• if they have liver or kidney function disorders. A dose adjustment by the doctor may be required.
• if they have diabetes. Taking Escitalopram Medreg may affect blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agents.
• if they have low sodium levels in the blood.
• if they have an increased tendency to bleed or bruise easily or if they are pregnant (see "Pregnancy, breastfeeding, and fertility").
• if they are being treated with electroconvulsive therapy.
• if they have coronary heart disease.
• if they have had heart problems or have recently had a heart attack.
• if they have a slow resting heart rate and/or if they may have electrolyte deficiencies due to prolonged severe diarrhea, vomiting, or the use of diuretics (medicines that increase urine production).
• if they experience rapid or irregular heartbeat, fainting, or dizziness when standing up, which may indicate an irregular heart rhythm.
• if they have had eye diseases, such as certain types of glaucoma (increased pressure inside the eyeball).

Caution

In some patients with bipolar affective disorder, a manic phase may occur. This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, the patient should consult their 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, the patient should immediately inform their doctor.
Medicines like Escitalopram Medreg (so-called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms may persist after treatment is discontinued.

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 behaviors 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:

• Patient who have had suicidal thoughts or behaviors before.
• Young adult patients. 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 the patient experiences suicidal thoughts or behaviors, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or close friendsabout their depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to monitor their condition and inform them if their depression or anxiety worsens or if they notice any worrying changes in their behavior.

Children and adolescents

Escitalopram Medreg 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 from 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 manifestations of anger). However, the doctor may prescribe Escitalopram Medreg to patients under 18 years of age if they consider it to be in their best interest. If the doctor prescribes Escitalopram Medreg to a patient under 18 years of age, and the patient has any doubts, they should consult their doctor. If the above symptoms develop or worsen in patients under 18 years of age taking Escitalopram Medreg, they should inform their doctor. Additionally, there is currently no data on the long-term safety of Escitalopram Medreg in this age group regarding growth, maturation, and cognitive and behavioral development.

Escitalopram Medreg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor if they are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, they should wait 14 days before starting to take Escitalopram Medreg. After stopping treatment with Escitalopram Aurovitas, the patient should wait 7 days before taking any of these medicines.
• Reversible, selective monoamine oxidase A inhibitors (RIMAs) 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 adverse reactions.
• The antibiotic linezolid.
• Lithium (used to treat bipolar affective disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraines) and tramadol and similar medicines (opioids, used to treat severe pain). They may increase the risk of adverse reactions.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may 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 (NSAIDs) (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). The doctor may order a blood clotting test at the start and after stopping treatment with Escitalopram Medreg 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.
• Antipsychotics (medicines 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 Medreg may be required.
• Medicines that lower potassium or magnesium levels in the blood, as they increase the risk of life-threatening heart rhythm disorders.

The patient should not take Escitalopram Medreg 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 agents (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial agents, especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). The patient should consult their doctor if they 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The patient should not take Escitalopram Medreg during pregnancy and breastfeeding, unless they have discussed the risks and benefits with their doctor.
If the patient takes Escitalopram Medreg during the last 3 months of pregnancy, they should be aware that the newborn may experience the following symptoms: breathing difficulties, blue skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood sugar, muscle stiffness or flaccidity, increased reflexes, tremors, restlessness, irritability, lethargy, constant crying, and sleep disturbances. If such symptoms occur in the newborn, the patient should immediately contact their doctor and/or midwife.
The patient should inform their midwife and/or doctor about taking Escitalopram Medreg. Taking medicines like Escitalopram Medreg, especially during the last 3 months of pregnancy, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and blue skin. These symptoms usually appear within the first 24 hours after birth. If such symptoms occur in the newborn, the patient should immediately contact their midwife and/or doctor.
If the patient takes Escitalopram Medreg at the end of pregnancy, there may be an increased risk of heavy bleeding from the uterus shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient takes Escitalopram Medreg, they should inform their doctor or midwife so that they can provide appropriate advice.
The patient should never stop taking Escitalopram Medreg abruptly during pregnancy.
It is assumed that escitalopram 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

The patient should not drive or operate machinery until they know how Escitalopram Medreg affects them.

Escitalopram Medreg contains sodium

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

3. How to take Escitalopram Medreg

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Adults

Depression
The recommended dose of Escitalopram Medreg is 10 mg, taken as a single dose once a day. The dose may be increased by the doctor to a maximum of 20 mg per day.
Panic disorder
The initial dose of Escitalopram Medreg 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 the doctor to a maximum of 20 mg per day.
Social phobia
The recommended dose of Escitalopram Medreg is 10 mg, taken as a single dose once a day. The doctor may reduce the dose to 5 mg per day or increase it to a maximum of 20 mg per day, depending on the patient's response to the medicine.
Generalized anxiety disorder
The recommended dose of Escitalopram Medreg is 10 mg, taken as a single dose once a day. The dose may be increased by the doctor to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The recommended dose of Escitalopram Medreg is 10 mg, taken as a single dose once a day. The dose may be increased by the doctor 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 dose once a day. The doctor may recommend increasing the dose to 10 mg per day.

Use in children and adolescents

Escitalopram Medreg should not be used in children and adolescents. Additional information can be found in section 2 "Warnings and precautions".

Patients with renal impairment

Caution should be exercised in patients with severe renal impairment. The medicine should be taken as directed by the doctor.

Patients with hepatic impairment

Patients with hepatic impairment should not take a dose higher than 10 mg per day. The medicine should be taken as directed by the doctor.

Patients who are poor metabolizers of medicines via the CYP2C19 enzyme

Patients with this known genotype should not take a dose higher than 10 mg per day. The medicine should be taken as directed by the doctor.

Method of administration

Escitalopram Medreg 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. The tablet can be divided into equal doses.

Duration of treatment

The patient may start to feel better after a few weeks of treatment. They should continue taking Escitalopram Medreg, even if it takes some time before their condition improves.
The patient should not change the dose without consulting their doctor.
The patient should continue taking Escitalopram Medreg for as long as their doctor recommends. If the patient stops treatment too early, their symptoms may return. It is recommended to continue treatment for at least 6 months after the patient has recovered.

Taking a higher dose of Escitalopram Medreg than recommended

If the patient has taken a higher dose of Escitalopram Medreg than prescribed, they should immediately contact their doctor or go to the emergency department of the nearest hospital. They should do this even if they do not feel any discomfort. Symptoms of overdose include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte disturbances. On the visit to the doctor or hospital, the patient should take the package or blister pack of Escitalopram Medreg with them.

Missing a dose of Escitalopram Medreg

The patient should not take a double dose to make up for a missed dose. If the patient has forgotten to take a dose and remembers before bedtime, they should take the missed dose immediately. They should take the next dose as usual the next day. If the patient remembers the missed dose at night or the next day, they should skip the missed dose and take the next dose as usual.

Stopping treatment with Escitalopram Medreg

The patient should not stop taking Escitalopram Medreg unless their doctor recommends it. When the patient stops treatment, it is usually recommended to gradually reduce the dose of Escitalopram Medreg over a period of several weeks.
After stopping treatment with Escitalopram Medreg, especially if it is stopped abruptly, the patient may experience withdrawal symptoms. These symptoms are common when treatment with Escitalopram Medreg is stopped. The risk is higher when Escitalopram Medreg has been taken for a long time, in high doses, or when 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 the patient experiences severe withdrawal symptoms after stopping treatment with Escitalopram Medreg, they should contact their doctor. The doctor may recommend restarting treatment with the medicine and tapering it off more slowly.
Withdrawal symptoms include: dizziness (instability or lack of balance), tingling sensation, burning sensation, and (less commonly) a sensation of electric shock, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea (feeling sick), sweating (including night sweats), restlessness or agitation, tremors, confusion or disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or arrhythmias.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Escitalopram Medreg can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. It should be remembered that some of these side effects may also be symptoms of the disease and will disappear as the patient's condition improves.

If the patient experiences any of the following side effects during treatment, they should contact their doctor or go to the hospital immediately:

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

• unusual bleeding, including bleeding from the gastrointestinal tract.

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

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

Frequency not known(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 may be a sign of liver function disorders or hepatitis
• 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"
• sudden swelling of the skin or mucous membranes (angioedema).

In addition to the above, the following side effects have 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 of the skin
• 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
• grinding of the teeth, agitation, nervousness, panic attack, confusion
• sleep disturbances, taste disorders, fainting (syncope)
• dilated pupils, 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, hallucinations
• slow heartbeat.

Frequency not known(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, such as bleeding from the skin and mucous membranes (ecchymoses) and low platelet count (thrombocytopenia)
• increased secretion of antidiuretic hormone (ADH), leading to water retention in the body, dilutional hyponatremia, and decreased sodium levels
• increased prolactin levels in the blood
• galactorrhea in men and women who are not breastfeeding
• mania
• patients taking medicines from this class have been observed to have an increased risk of fractures
• changes in heart rhythm (called "QT interval prolongation", visible on an ECG, a test that assesses heart function)
• heavy bleeding from the uterus shortly after delivery (postpartum hemorrhage), see also "Pregnancy, breastfeeding, and fertility" in section 2.

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

• restlessness (akathisia)
• loss of appetite.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Escitalopram Medreg

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
The patient should not take this medicine after the expiry date stated on the packaging and blister pack after: EXP.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Escitalopram Medreg contains

• The active substance of Escitalopram Medreg is escitalopram. Each film-coated tablet contains 10 mg of escitalopram (as escitalopram oxalate).
• The other ingredients are: tablet core: microcrystalline cellulose, sodium croscarmellose, talc, anhydrous colloidal 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 "C4" embossed 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 authorization holder and manufacturer/importer

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
phone: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s.
Výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic

This medicine is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: 07/2025