Mozarin

PATIENT INFORMATION LEAFLET: USER INFORMATION

Mozarin, 10 mg, coated tablets

Mozarin, 15 mg, coated tablets

Mozarin, 20 mg, coated tablets

Escitalopram

You should carefully read the contents of this 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 your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Mozarin and what is it used for

Mozarin contains escitalopram. Escitalopram 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 be a major factor in the development of depression and related diseases. Mozarin is used to treat depression (major depressive episodes) and anxiety disorders (such as panic attacks with or without agoraphobia, social anxiety disorder (social phobia))

2. Important information before taking Mozarin

When not to take Mozarin:

• if you are allergic to the active substance 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 congenital heart rhythm disorders or have had such episodes in the past (detected in an ECG - a test that allows you to check the heart's work);
• if you are taking medicines for heart rhythm disorders or medicines that affect heart rhythm (see section 2 "Mozarin and other medicines").

Warnings and precautions

Before starting treatment with Mozarin, you should discuss it with your doctor. You should tell your doctor if you have any other disorders or diseases, as your doctor should take this information into account. In particular, you should inform your doctor if:

• you have epilepsy. You should stop taking Mozarin if you experience or have an increased frequency of seizures (see also section 4 "Possible side effects");
• you have liver or kidney function disorders. Dose adjustment may be required by your doctor;
• you have diabetes. Treatment with Mozarin may disrupt blood glucose control (glycemia). Insulin dose adjustment and/or oral hypoglycemic agents may be necessary;
• you have low sodium levels in your blood;
• you have a tendency to easy bleeding or bruising;
• you are being treated with electroconvulsive therapy;
• you have coronary heart disease;
• you have or have had heart disease or have recently had a heart attack;
• you have low resting heart rate and/or may have low salt levels in your body, as a result of prolonged, severe diarrhea and vomiting (nausea) or taking diuretics;
• you experience rapid or irregular heartbeat, fainting, collapse, or dizziness when standing, which may indicate heart rhythm disorders;
• you have or have had eye problems, such as certain types of glaucoma (increased pressure inside the eyeball).
• you are taking sumatriptan or other triptans, opioids (such as buprenorphine and tramadol), or tryptophan. Taking these medicines with Mozarin may lead to a life-threatening condition called serotonin syndrome (see section "Mozarin and other medicines").
• you have or have had bleeding disorders or are pregnant (see "Pregnancy, breastfeeding, and fertility")

Medicines like Mozarin (so-called SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.

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 still or standing in one place may also occur. If such symptoms occur, you should immediately inform your doctor.

Suicidal thoughts and worsening of depression or anxiety disorders

People with depression and/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 self-harm in the past.
• young adult patients. Clinical trial data show 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 contact your doctor or go to the hospital immediately.It may be helpful to inform a relative or friend about your depression or anxiety disorder and ask them to read this leaflet. You can ask them to tell you if they notice that your depression or anxiety has worsened or if you have any worrying changes in your behavior.

Children and adolescents

Mozarin should not be used in children and adolescents under 18 years of age. It should be remembered that in patients under 18 years of age taking medicines of this group, there is a greater risk of side effects, such as suicidal attempts and suicidal thoughts, as well as hostility (especially aggression, rebellious behavior, and manifestations of anger). However, your doctor may prescribe Mozarin to a patient under 18 years of age if they consider it necessary. If your doctor has prescribed Mozarin to a patient in this age group and you have any doubts, you should consult your doctor again. You should inform your doctor if any of the above symptoms occur or worsen during treatment with Mozarin in a patient under 18 years of age. Additionally, the long-term safety of Mozarin in this age group regarding growth, maturation, cognitive and behavioral development has not yet been established.

Mozarin 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. You should inform your doctor about taking any of the following medicines:

• "non-selective monoamine oxidase inhibitors (IMAOs)" containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. When taking these medicines, you should wait 14 days before starting treatment with Mozarin. After stopping treatment with Mozarin, you should wait 7 days before starting to take any of the above medicines;
• "reversible, selective MAO-A inhibitors" containing moclobemide (used to treat depression);
• "irreversible monoamine oxidase B inhibitors (MAO-B)" containing selegiline (used to treat Parkinson's disease). They increase the risk of side effects;
• the antibiotic linezolid;
• lithium (used to treat bipolar disorder) and tryptophan;
• imipramine and desipramine (both used to treat depression)
• sumatriptan and similar medicines (used to treat migraines) and opioids such as buprenorphine and tramadol (used to treat severe pain). They may increase the risk of side effects. These medicines may interact with Mozarin and cause symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, excitement, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, body temperature above 38°C. If you experience such symptoms, you should contact your doctor;
• 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). They may cause an increase in escitalopram levels in the blood;
• St. John's Wort (Hypericum perforatum) - a herbal medicine for depression;
• acetylsalicylic acid and non-steroidal anti-inflammatory medicines (used as painkillers or to thin the blood, so-called anticoagulants). These medicines may increase the risk of bleeding;
• warfarin, dipyridamole, and phenprocoumon (anticoagulant medicines used to thin the blood). At the start and after stopping treatment with Mozarin, your doctor will probably check your blood clotting time to see if the dose of the anticoagulant medicine is still appropriate;
• mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) may lower the seizure threshold;
• neuroleptics (used to treat schizophrenia, psychosis) may lower the seizure threshold, as well as antidepressant medicines;
• flecainide, propafenone, and metoprolol (used to treat cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressant medicines), risperidone, tiordiazine, and haloperidol (antipsychotic medicines). Dose adjustment of Mozarin may be necessary;
• medicines that lower potassium or magnesium levels in the blood increase the risk of life-threatening heart rhythm disorders.

You should not take Mozarin if you are taking medicines for heart rhythm disorders or medicines that affect heart rhythm, such as anti-arrhythmic medicines of class Ia and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressant medicines, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines - especially halofantrine), certain antihistamine medicines (astemizole, mizolastine). If you have any further doubts, you should consult your doctor.

Mozarin with food, drink, and alcohol

Mozarin can be taken with or without food (see section 3 "How to take Mozarin"). Like many medicines, taking Mozarin and drinking alcohol at the same time is not recommended, although no interaction between Mozarin and alcohol is 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 or pharmacist before taking this medicine. PregnancyMozarin should not be used during pregnancy and breastfeeding, unless your doctor has advised you to do so and you have discussed the risks and benefits of treatment. If you are taking Mozarin in the last 3 months of pregnancy, you should be aware that the newborn may experience: breathing difficulties, bluish skin, seizures, fluctuations in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or weakness, increased reflexes, tremors, tremors, irritability, lethargy, constant crying, sleepiness, or difficulty sleeping. If the newborn experiences any of these symptoms, you should contact your doctor immediately. You should make sure that your midwife and/or doctor know that you are taking Mozarin. Taking medicines like Mozarin during pregnancy, especially in the last three months of pregnancy, may increase the risk of a serious condition in the child called persistent pulmonary hypertension in newborns (PPHN), which is characterized by rapid breathing and bluish skin discoloration. These symptoms usually occur within the first 24 hours after birth. If your child experiences such symptoms, you should contact your midwife and/or doctor immediately. In the case of taking Mozarin at the end of pregnancy, there may be an increased risk of severe bleeding from the vagina shortly after birth, especially if you have had bleeding disorders in the past. Your doctor or midwife should know that you are taking Mozarin so that they can advise you. You should not stop taking Mozarin during pregnancy. BreastfeedingIt is assumed that Mozarin passes into breast milk. FertilityIn 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 a car or operate machinery until you know how Mozarin affects you.

Mozarin contains sodium

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

3. How to take Mozarin

Mozarin should always be taken as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist again. Adults DepressionThe usual recommended dose of Mozarin is 10 mg, taken once a day. Your doctor may recommend increasing the dose to a maximum of 20 mg per day. Panic disorderThe initial dose of Mozarin is 5 mg once a day for the first week, then the dose is increased to 10 mg per day. Your doctor may recommend further increasing the dose to a maximum of 20 mg per day. Social anxiety disorder (social phobia)The usual recommended dose of Mozarin is 10 mg, taken once a day. Depending on the patient's response to treatment, your doctor may reduce the dose to 5 mg once a day or increase it to a maximum of 20 mg once a day. Obsessive-compulsive disorderThe usual recommended dose of Mozarin is 10 mg, taken once a day. Your doctor may increase the dose to a maximum of 20 mg per day. Elderly patients (over 65 years)The recommended initial dose of Mozarin is 5 mg, taken once a day. Your doctor may increase the dose to 10 mg per day. Children and adolescents (under 18 years)Mozarin is not usually used in children and adolescents. For more information, see section 2 "Important information before taking Mozarin". Mozarin can be taken with or without food. The tablet should be swallowed with water. The tablets should not be chewed, due to their bitter taste. If necessary, the tablet can be divided. To do this, place the tablet on a flat, even surface with the dividing line facing upwards. The tablet can then be broken by pressing each end downwards with your index fingers.

Duration of treatment

It may take several weeks of treatment before you feel better. You should continue taking the medicine even if it takes some time, until your condition improves. You should not change the dose of the medicine without consulting your doctor first. Mozarin should be taken for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. It is recommended to continue therapy for at least 6 months after improvement.

Taking a higher dose of Mozarin than recommended

If you have taken a higher dose of Mozarin than recommended, you should contact your doctor or go to the hospital immediately, even if you do not experience any symptoms. Some of the symptoms of overdose are: dizziness, tremors, restlessness, seizures, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and electrolyte disturbances. When contacting your doctor or going to the hospital, you should take the packaging of Mozarin with you.

Missing a dose of Mozarin

You should not take a double dose to make up for a missed dose. If you miss a dose and remember before going to bed, you should take the missed dose immediately. The next day, you should take the medicine as usual. If you remember about the missed dose at night or the next day, you should skip the missed dose and take the medicine as usual.

Stopping treatment with Mozarin

You should not stop taking Mozarin unless your doctor advises you to do so. In the case of planned termination of treatment, it is recommended to gradually reduce the dose of Mozarin over several weeks. After stopping treatment with Mozarin, especially if it is sudden, you may experience withdrawal symptoms. These symptoms are often seen after stopping treatment with Mozarin. The risk of withdrawal symptoms is higher in the case of long-term treatment with Mozarin or taking it in high doses, as well as after too rapid a dose reduction. In most patients, the symptoms are mild and resolve on their own within two weeks. However, in some patients, the symptoms may be severe or persist for longer (2-3 months or longer). If you experience severe withdrawal symptoms, you should contact your doctor. Your doctor may recommend restarting treatment with Mozarin and then tapering it off more slowly. The withdrawal symptoms include: dizziness (balance disturbances), tingling, burning, or (less often) a feeling of electric shock, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headache, nausea, excessive sweating (including night sweats), restlessness or agitation, tremors, confusion or disorientation, emotional instability or irritability, diarrhea, vision disturbances, palpitations (heart palpitations). If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Mozarin can cause side effects, although not everybody gets them. Side effects usually disappear after a few weeks of treatment. It should be noted that many of them may also be symptoms of the disease being treated and will resolve as your condition improves.

If you experience any of the following side effects, you should contact your doctor or go to the hospital immediately:

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 reactions)
• high fever, restlessness, disorientation, tremors, and sudden muscle contractions 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 "When to be careful when taking Mozarin"
• yellowing of the skin and whites of the eyes, which is a sign of liver function disorders and/or hepatitis
• rapid, irregular heartbeat, fainting, which may be a sign of a life-threatening condition called torsades de pointes
• suicidal thoughts and behaviors, see also section "Warnings and precautions"
• heavy vaginal bleeding shortly after birth (postpartum hemorrhage), more information in section 2 - Pregnancy, breastfeeding, and fertility.

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 (sinusitis)
• decreased or increased appetite
• anxiety, restlessness, vivid dreams, difficulty sleeping, sleepiness, dizziness, yawning, tremors, tingling
• diarrhea, constipation, vomiting, dry mouth
• increased sweating
• muscle and joint pain (arthralgia, myalgia)
• sexual disturbances (delayed ejaculation, erectile dysfunction, decreased libido, difficulty achieving orgasm in women)
• fatigue, fever
• weight gain

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

• hives, other rashes, itching
• grinding of teeth, restlessness, nervousness, panic attacks, disorientation
• sleep disturbances, taste disturbances, fainting
• pupil dilation, vision disturbances, tinnitus
• hair loss
• excessive menstrual bleeding
• irregular menstrual bleeding
• weight loss
• rapid heartbeat
• swelling of hands and feet
• nosebleeds

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

• aggression, depersonalization (feeling of loss of identity), 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, muscle weakness, and confusion)
• dizziness when standing up, related to low blood pressure (orthostatic hypotension)
• abnormal liver test results (increased liver enzyme activity in the blood)
• movement disorders (involuntary muscle movements)
• painful, prolonged erection (priapism)
• bleeding disorders, including bruising and bleeding into the skin and mucous membranes (ecchymoses) and decreased platelet count (thrombocytopenia)
• sudden swelling of the skin or mucous membranes (angioedema)
• excessive urine production (improper secretion of ADH - antidiuretic hormone - vasopressin)
• lactation in women who are not breastfeeding
• mania
• increased risk of fractures observed in patients taking this type of medicine
• changes in heart rhythm in the ECG (electrical activity of the heart) - so-called "QT interval prolongation"

In addition, it is known that medicines with a similar effect to escitalopram (the active substance of Mozarin) can cause side effects such as:

• 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. Side effects can be reported directly to the Department of Adverse Reactions of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 gather more information on the safety of this medicine.

5. How to store Mozarin

Store in a place out of sight and reach of children. Do not take Mozarin after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month. There are no special storage precautions. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Mozarin contains

The active substance is escitalopram. Each Mozarin tablet contains 10 mg or 15 mg or 20 mg of escitalopram (in the form of oxalate). In addition, the medicine contains: Core:microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate Coating:Opadry White Y-1-7000: hypromellose 6 cP, titanium dioxide (E 171), and macrogol 400

What Mozarin looks like and contents of the pack

Mozarin is available in the form of 10 mg, 15 mg, and 20 mg coated tablets. The tablets are described below. Mozarin 10 mg (8.1 x 5.6 mm) - oval, white, coated tablets with a dividing line on one side. The tablets can be divided into two equal doses. Mozarin 15 mg (10.4 x 5.6 mm) - oval, white, coated tablets with a dividing line on one side. The dividing line is intended to facilitate dividing the tablet to make it easier to swallow. Mozarin 20 mg (11.6 x 7.1 mm) - oval, white, coated tablets with a dividing line on one side. The tablets can be divided into two equal doses. Mozarin is available in packs of: Mozarin 10 mg: 28, 30, 56, 84 tablets Mozarin 15 mg: 28 tablets Mozarin 20 mg: 28 tablets Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów

Manufacturer

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów HBM Pharma s.r.o. Sklabinská 30 036 80 Martin Slovakia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

{Poland} {Mozarin}

Date of last revision of the leaflet:

• 02.2021