Mozarin Svift

Package Leaflet: Information for the User

Mozarin Swift, 10 mg, orally disintegrating tablets

Mozarin Swift, 15 mg, orally disintegrating tablets

Mozarin Swift, 20 mg, orally disintegrating tablets

Escitalopram

Read all of this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What Mozarin Swift is and what it is used for

Mozarin Swift belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work by increasing the levels of serotonin in the brain. Serotonin disturbances in the brain are believed to be a major factor in the development of depression and related diseases.

Mozarin Swift contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).

2. Before you take Mozarin Swift

Do not take Mozarin Swift:

• if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6);
• if you are taking other medicines that belong to a group called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic);
• if you have congenital or a history of heart rhythm disturbances (observed in ECG; a test that allows you to check the heart's work);
• if you are taking medicines for heart rhythm disturbances or medicines that affect heart rhythm (see section 2 "Mozarin Swift and other medicines").

Warnings and precautions

Before starting to take Mozarin Swift, discuss it with your doctor or pharmacist.

Tell your doctor if you have any other disorders or diseases, as your doctor should take this information into account.

Particularly, inform your doctor if:

• you have epilepsy; you should stop taking Mozarin Swift if you experience seizures or an increased frequency of seizures (see also section 4 "Possible side effects");
• you have liver or kidney disease; your doctor may need to adjust the dose;
• you have diabetes; treatment with Mozarin Swift may affect blood sugar control (glycemia); you may need to adjust the dose of insulin and/or oral hypoglycemic agents;
• you have low sodium levels in the blood;
• you have a tendency to bleed easily or bruise;
• 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 levels of salts in the body due to prolonged, severe diarrhea and vomiting (nausea) or are taking diuretics;
• you experience rapid or irregular heartbeat, fainting, collapse, or dizziness when standing, which may indicate heart rhythm disturbances;
• If you have eye problems, such as certain types of glaucoma or glaucoma in your medical history.
• You are being treated with buprenorphine. Taking this medicine with Mozarin Swift may lead to a life-threatening condition called serotonin syndrome (see section "Mozarin Swift and other medicines").
• if you have a history of bleeding disorders or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").

Medicines like Mozarin Swift (SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Caution

In some patients with bipolar affective disorder, a manic phase may occur. This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, you should consult your doctor.

In the first few weeks of treatment, symptoms such as anxiety or difficulty sitting or standing still may also occur. If you experience these symptoms, you should immediately inform your doctor.

Suicidal thoughts and worsening of depression or anxiety disorders

People with depression and/or anxiety disorders may sometimes think about self-harm or suicide. These thoughts may occur with particular intensity when starting to take antidepressant medicines, as all these medicines start to work only after some time, usually after about two weeks of taking them, although sometimes this time may be longer.

There is an increased risk of these types of thoughts if:

• you have had suicidal thoughts or self-harm in the past;
• you are a young adult (under 25 years old). Information from clinical trials has shown that there is an increased risk of suicidal behavior in young adults (under 25 years old) with mental disorders treated with antidepressant medication.

If you experience suicidal thoughts or self-harm at any time, you should contact your doctor or go to the hospital immediately. It may be helpful for you to tell someone in your family or a friendthat you have depression or an anxiety disorder and ask them to read this leaflet. You may want to ask them to tell you if they think your depression or anxiety has gotten worse or if they notice any changes in your behavior.

Children and adolescents

Mozarin Swift should not be used in children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age, there is a higher risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and signs of anger), when they take medicines of this class. Nevertheless, your doctor may prescribe Mozarin Swift to patients under 18 years of age if they consider it to be in their best interest. If you are under 18 years of age and have been prescribed Mozarin Swift, and you have any concerns, you should discuss them with your doctor. If the above symptoms develop or worsen in patients under 18 years of age taking Mozarin Swift, you should inform your doctor. Additionally, as yet, there are no data on the long-term safety of Mozarin Swift in this age group regarding growth, maturation, and cognitive and behavioral development.

Mozarin Swift and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Tell your doctor if you are taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAOIs) containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you are taking these medicines, you should wait 14 days before starting treatment with Mozarin Swift. After stopping treatment with Mozarin Swift, 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 inhibitors B (MAO-B), containing selegiline (used to treat Parkinson's disease), which can 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 tramadol, buprenorphine (used to treat severe pain). These medicines can increase the risk of side effects. They may interact with Mozarin Swift 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 these symptoms, you should contact your doctor;
• 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). They may cause an increase in escitalopram levels in the blood;
• St. John's Wort (Hypericum perforatum) - a herbal remedy for depression;
• acetylsalicylic acid and non-steroidal anti-inflammatory drugs (used as painkillers or to thin the blood, known as 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 Swift, your doctor will probably check your blood clotting time to see if the dose of 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 antidepressants;
• flecainide, propafenone, and metoprolol (used to treat cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), risperidone, tiordiazine, and haloperidol (antipsychotics). It may be necessary to adjust the dose of Mozarin Swift;
• medicines that lower potassium or magnesium levels in the blood, due to the increased risk of life-threatening heart rhythm disturbances.

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

Mozarin Swift with food, drink, and alcohol

Mozarin Swift can be taken with or without food (see section 3 "How to take Mozarin Swift").

As with many medicines, it is not recommended to take Mozarin Swift with alcohol, although interactions between Mozarin Swift and alcohol are not expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Do not take Mozarin Swift if you are pregnant or breastfeeding, unless the benefits and risks of taking the medicine have been discussed with your doctor.

If you take Mozarin Swift during the last 3 months of pregnancy, you should be aware that your newborn baby may experience the following symptoms: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, tremors, shakiness, irritability, lethargy, constant crying, and sleep disturbances. If your newborn baby experiences any of these symptoms, you should contact your doctor immediately.

Never stop taking Mozarin Swift during pregnancy.

Tell your doctor and/or midwife that you are taking Mozarin Swift. Taking medicines like Mozarin Swift, especially in the last 3 months of pregnancy, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and bluish skin and usually occurs in the first day after birth. If such symptoms occur in your newborn, you should contact your doctor and/or midwife immediately.

There may be an increased risk of heavy bleeding from the vagina shortly after delivery, especially if you have a history of bleeding disorders. You should inform your doctor and/or midwife that you are taking Mozarin Swift.

It is expected that Mozarin Swift will pass into breast milk.

In animal studies, it has been shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This could theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

You should not drive or operate machinery until you know how Mozarin Swift affects you.

Mozarin Swift contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

Mozarin Swift contains sodium

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

3. How to take Mozarin Swift

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Mozarin Swift orally disintegrating tablets are taken once daily, in one dose. Mozarin Swift can be taken with or without food.

Mozarin Swift orally disintegrating tablets are fragile, so handle them carefully. Do not touch the tablets with wet hands, as they may break apart. If a 5 mg dose is required, you should take a different medicinal product containing 5 mg of escitalopram.

• 1. Hold the blister by the edges and separate one tablet from the rest of the blister by gently tearing it off along the perforation.
• 2. Carefully peel off the rear foil.
• 3. Place the tablet on the tongue. The tablet will dissolve very quickly and can be swallowed without water.

Adults

Depression

The usual recommended dose of Mozarin Swift is 10 mg, taken as one dose per day. Your doctor may increase the dose to a maximum of 20 mg per day.

Panic disorder

The initial dose of Mozarin Swift is 5 mg per day for the first week of treatment (you should use a different medicinal product containing 5 mg of escitalopram), then the dose is increased to 10 mg per day. Your doctor may then increase the dose to a maximum of 20 mg per day.

Social anxiety disorder

The usual recommended dose of Mozarin Swift is 10 mg, taken as one dose per day. Your doctor may then reduce the dose to 5 mg per day (you should use a different medicinal product containing 5 mg of escitalopram) or increase it to a maximum of 20 mg per day, depending on your response to the medicine.

Generalized anxiety disorder

The usual recommended dose of Mozarin Swift is 10 mg, taken as one dose per day. Your doctor may increase the dose to a maximum of 20 mg per day.

Obsessive-compulsive disorder

The usual recommended dose of Mozarin Swift is 10 mg, taken as one dose per day. Your doctor may increase the dose to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)

The recommended initial dose of Mozarin Swift is 5 mg, taken as one dose per day (you should use a different medicinal product containing 5 mg of escitalopram). Your doctor may recommend increasing the dose to 10 mg per day.

Use in children and adolescents

Mozarin Swift should not normally be used in children and adolescents. Additional information is provided in section 2 "Important information before taking Mozarin Swift".

Duration of treatment

It may take several weeks of treatment before you feel better. You should continue to take Mozarin Swift even if it takes some time to feel better.

Do not change the dose of the medicine without consulting your doctor.

Mozarin Swift should be used for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. It is recommended to continue treatment for at least 6 months after the improvement of your condition.

Taking more than the recommended dose of Mozarin Swift

If you have taken more than the recommended dose of Mozarin Swift, you should contact your doctor or go to the hospital immediately, even if you do not feel any symptoms. Some of the symptoms of overdose are: dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and electrolyte disturbances. When going to the doctor or hospital, take the package leaflet and any remaining tablets with you.

Forgetting to take a dose of Mozarin Swift

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose and remember before going to bed, you should take the missed dose immediately. The next day, take the medicine as usual. If you remember the missed dose in the night or the next day, you should skip the missed dose and take the medicine as usual.

Stopping treatment with Mozarin Swift

Do not stop taking Mozarin Swift unless your doctor tells you to. When stopping treatment, it is recommended to gradually reduce the dose of Mozarin Swift over several weeks.

After stopping treatment with Mozarin Swift, especially if it is stopped suddenly, you may experience withdrawal symptoms. These symptoms are common when stopping treatment with Mozarin Swift. The risk of withdrawal symptoms is higher if you have been taking Mozarin Swift for a long time or at high doses, as well as if you stop taking the medicine too quickly. In most patients, the symptoms are mild and go away on their own within two weeks. However, in some patients, the symptoms may be severe or last longer (2-3 months or longer). If you experience severe withdrawal symptoms, you should contact your doctor. Your doctor may recommend restarting the medicine and then stopping it more slowly.

Withdrawal symptoms include: dizziness (balance disturbances), tingling, burning, or (less commonly) electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headache, nausea, excessive sweating (including night sweats), agitation or restlessness, tremors, confusion or disorientation, mood swings or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or rapid heartbeat.

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 Swift can cause side effects, although not everybody gets them.

Side effects usually go away after a few weeks of treatment. It should be noted that many of them can also be symptoms of the disease being treated and will improve as you feel better.

If you experience any of the following side effects, contact your doctor:

Uncommon (affecting less than 1 in 100 people):

• abnormal bleeding, including gastrointestinal bleeding

Rare (affecting less than 1 in 1,000 people):

• In case of skin swelling, tongue, lip, or face swelling, or difficulty breathing or swallowing (allergic reaction), you should contact your doctor or go to the hospital immediately;
• High fever, agitation, confusion, tremors, and convulsions may be symptoms of a rare disorder called serotonin syndrome. If you experience these symptoms, you should contact your doctor.

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

• difficulty urinating
• seizures, see also section "When to be careful when taking Mozarin Swift"
• yellowing of the skin and whites of the eyes, which is a sign of liver dysfunction and/or hepatitis
• rapid or irregular heartbeat, fainting, which may be a sign of a life-threatening condition called Torsades de Pointes

Some patients have reported (frequency cannot be estimated from the available data):

• heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see also section "Pregnancy, breastfeeding, and fertility"

In addition to the above, the following side effects have been reported:

Very common (affecting more than 1 in 10 people):

• nausea
• headache

Common (affecting less than 1 in 10 people):

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

Uncommon (affecting less than 1 in 100 people):

• hives, other rashes, itching
• teeth grinding, agitation, nervousness, panic attacks, disorientation
• sleep disturbances, taste disturbances, fainting
• pupil dilation, vision disturbances, ringing in the ears
• hair loss
• vaginal bleeding
• weight loss
• rapid heartbeat
• swelling of hands and feet
• nosebleeds

Rare (affecting less than 1 in 1,000 people):

• aggression, depersonalization (feeling of loss of identity), hallucinations
• slow heartbeat

Some patients have reported (frequency cannot be estimated from the available data):

• thoughts of self-harm or suicide, see also section "Warnings and precautions";
• decreased sodium levels in the blood (manifested as 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 erections (priapism);
• bleeding disorders, including 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 (inappropriate antidiuretic hormone secretion - vasopressin);
• lactation in women who are not breastfeeding;
• mania;
• increased risk of bone fractures in patients taking medicines of this class;
• 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 action to escitalopram (the active substance of Mozarin Swift) can cause side effects such as:

• restlessness (akathisia)
• loss of appetite

If any of your side effects get worse or if you experience any side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mozarin Swift

Keep this medicine out of the sight and reach of children.

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 month stated.

There are no special storage instructions for this medicine. Store in the original package to protect from moisture and light.

Medicines should 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 Mozarin Swift contains

• The active substance is escitalopram. Mozarin Swift 10 mg: Each orally disintegrating tablet contains 10 mg of escitalopram, equivalent to 12.775 mg of escitalopram oxalate. Mozarin Swift 15 mg: Each orally disintegrating tablet contains 15 mg of escitalopram, equivalent to 19.1625 mg of escitalopram oxalate. Mozarin Swift 20 mg: Each orally disintegrating tablet contains 20 mg of escitalopram, equivalent to 25.55 mg of escitalopram oxalate.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, potassium polacrilin, acesulfame potassium, neohesperidin dihydrochalcone, magnesium stearate, peppermint flavor [containing maltodextrin (corn), modified starch (corn), peppermint oil], concentrated hydrochloric acid

What Mozarin Swift looks like and contents of the pack

Mozarin Swift 10 mg: White or almost white, flat, round tablet with a broken edge and a diameter of 9 mm with the inscription "10" on one side.

Mozarin Swift 15 mg: White or almost white, flat, round tablet with a broken edge and a diameter of 11 mm with the inscription "15" on one side.

Mozarin Swift 20 mg: White or almost white, flat, round tablet with a broken edge and a diameter of 12 mm with the inscription "20" on one side.

Blisters in cartons containing 28 orally disintegrating tablets.

Marketing authorization holder:

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Manufacturers:

• 1. Adamed Pharma S.A. ul. Marszałka Józefa Piłsudskiego 5 95-200 Pabianice
• 2. Genepharm S.A. 18 km Marathon Avenue 15351 Pallini Attikis Greece
• 3. Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park, Paola, PLA 3000 Malta
• 4. Laboratorios Cinfa S.A. Olaz-Chipi, 10. Poligono Industrial Areta (Huarte-Pamplona (Navarra)) – 31620 – España
• 5. Pharmapath S.A. 28is Oktovriou 1 Agia Varvara, 123 51 Greece

Date of last revision of the leaflet:

10/2023