Mozarin Svift

Leaflet accompanying the packaging: 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

You should carefully read the contents of the 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.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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 Mozarin Swift and what is it used for
• 2. Important information before taking Mozarin Swift
• 3. How to take Mozarin Swift
• 4. Possible side effects
• 5. How to store Mozarin Swift
• 6. Contents of the packaging and other information

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

Mozarin Swift 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 thought to be a factor in the development of depression and related diseases.

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

2. Important information before taking Mozarin Swift

When not to take Mozarin Swift:

• 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), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic);
• if the patient has congenital or a history of heart rhythm disturbances (observed in ECG; a test that allows checking the heart's work);
• if the patient is 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, the patient should discuss it with their doctor or pharmacist.

The patient should tell their doctor if they have any 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; they should stop taking Mozarin Swift if they experience seizures or an increased frequency of seizures (see also section 4 "Possible side effects");
• they have liver or kidney function disorders; it may be necessary to adjust the dose by the doctor;
• they have diabetes; treatment with Mozarin Swift may disrupt blood glucose control (glycemia); it may be necessary to change the dose of insulin and/or oral hypoglycemic agents;
• they have low sodium levels in the blood;
• they have a tendency to easy bleeding or bruising;
• they are being treated with electroconvulsive therapy;
• they have coronary heart disease;
• they have or have had heart disease or have recently had a heart attack;
• they have low resting heart rate and/or may have a salt deficiency in the body as a result of prolonged, severe diarrhea and vomiting (nausea) or are taking diuretics;
• they experience rapid or irregular heartbeat, fainting, collapse, or dizziness when standing, which may indicate heart rhythm disturbances;
• If the patient has eye problems, such as certain types of glaucoma or glaucoma in their medical history.
• The patient is 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 they have a history of bleeding disorders or if they are pregnant (see "Pregnancy, breastfeeding, and fertility").

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

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, the patient should consult their doctor.

In the first few weeks of treatment, symptoms such as anxiety or difficulty sitting or standing still may also occur. If such symptoms appear, the patient should immediately inform their 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 likelihood of such thoughts if:

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult. Information obtained in clinical trials has shown an increased risk of suicidal behavior in young adults (under 25 years of age) with mental disorders treated with antidepressant medication.

If the patient experiences suicidal thoughts or self-harm at any time, they should immediately contact their doctor or go to the hospital. It may be helpful for the patient to tell someone in their family or friendsthat they have depression or an anxiety disorder and ask them to read this leaflet. They may ask them to tell them if they notice any worsening of their depression or anxiety or any worrying changes in their behavior.

Children and adolescents

Mozarin Swift should not be used in children and adolescents under 18 years of age. It is also important to note 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 manifestations of anger), when they take medicines of this class. Nevertheless, the doctor may prescribe Mozarin Swift to patients under 18 years of age if they consider it to be in their best interest. If Mozarin Swift has been prescribed to a patient under 18 years of age and there are any doubts, the patient should consult their doctor again. If the above symptoms develop or worsen in patients under 18 years of age taking Mozarin Swift, the patient should inform their 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

The patient should tell their doctor 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 active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If these medicines are taken, the patient should wait 14 days before starting treatment with Mozarin Swift. After stopping treatment with Mozarin Swift, the patient 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 may 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). They may increase the risk of side effects. These medicines 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 tension, and a body temperature above 38°C. If the patient experiences such symptoms, they should contact their 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, the doctor will probably check the 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, thioridazine, and haloperidol (antipsychotic medicines). 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.

The patient should not take Mozarin Swift if they are taking medicines for heart rhythm disturbances 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 the patient has any further doubts, they should consult their doctor.

Mozarin Swift with food, drink, and alcohol

Mozarin Swift can be taken during or between meals (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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine. The patient should not take Mozarin Swift if they are pregnant or breastfeeding, unless the benefits and risks of taking the medicine have been discussed with their doctor.

If the patient takes Mozarin Swift in the last 3 months of pregnancy, they should be aware that the following symptoms may occur in the newborn: 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 the newborn experiences any of these symptoms, the patient should immediately consult their doctor.

The patient should never stop taking Mozarin Swift abruptly during pregnancy.

The patient should inform their doctor and/or midwife about taking Mozarin Swift. Taking medicines like Mozarin Swift during pregnancy, especially in the last three months, 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 bluish skin and usually occurs in the first day after birth. If such symptoms occur in the newborn, the patient should immediately contact their doctor and/or midwife.

If the patient takes Mozarin Swift at the end of pregnancy, there may be an increased risk of severe bleeding from the vagina shortly after birth, especially if they have a history of bleeding disorders. The patient should inform their doctor and/or midwife about 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 may theoretically affect fertility, although no effect on fertility has been observed in humans yet.

Driving and using machines

The patient should not drive or operate machinery until they know how Mozarin Swift affects them.

Mozarin Swift contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Mozarin contains sodium

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

3. How to take Mozarin Swift

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

Mozarin Swift orally disintegrating tablets are taken once daily, in one dose. Mozarin Swift can be taken during or between meals.

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

• 1. Holding the blister by the edges, the patient should separate one tablet from the rest of the strip by gently tearing it off along the perforation.
• 2. The patient should carefully remove the rear foil.
• 3. The patient should place the tablet on their 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. The doctor may increase the dose to a maximum of 20 mg per day.

Panic disorder

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

Social phobia

The usual recommended dose of Mozarin Swift is 10 mg, taken as one dose per day. The doctor may then reduce the dose to 5 mg per day (the patient should use a different medicinal product containing 5 mg of escitalopram) or increase it 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 Mozarin Swift is 10 mg, taken as one dose per day. The 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. The 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 (the patient should use a different medicinal product containing 5 mg of escitalopram).

The 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 the patient feels better. The patient should continue taking Mozarin Swift even if it takes some time, until their condition improves.

The patient should not change the dose of the medicine without consulting their doctor.

Mozarin Swift should be used for as long as the doctor recommends. If treatment is stopped too early, the symptoms may return. It is recommended to continue therapy for at least 6 months after the patient's condition improves.

Taking a higher dose of Mozarin Swift than recommended

If the patient takes a higher dose of Mozarin Swift than recommended, they should immediately contact their doctor or go to the hospital, even if they do not experience 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 contacting the doctor or hospital, the patient should take the packaging of Mozarin Swift with them.

Missing a dose of Mozarin Swift

The patient should not take a double dose to make up for a missed dose. If the patient misses a dose and remembers before going to bed, they should take the missed dose immediately. The next day, they should take the medicine as usual. If the patient remembers the missed dose at night or the next day, they should skip the missed dose and take the medicine as usual.

Stopping treatment with Mozarin Swift

The patient should not stop taking Mozarin Swift unless their doctor recommends it. In case of planned termination of 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 abrupt, the patient may experience withdrawal symptoms. These symptoms are often observed after stopping treatment with Mozarin Swift. The risk of withdrawal symptoms is higher in case of long-term treatment with Mozarin Swift or treatment with high doses, as well as in case of too rapid 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 the patient experiences severe withdrawal symptoms, they should contact their doctor. The doctor may recommend restarting the treatment and then reducing the dose more slowly.

Withdrawal symptoms include: dizziness (balance disturbances), tingling, burning or (less often) electric shock sensations, including 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 (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, Mozarin Swift can cause side effects, although not everybody gets them.

Side effects usually resolve after a few weeks of treatment. It should be noted that many of them may also be symptoms of the treated disease and will resolve as the patient's condition improves.

If the patient experiences any of the following side effects, they should contact their doctor:

Uncommon (occurring in less than 1 in 100 people):

• abnormal bleeding, including gastrointestinal bleeding

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

• In case of skin swelling, tongue, lip, or face swelling, or difficulty breathing or swallowing (allergic reaction), the patient should immediately contact their doctor or go to the hospital;
• High fever, agitation, disorientation, tremors, and severe muscle contractions may be symptoms of a rare disorder called serotonin syndrome. If the patient experiences these symptoms, they should contact their doctor.

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

• difficulty urinating
• seizures, see also section "When to be cautious when taking Mozarin Swift"
• yellowing of the skin and whites of the eyes, which may be a sign of liver function disorders 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 birth (postpartum hemorrhage), see also section "Pregnancy, breastfeeding, and fertility"

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

Very common (occurring in at least 1 in 10 people):

• nausea
• headache

Common (occurring in less than 1 in 10 people):

• nasal congestion or sinusitis (sinus infection)
• decreased or increased appetite
• anxiety, restlessness, unusual dreams, sleep disturbances, drowsiness, 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 (occurring in 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, tinnitus
• hair loss
• vaginal bleeding
• weight loss
• rapid heartbeat
• swelling of hands and feet
• nosebleeds

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

• aggression, depersonalization (feeling of loss of one's 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 by nausea and malaise, muscle weakness, and confusion);
• dizziness when standing up, related to low blood pressure (orthostatic hypotension);
• abnormal liver function 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".

It is also known that medicines with a similar action to escitalopram (the active substance of Mozarin Swift) may cause side effects such as:

• restlessness (akathisia)
• loss of appetite

If the patient's side effects worsen or if they experience any side effects not listed in the leaflet, they should tell their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including those not listed in the 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, 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, it is possible to gather more information on the safety of this medicine.

5. How to store Mozarin Swift

The medicine should be stored out of the sight and reach of children.

The patient should not take this medicine after the expiry date stated on the packaging and blister after: EXP. The expiry date refers to the last day of the month stated.

There are no special storage instructions for the medicine. The patient should store it in the original packaging to protect it from moisture and light.

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 Mozarin Swift contains

• The active substance of Mozarin Swift 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, potassium acesulfame, neohesperidin dihydrochalcone, magnesium stearate, peppermint flavor [containing corn maltodextrin, modified corn starch, 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 beveled 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 beveled 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 beveled edge and a diameter of 12 mm, with the inscription "20" on one side.

Blisters in packs 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 Grecja
• 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