METAZYDYNA 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Metazydyna, 20 mg, Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Metazydyna and what is it used for
4. Important information before taking Metazydyna
   1. When not to take Metazydyna
   2. Warnings and precautions
   3. Athletes
   4. Children and adolescents
   5. Metazydyna and other medicines
   6. Metazydyna with food and drink
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Metazydyna contains carmoisine (E 124)
   10. Metazydyna contains sodium
5. How to take Metazydyna
   1. If you take more Metazydyna than you should
   2. If you forget to take Metazydyna
   3. If you stop taking Metazydyna
6. Possible side effects
   1. Reporting side effects
7. How to store Metazydyna
8. Contents of the pack and other information
   1. What Metazydyna contains
   2. What Metazydyna looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Metazydyna, 20 mg, Coated Tablets

Trimetazidini dihydrochloridum

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

• 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 experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Metazydyna and what is it used for

This medicine is intended for use in adults, in combination with other medicines, for the treatment of angina pectoris (chest pain caused by coronary artery disease). It protects heart cells from the effects of reduced oxygen supply during an angina attack.

2. Important information before taking Metazydyna

When not to take Metazydyna

• if you are allergic to trimetazidine or any of the other ingredients of this medicine (listed in section 6);
• if you have Parkinson's disease: a brain disease that affects movement (tremors, stiff posture, slow movements and shuffling gait, unsteady gait);
• if you have severe kidney disease.

Warnings and precautions

Before taking Metazydyna, discuss it with your doctor or pharmacist.

• Metazydyna is not intended for the treatment of angina attacks, unstable angina or myocardial infarction. If you experience an angina attack, inform your doctor, as tests and changes in treatment may be required.
• In patients with renal impairment and the elderly, your doctor may recommend a lower dose of the medicine.
• Patients with severe renal impairment (creatinine clearance less than 15 ml/min) should not take this medicine.
• Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP), have been reported with the use of Metazydyna. If you notice any symptoms of a severe skin reaction, as described in section 4, stop taking Metazydyna and seek medical attention immediately.

This medicine may cause or worsen symptoms such as tremors, stiff posture, slow movements and shuffling gait, unsteady gait, especially in elderly patients, which should be observed and reported to the doctor, who will reassess the treatment.

Athletes

This medicine contains an active substance that may give a positive reaction in anti-doping tests.

Children and adolescents

Metazydyna is not recommended for children and adolescents under 18 years of age.

Metazydyna and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to take. No interactions with other medicines or substances have been reported.

Metazydyna with food and drink

Take the medicine during meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Metazydyna during pregnancy, as the safety of the medicine in pregnant women has not been fully established. During treatment with Metazydyna, do not breastfeed, as it is not known whether the medicine passes into breast milk.

Driving and using machines

This medicine may cause dizziness and drowsiness, which may affect your ability to drive or use machines.

Metazydyna contains carmoisine (E 124)

The medicine contains carmoisine (E 124), which may cause allergic reactions.

Metazydyna contains sodium

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

3. How to take Metazydyna

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose of Metazydyna is 20 mg, one tablet taken three times a day during meals. If you have kidney disease or are over 75 years old, your doctor will adjust the recommended dose.

If you take more Metazydyna than you should

If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.

If you forget to take Metazydyna

Take the missed dose as soon as possible, unless it is time for the next dose. In this case, skip the missed dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking Metazydyna

Take Metazydyna for as long as your doctor recommends. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The medicine is generally well tolerated. Stop taking Metazydyna and seek medical attention immediately if you notice any of the following side effects: Common (may affect up to 1 in 10 people):dizziness, headache, abdominal pain, diarrhea, nausea, vomiting, rash, itching, hives, and feeling weak. Uncommon (may affect up to 1 in 100 people)unusual sensation on the skin, such as tingling or crawling sensation (paresthesia). Rare (may affect up to 1 in 1,000 people):fast or irregular heartbeat (also called palpitations), extra heartbeats, abnormal heart rhythm, low blood pressure when standing up, which can cause dizziness, lightheadedness or fainting, feeling unwell (general malaise), dizziness, falls, flushing. Frequency not known (frequency cannot be estimated from the available data):extrapyramidal symptoms (abnormal movements, including tremors and twitching of hands and fingers, twisting movements of the body, shuffling gait and stiffness of arms and legs), usually reversible after stopping treatment, thrombocytopenic purpura (bleeding of varying severity, e.g. nosebleeds, bleeding gums, bruising, caused by a low platelet count). Widespread rash, high fever, increased liver enzyme activity, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2. Severe generalized rash with redness of the skin and blisters. Sleep disorders (difficulty sleeping, drowsiness), constipation, swelling of the face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing. Significant decrease in white blood cell count, which increases the risk of infection, decrease in platelet count, which increases the risk of bleeding or bruising. Liver disease (nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, pale stools, dark urine). Other side effectsIn a very small number of patients, other side effects have been reported, but their frequency is unknown: balance disorders (dizziness of labyrinthine origin).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported 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 Metazydyna

Keep the medicine out of the sight and reach of children. Store in the original package, at a temperature below 25°C. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month. 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 Metazydyna contains

• The active substance is trimetazidine dihydrochloride. Each tablet contains 20 mg of trimetazidine dihydrochloride.
• The other ingredients are: microcrystalline cellulose, sodium carmellose, povidone 90, magnesium stearate. The coating contains: hypromellose E 5, hypromellose E 15, hydroxypropylcellulose, macrogol 4000, red iron oxide (E 172), carmoisine (E 124).

What Metazydyna looks like and contents of the pack

The tablets are red, round, biconvex, smooth. Available packs: 60 coated tablets

Marketing authorization holder

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, tel. +48 22 732 77 00

Manufacturer

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

Date of last revision of the leaflet: