VASCOTAZIN 35 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   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
2. What is Vascotazin and what is it used for
3. Important information before taking Vascotazin
   1. When not to take Vascotazin
   2. Warnings and precautions
   3. Children and adolescents
   4. Vascotazin and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Vascotazin contains sodium
4. How to take Vascotazin
   1. Use in children
   2. Overdose of Vascotazin
   3. Missed dose of Vascotazin
5. Possible side effects
   1. Reporting side effects
6. How to store Vascotazin
7. Contents of the pack and other information
   1. What Vascotazin contains
   2. What Vascotazin looks like and contents of the pack
   3. Marketing authorization holder:
   4. Importer:
   5. Date of approval of the leaflet: October 2020

Package Leaflet: Information for the Patient

Vascotazin, 35 mg, modified-release tablets
Trimetazidine dihydrochloride

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 only. 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Vascotazin and what is it used for

Vascotazin contains trimetazidine as the active substance and belongs to the group of cardiac medicines. 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).

2. Important information before taking Vascotazin

When not to take Vascotazin

• if you are allergic to trimetazidine dihydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you have Parkinson's disease: a brain disease affecting body movements (tremors, stiff posture, slow movements and dragging of the feet while walking, unsteady gait), parkinsonian syndrome, tremors, restless legs syndrome or other movement disorders
• if you have severe kidney disease.

Warnings and precautions

Before taking Vascotazin, discuss it with your doctor or pharmacist. Vascotazin should not be used in acute angina attacks or for the initial treatment of unstable angina or myocardial infarction. Vascotazin should not be used before hospitalization or in the first days of hospital treatment. If you experience an angina attack during treatment with Vascotazin, tell your doctor, who may prescribe other treatment if necessary. This medicine may cause or worsen symptoms such as tremors, stiff posture, slow movements and dragging of the feet while walking, unsteady gait, especially in elderly patients, which should be observed and reported to the doctor, who will reassess the treatment. Tell your doctor if you have impaired kidney function. Tell your doctor if you have severe liver disease - Vascotazin is not recommended.

Children and adolescents

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

Vascotazin and other medicines

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

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. You should not take Vascotazin during breastfeeding.

Driving and using machines

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

Vascotazin contains sodium

This medicine contains 54.5 mg of sodium (the main component of common salt) per tablet. This corresponds to 2.7% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Vascotazin

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose of Vascotazin is 35 mg, one tablet taken twice a day during meals, in the morning and evening. If you have kidney disease or are over 75 years old, your doctor may adjust the recommended dose. The outer shell of the tablet may appear in the toilet or in the stool. This is normal, as the tablet shell is not absorbed in the gastrointestinal tract.

Use in children

The safety and efficacy of trimetazidine in children have not been established. Vascotazin is not recommended for children.

Overdose of Vascotazin

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

Missed dose of Vascotazin

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a missed dose. 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. Common (may affect up to 1 in 10 people):dizziness, headache, abdominal pain, diarrhea, nausea, vomiting, rash, itching, hives, and feeling weak. Rare (may affect up to 1 in 1,000 people):fast or irregular heartbeat (also called palpitations), extra heartbeats, faster heartbeat, low blood pressure when standing up, which can cause dizziness, feeling faint or fainting, malaise (general feeling of being unwell), dizziness, falls, flushing. Frequency not known (frequency cannot be estimated from the available data):extrapyramidal symptoms (abnormal movements, including tremors and twitching of the hands and fingers, twisting movements of the body, dragging of the feet while walking, and stiffness of the arms and legs), usually transient after discontinuation of treatment. Sleep disorders (difficulty sleeping, drowsiness), constipation, severe red rash all over the body with blisters, swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing. Feeling of spinning (dizziness). Significant decrease in white blood cell count, which increases the risk of infections, decrease in platelet count, which increases the risk of bleeding or bruising. Liver disease (nausea, vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, pale stools, dark urine).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported 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.: +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 Vascotazin

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 that month. There are no special storage precautions. 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 Vascotazin contains

The active substance is trimetazidine dihydrochloride. Each tablet contains 35 mg of trimetazidine dihydrochloride. The other ingredients are: sodium chloride, povidone K 30, magnesium stearate, cellulose acetate, hypromellose 6 cps.

What Vascotazin looks like and contents of the pack

Modified-release tablets. White to almost white, round, biconvex, film-coated tablets with a smooth surface on both sides, 7.6 mm x 3.0 mm in size, with a small hole on one side. The modified-release tablets are packaged in blisters containing 60 tablets.

Marketing authorization holder:

Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland

Importer:

Balkanpharma - Dupnitsa AD, 3 Samokovsko Shosse Str., 2600 Dupnitsa, Bulgaria. For more information on this medicine and its authorized names in the Member States of the European Economic Area, please contact the representative of the marketing authorization holder: Actavis Export International Limited, BLB 016 Bulebel Industrial Estate, ZTN3000, Zejtun, Malta. Contact in Poland: tel. (+48 22) 512 29 00.

Date of approval of the leaflet: October 2020