Protevasc Sr

Leaflet included in the packaging: information for the user

Protevasc SR, 35 mg, prolonged-release tablets

trimetazidine dihydrochloride
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.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific condition. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

1.

What is Protevasc SR and what is it used for

2.

Important information before taking Protevasc SR

3.

How to take Protevasc SR

4.

Possible side effects

5.

How to store Protevasc SR

6.

Contents of the packaging and other information

1. What is Protevasc SR 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).

2. Important information before taking Protevasc SR

When not to take Protevasc SR

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Warnings and precautions

Before starting treatment with Protevasc SR, you should discuss it with your doctor or pharmacist

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In connection with the use of Protevasc SR, severe skin reactions have occurred, including drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). If any symptoms associated with this severe skin reaction occur, as described in section 4, you should stop taking Protevasc SR and seek medical attention immediately. This medicine may cause or worsen symptoms such as tremors, stiff posture, slow movements, and shuffling gait, especially in elderly patients, which should be observed and reported to the doctor, who will reassess the treatment. Protevasc SR is not suitable for the treatment of angina attacks.

Children and adolescents

Protevasc SR is not recommended for use in children and adolescents under 18 years of age.

Protevasc SR 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.

Protevasc SR with food and drink

Food and drink do not significantly affect the absorption and efficacy of the medicine.

Pregnancy and breastfeeding

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. Pregnancy: You should avoid taking this medicine during pregnancy. If you become pregnant while taking the medicine, you should consult your doctor for advice. Only your doctor can decide whether to continue treatment with Protevasc SR. Breastfeeding: It is not known whether trimetazidine is excreted in breast milk. Therefore, you should avoid taking Protevasc SR while breastfeeding.

Driving and using machines

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

Protevasc SR contains soy lecithin

If you are allergic to soy or peanuts, you should not take this medicine.

3. How to take Protevasc SR

You should always take this medicine exactly as your doctor has told you. If you are unsure, you should consult your doctor or pharmacist.

Adults

The recommended dose of Protevasc SR is one 35 mg tablet taken twice a day, in the morning and evening, with meals. You should take the tablets in the morning and evening, with meals, and if necessary, with a glass of water. If you have kidney problems or are over 75 years old, your doctor will adjust the recommended dose.

Use in children

Protevasc SR is not recommended for use in children.

Taking a higher dose of Protevasc SR than recommended

If you have taken too many tablets, you should contact your doctor or go to the nearest hospital emergency department immediately for appropriate treatment.

Missing a dose of Protevasc SR

It is important to take the medicine every day. However, if you miss a dose or several doses, you should take them as soon as you remember and then return to your usual dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping treatment with Protevasc SR

You should follow your doctor's instructions, who will determine the dose and duration of treatment. If you decide to stop taking Protevasc SR earlier, you should immediately inform your doctor. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported in connection with the use of Protevasc SR: You should stop taking Protevasc SR and seek medical attention immediately if you experience any of the following side effects: Frequency not known (frequency cannot be estimated from the available data): Widespread rash, high body temperature, 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. Other possible side effects: Common side effects (may affect up to 1 in 10 people): Dizziness, headache, abdominal pain, diarrhea, nausea, vomiting, rash, itching, and feeling weak. Uncommon side effects (may affect up to 1 in 100 people): Unusual sensation on the skin, such as tingling or crawling sensation (paresthesia). Rare side effects (may affect up to 1 in 1,000 people): Rapid or irregular heartbeat (also known as palpitations), extra heartbeats, faster heartbeat, low blood pressure when standing up, which can cause dizziness, feeling faint, or fainting, general malaise, dizziness, falls, flushing. Frequency not known (frequency cannot be estimated from the available data): Extrapyramidal symptoms (unusual movements, including tremors and twitching of the arms and fingers, twisting movements of the body, shuffling gait, and stiffness of the arms and legs), usually transient and disappearing after treatment is stopped. Sleep disorders (difficulty sleeping, drowsiness), balance disorders (dizziness of labyrinthine origin), constipation, facial swelling, lip swelling, mouth swelling, tongue swelling, or throat swelling, which can cause difficulty swallowing or breathing. Significant decrease in white blood cell count, which can increase the risk of infections, decrease in platelet count, which can increase 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). In such cases, after consulting a doctor, treatment should be discontinued as soon as possible.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the 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 Protevasc SR

The medicine should be stored at a temperature below 25°C. The medicine should be stored in the original packaging to protect it from moisture. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. 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 packaging and other information

What Protevasc SR contains

The active substance of the medicine is trimetazidine dihydrochloride. Each prolonged-release tablet contains 35 mg of trimetazidine dihydrochloride.

What else Protevasc SR contains

Core:

• Microcrystalline cellulose type 102
• Corn starch
• Hypromellose
• Colloidal anhydrous silica
• Magnesium stearate

Coating:

• Polyvinyl alcohol
• Talc
• Titanium dioxide (E171)
• Macrogol 3350
• Soy lecithin
• Red iron oxide (E172)
• Yellow iron oxide (E172)
• Black iron oxide (E172)

What Protevasc SR looks like and contents of the pack

Protevasc SR is a pink, round, biconvex tablet with a diameter of about 8 mm, without any markings. The pack sizes are 60 or 120 prolonged-release tablets packaged in aluminum/PVC blisters in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

GEDEON RICHTER POLSKA Sp. z o.o. ul. Ks. J. Poniatowskiego 5 05-825 Grodzisk Mazowiecki Poland

Manufacturer

Gedeon Richter Plc. 1103 Budapest Gyömrői út 19-21 Hungary GEDEON RICHTER POLSKA Sp. z o.o. ul. Ks. J. Poniatowskiego 5 05-825 Grodzisk Mazowiecki Poland Gedeon Richter România S.A. Str. Cuza-Vodă Nr. 99-105 540306 Târgu-Mureș Romania For more detailed information on the medicine and its names in other EU member states, you should contact the local representative of the marketing authorization holder: GEDEON RICHTER POLSKA Sp. z o.o. Medical Department ul. Ks. J. Poniatowskiego 5 05-825 Grodzisk Mazowiecki Tel. +48 (22)755 96 48 lekalert@grodzisk.rgnet.org Date of last revision of the leaflet: September 2024 ((logo of the marketing authorization holder))((pharmacode))