TRIMEDUCTAN 35 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Trimeductan MR, 35 mg, Modified-Release 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 Trimeductan MR and what is it used for
4. Important information before taking Trimeductan MR
   1. When not to take Trimeductan MR:
   2. Warnings and precautions
   3. Children and adolescents
   4. Trimeductan MR and other medicines
   5. Trimeductan MR with food and drink
   6. Elderly patients
   7. Pregnancy and breastfeeding
   8. Driving and using machines
5. How to take Trimeductan MR
   1. Overdose of Trimeductan MR
   2. Missed dose of Trimeductan MR
   3. Stopping treatment with Trimeductan MR
6. Possible side effects
   1. Common side effects:
   2. Rare side effects:
   3. Side effects with unknown frequency:
   4. Reporting side effects
7. How to store Trimeductan MR
8. Contents of the pack and other information
   1. What Trimeductan MR contains
   2. What Trimeductan MR looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Trimeductan MR, 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. 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Trimeductan MR and what is it used for

Trimeductan MR is available in the form of modified-release tablets. It contains trimetazidine dihydrochloride as the active substance.
Trimetazidine has a protective effect on cardiac muscle cells under hypoxic conditions caused by ischemia, by maintaining metabolic processes and slowing down the depletion of high-energy compounds.
Trimeductan MR 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 Trimeductan MR

When not to take Trimeductan MR:

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

Warnings and precautions

Before taking Trimeductan MR, discuss it with your doctor or pharmacist.
Trimeductan MR is not intended for the treatment of angina attacks, or initial treatment of unstable angina or myocardial infarction. If an angina attack occurs, inform your doctor. In such cases, tests and changes in treatment may be required.
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.
Trimetazidine is mainly excreted by the kidneys, and in patients with renal impairment, special caution is required, and the dose may need to be reduced if necessary.
In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), the recommended dose is 1 tablet of 35 mg in the morning, during breakfast.

Children and adolescents

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

Trimeductan MR and other medicines

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

Trimeductan MR with food and drink

It is recommended to take Trimeductan MR during meals.

Elderly patients

In elderly patients, where trimetazidine elimination may be slowed down, the dose should be reduced.

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.
Trimeductan MR is not recommended during pregnancy.
Trimeductan MR is not recommended during breastfeeding. Women taking this medicine should not breastfeed.

Driving and using machines

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

3. How to take Trimeductan MR

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 Trimeductan MR is one tablet (35 mg) taken twice a day, during meals, in the morning and evening.
If you have kidney disease or are over 75 years old, your doctor will adjust the recommended dose.

Overdose of Trimeductan MR

There are limited data on trimetazidine overdose. Treatment should be symptomatic.
If you have taken more than the recommended dose of Trimeductan MR, contact your doctor.

Missed dose of Trimeductan MR

Take the missed dose as soon as possible, except when the next dose is near. Do not take a double dose to make up for the missed dose.

Stopping treatment with Trimeductan MR

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trimeductan MR can cause side effects, although not everybody gets them.
Trimeductan MR may cause the following side effects, grouped by frequency of occurrence:
very common (occurring in more than 1 in 10 patients); common (occurring in 1 to 10 in 100 patients); uncommon (occurring in 1 to 10 in 1,000 patients); rare (occurring in 1 to 10 in 10,000 patients); very rare (occurring in less than 1 in 10,000 patients); frequency not known (frequency cannot be estimated from the available data).

Common side effects:

dizziness, headache, abdominal pain, diarrhea, nausea, vomiting, rash, itching, hives, and feeling weak.

Rare side effects:

rapid or irregular heartbeat (also called palpitations), extra heartbeats, faster heartbeat, low blood pressure when standing up, which can cause dizziness, lightheadedness, or fainting, general malaise, dizziness, falls, flushing of the face.

Side effects with unknown frequency:

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 transient after discontinuation of treatment.
Sleep disorders (difficulty sleeping, drowsiness), constipation, severe generalized rash, including redness of the skin and blisters, 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 infections, 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).
Balance disorders (dizziness of labyrinthine origin).
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform 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,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Trimeductan MR

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging to protect from light.
Do not use the medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the 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 Trimeductan MR contains

The active substance is trimetazidine dihydrochloride.
The other excipients are:
Core:hypromellose, calcium hydrogen phosphate dihydrate, colloidal anhydrous silica, magnesium stearate;
Coating:talc, polyvinyl alcohol, macrogol 3350, titanium dioxide.

What Trimeductan MR looks like and contents of the pack

Trimeductan MR modified-release tablets are round, white, biconvex.
Trimeductan MR is packaged in PVC/Aluminum blisters, and together with the patient leaflet in a cardboard box.
The single pack contains 60 tablets.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A,
05-170 Zakroczym
phone: (+48) (22) 785 27 60
fax: (+48) (22) 785 27 60 ext. 106

Date of last revision of the leaflet: