Preductal Mr

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Preductal MR

35 mg, modified-release tablets

Trimetazidine dihydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 Preductal MR and what is it used for
• 2. Important information before taking Preductal MR
• 3. How to take Preductal MR
• 4. Possible side effects
• 5. How to store Preductal MR
• 6. Package contents and other information

1. What is Preductal MR 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 Preductal MR

When not to take Preductal MR:

• if the patient is allergic to trimetazidine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has Parkinson's disease: a brain disease that disrupts movement (tremors, stiff posture, slow movements, and dragging of the feet while walking, unsteady gait);
• if the patient has severe kidney disease.

Warnings and precautions

Before starting to take Preductal MR, discuss it with your doctor or pharmacist.
Preductal MR is not suitable for the treatment of angina pectoris attacks, or for the initial treatment of unstable angina pectoris or myocardial infarction.
In the event of an angina pectoris attack, inform your doctor. In such a situation, tests and a change of treatment may be required.
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.
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 Preductal MR. If any of the symptoms of this serious skin reaction, described in section 4, occur, stop taking Preductal MR and seek medical attention immediately.
Consult your doctor even if the above warnings refer to past situations.
Athletes
This medicine contains an active substance that may cause a positive result in an anti-doping test.

Children and adolescents

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

Preductal MR and other medicines

Tell your doctor 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 identified.

Preductal MR with food and drink

It is recommended to take Preductal MR during meals.

Pregnancy and breastfeeding

Preductal MR is not recommended during pregnancy.
Preductal MR is not recommended during breastfeeding. Women taking this medicine should not breastfeed.
If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

3. How to take Preductal MR

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Preductal MR, 35 mg, is 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 will adjust the recommended dose.
No dose modification is necessary in patients undergoing surgery.
If you feel that the effect of Preductal MR is too strong or too weak, consult your doctor.

Taking a higher dose of Preductal MR than recommended

There are limited data available on the overdose of Preductal MR. Treatment should be symptomatic. In case of overdose, contact your doctor.

Missing a dose of Preductal MR

Take the missed dose as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.

Stopping treatment with Preductal MR

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Preductal MR can cause side effects, although not everybody gets them.
The frequency of possible side effects is defined as follows:

• very common (affects more than 1 in 10 people);
• common (affects 1 to 10 people in 100);
• uncommon (affects 1 to 10 people in 1,000);
• rare (affects 1 to 10 people in 10,000);
• very rare (affects less than 1 in 10,000 people);
• not known (frequency cannot be estimated from the available data).

Stop taking Preductal MR and seek medical attention immediately if you notice 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 skin redness and blisters.

Common:
dizziness, headache, abdominal pain, diarrhea, nausea, vomiting, rash, itching, hives, and feeling weak.
Uncommon:
abnormal sensation on the skin, such as tingling or crawling sensation (paresthesia).
Rare:
rapid or irregular heartbeat (also called palpitations), extra heartbeats, faster heartbeat, low blood pressure when standing up, which can cause dizziness, feeling of emptiness in the head, or fainting, general malaise, dizziness, falls, flushing of the face.
Frequency not known:
extrapyramidal symptoms (abnormal movements, including tremors and twitching of hands and fingers, twisting movements of the body, dragging of the feet while walking, and stiffness of the arms and legs), usually transient after stopping treatment.
Sleep disorders (difficulty sleeping, somnolence), balance disorders (dizziness of labyrinthine origin), 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 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).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Preductal MR

Keep the medicine out of the sight and reach of children.
There are no special storage precautions.
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.
The batch number (abbreviated as "Lot") on the carton and blister pack is the batch number of the medicine.
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. Package contents and other information

What Preductal MR contains

• The active substance of Preductal MR is trimetazidine dihydrochloride. One modified-release tablet contains 35 mg of trimetazidine dihydrochloride.
• The other excipients are: calcium hydrogen phosphate dihydrate, hypromellose 2208/4000, magnesium stearate, povidone, colloidal anhydrous silica; coating ingredients:glycerol, hypromellose, macrogol 6000, magnesium stearate, red iron oxide (E 172), titanium dioxide (E 171).

What Preductal MR looks like and contents of the pack

Preductal MR is available in blisters in a cardboard box. The pack contains 60 modified-release tablets.
For more detailed information, consult the marketing authorization holder or the parallel importer.
Marketing authorization holder in the Czech Republic, the country of export:
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer:

Les Laboratoires Servier Industrie, 905, Route de Saran, 45520 Gidy, France
Servier (Ireland) Industries Limited, Moneylands, Gorey Road, Arklow, Co. Wicklow, Ireland
Anpharm Przedsiębiorstwo Farmaceutyczne S.A., ul. Annopol 6B, 03-236 Warsaw, Poland

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:83/328/01-C
Parallel import authorization number:483/15

Date of leaflet approval: 24.06.2025

[Information about the trademark]