Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Preductal MR (Trimetazidine MR Servier)
35 mg, modified-release tablets
Trimetazidini dihydrochloridum
Preductal MR and Trimetazidine MR Servier are different trade names for the same medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Preductal MR is and what it is used for
Important information before taking Preductal MR
How to take Preductal MR
Possible side effects
How to store Preductal MR
Contents of the pack and other information

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

This medicine is intended for use in adults, in combination with other medications, for the treatment of angina
pectoris (chest pain caused by coronary artery disease).

2. Important information before using 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 disorder affecting movement (tremors, rigid posture, slow movements and shuffling gait, unbalanced walking);
if the patient has severely impaired kidney function.

Warnings and precautions
Before starting treatment with Preductal MR, consult your doctor or pharmacist.
Preductal MR is not suitable for the treatment of acute angina attacks, nor for the initial treatment of unstable angina or myocardial infarction.
If an angina attack occurs, inform your doctor. In such a case, further investigations and a change in therapy may be required.
This medicine may cause or worsen symptoms such as: tremors, rigid posture, slow movements and shuffling gait, unbalanced walking, especially in elderly patients. These symptoms should be monitored and reported to the doctor, who will reassess the treatment.
Consult your doctor even if the above warnings refer to conditions that occurred in the past.

Athletes
This medicine contains an active substance that may lead to a positive anti-doping test result.

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

Preductal MR and other medicines
Inform your doctor about all medicines currently taken or recently used, as well as any medicines planned for future use.
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 for use in pregnant women.
Preductal MR is not recommended for use in breastfeeding women. Women taking this medicine should not breastfeed.
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

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

3. How to use Preductal MR

This medicine should always be taken according to the doctor's instructions. In case of doubts, consult
your doctor or pharmacist.
The recommended dose of Preductal MR 35 mg is one tablet taken twice daily during meals, in the morning and evening.
If the patient has kidney problems or is over 75 years of age, the doctor will adjust the recommended dose.
Dose modification is not required for patients undergoing surgical procedures.
If the patient feels that the effect of Preductal MR is too strong or too weak, they should consult
their doctor.
Taking more Preductal MR than recommended
Limited data are available regarding overdose with Preductal MR. Treatment should be symptomatic. In case of overdose, contact your doctor.
Missed 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 Preductal MR
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of possible adverse reactions is defined as follows:

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

Common:
dizziness, headache, abdominal pain, diarrhoea, indigestion, nausea, vomiting, rash,
itching, urticaria, and feeling of weakness.

Rare:
rapid or irregular heartbeat (also called palpitations), extra heartbeats, faster heartbeat,
drop in blood pressure when standing, causing dizziness, feeling faint or lightheaded, fainting,
malaise (general feeling of being unwell), dizziness, falls, facial flushing.

Frequency unknown:
extrapyramidal symptoms (abnormal movements, including tremors and shaking of hands and fingers,
twisting body movements, dragging of legs while walking, and stiffness of arms and legs), usually
reversible after discontinuation of treatment.
Sleep disorders (difficulty falling asleep, drowsiness), balance disorders (vertigo-related dizziness),
constipation, severe generalized rash with skin redness and blisters, swelling of the face, lips, mouth,
tongue or throat, which may cause difficulty in swallowing or breathing.
Marked decrease in white blood cell count, increasing the likelihood of infections;
decrease in platelet count, increasing 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 of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions
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 .
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Preductal MR

Keep this medicine out of sight and reach of children.
No special storage instructions are required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must 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 Preductal MR contains

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

What Preductal MR looks like and contents of the pack
Preductal MR is available in PVC/Aluminium blisters, packed in a cardboard box.
The pack contains 60, 90 or 120 modified-release tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Lithuania, the country of export:
Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France
Manufacturer:
Les Laboratoires Servier Industrie
905 route de Saran, 45520 Gidy, France
Servier (Ireland) Industries Ltd.
Moneylands, Gorey Road, Arklow, Co. Wicklow, Ireland
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
ul. Annopol 6, 03-236 Warsaw, Poland
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged at:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Lithuania, the country of export: LT/1/02/3178/001
Parallel Import Authorisation Number: 115/23