PREDUCTAL MR

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Preductal MR, 35 mg, modified-release tablets
Trimetazidini dihydrochloridum
Please read the entire leaflet carefully before using this 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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist immediately. See section 4.

Table of Contents:

1. What Preductal MR is and what it is 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. 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 dragging feet while walking, unbalanced gait);
• if the patient has severely impaired kidney function.

Warnings and precautions
Before starting treatment with Preductal MR, discuss this with 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 examinations and a change in treatment may be required.
This medicine may cause or worsen symptoms such as: tremors, rigid posture, slow movements and dragging feet while walking, unbalanced gait, particularly 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 result in anti-doping tests.

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 you are currently taking or have recently taken, as well as any medicines you plan to 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 using machines
This medicine may cause dizziness and drowsiness, which could affect the ability to drive or operate machinery.

3. How to use Preductal MR

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
The recommended dose of Preductal MR 35 mg is one tablet taken twice daily with meals, in the morning and evening.
If the patient has impaired kidney function or is over 75 years of age, the physician will adjust the recommended dose.
Dose modification is not necessary for patients undergoing surgical procedures.
If you feel that the effect of Preductal MR is too strong or too weak, consult your doctor.
Taking more Preductal MR than recommended
Limited data are available regarding overdose with Preductal MR. Treatment of poisoning 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 Preductal MR
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in all
patients.
The frequency of possible adverse effects 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 less than 1 in 10,000 people);
• unknown (frequency cannot be estimated from available data).

Common:
dizziness, headache, abdominal pain, diarrhoea, indigestion, nausea, vomiting, rash,
itching, urticaria, and feeling of weakness.
Rare:
rapid or irregular heartbeat (also known as palpitations), extra heartbeats, faster heartbeat,
drop in blood pressure when standing, causing dizziness, feeling faint or fainting, malaise (general feeling of being unwell), dizziness, falls, facial flushing.
Frequency unknown:
extrapyramidal symptoms (unusual movements, including tremor and shaking of hands and fingers, twisting movements of the body, shuffling gait, and stiffness of arms and legs), usually reversible after discontinuation of treatment.
Sleep disorders (difficulty sleeping, drowsiness), balance disorders (vertigo), 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Preductal MR

Keep this medicine out of the 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Preductal MR contains

• The active substance is trimetazidine dihydrochloride. One modified-release tablet contains 35 mg of trimetazidine dihydrochloride.
• Other excipients: calcium hydrogen phosphate dihydrate, hypromellose 4000, magnesium stearate, povidone, anhydrous colloidal silicon dioxide; 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, 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 Warszawa, Poland

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warszawa, Poland

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa, Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa, Poland

Marketing Authorisation Numbers in Lithuania, country of export:
LT/1/02/3176/001
LT/1/02/3176/002

Parallel Import Authorisation Number: 270/19