PREDUCTAL MR

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Preductal MR
35 mg, modified-release tablets
Trimetazidini dihydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• 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 others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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 the 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 initial treatment of unstable angina or myocardial infarction.
If an angina attack occurs, inform your doctor. In such a case, further investigations and changes in treatment may be required.
This medicine may cause or worsen symptoms such as: tremors, rigid posture, slow movements and dragging the feet while walking, unbalanced gait, particularly in elderly patients. These symptoms should be monitored and reported to the doctor, who will reassess the treatment.
Serious 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 symptoms related to this serious skin reaction described in section 4 occur, treatment with Preductal MR must be discontinued immediately and medical help must be sought without delay.
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 currently used or recently taken, as well as any medicines planned for 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 during pregnancy.
Preductal MR is not recommended for use during breastfeeding. Women taking this medicine should not breastfeed.
If you are pregnant, suspect 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 may affect the ability to drive or operate machinery.

3. How to use Preductal MR

This medicine should always be taken exactly as directed by the physician. In case of doubt, 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 kidney disease or is over 75 years of age, the physician will adjust the recommended dose.
Dose modification is not required for patients undergoing surgical procedures.
If the effect of Preductal MR appears 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience 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).

You should stop taking Preductal MR and immediately consult a doctor if you notice any of the following adverse reactions:
Frequency unknown – frequency cannot be estimated from the available data:

• Extensive rash, high fever, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen 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.

Common:
dizziness, headache, abdominal pain, diarrhoea, indigestion, nausea, vomiting, rash, itching, urticaria and feeling unwell.
Uncommon:
unusual skin sensations such as tingling or crawling sensations (paraesthesia).
Rare:
rapid or irregular heartbeat (also known as palpitations), extra heartbeats, faster heartbeat, drop in blood pressure when standing up, causing dizziness, feeling faint or fainting, malaise (general feeling of being unwell), dizziness, falls, facial flushing.
Frequency unknown:
extrapyramidal symptoms (abnormal movements including tremor and shaking of hands and fingers, twisting movements of the body, dragging of legs while walking, and stiffness of arms and legs), usually reversible after discontinuation of treatment.
Sleep disturbances (difficulty falling asleep, drowsiness), balance disorders (vertigo), constipation, 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 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 reactions helps 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. The code marked on the cardboard box and blister labelled "Lot" indicates the batch number of the medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 ingredients are: calcium hydrogen phosphate dihydrate, hypromellose 2208/4000, magnesium stearate, povidone, colloidal anhydrous silica; coating ingredients: 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 blisters packed in a cardboard box. The pack contains 60 modified-release tablets.
For further detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in the Czech Republic, 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., Annopol Street 6B, 03-236 Warsaw, Poland
Parallel Importer:
InPharm Sp. z o.o.
Strumykowa Street 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska Street 249
04-458 Warsaw
Marketing Authorisation Number in the Czech Republic, country of export: 83/328/01-C
Parallel Import Licence Number: 483/15