PREDUCTAL 35 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.
3. Preductal MR, 35 mg, Modified-Release Tablets
   1. Read the Leaflet Carefully Before Taking the Medicinal Product, as it Contains Important Information for You.
   2. Table of Contents of the Leaflet:
4. What is Preductal MR and What is it Used For
5. Important Information Before Taking Preductal MR
   1. When Not to Take Preductal MR:
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Preductal MR and Other Medicinal Products
   5. Preductal MR with Food and Drink
   6. Pregnancy and Breast-Feeding
   7. Driving and Using Machines
6. How to Take Preductal MR
   1. Overdose of Preductal MR
   2. Missed Dose of Preductal MR
   3. Stopping Treatment with Preductal MR
7. Possible Side Effects
   1. Reporting of Side Effects
8. How to Store Preductal MR
9. Contents of the Pack and Other Information
   1. What Preductal MR Contains
   2. What Preductal MR Looks Like and Contents of the Pack
   3. Marketing Authorization Holder in Lithuania, Country of Export:
   4. Manufacturer:
   5. Parallel Importer:
   6. Repackaged by:
   7. Date of Approval of the Leaflet: 11.07.2024

Package Leaflet: Information for the Patient

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 Medicinal Product, as it Contains Important Information for You.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product has been prescribed to 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 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. Contents of the Pack and Other Information

1. What is Preductal MR and What is it Used For

This medicinal product is intended for use in adults, in combination with other medicinal products, 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 you are allergic to trimetazidine or any of the other ingredients of this medicinal product (listed in section 6);
• if you have Parkinson's disease: a brain disorder that affects movement (tremors, stiff posture, slow movements, and dragging of the feet while walking, unsteady gait);
• if you have severe kidney disease.

Warnings and Precautions

Before taking 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 medicinal product 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.
You should consult your doctor even if the above warnings refer to past situations.
Athletes
This medicinal product contains an active substance that may cause a positive result in an anti-doping test.

Children and Adolescents

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

Preductal MR and Other Medicinal Products

Tell your doctor about all the medicinal products you are taking or have recently taken, as well as any medicinal products you plan to take.
No interactions with other medicinal products have been identified.

Preductal MR with Food and Drink

It is recommended to take Preductal MR during meals.

Pregnancy and Breast-Feeding

Preductal MR is not recommended during pregnancy.
Preductal MR is not recommended during breast-feeding. Women taking this medicinal product should not breast-feed.
In pregnancy, during breast-feeding, or if you think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicinal product.

Driving and Using Machines

This medicinal product may cause dizziness and somnolence, which may affect your ability to drive or use machines.

3. How to Take Preductal MR

Take this medicinal product always as directed by your doctor. If you are unsure, 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 you have kidney disease or are over 75 years old, your doctor will adjust the recommended dose.
In patients undergoing surgery, dose modification is not necessary.
If you feel that the effect of Preductal MR is too strong or too weak, consult your doctor.

Overdose of Preductal MR

There are limited data available on the overdose of Preductal MR. Treatment should be symptomatic. In the event of an 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 forgotten dose.

Stopping Treatment with Preductal MR

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

4. Possible Side Effects

Like all medicinal products, 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).

Common:
dizziness, headache, abdominal pain, diarrhea, nausea, vomiting, rash, itching, urticaria, and feeling of weakness.
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 discontinuation of treatment.
Sleep disorders (difficulty sleeping, somnolence), balance disorders (dizziness of labyrinthine origin), constipation, severe generalized rash with redness of the skin and blisters, swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in 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 of 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, 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 medicinal product.

5. How to Store Preductal MR

Keep this medicinal product out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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 Preductal MR Contains

• The active substance is trimetazidine dihydrochloride. One modified-release tablet contains 35 mg of trimetazidine dihydrochloride.
• The other excipients are: calcium hydrogen phosphate dihydrate, hypromellose 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 PVC/Aluminium blisters, in a cardboard box.
The pack contains 60, 90, or 120 modified-release tablets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization 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 Warsaw, Poland

Parallel Importer:

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

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in Lithuania, Country of Export:LT/1/02/3176/001
LT/1/02/3176/002
Parallel Import Authorization Number:270/19

Date of Approval of the Leaflet: 11.07.2024

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