PREDUCTAL 35 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Preductal MR
3. 35 mg
   1. Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   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 with other medicines
   5. Preductal MR with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
6. How to take Preductal MR
   1. Taking more than the recommended dose of Preductal MR
   2. Forgetting to take a dose of Preductal MR
   3. Stopping treatment with Preductal MR
7. Possible side effects
   1. Reporting 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
   4. Manufacturer
   5. Date of last revision of the leaflet: 07/2024

Leaflet attached to the packaging: patient information

Preductal MR

35 mg

prolonged-release tablets
Trimetazidine dihydrochloride

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you personally. 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 those 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 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 you are allergic to trimetazidine or any of the other ingredients of this medicine (listed in section 6);
• if you have Parkinson's disease: a brain disease that affects movement (tremors, stiff posture, slow movements, and shuffling gait);
• if you have 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 attacks, or for the initial treatment of unstable angina or myocardial infarction.
In the event of an angina attack, inform your doctor. In such cases, tests and changes to treatment may be required.
This medicine may cause or worsen symptoms such as: tremors, stiff posture, slow movements, and shuffling gait, unsteady walk, 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 you notice any of the symptoms of this serious skin reaction, described in section 4, stop taking Preductal MR and seek medical help immediately.
You should 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 use in children and adolescents below 18 years of age.

Preductal MR with other medicines

Tell your doctor about all the medicines you are taking now or have recently taken, as well as 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 or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

3. How to take Preductal MR

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Preductal MR is 35 mg, 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 adjustment is necessary in patients undergoing surgery.
If you feel that the effect of Preductal MR is too strong or too weak, talk to your doctor.

Taking more than the recommended dose of Preductal MR

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

Forgetting to take a dose of Preductal MR

Take the missed dose as soon as you remember, 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 help 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 redness of the skin and blisters.

Common:
dizziness, headache, abdominal pain, diarrhea, nausea, vomiting, rash, itching, hives, and feeling weak.
Uncommon:
unusual 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, lightheadedness, or fainting, general feeling of being unwell, 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, shuffling gait, and stiffness of 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 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 feeling of being unwell, fever, itching, yellowing of the skin and eyes, pale stools, dark urine).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Preductal MR

Keep this 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 carton and blister after the abbreviation "EXP" (used to describe the expiry date). The expiry date refers to the last day of the month.
The abbreviation "Lot" on the carton and blister refers to 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. Contents of the pack and other information

What Preductal MR contains

• The active substance is trimetazidine dihydrochloride. One prolonged-release tablet contains 35 mg of trimetazidine dihydrochloride.
• The other ingredients are: calcium hydrogen phosphate dihydrate, hypromellose 4000, magnesium stearate, povidone, colloidal anhydrous silica; coating ingredients: glycerol, hypromellose, macrogol, magnesium stearate, red iron oxide (E172), titanium dioxide (E171).

What Preductal MR looks like and contents of the pack

Preductal MR is available in blisters. The pack contains 60, 90, or 120 prolonged-release tablets.

Marketing authorization holder

ANPHARM Pharmaceutical Company S.A.
ul. Annopol 6B
03-236 Warsaw

Manufacturer

ANPHARM Pharmaceutical Company S.A.
ul. Annopol 6B
03-236 Warsaw
or
Servier (Ireland) Industries Ltd. (SII)
Gorey road, Arklow, Co. Wicklow
Ireland
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Servier Polska Sp. z o.o.
Phone number: (22) 594-90-00

Date of last revision of the leaflet: 07/2024