Triacit Mr

Package Leaflet: Information for the Patient

TRIACYT MR

35 mg, modified-release tablets

Trimetazidine dihydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Triacyt MR and what is it used for
• 2. Important information before taking Triacyt MR
• 3. How to take Triacyt MR
• 4. Possible side effects
• 5. How to store Triacyt MR
• 6. Contents of the pack and other information

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

Triacyt MR is a modified-release tablet containing the active substance trimetazidine dihydrochloride.
Trimetazidine acts protectively on heart muscle cells under conditions of hypoxia caused by ischemia by maintaining metabolic processes and slower depletion of high-energy compounds.
Taking this medicine by patients with coronary heart disease reduces the frequency and severity of angina pectoris (chest pain) and increases tolerance to physical exertion.
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 Triacyt MR

When not to take Triacyt MR

Warnings and precautions

Before taking Triacyt MR, discuss it with your doctor or pharmacist.
Triacyt MR is not a medicine for the treatment of angina pectoris attacks, nor for the initial treatment of unstable angina pectoris or myocardial infarction.
In case of an angina pectoris attack (severe chest pain), inform your doctor. In such a situation, tests and a change of treatment may be required.
This medicine may cause or worsen symptoms such as tremors, stiff posture, slow movements, and shuffling gait, especially in elderly patients, which should be observed and reported to the doctor, who will reassess the treatment.
Discuss this with your doctor, even if the above warnings refer to situations that have occurred in the past.
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 Triacyt MR. If any of the symptoms of this serious skin reaction, described in section 4, occur, stop taking Triacyt MR and seek medical help immediately.

Children and adolescents

Triacyt MR is not recommended for children and adolescents under 18 years of age.

Triacyt MR and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
No interactions with other medicines have been found.

Triacyt MR with food and drink

It is recommended to take Triacyt MR during meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
It is recommended to avoid taking this medicine during pregnancy. If you become pregnant while taking Triacyt MR, contact your doctor, who will decide whether to continue taking the medicine. Only your doctor can determine whether you can continue to take the medicine.
Breastfeeding
It is not known whether trimetazidine passes into breast milk, so it is not recommended to take this medicine while breastfeeding.

Driving and using machines

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

Triacyt MR contains lactose.

One modified-release tablet contains 59 mg of lactose monohydrate.
If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Triacyt 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 Triacyt MR is 35 mg, one tablet taken twice a day during meals, in the morning and evening.
Swallow the tablet whole with a glass of water.
If you have kidney problems or are over 75 years old, your doctor will adjust the recommended dose.
In patients undergoing surgery, a dose change is not necessary.

Take more than the recommended dose of Triacyt MR

No cases of overdose have been reported. However, in case of overdose, contact your doctor.

Miss a dose of Triacyt MR

Do not take a double dose to make up for a forgotten dose.
Take the forgotten dose as soon as possible, unless it is almost time for the next dose.

Stop taking Triacyt MR

If you have any further questions about taking 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.
Stop taking Triacyt MR andseek 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.

Triacyt MR may cause side effects with the following frequency:
Common(occurring in less than 1 in 10 patients):
dizziness, headache, abdominal pain, diarrhea, nausea, vomiting, rash, itching, urticaria, and feeling weak.
Uncommon side effects(occurring in less than 1 in 100 patients):
unusual sensation on the skin, such as tingling or crawling sensation (paresthesia).
Rare(occurring in less than 1 in 1000 patients):
rapid or irregular heartbeat (also called palpitations), extra heartbeats, irregular heartbeat, low blood pressure when standing up, which can cause dizziness, feeling faint, or fainting, general malaise, dizziness, falls, flushing of the face.
Frequency not known(frequency cannot be estimated from the available data):
extrapyramidal symptoms (unusual 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, drowsiness), constipation, swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty 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).
Balance disorders (dizziness of labyrinthine origin).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Triacyt MR

Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
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 Triacyt MR contains

• The active substance is trimetazidine dihydrochloride. One modified-release tablet contains 35 mg of trimetazidine dihydrochloride.
• The other ingredients are: tablet core: calcium hydrogen phosphate dihydrate, lactose monohydrate, carbomer, povidone K-30, magnesium stearate, colloidal silica anhydrous;

coating: Opadry II white with the composition: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc.

What Triacyt MR looks like and contents of the pack

White, round, biconvex, film-coated tablets.
Tablets are packaged in aluminum/aluminum blisters or aluminum/aluminum blisters with a desiccant, placed in a cardboard box.
The pack contains 10, 30, 60, or 90 modified-release tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505

Date of last revision of the leaflet: