Package leaflet: Information for the patient

TRIACYT MR
35 mg, modified-release tablets
Trimetazidini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Triacyt MR is and what it is used for
Important information before taking Triacyt MR
How to take Triacyt MR
Possible side effects
How to store Triacyt MR
Contents of the pack and other information

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

Triacyt MR is a medicine in the form of modified-release tablets containing the active substance
trimetazidine dihydrochloride.
Trimetazidine exerts a protective effect on cardiac muscle cells under conditions of hypoxia caused by ischaemia, by maintaining metabolic processes and slowing the depletion of high-energy compounds.
In patients with ischaemic heart disease, treatment with this medicine reduces the frequency and severity of angina attacks (chest pain) and improves exercise tolerance.
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 using Triacyt MR

When not to use Triacyt MR

if the patient is allergic to trimetazidine or to 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, dragging feet while walking, unbalanced gait);
if the patient has severe kidney disease.

Warnings and precautions
Before starting treatment with Triacyt MR, discuss this with your doctor or pharmacist.
Triacyt MR is not a medicine for treating angina attacks, nor for initial treatment of unstable angina or myocardial infarction.
If an angina attack (severe chest pain) occurs, inform your doctor. In such a case, further examinations and changes in treatment may be required.
This medicine may cause or worsen symptoms such as tremors, rigid posture, slow movements, dragging feet while walking, and unbalanced gait, especially in elderly patients. These symptoms should be monitored and reported to the doctor, who will reassess the treatment.
Discuss this with your doctor, even if the above warnings refer to conditions that occurred in the past.
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 Triacyt MR. If any symptoms related to this serious skin reaction, described in section 4, occur, discontinue use of Triacyt MR immediately and seek medical help without delay.
Children and adolescents
Triacyt MR is not recommended for children and adolescents under 18 years of age.
Triacyt MR and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines planned for future use.
No interactions with other medicines have been reported.
Triacyt MR with food and drink
It is recommended to take Triacyt MR during meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Use of this medicine during pregnancy should be avoided. If pregnancy occurs while taking Triacyt MR, contact your doctor, who will decide whether to continue treatment. Only a doctor can determine whether the patient may continue taking the medicine.
Breastfeeding
It is not known whether trimetazidine passes into human milk; therefore, use of this medicine during breastfeeding is not recommended.
Driving and operating machinery
This medicine may cause dizziness and drowsiness, which may affect the ability to drive or operate machinery.
Triacyt MR contains lactose.
One modified-release tablet contains 59 mg of monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Triacyt MR

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The recommended dose of Triacyt MR, 35 mg, is one tablet taken twice daily during meals, in the morning and in the evening.
The tablet should be swallowed whole with a glass of water.
If the patient has kidney disease or is over 75 years of age, the doctor will adjust the recommended dose.
Dose adjustment is not necessary for patients undergoing surgical procedures.
Use of a higher than recommended dose of Triacyt MR
No cases of poisoning related to overdose have been reported. However, in case of overdose, contact your doctor.
Missing a dose of Triacyt MR
Do not take a double dose to make up for a missed dose.
Take the missed dose as soon as possible, except when it is almost time for the next dose.
Stopping Triacyt MR treatment
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.
You should stop taking Triacyt MR and seek immediate medical advice if you notice
any of the following adverse reactions:
Frequency unknown: frequency cannot be determined from 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 skin redness and blistering.

Triacyt MR may cause adverse reactions with the following frequency:
Common (occurring in up to 1 in 10 patients):
dizziness, headache, abdominal pain, diarrhoea, indigestion, nausea, vomiting, rash, itching,
urticaria and feeling of weakness.
Uncommon adverse reactions (occurring in up to 1 in 100 patients):
unusual skin sensations such as tingling or crawling sensations on the skin (paresthesia).
Rare (occurring in up to 1 in 1000 patients):
fast or irregular heartbeat (also known as palpitations), extra heartbeats, abnormally rapid heartbeat,
drop in blood pressure upon standing, causing dizziness, feeling of emptiness in the head or fainting,
malaise (general feeling of being unwell), dizziness, falls, facial flushing.
Frequency unknown (frequency cannot be determined from available data):
extrapyramidal symptoms (abnormal movements, including tremors and shaking of hands and fingers,
twisting body movements, dragging of legs while walking, and stiffness of arms and legs), usually
reversible after discontinuation of treatment.
Sleep disturbances (difficulty falling asleep, drowsiness), 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).
Balance disorders (vertigo-type dizziness).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Triacyt MR

Do not store above 30°C.
Keep the medicine out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures 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, monohydrate lactose, carbomer, povidone K-30, magnesium stearate, colloidal anhydrous silica;

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

What Triacyt MR looks like and contents of the pack
White, round, biconvex coated tablets.
The tablets are packed in aluminium/aluminium foil blisters or aluminium/aluminium foil 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 Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
Poland
Tel.: +48 61 66 51 500
Fax: +48 61 66 51 505