Package leaflet: Information for the patient

Trimeductan 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. It may harm them even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

Trimeductan MR is available as modified-release tablets. It contains
trimetazidine dihydrochloride as the active substance.
Trimetazidine exerts a protective effect on cardiac muscle cells under conditions of hypoxia caused by ischemia, by maintaining metabolic processes and slowing the depletion of high-energy compounds.
Trimeductan MR 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 Trimeductan MR

When not to use Trimeductan MR:

if the patient is allergic to the active substance 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 severely impaired kidney function.

Warnings and precautions
Before starting treatment with Trimeductan MR, discuss this with your doctor or pharmacist.
Trimeductan MR is not intended for the treatment of 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 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, unbalanced gait, especially in elderly patients. These symptoms should be monitored and reported to the doctor, who will reassess the treatment.
Trimetazidine is mainly eliminated via the kidneys; therefore, particular caution should be exercised in patients with impaired renal function, and the dose may need to be reduced.
In patients with moderate renal impairment (creatinine clearance 30–60 mL/min), the recommended dose is one 35 mg tablet in the morning with breakfast.
Children and adolescents
Trimeductan MR is not recommended for use in children and adolescents under 18 years of age.
Trimeductan MR with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions with other medicines have been reported.
Trimeductan MR with food and drink
It is recommended to take Trimeductan MR during meals.
Elderly patients
In elderly patients, elimination of trimetazidine may be slowed; therefore, the dose should be reduced.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Trimeductan MR is not recommended for use in pregnant women.
Trimeductan MR is not recommended for use in breastfeeding women. Women taking this medicine should not breastfeed.
Driving and operating machinery
This medicine may cause dizziness and drowsiness, which may impair the ability to drive or operate machinery.

3. How to use Trimeductan MR
This medicine should always be taken according to the doctor's instructions. If in doubt, consult your doctor or pharmacist.
The recommended dose of Trimeductan MR is one tablet (35 mg) taken twice daily during meals, in the morning and evening.
If the patient has impaired kidney function or is over 75 years old, the doctor will adjust the recommended dose.
Taking more Trimeductan MR than recommended
Limited data are available regarding overdose with trimetazidine. Treatment should be symptomatic.
If you have taken more than the recommended dose, consult your doctor immediately.
Missed dose
If a dose is missed, it should be taken 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 Trimeductan 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 experiences them.
Trimeductan MR may cause the following adverse reactions, grouped according to the frequency of occurrence listed below:
very common (occurring in more than 1 in 10 patients); common (occurring in 1 to 10 in 100 patients); uncommon (occurring in 1 to 10 in 1,000 patients); rare (occurring in 1 to 10 in 10,000 patients); very rare (occurring in less than 1 in 10,000 patients); frequency not known (frequency cannot be estimated from the available data).

Common adverse reactions:
dizziness, headache, abdominal pain, diarrhoea, indigestion, nausea, vomiting, rash, itching, urticaria (hives), and feeling of weakness.

Rare adverse reactions:
fast or irregular heartbeat (also known as palpitations), extra heartbeats, faster heartbeat, drop in blood pressure upon standing, causing dizziness, feeling faint or fainting, malaise (general feeling of being unwell), dizziness, falls, facial flushing.

Adverse reactions with unknown frequency:
Extrapyramidal symptoms (unusual movements, including tremor and shaking of hands and fingers, twisting movements of the body, shuffling gait, stiffness of arms and legs), usually resolving after discontinuation of treatment.
Sleep disturbances (difficulty falling asleep, somnolence), 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.
Marked decrease in the number of white blood cells, increasing the likelihood of infections; decrease in the number of platelets, increasing the risk of bleeding or bruising.
Liver disease (nausea, vomiting, loss of appetite, malaise, fever, itching, yellowing of the skin and eyes, pale stools, dark urine).
Disturbances in balance (vertigo of labyrinthine origin).

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult your doctor or pharmacist.

Reporting of adverse reactions
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
PL-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 this medicine.

5. How to store Trimeductan MR

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the stated month.
Medicines should 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 packaging and other information

What Trimeductan MR contains
The active substance is trimetazidine dihydrochloride.
The other ingredients are:
Tablet core: hypromellose, calcium hydrogen phosphate dihydrate, colloidal anhydrous silica,
magnesium stearate;
Tablet coating: talc, polyvinyl alcohol partially hydrolyzed, macrogol 3350, titanium dioxide.
What Trimeductan MR looks like and contents of the pack
Trimeductan MR modified-release tablets are round, white, biconvex.
Trimeductan MR is packed in PVC/Aluminium blisters and then placed with the patient leaflet into a cardboard box.
The unit pack contains 60 tablets.
Marketing Authorisation Holder and Manufacturer
LEK-AM Sp. z o.o. Pharmaceutical Company
ul. Ostrzykowizna 14A,
05-170 Zakroczym
tel.: (+48) (22) 785 27 60
fax: (+48) (22) 785 27 60 ext. 106
Date of the latest revision of the leaflet: