Setal mr

Package leaflet: Information for the user

SETAL MR, 35 mg, modified-release tablets
Trimetazidini dihydrochloridum
This medicinal product will be subject to additional monitoring. This will allow rapid
identification of new safety information. You can also help by reporting any adverse reactions that occur
after using the medicine.
For information on how to report adverse reactions – see section 4.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, 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:

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

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

Trimetazidine is a cytoprotective agent. Under conditions of tissue ischemia and hypoxia, it protects cellular, tissue, and organ structures and functions. It maintains metabolic processes in cells and prevents energy deficits. Trimetazidine reduces the mitochondrial requirement for oxygen. This enables optimization of cellular energy processes and maintenance of normal metabolism during hypoxia.
After oral administration, the drug is absorbed from the gastrointestinal tract, reaching maximum plasma concentration approximately 5 hours after dosing. Steady-state plasma concentration is achieved after 60 hours and remains stable throughout the treatment period.
The drug is excreted mainly unchanged in urine.
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. Information before using Setal MR

When not to take Setal 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 and shuffling gait, unbalanced walking);
• if the patient has severely impaired kidney function.

Warnings and precautions
Before starting treatment with Setal MR, consult your doctor or pharmacist.
This medicine may cause or worsen symptoms such as tremors, rigid posture, slow movements,
shuffling gait and unbalanced walking, especially in elderly patients. These symptoms should be monitored and reported to the doctor, who will reassess the treatment.
Severe skin reactions have been reported with the use of Setal MR, including drug reaction with
eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP).
If any of the symptoms associated with this serious skin reaction, described in section 4, occur,
treatment with Setal MR must be discontinued immediately and medical advice should be sought without delay.
Setal MR modified-release tablets are matrix tablets. Matrix tablets do not disintegrate or dissolve in the gastrointestinal tract; the active substance is released by diffusion. The tablet coating together with the insoluble core components is eliminated from the body. Patients should not be alarmed if they occasionally notice in their faeces something that looks like a whole tablet.
Children and adolescents
Setal MR is not recommended for children and adolescents under 18 years of age.
Setal MR with other medicines
Inform your doctor or pharmacist about any other medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions with other medicines or food have been reported.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The use of Setal MR is not recommended in pregnant women.
The use of Setal MR is not recommended during breastfeeding.
Driving and operating machinery
This medicine may cause dizziness and drowsiness, which may affect the ability to drive or operate machinery.
3. How to take Setal MR
This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult your doctor or pharmacist.
Do not change the dose or stop treatment without consulting your doctor.
The recommended dose of Setal MR is 35 mg: one tablet taken twice daily with meals, in the morning and evening.
If the patient has impaired kidney function or is over 75 years of age, the doctor will adjust the recommended dose.
Dose modification is not required in patients undergoing surgical procedures.
Taking more Setal MR than recommended
There have been no reported cases of poisoning due to overdose.
In case of accidental overdose, seek immediate medical advice from a doctor or pharmacist.
Missed dose of Setal MR
Do not take a double dose to make up for a missed dose.
Stopping Setal 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.
Setal MR is generally well tolerated.
The following adverse reactions, with the frequencies listed below, have been observed during treatment with trimetazidine:

Common (occur in up to 1 in 10 people):
dizziness, headache, abdominal pain, diarrhoea, indigestion, nausea, vomiting, rash, itching, urticaria, and feeling of weakness.

Uncommon (occur in up to 1 in 100 people):
unusual skin sensations such as tingling or crawling sensations on the skin (paraesthesiae).

Rare (occur in up to 1 in 1000 people):
rapid or irregular heartbeat (also known as palpitations), extra heartbeats, abnormally fast heartbeat, drop in blood pressure upon standing, causing dizziness, feeling faint or fainting, malaise (general feeling of being unwell), dizziness, falls, facial flushing.

Frequency not known (frequency cannot be estimated from available data):
extrapyramidal symptoms (unusual movements, including tremor and shaking of hands and fingers, twisting movements of the body, dragging of legs when walking, and stiffness of arms and legs), usually resolving after discontinuation of treatment.
Sleep disturbances (difficulty falling asleep, drowsiness), 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 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-coloured stools, dark-coloured urine).

Discontinue treatment with Setal MR and seek immediate medical advice if any of the following adverse reactions occur:
Frequency not known: frequency cannot be estimated from available data.

• Widespread rash, high body temperature, 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 redness of the skin and blisters.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department for 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 Setal MR

Keep this medicine out of sight and reach of children.
No special storage instructions are required.
Do not use this medicine after the expiry date stated on the carton and blister pack after:
"EXP". 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 will help protect
the environment.

6. Contents of the pack and other information

What Setal MR contains

• The active substance is trimetazidine dihydrochloride. One modified-release tablet contains 35 mg of trimetazidine dihydrochloride.
• Other ingredients are: calcium hydrogen phosphate dihydrate, glyceryl dibehenate, povidone, magnesium stearate. Coating: Kollicoat SR 30D, polyethylene glycol 6000, talc, titanium dioxide (E 171).

What Setal MR looks like and contents of the pack
Setal MR is a white, round, biconvex modified-release tablet, free from spots and damage.
The pack contains 60 tablets.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: [email protected]