SETAL 35 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. SETAL MR, 35 mg, Modified Release Tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information:
3. What Setal MR is and what it is used for
4. Before you take Setal MR
   1. Do not take Setal MR:
   2. Warnings and precautions
   3. Children and adolescents
   4. Setal MR and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
5. How to take Setal MR
   1. If you take more Setal MR than you should
   2. If you forget to take Setal MR
   3. If you stop taking Setal MR
6. Possible side effects
   1. Reporting of side effects
7. How to store Setal MR
8. Contents of the pack and other information
   1. What Setal MR contains
   2. What Setal MR looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the User

SETAL MR, 35 mg, Modified Release Tablets

Trimetazidine Dihydrochloride
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. To find out how to report side effects, see section 4.

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

• 1. What Setal MR is and what it is used for
• 2. Before you take Setal MR
• 3. How to take Setal MR
• 4. Possible side effects
• 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. It protects cell structures and functions from hypoxia and ischemia. It maintains metabolic processes in cells, prevents energy deficits. Trimetazidine reduces the oxygen requirement of mitochondria. This allows for the optimization of energy processes in cells and the maintenance of normal metabolism during hypoxia.
The medicine is absorbed from the gastrointestinal tract after oral administration, with maximum plasma concentrations reached after approximately 5 hours. Steady-state plasma concentrations are achieved after 60 hours and are maintained throughout the treatment period.
The medicine is excreted mainly in the urine, unchanged.
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. Before you take Setal MR

Do not take Setal 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 disorder that affects movement (tremors, stiffness, slow movements, and shuffling gait);
• if you have severe kidney disease.

Warnings and precautions

Before taking Setal MR, discuss it with your doctor or pharmacist.
This medicine may cause or worsen symptoms such as tremors, stiffness, slow movements, and shuffling gait, 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 Setal MR. If you notice any symptoms of a severe skin reaction, as described in section 4, you should stop taking Setal MR and seek medical attention immediately.
Setal MR modified-release tablets are matrix tablets. Matrix tablets do not break down or get absorbed in the gastrointestinal tract, and the active substance is released from them by diffusion. The tablet coating, along with the insoluble core components, is eliminated from the body; patients should not be concerned if they sometimes notice something in their stool that looks like a tablet.

Children and adolescents

Setal MR is not recommended for use in children and adolescents below 18 years of age.

Setal MR and other medicines

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

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.
Setal MR is not recommended during pregnancy.
Setal MR is not recommended during breastfeeding.

Driving and using machines

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

3. How to take Setal MR

Always take this medicine exactly as your doctor has told you. If you are not sure, check with 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 twice daily, taken during meals, in the morning and evening.
If you have kidney disease or are over 75 years of age, your doctor will adjust the recommended dose.
No dose adjustment is necessary in patients undergoing surgery.

If you take more Setal MR than you should

No cases of overdose have been reported. If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.

If you forget to take Setal MR

Do not take a double dose to make up for a forgotten dose.

If you stop taking Setal MR

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Setal MR is usually well tolerated.
The following side effects have been observed with trimetazidine treatment:
Common (may affect up to 1 in 10 people):
dizziness, headache, abdominal pain, diarrhea, nausea, vomiting, rash, itching, urticaria, and feeling weak.
Uncommon (may affect up to 1 in 100 people):
unusual sensation on the skin, such as tingling or crawling under the skin (paresthesia).
Rare (may affect up to 1 in 1,000 people):
rapid or irregular heartbeat (also known as palpitations), extra heartbeats, abnormal heart rhythm, low blood pressure when standing up, which can cause dizziness, lightheadedness, or fainting, general malaise, dizziness, falls, flushing.
Frequency not known (frequency cannot be estimated from the available data):
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 treatment discontinuation.
Sleep disorders (difficulty sleeping, 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 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).
If you notice any of the following side effects, stop taking Setal MR and seek medical attention immediately:
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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to 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
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 Setal 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 which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that 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. Each modified-release tablet contains 35 mg of trimetazidine dihydrochloride.
• The other ingredients are: calcium hydrogen phosphate dihydrate, glycerol dibehenate, povidone, magnesium stearate. Coating: collicoat SR 30D, macrogol 6000, talc, titanium dioxide (E 171).

What Setal MR looks like and contents of the pack

Setal MR is a white, round, biconvex tablet, without any spots or defects.
The pack contains 60 tablets.

Marketing authorization 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]

Date of last revision of the leaflet: