CYTO-PROTECTIN 35 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Cyto-Protectin MR
   1. 35 mg, modified-release tablets
   2. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet:
3. What is Cyto-Protectin MR and what is it used for
4. Important information before taking Cyto-Protectin MR
   1. When not to take Cyto-Protectin MR:
   2. Warnings and precautions
   3. Children and adolescents
   4. Cyto-Protectin MR and other medicines
   5. Cyto-Protectin MR with food and drink
   6. Taking Cyto-Protectin MR in elderly patients
   7. Pregnancy and breastfeeding
   8. Driving and using machines
5. How to take Cyto-Protectin MR
   1. Taking a higher dose of Cyto-Protectin MR than recommended
   2. Missing a dose of Cyto-Protectin MR
   3. Stopping treatment with Cyto-Protectin MR
6. Possible side effects
   1. Other side effects
   2. Reporting side effects
7. How to store Cyto-Protectin MR
8. Contents of the pack and other information
   1. What Cyto-Protectin MR contains
   2. What Cyto-Protectin MR looks like and contents of the pack
   3. Marketing authorisation holder
   4. Manufacturer

Leaflet attached to the packaging: patient information

Cyto-Protectin MR

Trimetazidine dihydrochloride

35 mg, modified-release tablets

Read the 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 only. 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:

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

1. What is Cyto-Protectin MR and what is it used for

Cyto-Protectin MR is an oral medication.
Cyto-Protectin MR maintains metabolic processes in cells under hypoxic conditions
of tissues.
Indications for use:
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 Cyto-Protectin MR

When not to take Cyto-Protectin 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 disease that affects movement (tremors, stiffness, slow movements and shuffling gait, unsteady gait);
• if you have severe kidney disease.

Warnings and precautions

Before starting to take Cyto-Protectin MR, discuss it with your doctor or pharmacist.
Be particularly cautious when taking Cyto-Protectin MR ifmoderate
renal impairment (creatinine clearance between 30 - 60 ml/min) is present. If necessary,
your doctor may reduce the dose.
You should contact your doctor if you have had kidney disease in the past.
This medicine may cause or worsen symptoms such as: tremors, stiffness, slow movements
and shuffling gait, unsteady gait, especially in elderly patients, which should be observed and reported to your doctor, who will reassess the treatment.

Children and adolescents

Cyto-Protectin MR is not recommended for children and adolescents under 18 years of age.

Cyto-Protectin MR and other medicines

Tell your doctor about all medicines you are taking, or have recently taken, and any medicines you plan to take.
No interactions with other medicines have been reported for Cyto-Protectin MR.

Cyto-Protectin MR with food and drink

No interaction with food and drink has been reported.

Taking Cyto-Protectin MR in elderly patients

You should contact your doctor to determine the recommended dose of the medicine for elderly patients.

Pregnancy and breastfeeding

Cyto-Protectin MR is not recommended during 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.

Driving and using machines

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

3. How to take Cyto-Protectin 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 Cyto-Protectin MR is 35 mg, one tablet taken twice a day during
meals, in the morning and evening.
If you have kidney disease or are over 75 years old, your doctor will adjust the recommended dose.
This medicine is intended for adults.
Do not divide, chew or crush the tablets.
Cyto-Protectin MR should be taken regularly and you should not stop taking it without consulting your doctor.
If you feel that the effect of Cyto-Protectin MR is too strong or too weak, ask your doctor.

Taking a higher dose of Cyto-Protectin MR than recommended

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

Missing a dose of Cyto-Protectin MR

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

Stopping treatment with Cyto-Protectin MR

If you have any further questions about the use of 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.
Common(affecting 1 to 10 people in 100) :
dizziness, headache, abdominal pain, diarrhea, nausea, vomiting, rash, itching,
hives and feeling weak.
Rare(affecting 1 to 10 people in 10,000) :
rapid or irregular heartbeat (also called palpitations), extra heartbeats, faster heartbeat, low blood pressure when standing up, which can cause dizziness, feeling faint or fainting, malaise (general feeling of being unwell), dizziness, falls,
flushing of the face.
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 stopping treatment.
Sleep disorders (difficulty sleeping, drowsiness), constipation, severe generalized rash with redness of the skin and blisters, swelling of the face, lips, mouth, tongue or throat, which can 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 feeling of being unwell, fever, itching,
yellowing of the skin and eyes, pale stools, dark urine).

Other side effects

In a very small number of patients, other side effects have been reported, but their frequency is unknown: 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 Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Jerozolimskie Avenue 181C
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cyto-Protectin MR

Keep the 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.
Store the medicine at a temperature below 25°C.
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 Cyto-Protectin MR contains

• The active substance is trimetazidine dihydrochloride. One modified-release tablet contains 35 mg of trimetazidine dihydrochloride.
• The other ingredients are: core components: calcium hydrogen phosphate dihydrate, hypromellose 4000, povidone, colloidal silica anhydrous, magnesium stearate; coating components Opadry Pink: iron oxide red (E 172), titanium dioxide (E 171), macrogol, hypromellose.

What Cyto-Protectin MR looks like and contents of the pack

Cyto-Protectin MR are modified-release tablets, smooth, round, biconvex, without breaking lines,
light pink in color.
Packaging:

• PP or HDPE container with HDPE cap with a guarantee closure in a cardboard box, with a patient information leaflet. 60 tablets.
• Blisters of Aluminium/PVC/PVdC in a cardboard box, with a patient information leaflet. 60 tablets.

Marketing authorisation holder

ETHIFARM Sp. z o.o. Sp. komandytowa
Hiacyntowa 39 Street
60-175 Poznań
www.ethifarm.pl
phone: +48 61 867 54 21
fax: +48 61 867 50 67
e-mail: [email protected]

Manufacturer

• 1. Zakład Chemiczno-Farmaceutyczny "FARMAPOL" Sp. z o.o. Św. Wojciech 29 Street 61-749 Poznań
• 2. Ethifarm Sp. z o.o. Sp. komandytowa Żeromskiego 9 Street 60-544 Poznań

To obtain more detailed information, contact the representative of the marketing authorisation holder.
Date of last revision of the leaflet:02.03.2023