Cyto-protectin mr

Package leaflet: Information for the patient

Cyto-Protectin MR
Trimetazidini dihydrochloridum
35 mg, modified-release coated tablets
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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Leaflet contents:
What Cyto-Protectin MR is and what it is 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 Cyto-Protectin MR is and what it is used for

Cyto-Protectin MR is a medicine intended for oral use.
Cyto-Protectin MR helps maintain cellular metabolic processes under conditions of tissue hypoxia.
Indications:
This medicine 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 Cyto-Protectin MR

When not to take Cyto-Protectin MR:

• if the patient is allergic to trimetazidine or 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 Cyto-Protectin MR, discuss it with your doctor or pharmacist.
Exercise special caution when using Cyto-Protectin MR if moderate renal impairment is present (creatinine clearance between 30 - 60 ml/min). If necessary,
your doctor may reduce the dose.
Contact your doctor if you have a history of kidney disease.
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.
Serious skin reactions have been reported during treatment with Cyto-Protectin MR, including
drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP).
If any symptoms related to these serious skin reactions described in section 4 occur, discontinue Cyto-Protectin MR immediately and seek urgent medical help.

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

Cyto-Protectin MR and other medicines
Inform your doctor about all medicines you are currently taking, have recently taken, or plan to take.
No interactions between Cyto-Protectin MR and other medicines have been reported.

Cyto-Protectin MR with food and drink
No interactions with food and beverages have been reported.

Use of Cyto-Protectin MR in elderly patients
Consult your doctor to determine the appropriate dose of Cyto-Protectin MR for elderly patients.

Pregnancy and breastfeeding
Cyto-Protectin MR is not recommended for use in pregnant or breastfeeding women.
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.

Driving and operating machinery
This medicine may cause dizziness and drowsiness, which could affect the ability to drive or operate machinery.

3. How to use Cyto-Protectin MR

This medicine should always be taken as directed by a physician. In case of doubt, consult a doctor or pharmacist.
The recommended dose of Cyto-Protectin MR, 35 mg, is 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.
This medicine is intended for adult use only.
Tablets must not be divided, chewed, or crushed.
Cyto-Protectin MR should be taken regularly, and treatment must not be discontinued without medical advice.
If the patient feels that the effect of Cyto-Protectin MR is too strong or too weak, medical advice should be sought.
Taking more than the recommended dose of Cyto-Protectin MR
In case of overdose, seek immediate medical attention.
To date, no cases of poisoning due to overdose of this medicine have been reported.
Missed dose of Cyto-Protectin MR
Do not take a double dose to make up for a missed dose.
Stopping treatment with Cyto-Protectin MR
If you have any further questions regarding 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.
You should stop taking Cyto-Protectin MR and immediately contact your doctor if you notice any of the following adverse reactions:

Common (occur in no more than 1 in 10 people):
dizziness, headache, abdominal pain, diarrhoea, indigestion, nausea, vomiting, rash, itching, urticaria (hives), and feeling of weakness.

Uncommon (occur in no more than 1 in 100 people):
unusual sensations in the skin, such as tingling or a crawling sensation (paresthesia).

Rare (occur in no more than 1 in 1000 people):
rapid or irregular heartbeat (known as palpitations), extra heartbeats, faster heartbeat, drop in blood pressure when 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 (abnormal movements, including tremor 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.
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 skin redness and blisters.
Sleep disturbances (difficulty falling asleep, drowsiness), balance disorders (vertigo-related dizziness), 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).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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

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 Cyto-Protectin MR

Keep this 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.
Store the medicine at a temperature below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps 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 coated tablet contains 35 mg of trimetazidine dihydrochloride.
• Excipients: core ingredients: calcium hydrogen phosphate dihydrate, hypromellose 4000, povidone, colloidal anhydrous silica, magnesium stearate; coating ingredients 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 coated tablets, smooth, round, biconvex, without chips,
light pink in colour.
Available pack sizes:

• PP or HDPE container with HDPE screw cap with tamper-evident closure, in a cardboard box, with patient information leaflet included. 60 tablets.
• Aluminium/PVC/PVdC blisters in a cardboard box, with patient information leaflet included. 60 tablets.

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

Manufacturer

1. Chemical and Pharmaceutical Plant "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

For further information, please contact the marketing authorisation holder.