Package leaflet: Information for the patient

Metazydyna, 20 mg, film-coated tablets
Trimetazidini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Metazydyna is and what it is used for

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). It protects heart cells against the effects of reduced oxygen supply during episodes of angina.

2. Information before using Metazydyna

When not to use Metazydyna

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 and shuffling gait, unbalanced walking);
if the patient has severely impaired kidney function.

Warnings and precautions
Before starting treatment with Metazydyna, discuss this with your doctor or pharmacist.

Metazydyna is not intended for the treatment of angina attacks, unstable angina, or myocardial infarction. If an angina attack occurs, inform your doctor, as further investigations and changes in treatment may be required.
In patients with impaired renal function and in elderly patients, the doctor may prescribe a lower dose.
Patients with severe renal impairment (creatinine clearance less than 15 ml/min) should not take this medicine.
Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP), have been reported with the use of Metazydyna. If any symptoms related to this serious skin reaction, described in section 4, occur, treatment with Metazydyna must be discontinued immediately and medical help must be sought without delay.

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.

Athletes
This medicine contains an active substance that may cause a positive result in doping tests.

Children and adolescents
Metazydyna is not recommended for use in children and adolescents under 18 years of age.

Metazydyna and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take. No interactions with other medicines or substances have been reported.

Metazydyna with food and drink
Take this medicine during meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not use Metazydyna during pregnancy, as the safety of this medicine in pregnant women has not been fully established.
Breastfeeding should be avoided during treatment with Metazydyna, as it is not known whether the medicine passes into breast milk.

Driving and using machines
This medicine may cause dizziness and drowsiness, thereby affecting the ability to drive or operate machinery.

Metazydyna contains carmine (E 124)
This medicine contains carmine (E 124), which may cause allergic reactions.

Metazydyna contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Metazydyna

This medicine should always be taken as directed by the doctor. In case of doubts, consult a
doctor or pharmacist.
The recommended dose of Metazydyna, 20 mg, is one tablet taken three times a day during
meals.
If the patient has impaired kidney function or is over 75 years of age, the doctor will adjust the recommended dose.
Taking more Metazydyna than recommended
If an overdose is taken, seek immediate advice from a doctor or pharmacist.
Missed dose of Metazydyna
A missed dose should be taken as soon as possible, unless it is almost time for the next dose. In that case, the missed dose should be skipped.
Do not take a double dose to make up for a missed dose.
Stopping Metazydyna
Metazydyna should be taken for as long as directed by the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The medicine is generally well tolerated.
You should stop using Metazydyna and contact your doctor immediately if you notice any of the following adverse effects:

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

Uncommon (may affect up to 1 in 100 people):
Unusual skin sensations such as tingling or a crawling sensation on the skin (paraesthesiae).

Rare (may affect up to 1 in 1,000 people):
rapid or irregular heartbeat (also known as palpitations), extra heartbeats, abnormally fast heartbeat,
drop in blood pressure when standing up, causing dizziness, feeling faint or lightheadedness, 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 while walking, and stiffness of arms and legs),
usually resolving after discontinuation of treatment; thrombocytopenia (bleeding of varying severity, e.g.
from nose, gums, skin petechiae or bruising, caused by too low a platelet count);
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 blistering.
Sleep disturbances (difficulty falling asleep, drowsiness), 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).

Other adverse effects
Other adverse effects have occurred in a very small number of patients, but their frequency is unknown:
balance disorders (vestibular dizziness).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can 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, 02-222 Warsaw, Tel.: +48 22 4921301, Fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl .
Adverse effects can also be reported to the marketing authorization holder. Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicinal product Metazydyna

Keep the medicine out of sight and reach of children.
Store in the original packaging at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the cardboard box and
blister pack. The expiry date refers to the last day of the specified month.
Medicines must 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 Metazydyna contains

The active substance is trimetazidine dihydrochloride. Each tablet contains 20 mg of trimetazidine dihydrochloride.
Other ingredients are: microcrystalline cellulose, sodium croscarmellose, povidone 90, magnesium stearate.
Coating ingredients: hypromellose E 5, hypromellose E 15, hydroxypropyl cellulose, macrogol 4000, lac red (E 124), carmine red (E 124).

What Metazydyna looks like and contents of the pack
The tablets are red, round, biconvex, smooth.
Available pack: 60 coated tablets
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. +48 22 732 77 00
Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów