TRIMETAZIDINE CINFA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

trimetazidina cinfa 20 mg film-coated tablets EFG

trimetazidina dihydrochloride

Read all of this leaflet carefully before you start 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 symptoms are the same as yours.
• If you experience 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 package leaflet

1. What is trimetazidina cinfa and what is it used for
2. What you need to know before you take trimetazidina cinfa
3. How to take trimetazidina cinfa
4. Possible side effects
5. Storage of trimetazidina cinfa

Contents of the pack and further information

1. What is trimetazidina cinfa and what is it used for

This medicinal product is indicated in adult patients, in combination with other medicinal products for the treatment of angina pectoris (chest pain caused by coronary heart disease).

2. What you need to know before you take trimetazidina cinfa

Do not taketrimetazidina cinfa

• If you are allergic to trimetazidina or any of the other ingredients of this medicinal product (listed in section 6).
• If you have Parkinson's disease: a brain disease that affects movement (tremors, rigid posture, slow movements and shuffling gait, instability when walking).
• If you have severe kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before taking trimetazidina cinfa.

This medicinal product is not a curative treatment for angina pectoris attacks, nor is it indicated as initial treatment for unstable angina pectoris. It is not a treatment for myocardial infarction.

In the event of an angina pectoris attack, inform your doctor. You may need to undergo tests and your treatment may need to be modified.

This medicinal product may cause or worsen symptoms such as tremors, rigid posture, slow movements and shuffling gait, instability when walking, especially in elderly patients, who should be investigated and reported to your doctor, who may reconsider treatment.

Falls may occur due to a drop in blood pressure or loss of balance (see description in adverse effects).

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP), have been reported in association with trimetazidina. Stop taking trimetazidina and seek immediate medical attention if you notice any of the symptoms related to this severe skin reaction described in section 4.

Children and adolescents

Trimetazidina is not recommended in children under 18 years of age.

Other medicines and trimetazidina cinfa

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

No interactions with other medicines have been identified.

Taking trimetazidina cinfa with food and drinks

Trimetazidina can be taken with food and drinks.

Pregnancy andbreast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

It is preferable not to take this medicine during pregnancy. If you discover that you are pregnant while taking this medicine, consult your doctor, as only he can judge the need to continue treatment.

Breast-feeding

In the absence of data on excretion in breast milk, you should not take trimetazidina during breast-feeding.

Driving and using machines

This medicinal product may cause dizziness and somnolence that may affect your ability to drive or use machines.

trimetazidina cinfa contains sodium

This medicinal product contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

trimetazidina cinfa contains Red Allura AC(E-129)

This medicinal product may cause allergic reactions because it contains Red Allura AC (E-129). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take trimetazidina cinfa

Follow exactly the administration instructions of this medicinal product given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet three times a day with meals.

If you have kidney problems or are over 75 years old, your doctor may adjust the recommended dose.

The tablets should be swallowed with a glass of water with meals.

Your doctor will indicate the duration of your treatment with trimetazidina.

If you take more trimetazidina cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take trimetazidina cinfa

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

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.

Frequent(may affect up to 1 in 10 people)

Dizziness, headache, abdominal pain, diarrhea, indigestion, feeling of dizziness, vomiting, skin rash, itching, urticaria, and feeling of weakness.

Uncommon(may affect up to 1 in 100 people)

Unusual sensation in the skin, such as tingling or numbness (paresthesia)

Rare(may affect up to 1 in 1,000 people)

Rapid or irregular heartbeats (also called palpitations), extra heartbeats, rapid heartbeat, drop in blood pressure when standing up that causes dizziness, fainting or fainting, general malaise (generally indisposition), falls, flushing.

Frequency not known(cannot be estimated from the available data)

• Extrapyramidal symptoms (abnormal movements, including trembling hands and fingers, twisting body movements, shuffling gait and rigidity of arms and legs), generally reversible after treatment discontinuation.

• Generalized skin rash, elevated body temperature, increased liver enzyme levels, blood abnormalities (eosinophilia), increased lymph nodes and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2.

• Severe generalized red skin rash with blistering
• Sleep disorders (difficulty sleeping, somnolence), constipation, swelling of the face, lips, mouth, tongue or throat that may cause difficulty swallowing or breathing.

• Severe reduction in the number of white blood cells in the blood, which increases the risk of infections, decrease in blood platelets, 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, light-colored stools, dark-colored urine).

• Dizzy sensation (vertigo).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of trimetazidina cinfa

Keep this medicinal product out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicinal product after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

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 further information

Composition of trimetazidinacinfa

• The active substance is trimetazidina dihydrochloride. Each film-coated tablet contains 20 mg of trimetazidina dihydrochloride.
• The other ingredients are:

Core of the tablet: maize starch, sodium carboxymethyl starch (type A) (potato), microcrystalline cellulose (E-460), magnesium stearate, povidone (E-1201) and anhydrous colloidal silica.

• Coating of the tablet: hypromellose (E-464), microcrystalline cellulose (E-460), acetic acid esters of mono- and diglycerides of fatty acids (E-472 a), titanium dioxide (E-171) and Red Allura AC (E-129).

Appearance of the product and contents of the pack

Red, cylindrical, biconvex, film-coated tablets with the code "T" on one side.

Available in Triplex/Aluminum or PVC-PVDC/Aluminum blisters. Each pack contains 60 or 500 (clinical pack) tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet:July 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information on this medicinal product by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68228/P_68228.html

QR code to: https://cima.aemps.es/cima/dochtml/p/68228/P_68228.html