Leaflet: information for the user

Trimetazidine cinfa 20 mg film-coated tablets

Trimetazidine dihydrochloride

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

This medication is indicated for adult patients, in combination with other medications, to treat angina pectoris (chest pain caused by coronary artery disease).

Do not taketrimetazidine cinfa

• If you are allergic to trimetazidine or any of the other ingredients of this medication (listed in section 6).
• If you have Parkinson's disease: a brain disorder that affects movement (tremors, stiff posture, slow movements, and dragging your feet, instability while walking).
• If you have severe kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take trimetazidine cinfa.

This medication is not a curative treatment for angina attacks, nor is it indicated as initial treatment for unstable angina. It is not a treatment for heart attack.

In case of an angina attack, inform your doctor. You may need to undergo tests and have your treatment modified.

This medication may cause or worsen symptoms such as tremors, stiff posture, slow movements, and dragging your feet, instability while walking, especially in elderly patients, which must be investigated and notified to your doctor, who may reconsider treatment.

Falls may occur after a drop in blood pressure or loss of balance (see description in adverse reactions).

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized pustular psoriasis (PEGA), have been reported in association with trimetazidine. Stop using trimetazidine and seek medical attention immediately if you notice any of the symptoms related to this severe skin reaction described in section 4.

Children and adolescents

Trimetazidine is not recommended for children under 18 years.

Other medications and trimetazidine cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

No interactions with other medications have been identified.

Taking trimetazidine cinfa with food and drinks

Trimetazidine can be taken with food and drinks.

Pregnancy andbreastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

In the absence of data on excretion in breast milk, do not take trimetazidine during breastfeeding.

Driving and operating machines

This medication may cause dizziness and drowsiness that may affect your ability to drive or operate machinery.

Trimetazidine cinfa contains sodium

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

Trimetazidine cinfa contains Red Allura AC(E-129)

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in 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.

Tablets should be swallowed with a glass of water with meals.

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

If you take more trimetazidine cinfa than you should

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

If you forgot to take trimetazidine cinfa

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Frequent(may affect up to 1 in 10 patients)

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

Infrequent (may affect up to 1 in 100 people)

Unusual sensation in the skin, such as tingling or pins and needles (paresthesia)

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

Fast or irregular heartbeat (also known as palpitations), extra heartbeats, rapid heartbeat, drop in blood pressure when standing that causes dizziness, fainting or dizziness, general discomfort (usually indisposition), falls, redness.

Frequency not known(cannot be estimated from available data)

• Extrapyramidal symptoms (unusual movements, including trembling hands and fingers, body twisting movements, dragging gait, and stiffness of arms and legs), generally reversible after treatment interruption.

• Generalized skin rash, elevated body temperature, increased levels of liver enzymes, blood abnormalities (eosinophilia), enlarged 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 blister formation
• Sleep disorders (difficulty sleeping, somnolence), constipation, facial swelling, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing.

• Severe reduction in the number of white blood cells, increasing the risk of infections, decreased platelets, increasing the risk of bleeding or bruising.

• Liver disease (nausea, vomiting, loss of appetite, general discomfort, fever, itching, yellow discoloration of the skin and eyes, light-colored stools, dark-colored urine).

• Sensation of spinning (dizziness).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Trimetazidine composition cinfa

• The active ingredient is trimetazidine dihydrochloride. Each film-coated tablet contains 20 mg of trimetazidine dihydrochloride.
• The other components are:

Tablet core: maize starch, carboxymethyl starch sodium (type A) (from potato), microcrystalline cellulose (E-460), magnesium stearate, povidone (E-1201), and anhydrous colloidal silica.

• Tablet coating: 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).

Product appearance and packaging contents

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: July 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your 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