Triflusal Cinfa 300 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

triflusal cinfa 300 mg hard capsules EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What triflusal cinfa is and what it is used for
2. What you need to know before taking triflusal cinfa
3. How to take triflusal cinfa
4. Possible side effects
5. How to store triflusal cinfa
6. Contents of the pack and other information

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

Triflusal belongs to a group of medicines called antiplatelet agents, which work by preventing the formation of blood clots (thrombi) that may block blood vessels.

This medicine is indicated in adults to reduce the risk of recurrence of myocardial infarction, stable or unstable angina, or cerebral infarction in patients who have previously experienced any of these conditions.

It is also indicated in patients who have undergone coronary artery bypass surgery.

2. What you need to know before starting to take triflusal cinfa

Do not take triflusal cinfa

• If you are allergic to triflusal or to any of the other ingredients of this medicine (listed in section 6).
• If you have a stomach ulcer or a history of complicated stomach ulcer.
• If you suffer from any other disorder causing bleeding.
• If you are allergic (hypersensitive) to salicylates.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take triflusal cinfa.

• If you have renal or hepatic impairment.
• If you are at risk of bleeding, either due to trauma or other pathological conditions, or because you are taking non-steroidal anti-inflammatory drugs (medicines used to treat pain and/or inflammation of muscles or joints) for prolonged periods.
• If you are going to undergo any surgical procedure. In this case, bleeding risk must be assessed and, if necessary, you will have to stop taking triflusal seven days before the procedure.

Consult your doctor, even if any of the above-mentioned circumstances occurred in the past.

Children and adolescents

The safety and efficacy in patients under 18 years of age have not been established; therefore, administration is not recommended in this age group.

Other medicines and triflusal cinfa

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

Certain medicines may interact with triflusal; in such cases, it may be necessary to adjust the dose or discontinue treatment.

It is important that you inform your doctor if you are taking any of the following medicines: non-steroidal anti-inflammatory drugs, oral antidiabetics, or oral anticoagulants, as the effects of these medicines, including those of triflusal, may be enhanced.

Taking triflusal cinfa with food and drink

Taking triflusal with meals reduces the likelihood of gastrointestinal adverse effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

3. How to take triflusal cinfa

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is two capsules (600 mg of triflusal) daily, taken as a single dose or divided into two doses, or three capsules (900 mg of triflusal) daily, divided into three doses.

Do not stop taking it without your doctor's instruction.

Method of administration

Oral use.

Take the capsule with a sufficient amount of liquid and preferably with meals.

If you take more triflusal cinfa than you should

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

Symptoms of salicylate poisoning (headache, tinnitus, dizziness, nausea, vomiting, rapid breathing) may occur after ingestion of very high doses.

If you forget to take triflusal cinfa

If you miss a dose, wait until the next scheduled dose.

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

• Very common adverse effects (may affect more than 1 in 10 people):

Stomach heaviness.

• Common adverse effects (may affect up to 1 in 10 people):

Headache, abdominal pain, nausea, constipation, vomiting, flatulence, and anorexia. These symptoms are usually mild and disappear after a few days, even without stopping treatment.

• Uncommon adverse effects (may affect up to 1 in 100 people):

Gastrointestinal bleeding, abdominal distension, diarrhea, blood in the stools, rectal bleeding, blood in the urine, bruising, purpura (purple spots on the skin or mucous membranes), nosebleeds, bleeding gums, and cerebral hemorrhage. Urinary tract infection, itching and skin rash, confusion, vertigo, dizziness, seizures, tinnitus, decreased hearing ability, taste disturbances, increased blood pressure, transient ischemic attack, difficulty breathing, upper respiratory tract infection (nose, throat), anemia, fever, flu-like symptoms.

• Very rare adverse effects (may affect up to 1 in 10,000 people):

Allergic skin reaction to sunlight-exposed skin.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of triflusal cinfa

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of triflusal cinfa

• The active substance is triflusal. Each hard capsule contains 300 mg of triflusal.
• The other component is the gelatin of the capsule.

Nature of the product and contents of the container

Transparent hard gelatin capsules containing a white or almost white crystalline powder.

Presented in aluminum/PVC-PVDC blisters.

Each pack contains 30 or 50 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid) Spain

Date of the most recent review of this leaflet: October 2021

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68201/P_68201.html

QR code to: https://cima.aemps.es/cima/dochtml/p/68201/P_68201.html