Leaflet: information for the user

triflusal cinfa 300 mg hard capsules EFG

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.

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

This medicine is indicated for adults to reduce the risk of recurrence of a myocardial infarction, stable or unstable angina, or a cerebral infarction in patients who have previously suffered from any of these processes.

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

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 have any other condition that causes bleeding.
• If you are allergic (hypersensitive) to salicylates.

Warnings and precautions

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

• If you have kidney or liver insufficiency.
• If you are at risk of bleeding, either due to trauma or other pathological conditions or because you are taking, for prolonged periods of time, nonsteroidal anti-inflammatory drugs (medicines used to treat pain and/or inflammation of muscles or joints).
• If you are about to undergo any surgical intervention. In this case, the risk of bleeding must be evaluated and, if necessary, you will have to stop taking triflusal seven days before the intervention.

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Children and adolescents

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

Other medicines and triflusal cinfa

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

Certain medicines may interact with triflusal, in which case, it may be necessary to change the dose or interrupt treatment.

It is essential to inform your doctor if you are taking any of the following medicines: nonsteroidal anti-inflammatory drugs, oral antidiabetic drugs or oral anticoagulants, as they may intensify the effects of these medicines, including those of triflusal.

Taking triflusal cinfa with food and drinks

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

Pregnancy and breastfeeding

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

Driving and operating machinery

No effects on the ability to drive and operate machinery have been described.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is two capsules (600 mg of triflusal) per day, in a single dose or divided into two doses, or three capsules (900 mg of triflusal) per day, divided into three doses.

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

Administration Form

Oral route.

Swallow 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

After ingesting very high doses, symptoms of salicylate poisoning may appear (headache, buzzing, dizziness, nausea, vomiting, rapid breathing).

If you forgot to take Triflusal Cinfa

In case of forgotten dose, wait for the next one.

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 medications, this medication may produce adverse effects, although not all people will experience them.

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

Stomach discomfort.

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

Headache, abdominal pain, nausea, constipation, vomiting, flatulence, and anorexia. These symptoms are usually mild and may disappear within a few days without discontinuing treatment.

• Rare adverse effects (may affect up to 1 in 100 patients):

Gastrointestinal bleeding, abdominal distension, diarrhea, blood in the stool, rectal bleeding, blood in the urine, hematomas, purpura (purple patches on the skin or mucous membranes), nasal bleeding, gum bleeding, and cerebral hemorrhage. Urinary tract infection, itching, skin rash, confusion, dizziness, vertigo, seizures, tinnitus, hearing loss, altered taste, 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 patients):

Phototoxic skin reaction.

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 30°C.

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 the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of triflusal cinfa

• The active ingredient is triflusal.Each hard capsule contains 300 mg of triflusal.
• The other components are: gelatin of the capsule.

Appearance of the product and contents of the packaging

Hard, transparent gelatin capsules containing a white or almost white crystalline powder.

It is presented in aluminum/PVC-PVDC blisters.

Each package contains 30 or 50 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra)- Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) -Spain

or

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid)Spain

Last review date of this leaflet:October 2021

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 with your smartphone the QR code included in the leaflet and 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