TRIFLUSAL CINFA 300 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Triflusal Cinfa 300 mg Hard Capsules EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Triflusal Cinfa and what is it used for
2. What you need to know before taking Triflusal Cinfa
3. How to take Triflusal Cinfa
4. Possible side effects
5. Storage of Triflusal Cinfa
6. Contents of the pack and further information

1. What is Triflusal Cinfa and what is it used for

Triflusal belongs to a group of medications called antiplatelet agents that work by preventing the formation of blood clots (thrombi) that can block blood vessels.

This medication is indicated in 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 conditions.

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

2. What you need to know before taking Triflusal Cinfa

Do not take Triflusal Cinfa

• If you are allergic to Triflusal or any of the other components of this medication (listed in section 6).
• If you have a stomach ulcer or a history of complicated stomach ulcers.
• If you have any other disorder that causes bleeding.
• If you are allergic (hypersensitive) to salicylates.

Warnings and precautions

Consult your doctor or pharmacist before taking Triflusal Cinfa.

• If you have kidney or liver failure.
• 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 (medications used to treat muscle or joint pain and inflammation) for prolonged periods.
• If you are going to undergo surgery. In this case, the risk of bleeding should be assessed, and if necessary, you should stop taking Triflusal seven days before the operation.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Children and adolescents

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

Other medications and Triflusal Cinfa

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

Certain medications may interact with Triflusal, and in this case, it may be necessary to change the dose or discontinue treatment.

It is essential to inform your doctor if you are taking any of the following medications: non-steroidal anti-inflammatory drugs, oral antidiabetics, or oral anticoagulants, as they may enhance the effects of these medications, including Triflusal.

Taking Triflusal Cinfa with food and drinks

Taking Triflusal with meals reduces the likelihood of gastrointestinal side effects.

Pregnancy and breastfeeding

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

Driving and using machines

No effects on the ability to drive and use machines have been reported.

3. How to take Triflusal Cinfa

Follow the instructions for administration of this medication indicated by your doctor or pharmacist. If you have any doubts, 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 advice.

Method of administration

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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

By ingesting very high doses, symptoms of salicylate intoxication (headache, ringing, dizziness, nausea, vomiting, rapid breathing) may appear.

If you forget to take Triflusal Cinfa

In case of forgetting a dose, wait for the next one.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

Stomach heaviness.

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

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

• Uncommon side 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 spots on the skin or mucous membranes), nosebleeds, and gum bleeding. Urinary tract infection, itching, and skin rash, confusion, dizziness, fainting, convulsions, ringing in the ears, decreased hearing, altered taste, increased blood pressure, transient ischemic attack, difficulty breathing, upper respiratory tract infection (nose, throat), anemia, fever, flu-like symptoms.

• Rare side effects (may affect up to 1 in 10,000 patients):

Phototoxic skin reaction.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Triflusal Cinfa

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

Do not store above 30°C.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Triflusal Cinfa

• The active ingredient is Triflusal. Each hard capsule contains 300 mg of Triflusal.
• The other ingredients are: capsule gelatin.

Appearance of the product and packaging contents

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 last revision of this package leaflet:October 2021

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

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