TRIFLUSAL FARMALIDER 300 mg HARD CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Triflusal Farmalider 300 mg hard capsules EFG

Read the package leaflet carefully before starting to take the medicine.

• Keep this package 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. Do not pass it on to others, even if their symptoms are the same as yours, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet:

1. What Triflusal Farmalider is and what it is used for.
2. Before taking Triflusal Farmalider.
3. How to take Triflusal Farmalider.
4. Possible side effects.
5. Storage of Triflusal Farmalider.
6. Further information.

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

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

This medicine is indicated in adults to reduce the risk of recurrence of a myocardial infarction, stable or unstable angina pectoris, 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. BEFORE TAKING Triflusal Farmalider

Do not take Triflusal Farmalider:

• If you have a stomach ulcer or a history of complicated stomach ulcers,

Be careful with Triflusal Farmalider:

• If you have kidney or liver disorders,
• the safety and efficacy in the pediatric population under 18 years of age have not been established, therefore, its administration is not recommended.

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

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

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

Taking Triflusal Farmalider with food and drinks

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

In case of pregnancy or breastfeeding, your doctor will assess the use of this medication.

Driving and using machines

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

Important information about some of the components of Triflusal Farmalider

This medicine may cause allergic reactions because it contains erythrosine (E127). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. HOW TO TAKE Triflusal Farmalider

Follow the instructions for administration of Triflusal Farmalider indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Triflusal Farmalider. Do not stop it without your doctor's indication.

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.

Method of administration

Triflusal Farmalider is administered orally.

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

If you take more Triflusal Farmalider than you should

If you have taken more triflusal than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone: 91 562 04 20.

It is recommended to take the package and package leaflet of the medicine to the healthcare professional. A too high dose of triflusal can cause headache, ringing in the ears, nausea, vomiting, and rapid breathing.

If you forget to take Triflusal Farmalider

In case of forgetting a dose, wait for the next one. Do not take a double dose to make up for the forgotten doses.

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

4. Possible side effects

Like all medicines, triflusal can cause side effects, although not everyone gets them.

The most common side effect is stomach heaviness. Headache, abdominal pain, nausea, constipation, vomiting, flatulence, and anorexia may also appear. These symptoms are usually mild and disappear after a few days, even without stopping treatment. Uncommonly, gastrointestinal bleeding, diarrhea, blood in urine, hematoma, nosebleeds, bleeding gums, and cerebral hemorrhage have been observed. Isolated cases of allergic skin reactions to sunlight have also been reported.

If you experience any of the mentioned side effects intensely or prolonged, interrupt treatment and consult your doctor as soon as possible.

If you consider that any of the side effects you suffer is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Triflusal Farmalider

Keep out of the reach and sight of children.

Do not store above 25°C.

Store in the original package.

Do not use Triflusal Farmalider after the expiry date stated on the package after "CAD". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Triflusal Farmalider

• The active substance is triflusal. Each capsule contains 300 mg of triflusal.
• The other components are: capsule gelatin and colorants: erythrosine (E127), iron oxides (E172), and titanium dioxide (E171).

Appearance of the product and package contents

Triflusal Farmalider is presented in the form of hard gelatin capsules, pink and cream in color. Each package contains 30, 50, or 500 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holder

Farmalider S.A.

C/ La Granja 1 3º

28108, Alcobendas, Madrid

Manufacturer

Toll Manufacturing Services, S.L

Aragoneses 2

28108 Alcobendas

Madrid

This package leaflet was approved in November 2003

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