TRIFLUSAL PENSA 300 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Triflusal Pensa 300 mg Hard Capsules EFG

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

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

Contents of the Package Leaflet

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

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

Triflusal Pensa belongs to a group of medicines called antiplatelet agents, which work by preventing the formation of 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, or a cerebral infarct 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 you take Triflusal Pensa

Do not take Triflusal Pensa

• if you are allergic (hypersensitive) to the active substance triflusal or to other salicylates 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 disorder that causes bleeding.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Triflusal Pensa.

Be especially careful with Triflusal Pensa

• if you have kidney or liver disorders.
• 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 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 Pensa seven days before the operation.

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

Children

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

Use of Triflusal Pensa with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Certain medicines may interact with Triflusal Pensa, 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 those of Triflusal Pensa, may be increased.

Taking Triflusal Pensa with food and drinks

Taking Triflusal Pensa with meals reduces the possibility of gastrointestinal side effects.

Pregnancy and breastfeeding

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

3. How to take Triflusal Pensa

Follow exactly the administration instructions of this medicine indicated by your doctor. 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.

Triflusal Pensa is administered orally.

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

Remember to take your medicine every day. Your doctor will indicate the duration of your treatment with Triflusal Pensa. Do not stop taking it without your doctor's advice.

If you take more Triflusal Pensa than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Triflusal Pensa

Do not take a double dose to make up for forgotten doses, but continue with the usual dose.

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

4. Possible side effects

Like all medicines, Triflusal Pensa can cause side effects, although not everybody gets them.

-Very common side effects (may affect more than 1 in 10 people):

Stomach heaviness.

-Common side effects (may affect between 1 and 10 in 100 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 side effects (may affect between 1 and 10 in 1,000 people):

Gastrointestinal bleeding, abdominal distension, diarrhea, blood in the stool, blood in the urine, hematoma, nosebleed, rectal bleeding, gum bleeding, and cerebral hemorrhage, increased blood pressure, transient ischemic attack, anemia, abnormal decrease in platelet count. Fever, flu-like symptoms. Itching and skin rash.

-Rare side effects (may affect less than 1 in 10,000 people, including isolated cases):

Allergic skin reaction to sunlight.

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

5. Storage of Triflusal Pensa

Do not store above 25°C.

Keep in the original package to protect from moisture.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Triflusal Pensa

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

Appearance of the product and contents of the pack

Triflusal Pensa is presented in the form of transparent capsules containing a crystalline powder of white or almost white color. Each pack contains 30 or 50 capsules.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

NOUCOR HEALTH, S.A.

Avda. Camí Reial 51-57

08184 Palau-solità i Plegamans

Barcelona, Spain

Date of the last revision of the leaflet: June 2012

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