Leaflet: information for the user

Triflusal pensa 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.

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

2. What you need to know before starting to take Triflusal Pensa

3. How to take Triflusal Pensa

4. Possible side effects

5. Storage of Triflusal Pensa

6. Contents of the pack and additional information

Triflusal Pensa belongs to a group of medications called antiplatelet agents, which act by preventing the formation of blood clots (thrombi) that may obstruct blood vessels.

This medication is indicated for adults to reduce the risk of recurrence of a myocardial infarction, stable or unstable angina, or 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 Pensa

• if you are allergic (hypersensitive) to the active ingredient triflusal or to other salicylates or to any of the other components of this medication (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.

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 take, for prolonged periods of time, non-steroidal anti-inflammatory drugs (medications 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 Pensa seven days before the intervention.

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

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 medications

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

Certain medications may interact with Triflusal Pensa, in which case it may be necessary to change the dose or interrupt treatment. It is essential that you inform your doctor if you are taking any of the following medications: non-steroidal anti-inflammatory drugs, oral antidiabetic drugs or oral anticoagulant drugs, as they may intensify the effects of these medications, including those of Triflusal Pensa.

Taking Triflusal Pensa with food and drinks

Taking Triflusal Pensa 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 medication.

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

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in 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 medication every day. Your doctor will indicate the duration of your treatment with Triflusal Pensa. Do not discontinue it without your doctor's indication.

If you take more Triflusal Pensa than you should

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

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

If you forgot to take Triflusal Pensa

Do not take a double dose to compensate for the missed doses, but rather continue with the usual dose.

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

Like all medications, Triflusal Pensa may produce adverse effects, although not all people will experience them.

-Adverse effects very frequent (may affect more than 1 in 10 people):

Stomach discomfort.

-Adverse effects frequent (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 within a few days even without suspending treatment.

-Adverse effects infrequent (may affect between 1 and 10 in 1,000 people):

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

-Adverse effects very rare (may affect less than 1 in 10,000 people, including isolated cases):

Solar light-exposed skin allergic reaction.

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

Do not store above a temperature of25°C.

Store in the original packaging to protect it from moisture.

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

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.

Medicines should not be disposed of through drains or in the trash. Dispose ofthe packaging and unused medications at the SIGRE collection pointofthe pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Triflusal Pensa

- The active ingredient is triflusal. Each capsule contains 300 mg of triflusal.

- The other components are capsule gelatin.

Appearance of the product and content of the packaging

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

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

NOUCOR HEALTH, S.A.

Avda. Camí Reial 51-57

08184 Palau-solità i Plegamans

Barcelona, Spain

Last review date of the leaflet: June 2012

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/