Patient Information

Triflusal Abamed 300 mg Capsules EFG

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

• Keepthisleaflet,asyoumayneedtoreaditagain.
• Ifyouareindoubt,consultyourdoctororpharmacist.
• Thismedicinehasbeenprescribedonlyforyou,andyoumustnotgiveittootherseveniftheyhavethesamesymptomsasyou,asitmayharmthem.
• Ifyouexperienceanysideeffects,consultyourdoctororpharmacist,eveniftheyarenotlistedinthisleaflet.Seesection4.

Contentsof theleaflet

1. WhatisTriflusalAbamed300mgCapsulesEFGandwhatisitusedfor
2. WhatyouneedtoknowbeforestartingtotakeTriflusalAbamed300mgCapsulesEFG
3. HowtotakeTriflusalAbamed300mgCapsulesEFG
4. Sideeffects
5. StorageofTriflusalAbamed300mgCapsulesEFG
6. Contentsofthepackandadditionalinformation

Triflusalbelongs to a group of medicines called antiplatelet agents, which 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 bypass surgery.

Do not take TriflusalAbamed300 mg Capsules EFG:

• If you are allergic 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 ulcers.
• If you have any other condition that causes bleeding.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Triflusal Abamed 300 mg Capsules EFG.

Be especially careful with Triflusal Abamed:

• 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 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 Abamed 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 individuals under 18 years have not been established, therefore, its administration is not recommended.

Taking Triflusal with other medications:

Inform your doctor or pharmacist if you are taking,have taken recentlyor might have to takeany other medication.

Certain medications may interact with Triflusal Abamed. In this case,it may be necessary to adjust the dose or discontinue treatment. It is essential to inform your doctor if you take any of the following medications: non-steroidal anti-inflammatory drugs, oral antidiabetic drugs, or oral anticoagulants, as they may intensify the effects of these medications, including those of Triflusal Abamed.

Taking Triflusal Abamed with food, drinks, and alcohol:

Taking Triflusal Abamed with meals reduces the possibility of adverse gastrointestinal effects.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or if you think you might be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery:

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

Follow exactly the administration instructions indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. If in doubt, consult your doctor or pharmacist again.

T riflusal A bamed is administered orally.

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.

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 T riflusal A bamed . Do not discontinue without your doctor's instruction.

If you take more T riflusal A bamed than you should

High doses may cause symptoms of salicylate poisoning (headache, buzzing, dizziness, nausea, vomiting, rapid breathing).

In case of overdose or accidental ingestion, consult your doctor, pharmacist, the nearest emergency service, or the Toxicological Information Service, telephone 915 620 420, indicating the medication and the amount ingested.

If you forgot to take T riflusal A bamed

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

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

Very frequent adverse effects (in more than 1 in 10 people):

Indigestion (dyspepsia)

Frequent adverse effects (in more or equal to 1 in 100 people and less than 1 in 10 people):

Headache, abdominal pain, nausea, constipation, vomiting, flatulence, anorexia.

These symptoms are usually mild and disappear within a few days, even without suspending treatment.

Rare adverse effects (in more or equal to 1 in 1000 people and less than 1 in 100 people):

Itching, skin rash, confusion, dizziness, vertigo, convulsions, alteration of taste, tinnitus (ringing in the ears),hearing loss, diarrhea, gastrointestinal bleeding, melena (blood in stool), rectal bleeding, hypertension, transient ischemic accident, cerebral hemorrhage, dyspnea (shortness of breath), upper respiratory tract infection, anemia, epistaxis (nosebleed), hematomas, purpura (purple spots on the skin or mucous membranes), gingival bleeding (bleeding gums),hematuria (blood in urine), urinary tract infection, distended abdomen, fever, flu-like symptoms.

There have also been isolated cases of skin allergy reaction to sunlight exposure.

If you observe any of the adverse effects mentioned intensely or prolonged, discontinue treatment and consult your doctor as soon as possible.

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 the Spanish System of Pharmacovigilance of Medicines 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 86°F (30°C).

Store in the original packaging to protect it from moisture.

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. Deposit empty packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of empty packaging and unused medications.

By doing so, you will help protect the environment.

Composition of Triflusal Abamed:

• The active ingredient is triflusal. Each capsule contains 300 mg of triflusal.
• The other components are the capsule gelatin and the colorants: erythrosine (E-127), iron oxides (E-172) and titanium dioxide (E-171).

Appearance of the product and content of the packaging

Hard gelatin capsules with a pink body and a cream-colored cap containing white powder.

This medication is presented in packaging of 30 or 50 capsules.

Holder of the marketing authorization

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908 L'Hospitalet de Llobregat

(Barcelona)

Spain

Responsible for manufacturing

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas

(Madrid)

Spain

Last review date of the prospectus: September 2014

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