ANPEVAL 300 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Anpeval 300 mg Hard Capsules EFG

triflusal

1. What is Anpeval and what is it used for

Anpeval 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 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 Anpeval

Do not take Anpeval:

• If you are allergic to triflusal or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to salicylates
• If you have a stomach ulcer or a history of stomach ulcer complications. If you have any other disorder that causes bleeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Anpeval

• 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 (medicines used to treat pain and/or inflammation of muscles or joints) 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 Anpeval 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 in children under 18 years have not been established, therefore, its administration is not recommended in this age group.

Taking Anpeval with other medicines

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

Certain medicines may interact with Anpeval, 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 they may enhance the effects of these medicines, including those of Anpeval.

Taking Anpeval with food and drinks:

Taking Anpeval 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.

Driving and using machines:

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

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3. How to take Anpeval

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

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 Anpeval 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 medicine and the amount ingested.

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

If you forget to take Anpeval:

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 patients):stomach heaviness.

Common side effects (may affect between 1 and 10 in 100 patients):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 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, gum bleeding, and cerebral hemorrhage. 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):allergic skin reaction to sunlight.

If you notice any of the side effects mentioned in an intense or prolonged manner, stop treatment and consult your doctor as soon as possible.

If you notice any other reaction not described in this leaflet, consult your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Anpeval

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

Do not store above 25°C.

Keep in the original package to protect from moisture.

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

Medicines should not be disposed of via wastewater or household waste. Place the package and any unused medicines in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of packages and medicines no longer needed. This will help protect the environment.

6. Contents of the pack and further information

Composition of Anpeval:

• The active ingredient is triflusal. Each capsule contains 300 mg of triflusal.
  • The other component is the gelatin of the capsule

Appearance of the product and pack contents:

Anpeval is presented in the form of hard gelatin capsules that contain a white or almost white crystalline powder, each package contains 30 or 50 capsules.

Marketing authorization holder:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

SEID, S.A.

(Ctra.Sabadell-Granollers, Km 15.,

Llissa de Vall - Barcelona,

Spain).

Date of the last revision of this leaflet:December 2023

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