Prospect: information for the user

Anpeval 300 mg hard EFG capsules

triflusal

Anpeval 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 in adults to reduce the risk of recurrence of a myocardial infarction, stable or unstable angina, or cerebral infarction in patients who have previously experienced one of these processes. It is also indicated in patients who have undergone coronary artery bypass surgery.

Do not take Anpeval:

• If you are allergic to triflusal or any of the other ingredients of this medication (listed in section 6).
• If you are allergic (hypersensitive) to salicylates.
• 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 Anpeval.

− If you have kidney or liver insufficiency.

− If you are at risk of bleeding, whether 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 Anpeval 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 in this age group.

Taking Anpeval with other medications:

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

Certain medications may interact with Anpeval, in which case it may be necessary to change the dose or interrupt 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 Anpeval.

Taking Anpeval with food and drinks:

Taking Anpeval with meals reduces the likelihood of digestive adverse 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.

Driving and operating machinery:

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

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Follow exactly the administration instructions for this medication as 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 discontinue without your doctor's indication.

Administration Form

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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot to take Anpeval:

In case of forgotten dose, wait for the next one.

Do not take a double dose to compensate for the missed dose.

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

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

Common adverse 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 may disappear within a few days without discontinuing treatment.

Rare adverse effects (may affect between 1 and 10 in 1,000 patients):gastrointestinal bleeding, distended abdomen, diarrhea, blood in the stool, rectal bleeding, blood in the urine, hematomas, purpura (purple patches on the skin or mucous membranes), nasal bleeding, gum bleeding, and cerebral hemorrhage.Urinary tract infection, itching, skin rash, confusion, dizziness, vertigo, convulsions, tinnitus, hearing loss, altered taste, increased blood pressure, transient ischemic attack, difficulty breathing, upper respiratory tract infection (nose, throat), anemia, fever, flu-like symptoms.

Very rare adverse effects (may affect up to 1 in 10,000 patients):allergic skin reaction to sunlight exposure.

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

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

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 for 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 25°C.

Store in the original packaging to protect it from humidity.

Do not use this medication after the expiration date indicated 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. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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 contents of the packaging:

Anpeval is presented in the form of hard gelatin capsules that are transparent and contain a white or almost white crystalline powder. Each package contains 30 or 50 capsules.

Holder of the marketing authorization:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Responsible for manufacturing:

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).

Last review date of this leaflet:December 2023

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