Anpeval 300 mg hard capsules EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Anpeval 300 mg hard capsules EFG
triflusal
Read the entire leaflet carefully before you start taking this medicine as it contains important information for you
Contents of the leaflet
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1. What Anpeval is and what it is used for
Anpeval belongs to a group of medicines called platelet aggregation inhibitors, which work by preventing the formation of blood clots (thrombi) that could block blood vessels.
This medicine is indicated in adults to reduce the risk of recurrence of myocardial infarction, stable or unstable angina, or cerebral infarction in patients who have previously experienced 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 to any of the other components of this medicine (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 suffer from any other disorder causing bleeding.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Anpeval:
- If you have kidney or liver impairment.
- If you are at risk of bleeding, either due to trauma, 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 any surgical procedure. In this case, bleeding risk must be assessed and, if necessary, you will need to stop taking Anpeval seven days before the procedure.
Consult your doctor, even if any of the above-mentioned circumstances occurred in the past.
Children and adolescents
The safety and efficacy in individuals under 18 years of age have not been established; therefore, administration to this age group is not recommended.
Taking Anpeval with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines may interact with Anpeval; in such cases, it may be necessary to adjust the dose or discontinue 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 Anpeval, may be enhanced.
Taking Anpeval with food and drinks:
Taking Anpeval with meals reduces the likelihood of gastrointestinal adverse effects.
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines:
No effects on the ability to drive or operate machinery have been reported.
3. How to take Anpeval
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is two capsules (600 mg of triflusal) daily, taken either as a single dose or divided into two doses, or three capsules (900 mg of triflusal) daily, divided into three doses.
Do not stop taking it unless your doctor tells you to.
Method of administration
Oral use.
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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
After ingestion of very high doses, symptoms of salicylate poisoning may occur (headache, tinnitus, dizziness, nausea, vomiting, rapid breathing).
If you forget to take Anpeval:
If you miss a dose, wait until the next scheduled dose.
Do not take a double dose to make up for the missed dose.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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 disappear within a few days, even without stopping treatment.
Uncommon adverse 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, bruising, purpura (purple spots on the skin or mucous membranes), nosebleeds, bleeding gums, and cerebral hemorrhage. Urinary tract infection, itching and skin rash, confusion, dizziness, vertigo, seizures, tinnitus, decreased hearing, taste disturbances, increased blood pressure, transient ischemic attack, difficulty breathing, upper respiratory tract infection (nose, throat), anemia, fever, flu-like symptoms.
Rare adverse effects (may affect up to 1 in 10,000 patients): allergic skin reaction to sunlight-exposed skin.
If you notice any of the mentioned adverse effects intensely or for a prolonged period, 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 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Anpeval
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original container to protect it from moisture.
Do not use this medicine after the expiry date 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. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Anpeval:
- The active substance is triflusal. Each capsule contains 300 mg of triflusal.
- The other component is the capsule gelatin.
Nature of the product and contents of the pack:
Anpeval is presented as hard, transparent gelatin capsules containing white or almost white crystalline powder. Each pack 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 most recent revision of this leaflet: December 2023
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