Disgren 300 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Disgren 300 mg hard capsules

Triflusal

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Disgren 300 mg hard capsules is and what it is used for
2. What you need to know before taking Disgren 300 mg hard capsules
3. How to take Disgren 300 mg hard capsules
4. Possible adverse effects
5. How to store Disgren 300 mg hard capsules
6. Contents of the pack and other information

1. What Disgren 300 mg hard capsules is and what it is used for

Disgren belongs to a group of medicines called platelet aggregation inhibitors, which work by preventing the formation of blood clots (thrombi) that may 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 Disgren 300 mg hard capsules

Do not take Disgren:

• 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 have any other disorder causing bleeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Disgren.

• If you have renal or hepatic 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 (medications used to treat pain and/or inflammation of muscles or joints) for prolonged periods.
• If you are scheduled for surgery. In this case, the bleeding risk must be assessed and, if necessary, you will need to stop taking Disgren seven days before the procedure.

Consult your doctor, even if any of the above circumstances occurred in the past.

Children and adolescents

The safety and efficacy in patients under 18 years of age have not been established; therefore, administration is not recommended in this age group.

Taking Disgren with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Certain medicines may interact with Disgren, in which case 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 Disgren, may be enhanced.

Taking Disgren with food and drink

Taking Disgren with food 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 Disgren 300 mg hard capsules

Follow exactly the instructions for use of this medicine as provided 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 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 sufficient liquid and, preferably, with meals.

If you take more Disgren than you should

If you have taken more Disgren than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone: 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 Disgren

If you miss a dose, wait until the next scheduled dose.

Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

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 every 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 adverse effects (may affect between 1 and 10 in every 1,000 patients): gastrointestinal bleeding, abdominal distension, diarrhoea, blood in the stools, rectal bleeding, blood in the urine, bruising, purpura (purple spots on the skin or mucous membranes), nosebleeds, bleeding gums, and cerebral haemorrhage. Urinary tract infection, itching and skin rash, confusion, vertigo, dizziness, seizures, tinnitus (ringing in the ears), decreased hearing ability, taste disturbances, increased blood pressure, transient ischaemic attack, difficulty breathing, upper respiratory tract infection (nose, throat), anaemia, fever, flu-like symptoms.

• Very rare adverse effects (may affect up to 1 in every 10,000 patients): allergic skin reaction in sun-exposed areas.

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.

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Disgren 300 mg capsules

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

Do not store above 25°C.

Store in the original container to protect 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 must not be disposed of via wastewater or household waste. Discard unused containers and medicines at the SIGRE Point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Disgren 300 mg hard capsules

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

Nature of the product and pack contents

Disgren is presented as transparent hard gelatin capsules containing a white powder.

Each pack contains 30 or 50 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios ERN, S.A.

Perú, 228

08020 Barcelona

Spain

Manufacturer:

Noucor Health, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans

Barcelona – Spain

Date of the most recent review of this leaflet: December 2020

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/.