DISGREN 300 mg HARD CAPSULES

Introduction

Patient Information Leaflet

Disgren 300 mg hard capsules

Triflusal

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What Disgren 300 mg hard capsules are and what they are 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 side effects
5. Storage of Disgren 300 mg hard capsules
6. Package contents and additional information

1. What Disgren 300 mg hard capsules are and what they are used for

Disgren belongs to a group of medications called antiplatelet agents, which work by preventing the formation of blood clots (thrombi) that can block blood vessels.

This medication 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 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 Disgren 300 mg hard capsules

Do not take Disgren:

• If you are allergic to triflusal or any of the other components 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 disorder that causes bleeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Disgren.

• 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 (medications used to treat muscle or joint pain and inflammation) 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 Disgren 7 days before the intervention.

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

Children and adolescents

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

Taking Disgren with other medications

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

Certain medications may interact with Disgren, and in this case, it may be necessary to change the dose or interrupt treatment.

It is essential to inform your doctor if you are taking any of the following medications: non-steroidal anti-inflammatory drugs, oral antidiabetics, or oral anticoagulants, as they may enhance the effects of these medications, including those of Disgren.

Taking Disgren with food and drinks

Taking Disgren with meals reduces the likelihood of gastrointestinal side effects.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

No effects on the ability to drive or use machinery have been reported.

3. How to take Disgren 300 mg hard capsules

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, 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 Disgren than you should

If you have taken more Disgren than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone: 91 562 04 20), indicating the medication and the amount ingested.

Very high doses may cause symptoms of salicylate intoxication (headache, ringing in the ears, dizziness, nausea, vomiting, rapid breathing).

If you forget to take Disgren

If you forget a dose, wait for the next one.

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

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

4. Possible side effects

Like all medications, Disgren can cause side effects, although not everyone will experience 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, 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 experience any of the side effects mentioned above in an intense or prolonged manner, stop treatment and consult your doctor as soon as possible.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Monitoring System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Disgren 300 mg hard capsules

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

Do not store above 25°C.

Keep in the original package to protect it from moisture.

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the pharmacy's SIGRE point. If you have any doubts, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Disgren 300 mg hard capsules

• The active ingredient is triflusal. Each capsule contains 300 mg of triflusal.
• The other ingredients are gelatin.

Appearance and package contents

Disgren is presented in the form of hard gelatin capsules containing a white powder.

Each package 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 last revision of this leaflet:December 2020

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