Patient Information Leaflet

Disgren 300 mg Hard Capsules

Triflusal

Read this leaflet carefully before you start to take 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

Disgren belongs to a group of medicines called antiplatelet agents, which act 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 a myocardial infarction, stable or unstable angina, or a cerebral infarction in patients who have previously suffered from any of these processes.

It is also indicated in patients who have undergone coronary artery bypass grafting.

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 condition that causes bleeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Disgren.

• If you have kidney or liver insufficiency.
• If you are at risk of bleeding, either 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 Disgren 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 Disgren 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 Disgren, 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 Disgren.

Taking Disgren with food and beverages

Taking Disgren with meals reduces the likelihood of gastrointestinal side 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.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in 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 indication.

Administration form

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

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

If you forgot to take Disgren

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

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

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

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.

- Uncommon 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, seizures, tinnitus, hearing loss, altered taste, 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):photosensitive skin reaction.

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.

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 above25°C.

Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears 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. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Disgren 300 mg hard capsules

–The active ingredient is triflusal. Each capsule contains 300 mg of triflusal.

–The other components are gelatin capsule.

Appearance of the product and contents of the packaging

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

Each package contains 30 or 50 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios ERN, S.A.

Perú, 228

08020 Barcelona

Spain

Responsible for manufacturing:

Noucor Health, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans

Barcelona – Spain

Last review date of this leaflet:December 2020

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/.