PROSPECTO : INFORMATION FOR THE USER

TROMALYT 300 mg, prolonged-release hard capsules

(Acid acetylsalicylic)

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Tromalyt 300 mg belongs to a group of medicines called antiplatelet agents and its active ingredient is acetylsalicylic acid.

Tromalyt 300 mg is indicated to prevent the formation of blood clots in patients who have previously experienced:

• Myocardial infarction.
• Angina pectoris.
• Non-hemorrhagic stroke.
• Surgical intervention, such as coronary angioplasty or coronary bypass.

Do not take Tromalyt 300 mg:

• if you are allergic (hypersensitive) to acetylsalicylic acid or to any of the other components of this medication (listed in section 6).
• if you have or have had a stomach ulcer, duodenal ulcer, or recurring stomach problems.
• if you have had allergic reactions of the asthmatic type (difficulty breathing, choking, bronchospasm, and in some cases coughing or wheezing) when taking anti-inflammatory medications, acetylsalicylic acid, other analgesics, or products containing the colorant tartrazine.

• if you have hemophilia or other bleeding disorders that predispose you to internal bleeding.

• if you have severe kidney and/or liver disease (severe renal and/or hepatic insufficiency)
• if you have or have had asthma, with or without nasal polyps, after taking acetylsalicylic acid.

• if you are being treated with anticoagulant medications (oral anticoagulants)

• if you are under 16 years old, unless a doctor's explicit indication, as the use of acetylsalicylic acid is related to the appearance of Reye's syndrome, a rare but serious disease.
• if you are in your third trimester of pregnancy.
• if you have severe uncontrolled heart failure
• if you are being treated with methotrexate

Warnings and precautions

Consult your doctor before taking this medication if you are in any of the following situations:

• if you have recently undergone surgery, including dental surgery.
• if you are about to undergo surgery, including dental surgery in the next seven days.
• if you are taking anti-inflammatory medications or other types of medications, as certain medications may interact with Tromalyt 300 mg and produce undesirable effects (see "Use of other medications")
• if you have high blood pressure, reduced kidney, heart, or liver function, or if you have bleeding disorders or are being treated with anticoagulants.
• if you are allergic to other anti-inflammatory or antirheumatic medications.
• if you have a deficiency of glucose-6-phosphate dehydrogenase.
• if you have rhinitis and/or urticaria.
• if skin or mucous membrane lesions appear, discontinue treatment immediately.
• In some cases, it may trigger gout attacks.

Renal and hepatic insufficiency

This medication should not be used in patients with renal or hepatic insufficiency.

Children

This medication should not be administered to children under 16 years old, unless a doctor's explicit indication, as the use of acetylsalicylic acid is related to the appearance of Reye's syndrome, a rare but serious disease.

Older adults

No dose reduction is necessary in elderly patients.

Use of Tromalyt 300 mg with other medications:

Inform your doctor or pharmacist if you are using or have used recently or may need to use another medication, including over-the-counter medications, homeopathic medications, herbal remedies, and other health-related products, as it may be necessary to discontinue treatment or adjust the dose of one of them.

This is especially important in the case of:

• Medications used to prevent transplant rejection (ciclosporin and tacrolimus).
• High blood pressure (diuretics and ACE inhibitors).
• Cancer, rheumatoid arthritis (methotrexate).
• Other analgesics or nonsteroidal anti-inflammatory drugs (medications used to treat pain and/or muscle inflammation).
• Anticoagulants (medications used to "thin" the blood and prevent the formation of blood clots) such as warfarin.
• Medications used to treat gout (probenecid).
• Corticosteroids, as it may increase the risk of gastrointestinal bleeding.
• Diuretics.
• Some antidepressants, such as selective serotonin reuptake inhibitors, as it increases the risk of bleeding.
• Some medications for controlling high blood pressure.
• Medications to lower blood sugar levels
• Vancomycin, an antibiotic used for some infections).
• Interferon alfa.
• Lithium, used for some psychiatric diseases.
• Antacids.
• Digoxin, used for heart problems.
• Barbiturates, medications used as sedatives for sleep problems and to treat seizures.
• Zidovudine, used to treat HIV infections.
• Phenytoin and valproic acid, medications for epilepsy.

If administered together, metamizole (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells come together and form a blood clot). Therefore, this combination should be used with caution in patients taking low doses of acetylsalicylic acid as a cardioprotector.

Interference with diagnostic tests:

If you are to undergo any diagnostic test (including blood, urine, etc.) inform your doctor that you are taking this medication, as it may alter the results.

Taking Tromalyt 300 mg with food, drinks, and alcohol:

Take this medication after meals or with food and sufficient liquid.

If you habitually consume large amounts of alcohol (three or more alcoholic beverages - beer, wine, liquor, etc. per day) taking this medication may cause gastrointestinal bleeding.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Tromalyt 300 mg should only be used during the first and second trimesters of pregnancy, unless strictly necessary and at the lowest possible dose, as well as the duration of treatment should be reduced to the minimum possible.

It is contraindicated during the third trimester of pregnancy.

It is excreted through breast milk, so it is not recommended to use it during the lactation period due to the risk of adverse effects in the child.

Driving and operating machinery

No effects have been described on the ability to drive and operate machinery at the doses at which this medication is administered.

Tromalyt contains saccharose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

If you estimate that the action of Tromalyt 300 mg is too strong or too weak, inform your doctor or pharmacist.

The recommended dose is:

• Adults:1 capsule per day (300 mg of acetylsalicylic acid) by oral route.

Take the capsules whole with a little liquid, preferably during meals.

You can start treatment on any day of the week, following the order set in the blister calendar, until completing full cycles of four weeks, in accordance with the doctor's indications.

• Seniors:The same as adults

• Patients with renal insufficiency:According to medical advice

Treatment Duration

Your doctor will indicate the duration of your treatment with Tromalyt 300 mg.

Do not discontinue treatment before, as the expected beneficial results will not be obtained.

If you take more Tromalyt 300 mg than you should:

With very high doses above the recommended dose, you may experience headache, dizziness, tinnitus, blurred vision, drowsiness, sweating, rapid breathing, mental confusion, nausea, vomiting, and, occasionally, diarrhea.

Consult your doctor or pharmacist immediately, who will advise you on the necessary measures.

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.

If you forgot to take Tromalyt 300 mg:

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

Take the missed capsule with another meal on the same day. If a full day has passed, continue treatment without taking the missed capsule.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Due to its effect on platelet aggregation, acetylsalicylic acid may increase the risk of bleeding.

Frequent side effects:

• Gastrointestinal disorders, such as gastric ulcer, duodenal ulcer, gastrointestinal bleeding, abdominal pain, stomach discomfort, nausea, vomiting.

• Respiratory disorders, such as difficulty breathing, bronchial spasm, rhinitis.
• Urticaria, skin rash, angioedema
• At high doses, a decrease in blood prothrombin levels that can cause bleeding, (Hypoprothrombinemia).

Rare side effects:

• Reye's syndrome in children under 16 years with fever, flu, or chickenpox
• Liver disorders, especially in patients with juvenile arthritis.

Unknown frequency:

• Bleeding, including severe bleeding (e.g. cerebral hemorrhage)

Side effects in long-term treatments at high doses

May appear: dizziness, ear noises, hearing loss, sweating, headache, confusion, and kidney problems. Treatment should be suspended immediately if the patient notes any episode of hearing loss, ear noises, or dizziness.

Allergic reactions

In patients who have had an allergic reaction to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs, anaphylactic or anaphylactoid reactions may occur. This can also happen in patients who have not previously shown hypersensitivity (allergy) to these medications.

Cardiac disorders

Edema, hypertension, and heart failure.

Vascular disorders:

Bleeding, including severe bleeding (cerebral hemorrhage and gastrointestinal bleeding) and hemorrhagic tendency (epistaxis, gum bleeding, purpura, etc.) with prolonged bleeding, bleeding after the procedure.

Gastrointestinal disorders

Diarrhea, flatulence, exacerbation of colitis and Crohn's disease, and gastritis

Skin and subcutaneous tissue disorders

Stevens-Johnson syndrome and toxic epidermal necrolysis

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging.

Do not store at a temperature above30°C.

Expiration Date

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. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Tromalyt 300 mg

The active ingredient is 300 mg of acetylsalicylic acid in the form of prolonged-release micropellets.

The other components are:

Inert cores: Cornstarch and Sucrose 20:80 and Coating: Copovidone, Eudragit L 12.5, Ethylcellulose and Triacetin.

The components of the capsules are titanium dioxide, gelatin, erythrosine, and indigotin.

Appearance of the product and content of the packaging

Tromalyt 300 mg is presented in hard capsules. Each package contains 4 blister-calendars with 7 capsules each.

Holder of the marketing authorization :

Meda Pharma SL

C/ General Aranaz, 86.

28027 Madrid

Spain

Responsible for manufacturing:

ROTTAPHARM Ltd

Damastown Ind Park,

Mulhuddart, Dublin 15 (Ireland)

or

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind. Zona Franca,

08040 Barcelona

Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Mylan Pharmaceuticals, S.L.

C/ Plom, 2-4, 5th floor

08038 - Barcelona

Spain

Date of the last review of this leaflet: December 2019

Other sources of information:

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/