Tromalyt 300, prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

TROMALYT 300 mg, prolonged-release hard capsules

(acetylsalicylic acid)

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Tromalyt 300mg is and what it is used for

Tromalyt 300 mg belongs to a group of medicines called antiplatelet agents, and its active substance 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-haemorrhagic stroke.
• Surgical procedures such as coronary angioplasty or coronary bypass surgery.

2. Before taking Tromalyt 300mg

Do not take Tromalyt 300 mg:

• if you are allergic (hypersensitive) to acetylsalicylic acid or to any of the other components of this medicine (listed in section 6).

• if you have or have had gastric, duodenal ulcer or recurrent gastric discomfort.

• if you have experienced allergic-type asthma reactions (difficulty breathing, suffocation, bronchospasm and in some cases coughing or wheezing) when taking anti-inflammatory drugs, acetylsalicylic acid, other analgesics or products containing tartrazine dye.

• if you have haemophilia or other blood coagulation 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 drugs (oral anticoagulants).

• if you are under 16 years of age, unless otherwise directed by a physician, as the use of acetylsalicylic acid is associated with the development of Reye's syndrome, a rare but serious illness.

• if you are in the third trimester of pregnancy.

• if you have uncontrolled severe heart failure.

• if you are being treated with methotrexate.

• if you are in the last three months of pregnancy, you should not use doses exceeding 100 mg per day (see section "Pregnancy, lactation and fertility").

Warnings and precautions

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

• if you have recently undergone surgery, including dental surgery.
• if you are scheduled to undergo surgery, including dental surgery, within the next seven days.
• if you are taking anti-inflammatory drugs or other types of medication, as certain medicines may interact with Tromalyt 300 mg and cause undesirable effects (see "Use with other medicines").
• if you have hypertension, reduced kidney, heart or liver function, blood coagulation disorders, or are on anticoagulant therapy.
• if you are allergic to other anti-inflammatory or anti-rheumatic drugs.
• if you have glucose-6-phosphate dehydrogenase deficiency.
• if you have rhinitis and/or urticaria.
• If skin or mucosal lesions appear, treatment must be stopped immediately.
• In some cases, it may trigger gout attacks.

Renal and hepatic insufficiency

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

Children

This medicine should not be administered to children under 16 years of age, unless specifically indicated by a physician. The use of acetylsalicylic acid in children under 16 years of age is associated with the development of Reye's syndrome, a rare but serious illness.

Elderly

Dose reduction is not necessary in elderly patients.

Use of Tromalyt 300 mg with other medicines:

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine, including over-the-counter medicines, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one or more of these medicines.

This is especially important in the case of:

• Medicines used to prevent transplant rejection (cyclosporine and tacrolimus).
• High blood pressure (diuretics and ACE inhibitors).
• Cancer, rheumatoid arthritis (methotrexate).
• Other painkillers or non-steroidal anti-inflammatory drugs (medicines used to treat pain and/or muscle inflammation).
• Anticoagulants (medicines used to "thin" the blood and prevent blood clots), such as warfarin.
• Medicines used to treat gout (probenecid).
• Corticosteroids, as they may increase the risk of gastrointestinal bleeding.
• Diuretics.
• Some antidepressants, such as selective serotonin reuptake inhibitors, as they increase the risk of bleeding.
• Some medicines for controlling hypertension.
• Medicines to lower blood sugar levels.
• Vancomycin, an antibiotic used in some infections.
• Interferon alfa.
• Lithium, used in certain psychiatric conditions.
• Antacids.
• Digoxin, used for heart problems.
• Barbiturates, medicines used as sedatives for sleep disorders and to treat seizures.
• Zidovudine, used in the treatment of HIV infections.
• Phenytoin and valproic acid, medicines for epilepsy.

When administered concomitantly, metamizole (a substance used to relieve pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clumping together to form a blood clot). Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid for cardioprotection.

Interference with diagnostic tests:

If you are scheduled for any diagnostic tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

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

Take this medicine after meals or with food and with sufficient fluid.

If you regularly consume large amounts of alcohol (three or more alcoholic drinks – beer, wine, spirits, etc. – per day), taking this medicine may cause gastrointestinal bleeding.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Tromalyt 300 mg should only be used during the first and second trimesters of pregnancy if strictly necessary, at the lowest possible dose, and for the shortest possible duration.

During the third trimester of pregnancy, it is contraindicated.

If you continue or start treatment with Tromalyt 300 mg during pregnancy as directed by your doctor, use Tromalyt 300 mg exactly as instructed by your doctor and do not exceed the recommended dose.

Pregnancy – third trimester

Do not take more than 100 mg per day if you are in the last three months of pregnancy, as it could harm the fetus or cause complications during delivery. It may cause kidney and heart problems in the fetus. It may affect your bleeding tendency and that of your baby, and may delay or prolong labor.

If you take Tromalyt 300 mg at low doses (up to 100 mg per day inclusive), you will require strict obstetric monitoring as directed by your doctor.

Pregnancy – first and second trimesters

You should not take Tromalyt 300 mg during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to become pregnant, the lowest possible dose should be used for the shortest possible time. If taken for more than a few days beyond 20 weeks of pregnancy, Tromalyt 300 mg may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.

If treatment is needed for more than a few days, your doctor may recommend additional monitoring.

This medicine is excreted in breast milk; therefore, its use during breastfeeding is not recommended due to the risk of adverse effects in the infant.

Driving and use of machines

No effects on the ability to drive and use machinery have been reported at the doses at which this medicinal product is administered.

Tromalyt contains sucrose.

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Tromalyt 300mg

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

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

The recommended dose is:

• Adults: 1 capsule daily (300 mg acetylsalicylic acid) to be taken orally.

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

You may start treatment on any day of the week, following the order indicated on the calendar blister pack, continuing complete four-week cycles as directed by your doctor.

• Elderly patients: Same as adults

• Patients with renal impairment: as advised by physician

Duration of treatment

Your doctor will determine how long you should take Tromalyt 300 mg.

Do not stop treatment prematurely, as the expected beneficial effects will not be achieved.

If you take more Tromalyt 300 mg than you should:

With doses far exceeding the recommended amount, you may experience headache, dizziness, tinnitus, blurred vision, drowsiness, sweating, rapid breathing, confusion, nausea, vomiting, and occasionally diarrhea.

Contact your doctor or pharmacist immediately for advice on the measures to be taken.

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.

If you forget to take Tromalyt 300 mg:

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

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

Common adverse effects:

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

• Respiratory disorders, such as difficulty breathing, bronchospasm, rhinitis.

• Urticaria, skin rashes, angioedema.

• At high doses, decreased blood prothrombin levels which may lead to hemorrhage (hypoprothrombinemia).

Uncommon adverse effects:

• Reye's syndrome in patients under 16 years of age with febrile illnesses, influenza, or varicella.
• Hepatic disorders, especially in patients with juvenile arthritis.

Frequency not known:

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

Adverse effects with long-term, high-dose treatment

May occur: dizziness, tinnitus, hearing loss, sweating, headache, confusion, and kidney problems. Treatment must be stopped immediately if the patient experiences any episode of hearing loss, tinnitus, or dizziness.

Allergic reactions

In patients who have previously experienced an allergic reaction to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), anaphylactic or anaphylactoid reactions may occur. This could also happen in patients who have not previously shown hypersensitivity (allergy) to these drugs.

Cardiac disorders

Edema, hypertension, and cardiac failure.

Vascular disorders:

Bleeding, including serious bleeding (cerebral hemorrhage and gastrointestinal hemorrhage) and hemorrhagic tendency (epistaxis, gum bleeding, purpura, etc.), prolonged bleeding, post-procedural bleeding.

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 any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform 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 via the Spanish Pharmacovigilance System for Human Medicinal Products at www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tromalyt 300mg

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

Store in the original container.

Do not store above 30°C.

Expiry

Do not use this medicine after the expiry date stated on the packaging after Cad or Exp. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Tromalyt 300 mg

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

The other components are:

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

The capsule components are titanium dioxide, gelatin, erythrosine and indigotine.

Appearance of the product and contents of the pack

Tromalyt 300 mg is presented in hard capsules. Each pack contains 4 calendar blister packs with 7 capsules each, in PVC–aluminum blisters.

Marketing Authorization Holder:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

ROTTAPHARM Ltd
Damastown Ind Park,
Mulhuddart, Dublin 15 (Ireland)

or

Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind. Zona Franca,
08040 Barcelona
Spain

Further information on this medicinal product is available by contacting the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

Date of latest review of this leaflet: June 2025

Other sources of information:

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