ACETILSALICYLIC ACID VIATRIS 100 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Acetylsalicylic AcidViatris 100 mg Gastro-Resistant Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• 1. If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Acetylsalicylic Acid Viatris and what is it used for
2. What you need to know before you take Acetylsalicylic Acid Viatris
3. How to take Acetylsalicylic Acid Viatris
4. Possible side effects

5 Storage of Acetylsalicylic Acid Viatris

1. Contents of the pack and other information

1. What is Acetylsalicylic Acid Viatris and what is it used for

This medicine contains acetylsalicylic acid, which at low doses belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that produce blood clotting and are involved in thrombosis. When a blood clot forms in an artery, it stops blood flow and cuts off oxygen supply. When this happens in the heart, it can cause a heart attack or angina; in the brain, it can cause a stroke.

This medicine is taken to reduce the risk of thrombus formation and consequently prevent:

• heart attacks
• strokes
• cardiovascular problems in patients with stable or unstable angina (a type of chest pain)

This medicine is also used to prevent thrombus formation after certain types of heart surgery to widen or unblock blood vessels.

This medicine is not recommended for emergency cases. It can only be used as a preventive treatment.

2. What you need to know before you take Acetylsalicylic Acid Viatris

Do not takeAcetylsalicylic Acid Viatris

• if you are allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other salicylates or non-steroidal anti-inflammatory medicines (NSAIDs). NSAIDs are often used for arthritis or rheumatism and pain.
• if you have had an asthma attack or swelling of some parts of the body, such as face, lips, throat, or tongue (angioedema), after taking salicylates or NSAIDs.
• if you currently have or have ever had a stomach or intestinal ulcer or any other type of bleeding, such as a stroke.
• if you have ever had a problem with your blood not clotting properly.
• if you have severe liver or kidney problems.
• if you have severe heart problems that cause you difficulty breathing and swelling of the ankle.
• if you are in the last 3 months of pregnancy; you should not take more than 100 mg per day (see section "Pregnancy and breastfeeding").
• if you are taking a medicine called methotrexate (for example, to treat cancer or rheumatoid arthritis) in doses greater than 15 mg per week.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you have kidney, liver, or heart problems
• if you have or have had stomach or intestinal ulcers that can cause bleeding. This type of ulcers are open sores that develop in the lining of the stomach and intestines.
• if you are taking anticoagulant medicines (used to prevent blood clots).
• if you have high blood pressure and it is not controlled.
• if you are asthmatic, have hay fever, inflammation of the mucous membrane of the nose (nasal polyps), or other chronic respiratory diseases; acetylsalicylic acid may induce an asthma attack.
• if you are elderly. Elderly people are especially susceptible to the adverse effects of NSAIDs, including acetylsalicylic acid.
• if you have ever had gout.
• if you have very heavy menstrual periods.
• if you are taking medicines that can modify the process that makes bleeding stop with the intention of keeping the blood inside a damaged blood vessel (hemostasis) (see section "Other medicines and Acetylsalicylic Acid Viatris").
• if you are taking medicines that can increase the risk of developing ulcers, such as oral corticosteroids (often used to relieve inflammation), selective serotonin reuptake inhibitors (normally used as antidepressants), and deferasirox (used to remove excess iron from the blood) (see section "Other medicines and Acetylsalicylic Acid Viatris").
• if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD).

You should consult a doctor immediately if your symptoms worsen or if you experience serious or unexpected side effects, for example, unusual bleeding symptoms, severe skin reactions, or any other sign of severe allergy (see section "Possible side effects").

Inform your doctor if you have a planned surgical intervention (even a minor one, such as a tooth extraction), as acetylsalicylic acid is an anticoagulant, there may be an increased risk of bleeding.

You should be careful not to become dehydrated (you may feel thirsty and have a dry mouth) as the use of acetylsalicylic acid at the same time may cause deterioration of kidney function.

This medicine is not suitable as an anti-inflammatory, to relieve pain, or reduce fever.

If you are in any of the above cases, or if you are not sure, consult your doctor or pharmacist.

Children and adolescents

Acetylsalicylic acid may cause Reye's syndrome when administered to children. Reye's syndrome is a very rare disease that affects the brain and liver and can be life-threatening. For this reason, this medicine should not be given to children under 16 years of age, unless indicated by a doctor.

Other medicines andAcetylsalicylic Acid Viatris

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

The effect of treatment may be influenced if acetylsalicylic acid is taken at the same time as other medicines that are used to:

• prevent the formation of clots or their dissolution (for example, coumarin, warfarin, heparin, clopidogrel, alteplase, ticlopidine, cilostazol, and dipyridamole).
• prevent organ transplant rejection (cyclosporin, tacrolimus).
• treat high blood pressure (for example, diuretics and ACE inhibitors).
• regulate heart rate (digoxin).
• treat manic-depressive disorder (lithium).
• relieve pain and inflammation (for example, NSAIDs like ibuprofen, or steroids).
• treat gout (for example, probenecid, sulfinpyrazone).
• treat epilepsy (valproate, phenytoin).
• treat glaucoma (acetazolamide).
• treat cancer or rheumatoid arthritis (methotrexate, in doses less than 15 mg per week).
• treat diabetes (for example, sulfonylureas, insulin).
• treat depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine).
• are used as hormone replacement therapy when adrenal or pituitary glands have been destroyed or removed, or medicines to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids).

Metamizol (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on the reduction of platelet aggregation (blood cells that clump together and form a blockage), if administered together with acetylsalicylic acid. Therefore, this combination should be used with caution in patients who are taking it to protect the heart (cardioprotector).

TakingAcetylsalicylic Acid Viatriswithalcohol

Drinking alcohol may increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you continue or start treatment with acetylsalicylic acid during pregnancy on the advice of your doctor, use acetylsalicylic acid according to your doctor's instructions and do not use a dose higher than recommended.

Pregnancy – last trimester

Do not take acetylsalicylic acid at doses above 100 mg per day if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your tendency to bleed and that of your baby and cause delivery to be delayed or prolonged more than expected.

If you take acetylsalicylic acid at low doses (up to 100 mg per day, inclusive), you will need strict obstetric monitoring as indicated by your doctor.

Pregnancy - first and second trimester

You should not take acetylsalicylic acid during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises you to do so. If you need treatment during this period, or while you are trying to become pregnant, you should use the lowest dose for the shortest possible time. If you take it for more than a few days from the 20th week of pregnancy, acetylsalicylic acid may cause kidney problems in the fetus that can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.

If you need treatment for more than a couple of days, your doctor may recommend additional monitoring.

Breastfeeding

Women who are breastfeeding should not take acetylsalicylic acid unless their doctor advises them to do so.

Driving and using machines

This medicine should not affect your ability to drive or use machines.

Acetylsalicylic Acid Viatriscontains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Acetylsalicylic Acid Viatris

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

Adults

Prevention of heart attacks:

• The recommended dose is 100 mg once a day.

Prevention of strokes:

• The recommended dose is 100 mg once a day.

Prevention of cardiovascular problems in patients with stable or unstable angina (a type of chest pain):

• The recommended dose is 100 mg once a day.

Prevention of thrombus formation after certain types of heart surgery:

• The recommended dose is 100 mg once a day.

This medicine should not be used at doses higher than recommended, unless a doctor indicates otherwise, and the dose should not exceed 100 mg per day.

Elderly patients

Doses are the same as for adults. This medicine should be used with caution in elderly patients who are more prone to adverse effects. Treatment should be reviewed at regular intervals.

Use in childrenand adolescents

This medicine should not be given to children and adolescents under 16 years of age, unless prescribed by a doctor (see section "Warnings and precautions").

Method of administration

Oral use.

The tablets should be swallowed whole with a sufficient amount of liquid (half a glass of water). The tablets have a gastro-resistant coating that prevents irritating effects on the intestine, and therefore should not be crushed, broken, or chewed.

If you take moreAcetylsalicylic Acid Viatristhan you should

If you (or someone else) accidentally take too many tablets, you should inform your doctor immediately, contact the nearest emergency service immediately, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. Show your doctor the medicine or the empty package.

Symptoms of overdose may include ringing in the ears, hearing problems, headache, dizziness, confusion, nausea, vomiting, and abdominal pain. A large overdose can lead to faster than normal breathing (hyperventilation), fever, excessive sweating, restlessness, convulsions, hallucinations, low blood sugar levels, coma, and shock.

If you forget to takeAcetylsalicylic Acid Viatris

If you forget to take a dose, wait until it is time to take the next dose and continue treatment as usual.

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

If you stop takingAcetylsalicylic Acid Viatris

Consult your doctor before stopping your treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking this medicine and contact your doctor immediately:

Rare side effects (may affect up to 1 in 1,000 people):

• Severe allergic reaction that can present with the following symptoms: swelling of the face, lips, larynx, abdomen, or arms and legs, rash, difficulty breathing, vomiting, dizziness, and low blood pressure.
• Redness of the skin with blisters or peeling and may be associated with high fever and joint pain. This could be erythema multiforme, Stevens-Johnson syndrome, or Lyell syndrome.
• Cerebral hemorrhage (acute bleeding inside the skull or brain). Symptoms may include sudden headache and symptoms similar to those of a stroke, such as slurred speech and weakness on one side of the body, with nausea or vomiting, changes in vision, convulsions, or loss of consciousness.

Frequency not known (cannot be estimated from the available data):

• Unusual bleeding, such as coughing up blood, blood in vomit or urine, or black stools.
• Acute kidney failure (sudden damage to the kidneys that causes them to malfunction). Symptoms may include nausea or vomiting, dehydration, confusion, high blood pressure, abdominal pain, mild back pain, and fluid accumulation in the body.

Otherside effectsinclude:

Common side effects (may affect up to 1 in 10 people)

• Nausea, vomiting, diarrhea.
• Indigestion.
• Increased tendency to bleed.

Uncommon side effects (may affect up to 1 in 100 people)

• Hives.
• Runny nose.
• Difficulty breathing.

Rare side effects (may affect up to 1 in 1,000 people)

• Severe bleeding in the stomach or intestines.
• Altered blood cell count.
• Bronchospasm (contraction of the muscles that line the airways (bronchi) of the lungs: you feel your chest tight and may have difficulty breathing).
• Asthma attack.
• Inflammation of blood vessels.
• Bruises with purple spots (bleeding into the skin).
• Erythema nodosum (fatty swelling under the skin that causes red lumps).
• Reye's syndrome (a rare disease in children that affects the brain and liver, see section 2 "Children and adolescents").
• Abnormally heavy or prolonged menstrual periods.

Frequency not known (cannot be estimated from the available data):

• Ringing in the ears (tinnitus) or reduced hearing ability.
• Headache.
• Dizziness (you feel that you or everything around you is spinning).
• Ulcers in the stomach or intestine and perforation.
• Prolonged bleeding time, such as nosebleeds or bleeding gums.
• Kidney function disorder.
• Liver function disorder.
• Elevated liver enzymes in blood tests.
• High levels of uric acid in the blood.
• Low blood sugar levels.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylsalicylic Acid Viatris

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the label and carton after CAD or EXP. The expiry date is the last day of the month stated.

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

6. Packaging Contents and Additional Information

Composition ofViatris Acetylsalicylic Acid

• The active ingredient is acetylsalicylic acid.

Each tablet contains 100 mg of acetylsalicylic acid.

• The other ingredients are lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, potato starch, talc, triacetin, and methacrylic acid:ethyl acrylate copolymer (1:1).

Appearance of the Product and Packaging Contents

Viatris Acetylsalicylic Acid are white, round, biconvex tablets with a gastro-resistant coating, approximately 8.1 mm in diameter and 3.5 mm in width.

Each package contains 30 tablets.

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Spain Acetylsalicylic Acid Viatris 100 mg gastro-resistant tablets

France Acetylsalicylic Acid Viatris 100 mg, gastro-resistant tablet

Italy Acetylsalicylic Acid Mylan 100 mg gastro-resistant tablets

Portugal Acetylsalicylic Acid Mylan

Date of the last revision of thisleaflet: April/2025.

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/