Acetylsalicylic acid Viatris 100 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acetylsalicylic Acid Viatris 100 mg gastro-resistant tablets

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.

  1. If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

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

Contents of the leaflet

1. What Acetylsalicylic Acid Viatris is and what it is used for
2. What you need to know before taking Acetylsalicylic Acid Viatris
3. How to take Acetylsalicylic Acid Viatris
4. Possible side effects
5. Storage of Acetylsalicylic Acid Viatris
6. 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 cause blood to clot and are involved in thrombosis. When a blood clot forms in an artery, it blocks blood flow and cuts off the supply of oxygen. When this occurs in the heart, it may cause a heart attack or angina; in the brain, it may cause a stroke.

This medicine is taken to reduce the risk of blood clot formation and thereby prevent:

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

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

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

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

Do not take Acetylsalicylic Acid Viatris

• if you are allergic to acetylsalicylic acid or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other salicylates or to non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are commonly used for arthritis or rheumatism and pain.
• if you have previously experienced an asthma attack or swelling of certain body parts, for example, face, lips, throat or tongue (angioedema), after taking salicylates or NSAIDs.
• if you currently have or have ever had a stomach or small intestine ulcer or any other type of bleeding, such as a cerebral haemorrhage.
• 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 causing difficulty breathing and ankle swelling.
• if you are in the last 3 months of pregnancy; you must not use doses higher than 100 mg per day (see section “Pregnancy and breastfeeding”).
• if you are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) at doses greater than 15 mg per week.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have kidney, liver or heart problems
• if you have or have ever had stomach or small intestine ulcers that may cause bleeding. These ulcers are open sores that develop in the lining of the stomach or small intestine.
• if you are taking anticoagulant medicines (used to prevent blood clots).
• if you have uncontrolled high blood pressure.
• if you have asthma, hay fever, inflammation of the nasal mucosa (nasal polyps), or other chronic respiratory diseases; acetylsalicylic acid may trigger an asthma attack.
• if you are elderly. Older people are particularly 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 may affect the process that stops bleeding and keeps blood within a damaged blood vessel (haemostasis) (see section “Other medicines and Acetylsalicylic Acid Viatris”).
• if you are taking medicines that may increase the risk of developing ulcers, such as oral corticosteroids (often used to reduce inflammation), selective serotonin reuptake inhibitors (SSRIs, commonly 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, serious skin reactions, or any other signs of a severe allergic reaction (see section “Possible side effects”).

Inform your doctor if you have planned surgery (including minor procedures such as dental extraction), as acetylsalicylic acid is an anticoagulant and may increase the risk of bleeding.

Be careful not to become dehydrated (you may feel thirsty and have a dry mouth), as using acetylsalicylic acid at the same time may lead to impaired 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 situations, or if you are unsure, consult your doctor or pharmacist.

Children and adolescents

Acetylsalicylic acid may cause Reye's syndrome when given to children. Reye's syndrome is a very rare condition affecting the brain and liver and may be life-threatening. For this reason, this medicine must not be given to children under 16 years of age unless directed by a doctor.

Other medicines and Acetylsalicylic Acid Viatris

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

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

• preventing blood clots or dissolving them (e.g. coumarin, warfarin, heparin, clopidogrel, alteplase, ticlopidine, cilostazol, and dipyridamole).
• preventing organ transplant rejection (cyclosporine, tacrolimus).
• treating high blood pressure (e.g. diuretics and ACE inhibitors).
• regulating heart rhythm (digoxin).
• bipolar disorder (lithium).
• pain and inflammation (e.g. NSAIDs such as ibuprofen, or steroids).
• gout (e.g. probenecid, sulfinpyrazone).
• epilepsy (valproate, phenytoin).
• glaucoma (acetazolamide).
• cancer or rheumatoid arthritis (methotrexate, at doses less than 15 mg per week).
• diabetes (e.g. sulfonylureas, insulin).
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine).
• used as hormone replacement therapy when adrenal or pituitary glands have been destroyed or removed, or medicines used to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids).

Metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells that clump together to form a blockage) when administered together with acetylsalicylic acid. Therefore, this combination should be used with caution in patients taking it for cardioprotection.

Taking Acetylsalicylic Acid Viatris with alcohol

Drinking alcohol may possibly 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 plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

If you continue or start treatment with acetylsalicylic acid during pregnancy under medical advice, use acetylsalicylic acid as directed by your doctor and do not exceed the recommended dose.

Pregnancy – third trimester

Do not take acetylsalicylic acid above 100 mg per day if you are in the last 3 months of pregnancy, as it could harm the unborn baby or cause delivery complications. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and may cause labour to be delayed or prolonged.

If you take low-dose acetylsalicylic acid (up to 100 mg per day, inclusive), you will require strict obstetric monitoring as advised by your doctor.

Pregnancy – first and second trimesters

You should not take acetylsalicylic acid during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period, or while trying to become pregnant, you should use the lowest possible dose for the shortest possible time. If taken for more than a few days beyond week 20 of pregnancy, acetylsalicylic acid 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.

Breastfeeding

Women who are breastfeeding should not take acetylsalicylic acid unless advised by their doctor.

Driving and using machines

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

Acetylsalicylic Acid Viatris contains lactose

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

3. How to take Acetylsalicylic Acid Viatris

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults

Prevention of heart attacks:

• The recommended dose is 100 mg once daily.

Prevention of strokes:

• The recommended dose is 100 mg once daily.

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

• The recommended dose is 100 mg once daily.

Prevention of blood clot formation after certain types of heart surgery:

• The recommended dose is 100 mg once daily.

This medicine should not be used at higher doses unless otherwise directed by a doctor, and the dose must not exceed 100 mg per day.

Elderly patients

Dose is 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 children and adolescents

This medicine must 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

For oral use.

The tablets should be swallowed whole with sufficient liquid (half a glass of water). The tablets have an enteric coating that prevents irritating effects in the intestine; therefore, they must not be crushed, broken, or chewed.

If you take more Acetylsalicylic Acid Viatris than you should

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

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

If you forget to take Acetylsalicylic 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 taking Acetylsalicylic Acid Viatris

Consult your doctor before stopping your treatment.

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

4. Possible adverse effects

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

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

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

• Severe allergic reaction which may present the following symptoms: swelling of the face, tongue, larynx, abdomen, or arms and legs, rash, difficulty breathing, vomiting, dizziness, and low blood pressure.
• Skin redness with blisters or peeling, which may be associated with high fever and joint pain. This could be erythema multiforme, Stevens-Johnson syndrome, or Lyell's syndrome.
• Intracranial hemorrhage (acute bleeding within the skull or brain). Symptoms may include sudden headache and stroke-like symptoms such as slurred speech and weakness on one side of the body, nausea or vomiting, changes in vision, seizures, or loss of consciousness.

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

• Unusual bleeding, such as coughing up blood, blood in vomit or urine, or black stools.
• Acute kidney failure (sudden kidney damage causing the kidneys to not function properly). Symptoms may include nausea or vomiting, dehydration, confusion, high blood pressure, abdominal pain, mild back pain, and fluid accumulation in the body.

Other adverse effects include:

Frequent adverse effects (may affect up to 1 in 10 people)

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

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

• Urticaria (hives).
• Runny nose.
• Difficulty breathing.

Rare adverse 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 lining the airways (bronchi) of your lungs: you feel tightness in your chest and may have difficulty breathing).
• Asthma attack.
• Inflammation of blood vessels.
• Bruising with purple spots (cutaneous bleeding).
• Erythema nodosum (swollen fat under the skin causing red lumps and patches).
• Reye's syndrome (a rare illness in children affecting the brain and liver (see section 2 "Children and adolescents")).
• Abnormally heavy or prolonged menstrual periods.

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

• Ringing in the ears (tinnitus) or reduced hearing ability.
• Headache.
• Dizziness (feeling that you or your surroundings are spinning).
• Ulcers in the stomach or small intestine and perforation.
• Prolonged bleeding time, such as nosebleeds or blood in the 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 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: https://www.notificaram.es. By reporting adverse 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 30ºC.

Do not use this medicine after the expiry date stated on the label and the carton 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. Dispose of empty containers and unused medicines at the Sigre Point of your pharmacy. Ask your pharmacist how to get rid of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Acetylsalicylic Acid Viatris

• The active substance is acetylsalicylic acid.

Each tablet contains 100 mg of acetylsalicylic acid.

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

Appearance of the product and contents of the pack

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

Each pack 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 further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

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

This medicinal product 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: Acide acétylsalicylique Viatris 100 mg, comprimé gastro-résistant
Italy: Acido Acetilsalicilico Mylan 100 mg compresse gastroresistenti
Portugal: Ácido Acetilsalicílico Mylan

Date of the most recent review of this leaflet: April 2025.

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