Acido acetilsalicilico viatris 100 mg comprimidos gastrorresistentes

Product Information for the Patient

AspirinViatris 100 mg gastro-resistant tablets

Read this 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 doubts, consult your doctororpharmacist.

-This medicine has been prescribedonlyfor you, and you must not give it to others even if they have the same symptomsas you,as it may harm them.

• If you experience any side effects,consult your doctor or pharmacist, evenifthey are not listed in this leaflet. See section 4.

1.What is Aspirin Viatris and what it is used for

2.What you need to know beforestartingtotake Aspirin Viatris

3.How to take Aspirin Viatris

4.Possible side effects

5Storage of Aspirin Viatris

6.Contents of the pack and additional information

This medication contains acetylsalicylic acid, which at low doses belongs to a group of medications 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 occurs in the heart, it can cause a heart attack or angina; in the brain, it can cause a cerebral infarction.

This medication is taken to reduce the risk of blood clots forming and consequently prevent:

-heart attacks

-cerebral infarctions

-cardiovascular problems in patients who have stable or unstable angina (a type of chest pain)

This medication is also used to prevent blood clots from forming after certain types of cardiac surgery to widen or unblock blood vessels.

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

Do not takeAcetaminophen Viatris

• if you are allergic toacetylsalicylic acidor any of the other ingredients ofthis medication (listed in section 6).
• if you are allergic to other salicylates or nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used to treat arthritis or rheumatism and pain.
• if you have had an asthma attack or swelling of some parts of your body, such as your face, lips, throat, or tongue (angioedema), after taking salicylates or NSAIDs.
• if you currently have or have ever had an ulcer in your stomach or small intestine 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 difficulty breathing and swelling of your ankle.
• if you are in the last 3 months of pregnancy; do not take doses greater than 100 mg per day (see section “Pregnancy and breastfeeding”).
• if you are taking a medication 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 medication:

• if you have kidney, liver, or heart problems
• if you have or have had stomach or small intestine ulcers that may cause bleeding. This type of ulcer is an open wound that develops in the lining of the stomach and small intestine.
• if you are taking anticoagulant medications (used to prevent blood clots).
• if you have high blood pressure that is not controlled.
• if you are asthmatic, have hay fever,nasal mucosa inflammation (nasal polyps) or other chronic respiratory diseases; acetylsalicylic acid may induce an asthma attack.
• if you are elderly. Older people are especially susceptible to the adverse effects of NSAIDs, including acetylsalicylic acid.
• if you have ever had gout.
• if you have heavy menstrual bleeding.
• if you are taking medications that may modify the process that makes bleeding stop with the intention of keeping blood inside a damaged blood vessel (hemostasis) (see section “Other medications and Acetaminophen Viatris”).
• if you are taking medications that may increase the risk of developing ulcers, such as oral corticosteroids (often used to reduce inflammation), selective serotonin reuptake inhibitors (usually used as antidepressants), and deferasirox (used to remove excess iron from the blood) (see section “Other medications and Acetaminophen Viatris”).
• if you have a deficiency of the enzymeglucose-6-phosphate dehydrogenase (G6PD).

You must consult a doctor immediately if your symptoms worsen or if you experience severe or unexpected adverse effects, such as abnormal bleeding symptoms, severe skin reactions, or any other sign of severe allergy (see section “Possible adverse effects”).

Inform your doctor if you are planning a surgical procedure (including minor procedures, such as a tooth extraction), as acetylsalicylic acid is an anticoagulant, there may be an increased risk of bleeding.

You must 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 renal function.

This medication 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 unsure, consult your doctor or pharmacist.

Children and adolescents

Acetylsalicylic acid may cause Reye's syndrome when administered to children. Reye's syndrome is a rare disease that affects the brain and liver and may put your life at risk. For this reason, this medication should not be administered to children under 16 years of age, unless a doctor indicates it.

Other medications andAcetaminophen Viatris

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may have to take any other medication.

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

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

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

Acetaminophen Viatriswith alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consultyour doctor or pharmacist before taking this medication.

Pregnancy

Pregnant women should not take acetylsalicylic acid during pregnancy unless their doctor indicates it. Do not take this medication if you are in the last 3 months of pregnancy, unless your doctor indicates it and in that case, the daily dose should not exceed 100 mg (see section “Do not take Acetaminophen Viatris”). Normal or high doses of this medication during the last phase of pregnancy may cause serious complications in the mother or baby.

Breastfeeding

Women who are breastfeeding should not take acetylsalicylic acid unless their doctor indicates it.

Driving and operating machinery

This medication should not affect your ability to drive and operate machinery.

Acetaminophen Viatriscontains lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should not be used at higher doses unless a doctor indicates otherwise, and the dose should not exceed 100 mg per day.

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 cardiac surgery:

• The recommended dose is 100 mg once a day.

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

Older patients

The same dose as adults. This medication should be used with caution in older patients who are more prone to adverse effects. Treatment should be reviewed at regular intervals.

Use in children and adolescents

This medication should not be administered to children and adolescents under 16 years of age, unless prescribed by a doctor (see section “Warnings and precautions”).

Administration form

Oral administration.

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 in the intestine, and therefore should not be crushed, broken, or chewed.

If you take moreAspirin Viatristhan you should

If you (or another person) accidentally take too many tablets, you should immediately inform your doctor, contact the nearest emergency service or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Show your doctor the medication or the empty packaging.

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

If you forget to takeAspirin Viatris

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

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

If you interrupt treatment withAspirin Viatris

Consult your doctor before interrupting your treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 may present the following symptoms: swelling of the face, tongue, larynx, abdomen, or arms and legs, hives, 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 within the skull or brain). Symptoms may include sudden headache and symptoms similar to a heart attack, such as slurred speech and weakness on one side of the body, with nausea or vomiting, changes in vision, seizures, or loss of consciousness.

Unknown frequency(cannot be estimated from available data):

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

Otherside effectsinclude:

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

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

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

• Intense bleeding in the stomach or intestines.
• Altered number of blood cells.
• Bronchospasm (contraction of the muscles that cover the airways (bronchi) of the lungs: feels chest tightness and may have difficulty breathing).
• Asthma attack.
• Inflammation of blood vessels.
• Bruises with purple patches (cutaneous bleeding).
• Erythema nodosum (inflamed fatty tissue under the skin that causes red bumps and patches).
• Reye's syndrome (rare disease in children that affects the brain and liver (see section 2 “Children and adolescents”).
• Abnormally heavy or prolonged menstrual bleeding.

Unknown frequency(cannot be estimated from available data):

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above 30°C.

Do not usethis medicationafter the expiration date that appears onthe label and the boxafter CAD or EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the Sigrepoint of the pharmacy. Ask your pharmacist how to dispose of packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofAcid Acetilsalicilic Viatris

• The active ingredient is acid acetilsalicilic.

Each tablet contains 100 mg of acid acetilsalicilic.

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

Appearance of the product and contents of the packaging

Acid Acetilsalicilic Viatris is a white, round, biconvex, gastro-resistant coated tablet with a diameter of approximately 8.1 mm and a width of 3.5 mm.

Each package contains 30 tablets.

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing:

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 with the following names:

SpainAcid Acetilsalicilic Viatris 100 mg gastro-resistant tablets

FranceAcide acétylsalicylique Viatris 100 mg, gastro-resistant tablet

ItalyAcido Acetilsalicilico Mylan 100 mg gastro-resistant tablets

PortugalAcid Acetilsalicilic Mylan

SwedenAcetylsalicylsyra Mylan, 100 mg enteric-coated tablet

Last review date of thisleaflet: March/2022.

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/)(