Package Leaflet: Information for the User

A.A.S. 100 mg Tablets

Acetylsalicylic Acid

1. What isA.A.S. 100 mgand what it is used for

2. What you need to knowbefore starting to take A.A.S. 100 mg

3. How to takeA.A.S. 100 mg

4. Possible side effects

5. Storage ofA.A.S. 100 mg

6. Contents of the pack and additional information

A.A.S. 100 mg is indicated to prevent the formation of blood clots and reduce the risk of blockage of your arteries, as:

• you have previously experienced a heart attack or angina pectoris.
• you have experienced a transient or permanent ischemic stroke.
• you have undergone a surgical intervention, such as coronary angioplasty or coronary bypass surgery.

Do not take A.A.S. 100 mg:

• If you are allergic to acetylsalicylic acid or any of the other components of this medication (listed in section 6).
• If you have had mastocytosis (usually characterized by urticaria) as severe hypersensitivity reactions (exaggerated and severe allergic reactions with flushing, hypotension, tachycardia, and vomiting) may occur.
• If you have or have had gastric ulcers, duodenal ulcers, or repeated gastric discomfort.
• If you have had allergic reactions of the asthmatic type (difficulty breathing, choking, bronchospasm, and in some cases coughing or wheezing) when taking medications to reduce inflammation, acetylsalicylic acid, other analgesics, as well as when taking tartrazine dye.
• If you have or have had asthma or nasal polyps associated with asthma that are produced or increased by acetylsalicylic acid, rhinitis, or urticaria.
• If you have hemophilia or other bleeding disorders that predispose you to internal bleeding, have any other bleeding disease or risk of bleeding.
• If you are being treated with medications to promote blood circulation (oral anticoagulants) (see “Taking A.A.S. 100 mg with other medications”).
• If you are being treated with methotrexate at doses above 20 mg/week (see “Taking A.A.S. 100 mg with other medications”).
• If you have severe liver failure.
• If you have severe kidney failure.
• If you have severe and uncontrolled heart failure.
• If you are under 16 years old, unless a doctor's explicit indication, as the use of acetylsalicylic acid has been associated with Reye's syndrome, a rare but potentially fatal disease.
• If you are in your third trimester of pregnancy (more than 24 weeks of gestation), at doses above 100 mg/day (see “Pregnancy, breastfeeding, and fertility”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take A.A.S. 100 mg if you are in any of the following cases:

• You have any kidney, heart, or liver disease.
• You have mild or moderate liver failure (in case of severe liver failure, it is contraindicated, see “Do not take A.A.S. 100 mg”).
• You have alterations in blood coagulation or are being treated with anticoagulants.
• You have gout. Acetylsalicylic acid modifies serum uric acid at analgesic doses.
• You have uterine bleeding outside of menstruation or metrorrhagia or menorragia (prolonged and increased menstrual bleeding).
• You are to undergo surgical intervention, including dental surgery. In that case, you should inform your doctor or dentist.
• If you have recently been vaccinated.
• If you have rhinitis and/or urticaria.
• At high doses (anti-inflammatory doses), consult your doctor if you experience buzzing or noise in your ears, reduced hearing, or dizziness.
• If you have a deficiency of glucose-6-phosphate dehydrogenase due to the risk of hemolysis (see “Possible adverse effects”).
• Avoid concurrent treatment with levotiroxine (for hypothyroidism) and salicylates (see “Taking A.A.S. 100 mg with other medications”).
• If you are taking anti-inflammatory medications or other types of medications, as certain medications may interact with A.A.S. 100 mg and produce unwanted effects (see “Taking A.A.S. 100 mg with other medications”).
• You have hypertension.
• In treatments with doses ≥ 500 mg/day, female fertility may be altered due to an effect on ovulation, which is reversible upon withdrawal of treatment.
• Do not take alcohol as it increases the gastrointestinal adverse effects of acetylsalicylic acid, and is a trigger for chronic irritation caused by acetylsalicylic acid (see “Taking A.A.S. 100 mg with food, beverages, and alcohol”).
• In patients being treated with nicorandil and acetylsalicylic acid, there is a higher risk of severe complications such as gastrointestinal ulcers, perforation, and bleeding (see “Taking A.A.S. 100 mg with other medications”).
• History of gastric ulcers, gastrointestinal bleeding, or gastritis. Avoid taking it together with other medications that may increase the risk of bleeding. Consult your doctor.
• Patients with asthma: the appearance of asthma attacks may be related to an allergy to non-steroidal anti-inflammatory drugs or acetylsalicylic acid. In this case, this medication is contraindicated.

• Reye's syndrome, a rare but potentially fatal disease, has been observed in children and adolescents with viral infections (especially varicella and influenza) and who are taking acetylsalicylic acid. Therefore, acetylsalicylic acid should only be administered to these children and adolescents under medical recommendation, when other measures have failed. In case of persistent vomiting, loss of consciousness, or abnormal behavior, treatment with acetylsalicylic acid should be interrupted.
• This medication contains acetylsalicylic acid. Other medications also contain it, do not take them together to avoid exceeding the recommended daily dose.
• The regular use of analgesics, especially when combined with analgesics, can cause persistent renal damage with a risk of renal failure.
• This medication is not recommended for use during breastfeeding (see “Pregnancy, breastfeeding, and fertility”).

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Taking A.A.S. 100 mg with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription, homeopathic, herbal, and other health-related products, as it may be necessary to interrupt 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, angiotensin II receptor antagonists, and ECA inhibitors).

• Methotrexate (medication used to treat cancer and rheumatoid arthritis).

• Other analgesics or non-steroidal anti-inflammatory drugs (medications used to treat muscle pain and/or inflammation).
• Anticoagulants (medications used to thin the blood and prevent the formation of clots), thrombolytics (to dissolve clots), antiplatelet agents, and other medications associated with the risk of bleeding.
• Medications that reduce blood sugar levels (oral antidiabetics and insulin).
• Barbiturates (medications used to combat sleep disorders, such as sedatives and anticonvulsants).
• Corticosteroids (except for hydrocortisone), as they may potentiate the risk of gastrointestinal bleeding.
• Cimetidine and ranitidine (used to reduce stomach acidity).
• Digoxin (medication used to treat heart diseases).
• Phenytoin and valproic acid (antiepileptic medications).
• Lithium and serotonin receptor inhibitors (used in the treatment of depression).
• Probenecid and sulfinpyrazone (used in the treatment of gout).
• The antibiotic vancomycin and sulfonamides (used in the treatment of infections).
• Interferon alpha.
• Zidovudine (used in the treatment of AIDS).
• Metamizole (another analgesic/antipyretic medication).
• Acetazolamide (diuretic).
• Varicella vaccine (do not take salicylates for 6 weeks after vaccination).
• Levotiroxine (thyroid hormone).
• Tenofovir (used in the treatment of AIDS).
• Nicorandil (used in the treatment of heart diseases) (see “Warnings and precautions”).
• Pemetrexed: risk of increased toxicity by pemetrexed.
• Alcohol: alcohol may increase the risk of gastrointestinal damage when taken with acetylsalicylic acid (see “Warnings and precautions”).

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood and urine tests, etc.), inform your doctor that you are taking this medication, as A.A.S. 100 mg may alter the results.

Taking A.A.S. 100 mg with food, beverages, and alcohol

Take this medication after meals or with some food.

If you habitually consume alcohol (three or more alcoholic beverages -beer, wine, liquor, etc.- per day), taking A.A.S. 100 mg may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The consumption of this medication during the first and second trimesters of pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.

If acetylsalicylic acid is administered to a woman who wishes to become pregnant or is pregnant for less than six months, the dose should be as low as possible and the duration of treatment as short as possible. Prolonged use is not recommended.

Do not take this medication if you are in your third trimester of pregnancy (see “Do not take A.A.S. 100 mg”).

Breastfeeding

Women in the breastfeeding period should consult their doctor before using this medication, as acetylsalicylic acid passes into breast milk.This medication is not recommended for use during breastfeeding due to the risk of adverse effects in the child.

Fertility

Acetylsalicylic acid may alter fertility by affecting ovulation. The effect is reversible upon withdrawal of the medication.

Driving and operating machinery

A.A.S. 100 mg does not appear to have any effect on the ability to drive vehicles and operate machinery.

A.A.S. 100 mg contains yellow-orange S colorant

This medication may cause allergic reactions because it contains yellow-orange S colorant (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid

A.A.S. 100 mg contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

The administration route of A.A.S. 100 mg is oral.

• In the prevention of blood clot-induced embolism (heart attack, angina pectoris, biological valve prosthesis, bypass, blood vessel inflammation caused by a blood clot, and risk of clot formation in the circulatory system), the recommended average dose is 1 to 3 A.A.S. 100 mg tablets per day, i.e., 100 mg to 300 mg per day.

• Patients with liver or kidney problems should consult their doctor as it may be necessary to reduce the dose of acetylsalicylic acid.

Your doctor will indicate the duration of your treatment with A.A.S. 100 mg. Do not stop treatment before. Under no circumstances should you modify or stop the prescribed treatment without consulting your doctor.

Use in children and adolescents

A.A.S. 100 mg should not be administered to minors under 16 years old.

Use in elderly patients

Older people should not take this medication without consulting their doctor, as they are more prone to experiencing its adverse effects.

If you take more A.A.S. 100 mg than you should

The main symptoms of moderate overdosing are: headache, confusion, dizziness, ringing in the ears, sensation of deafness, blurred vision, sweating, nausea, vomiting, and occasionally diarrhea. These can be controlled by reducing the dose.

Severe intoxication symptoms include fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiorespiratory collapse, and respiratory failure.

A non-cardiogenic pulmonary edema may appear with acute and chronic acute salicylic acid overdose (see "Possible adverse effects").

Salicylate overdose is particularly important in elderly patients and, especially in small children, and can lead to severe hypoglycemia and potentially fatal poisoning.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take A.A.S. 100 mg

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

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

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

Frequent (may affect up to 1 in 10 patients):

Blood disorders:

• Alteration of coagulation when administered at high doses (hypoprothrombinemia).

Respiratory system disorders:

• Rhinitis, difficulty breathing.
• Sensation of shortness of breath.

Gastrointestinal disorders:nausea and vomiting.

Rare (may affect up to 1 in 100 patients):

Blood disorders:

• Anemia.

Liver disorders:

• Toxicity of the liver.

General disorders:

• In patients with allergy to acetylsalicylic acid and/or other nonsteroidal anti-inflammatory drugs, generalized allergic reactions may occur. This adverse effect may also occur in people who have not previously had allergy problems with acetylsalicylic acid.

After prolonged treatment with acetylsalicylic acid, the following adverse effects have been observed, whose frequency has not been established with precision:

• Bleeding syndromes: bruises, genital bleeding, nosebleeds, gum bleeding, appearance of red spots on the skin. If a wound or cut occurs, it is possible that bleeding may take a little longer than usual to stop.
• Fixed eruption, itching, accumulation of fluid in the skin and mucous membranes, skin reactions.
• Non-cardiogenic pulmonary edema (accumulation of fluid in the lungs without cardiac disease) with chronic use and associated with an allergic reaction due to acetyl-salicylic acid, bronchospasm, asthma.
• Confusion.
• Intracranial hemorrhage that can be fatal, especially in elderly patients.
• Tinnitus, hearing loss (see "If you take more A.A.S. 100 mg than you should").
• Gastrointestinal disorders:

• Inflammation of the esophagus, duodenum, and stomach mucosa, ulcers in the esophagus, intestinal ulcers, colitis, and perforation. These reactions may be associated or not with bleeding.
• Acute pancreatitis (inflammation of the pancreas).
• Abdominal pain, dyspepsia, gastric ulcer, and duodenal ulcer.
• Stomach bleeding, which may be observed in the stool or produce vomiting with blood.

• Blood disorders: thrombocytopenia (decrease in platelet levels), pancytopenia (decrease in white blood cells, red blood cells, and platelets), bictonopenia (decrease in two types of blood cells), aplastic anemia, bone marrow insufficiency, agranulocytosis (decrease in granulocytes: a type of white blood cell), neutropenia (decrease in neutrophils: a type of white blood cell) and leukopenia (decrease in white blood cells). Hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency (see "Warnings and precautions").
• Increased liver enzymes and liver damage. Chronic hepatitis. Reye's syndrome (in children with febrile processes, flu, or varicella) (see "Warnings and precautions").
• Inflammation of the kidney and other renal problems.
• Hematospermia (presence of blood in semen).
• Sweating, headache, dizziness, and confusion may appear with high doses and prolonged use.
• Bleeding that can be fatal, vasculitis including Henoch-Schönlein purpura.
• Simultaneous occurrence of cardiac events and allergic reactions (Kounis syndrome).
• Edema (fluid accumulation) with high doses (anti-inflammatory) of acetylsalicylic acid.
• Hypersensitivity reactions, anaphylactic reactions (severe allergic reaction that may cause respiratory difficulty and even loss of consciousness).

If you notice the appearance of:

• Uncomfortable or abdominal pain, stomach bleeding or intestinal bleeding, or black stools.
• Skin disorders, such as rashes or redness.
• Difficulty breathing.
• Unexpected change in the amount or appearance of urine.
• Swelling of the face, feet, or legs.
• Deafness, tinnitus, or dizziness.

Stop taking the medicine andconsult your doctor immediately, as they may indicate the appearance of side effects that require urgent medical attention.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Store below 25°C.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of A.A.S. 100 mg

• The active ingredient is acetylsalicylic acid. Each tablet contains 100 mg of acetylsalicylic acid.
• The other components (excipients) are: sodium saccharin, mannitol (E 421), cornstarch, gum arabic, orange flavor, and yellow colorant No. 10 (E 104) and yellow-orange colorant S (E 110).

Appearance of the product and content of the packaging

A.A.S. 100 mg is presented as round, biconvex, scored, yellow to orange tablets. Each package contains 30 tablets.

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

Spain

Responsible for manufacturing

sanofi-aventis, S.A

Ctra. C35 La Batlloria to Hostalrich, Km. 63.09

17404 - Riells i Viabrea (Girona)

Spain

Last review date of this leaflet: October 2022

Other sources of information

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