Package Insert: Information for the User

A.A.S. 500 mg Tablets

Acetylsalicylic Acid

Contents of the Package and Additional Information

Acetylsalicylic acid, the active ingredient of this medication, acts by reducing pain and fever.

This medication is indicated in adults and children over 16 years old for:

- Symptomatic relief of occasional mild or moderate pain.

- Treatment of fever.

Do not take A.A.S. 500 mg

• If you are allergic to acetylsalicylic acid, or to 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 reaction with flushing, hypotension, tachycardia, and vomiting) may occur.
• If you have or have had gastric, duodenal ulcers, or repeated gastrointestinal discomfort.
• If you have had asthmatic reactions (difficulty breathing, choking, bronchospasm, and in some cases coughing or wheezing) to taking medications to reduce inflammation, acetylsalicylic acid, other analgesics, as well as to 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 taking medications to promote blood circulation (oral anticoagulants) (see "Taking A.A.S. 500 mg with other medications").
• If you are taking methotrexate at doses greater than 20 mg/week (see "Taking A.A.S. 500 mg with other medications").
• If you have severe liver failure.
• If you have severe renal 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 greater than 100 mg/day (see "Pregnancy, lactation, and fertility").

Warnings and precautions

Consult your doctor or pharmacist before starting to take A.A.S. 500 mg if you are in any of the following cases:

• You have any kidney, heart, or liver disease (in case of severe renal failure, it is contraindicated, see "Do not take A.A.S. 500 mg").
• You have mild or moderate liver failure (in case of severe liver failure, it is contraindicated, see "Do not take A.A.S. 500 mg").
• You are to undergo surgery, including dental surgery. In that case, you should inform your doctor or dentist.
• You have been recently vaccinated.
• You have alterations in blood coagulation or are taking anticoagulants.
• You have gout. Acetylsalicylic acid modifies serum uric acid at analgesic doses.
• You have uterine bleeding outside of menstrual period or metrorrhagia or menorragia (prolonged and increased menstrual bleeding).
• You have rhinitis and/or urticaria.
• At high doses (anti-inflammatory doses), consult your doctor if you experience ringing in the 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 (to treat hypothyroidism) and salicylates (see "Taking A.A.S. 500 mg with other medications").
• Avoid taking other medications as certain medications may interact with A.A.S. 500 mg and produce unwanted effects (see "Taking A.A.S. 500 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 produced by acetylsalicylic acid (see "Taking A.A.S. 500 mg with food, drinks, and alcohol").
• In patients taking nicorandil and acetylsalicylic acid, there is a greater risk of severe complications such as gastrointestinal ulcers, perforation, and bleeding (see "Taking A.A.S. 500 mg with other medications").
• History of gastric or duodenal 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 occurrence of asthma attacks may be related to an allergy to nonsteroidal 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 taking acetylsalicylic acid. Therefore, acetylsalicylic acid should be administered to these children and adolescents only 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, may cause persistent renal damage with a risk of renal failure.
• This medication is not recommended for use during lactation (see "Pregnancy, lactation, and fertility").

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

Taking A.A.S. 500 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 nonsteroidal anti-inflammatory drugs (medications used to treat pain and/or muscle inflammation).
• Anticoagulants (medications used to "thin" the blood and prevent the formation of clots), thrombolytics (to dissolve blood clots), antiplatelet agents, and other medications associated with bleeding risk.
• Medications that reduce blood sugar levels (oral antidiabetics and insulin).
• Barbiturates (medications used to combat sleep disorders, such as sedatives and anticonvulsants).
• Corticosteroids (except hydrocortisone), as it 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. 500 mg may alter the results.

Taking A.A.S. 500 mg with food, drinks, 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. 500 mg may cause stomach bleeding.

Pregnancy, lactation, and fertility

Pregnancy

If you are pregnant or breastfeeding, or if you think you may be 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. 500 mg").

Lactation

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

Fertility

Acetylsalicylic acid may alter fertility due to an effect on ovulation. The effect is reversible upon withdrawal of treatment.

Driving and operating machinery

A.A.S. 500 mg does not appear to have any effect on the ability to drive vehicles and operate machinery.

A.A.S. 500 mg contains saccharose

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

A.A.S. 500 mg contains sodium

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The administration route for this medication is oral. The medication should be taken with meals or with milk, especially if digestive discomfort is noted. This medication should not be taken on an empty stomach.

The recommended dose is:

• Adults and individuals over 16 years old: 1 tablet of A.A.S. 500 mg every four or six hours, that is, 500 mg of acetylsalicylic acid every four or six hours, as needed, while symptoms persist. No more than 8 tablets should be administered daily, that is, 4 grams of acetylsalicylic acid in 24 hours.

Administration is subject to the appearance of symptoms and should be suspended when they disappear.

If pain persists for more than 5 days, or fever for more than 3 days, or worsens or other symptoms appear, treatment should be interrupted and the doctor consulted.

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

Always use the lowest effective dose.

Your doctor will indicate the duration of your treatment with A.A.S. 500 mg.

Use in children and adolescents

This medication should not be administered to individuals under 16 years old.

Use in elderly patients

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

If you take more A.A.S. 500 mg than you should

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

The symptoms of severe intoxication include fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiorespiratory collapse, respiratory failure.

Pulmonary edema not caused by heart disease may appear with acute and chronic overdose of acetylsalicylic acid (see “Possible adverse effects”).

Salicylate overdose is particularly important in elderly patients and, especially in small children, and may 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take A.A.S. 500 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 lack of air.

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 presented allergy problems to 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 any wound or cut occurs, it is possible that bleeding will take a little longer than usual to stop.
• Fixed eruption, itching, accumulation of fluid in the skin and mucous membranes, skin reactions.

-Pulmonary edema not cardiogenic (accumulation of fluid in the lungs without heart 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 in the ears, hearing loss, (see “If you take more A.A.S. 500 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), bictonia (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 fever, flu, or varicella) (see “Warnings and precautions”).

• Renal inflammation and other kidney problems.
• Haematospermia (presence of blood in semen).
• Sweating, headache, dizziness, and confusion may appear with high doses for a long time.
• Fatal hemorrhage, vasculitis, including Henoch-Schönlein purpura.
• Simultaneous appearance 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:

• Uncomfort 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 about possible adverse effects that do 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 about the safety of this medicine.

This medication does not require special conditions for conservation.

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 the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of A.A.S. 500 mg

• The active ingredient is acetylsalicylic acid. Each tablet contains 500 mg of acetylsalicylic acid.
• The other components (excipients) are: sodium saccharin, mannitol (E 421), cornstarch, gum arabic, and orange flavor (which contains sucrose, maltodextrin, modified cornstarch (E 1450), and butylhydroxyanisole (E 320)).

Appearance of the product and content of the packaging

A.A.S. 500 mg is presented as round, biconvex, double-scored, white tablets. Each package contains 20 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/