A.A.S. 500 mg TABLETS

2. What you need to know before taking A.A.S. 500 mg

Do not take A.A.S. 500 mg

• If you are allergic to acetylsalicylic acid or any of the other components of this medicine (listed in section 6).
• If you have had mastocytosis (usually characterized by hives) as severe hypersensitivity reactions (exaggerated and severe allergic reaction with flushing, hypotension, tachycardia, and vomiting) may occur.
• If you have or have had stomach ulcers, duodenal ulcers, or recurring stomach problems.
• If you have had allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases coughing or wheezing when breathing) when taking medicines to reduce inflammation, acetylsalicylic acid, other pain relievers, 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 hives.
• If you have hemophilia or other blood coagulation problems that predispose you to internal bleeding, have any other bleeding disorder, or risk of bleeding.
• If you are being treated with medicines to promote blood circulation (oral anticoagulants) (see "Taking A.A.S. 500 mg with other medicines").
• If you are being treated with methotrexate used at doses higher than 20 mg/week (see "Taking A.A.S. 500 mg with other medicines").
• If you have severe liver failure.
• If you have severe kidney failure.
• If you have severe uncontrolled heart failure.
• If you are under 16 years old, unless explicitly indicated by a doctor, as the use of acetylsalicylic acid has been linked to Reye's syndrome, a rare but serious disease.
• If you are in your third trimester of pregnancy (more than 24 weeks of gestation), at doses higher than 100 mg/day (see "Pregnancy, breastfeeding, 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 these situations:

• You have kidney, heart, or liver disease (in case of severe kidney 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 need to undergo surgery, including dental surgery. In that case, you should inform your doctor or dentist.
• If you have been recently vaccinated.
• You have blood coagulation disorders or are being treated with anticoagulants.
• You have gout. Acetylsalicylic acid modifies serum uric acid at analgesic doses.
• You have uterine bleeding outside of the menstrual period or metrorrhagia or menorrhagia (prolonged and increased menstrual bleeding).
• If you have rhinitis and/or hives.
• At high doses (anti-inflammatory doses), consult your doctor if you experience ringing or noises in the ears, reduced hearing, or dizziness.
• If you have a glucose-6-phosphate dehydrogenase deficiency due to the risk of hemolysis (see "Possible side effects").
• Concomitant treatment with levothyroxine (for hypothyroidism) and salicylates should be avoided (see "Taking A.A.S. 500 mg with other medicines").
• If you are taking anti-inflammatory medicines or other types of medicines, as certain medicines can interact with A.A.S. 500 mg and produce unwanted effects (see "Taking A.A.S. 500 mg with other medicines").
• You have high blood pressure.
• In treatments with doses ≥ 500 mg/day, female fertility may be altered due to an effect on ovulation, which is reversible with withdrawal of treatment.
• You should not drink alcohol because it increases the risk of gastrointestinal side effects of acetylsalicylic acid and is a triggering factor for chronic irritation caused by acetylsalicylic acid (see "Warnings and precautions").
• In patients treated with nicorandil and acetylsalicylic acid, there is a higher risk of serious complications such as gastrointestinal ulcers, perforation, and bleeding (see "Taking A.A.S. 500 mg with other medicines").
• History of gastroduodenal ulcers, gastrointestinal bleeding, or gastritis. Avoid taking concomitantly with other medicines that may increase the risk of bleeding. Consult your doctor.
• Patient with asthma: the appearance of asthma attacks may be related to an allergy to non-steroidal anti-inflammatory medicines or acetylsalicylic acid. In this case, this medicine is contraindicated.
• Reye's syndrome, a very rare but potentially fatal disease, has been observed in children and adolescents with viral infections (especially chickenpox and flu) and who are taking acetylsalicylic acid. Consequently, 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 discontinued.
• This medicine contains acetylsalicylic acid. Other medicines also contain it; do not take them at the same time to avoid exceeding the recommended daily dose.
• Regular use of pain relievers, especially when combining pain relievers, can cause persistent kidney damage with a risk of kidney failure.
• It is not recommended to use this medicine during breastfeeding (see "Pregnancy, breastfeeding, and fertility").

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Taking A.A.S. 500 mg with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription, homeopathic medicines, herbal remedies, 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:

• Medicines used to prevent transplant rejection (cyclosporine and tacrolimus).

• High blood pressure (diuretics, angiotensin II receptor antagonists, and ACE inhibitors).
• Methotrexate (medicine used to treat cancer and rheumatoid arthritis).
• Other pain relievers or non-steroidal anti-inflammatory medicines (medicines used to treat pain and/or muscle inflammation).
• Anticoagulants (medicines used to "thin" the blood and prevent blood clots), thrombolytics (to dissolve blood clots), antiplatelet agents, and other medicines associated with a risk of bleeding.
• Medicines that lower blood sugar levels (oral antidiabetics and insulin).
• Barbiturates (medicines used to combat sleep disorders, such as sedatives and anticonvulsants).
• Corticosteroids (except hydrocortisone), as they may increase the risk of gastrointestinal bleeding.
• Cimetidine and ranitidine (used to reduce stomach acidity).
• Digoxin (medicine used to treat heart diseases).
• Phenytoin and valproic acid (antiepileptic drugs).
• 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 medicine).
• Acetazolamide (diuretic).
• Chickenpox vaccine (do not take salicylates in the 6 weeks following vaccination).
• Levothyroxine (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 due to pemetrexed.
• Alcohol: alcohol can increase the risk of gastrointestinal damage when taken with acetylsalicylic acid (see "Warnings and precautions").

Interference with diagnostic tests

If you are going to undergo any diagnostic tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medicine, as A.A.S. 500 mg may alter the results.

Taking A.A.S. 500 mg with food, drinks, and alcohol

Take this medicine after meals or with some food.

If you regularly consume alcohol (three or more alcoholic beverages - beer, wine, liquor, ... - per day), taking A.A.S. 500 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 medicine.

Taking this medicine during the first and second trimester 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 medicine if you are in your third trimester of pregnancy (see "Do not take A.A.S. 500 mg").

Breastfeeding

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

Fertility

Acetylsalicylic acid may alter fertility due to an effect on ovulation. The effect is reversible after withdrawal of the medicine.

Driving and using machines

A.A.S. 500 mg does not seem to have any effect on the ability to drive vehicles and use machines.

A.A.S. 500 mg contains sucrose

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

A.A.S. 500 mg contains sodium

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

3. How to take A.A.S. 500 mg

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

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

The recommended dose is:

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

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

If the pain persists for more than 5 days or the fever for more than 3 days, or worsens, or other symptoms appear, you should discontinue treatment and consult your doctor.

Patient 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 medicine should not be administered to children under 16 years old.

Use in elderly patients

Elderly people should not take this medicine without consulting their doctor, as they are more likely to experience its 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, feeling of deafness, blurred vision, drowsiness, nausea, vomiting, and occasionally diarrhea. They can be controlled by reducing the dose.

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

Non-cardiogenic pulmonary edema may occur with acute and chronic overdose of acetylsalicylic acid (see "Possible side effects").

Overdose with salicylates is important in elderly patients and, particularly in young 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take A.A.S. 500 mg

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

If you have any other 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 all people suffer from them.

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

Blood disorders:

• Coagulation alteration when administered at high doses (hypoprothrombinemia).

Respiratory system disorders:

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

Gastrointestinal disorders: nausea and vomiting.

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

Blood disorders:

• Anemia.

Liver disorders:

• Liver toxicity.

General disorders:

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

After prolonged treatments with acetylsalicylic acid, the following adverse effects have been observed, whose frequency could not be established with accuracy:

• Hemorrhagic syndromes: hematomas, urogenital hemorrhage, nosebleeds, gum bleeding, appearance of red spots on the skin. If a wound or cut occurs, it is possible that the bleeding may take a little longer than normal to stop.
• Fixed eruption, itching, fluid accumulation in skin and mucous membranes, skin reactions.

• Non-cardiogenic pulmonary edema (fluid accumulation in the lungs without cardiac involvement) with chronic use and associated with an allergic reaction due to acetylsalicylic acid, bronchospasm, asthma.
  • Confusion.

• Intracranial hemorrhage that can be fatal, especially in elderly patients.
• Tinnitus, deafness, (see "If you take more A.A.S. 500 mg than you should").
  • Gastrointestinal disorders:
  • • Inflammation of the esophagus, duodenum, and stomach mucosa, esophageal ulcer, intestinal ulcers, colitis, and perforation. These reactions may or may not be associated with bleeding.
    • Acute pancreatitis (inflammation of the pancreas).
    • Abdominal pain, dyspepsia, gastric ulcer, and duodenal ulcer.
    • Stomach bleeding, which can 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), bicytopenia (decrease in two types of blood cells), aplastic anemia, bone marrow failure, 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 chickenpox) (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 prolonged high doses.
  • possibly fatal bleeding, 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 with difficulty breathing and even loss of consciousness).

If you observe the appearance of:

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

Stop taking the medicine and consult 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of A.A.S. 500 mg

It does not require special storage conditions.

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

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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 Package Contents

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

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

Spain

Manufacturer

sanofi-aventis, S.A

Ctra. C35 La Batlloria a Hostalrich, Km. 63,09

17404 - Riells i Viabrea (Girona)

Spain

Date of the Last Revision of this Prospectus: October 2022

Other Sources of Information

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