A.A.S. 100 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

A.A.S. 100 mg tablets

Acetylsalicylic acid

Package leaflet contents

1. What A.A.S. 100 mg is and what it is used for
2. What you need to know before taking A.A.S. 100 mg
3. How to take A.A.S. 100 mg
4. Possible side effects
5. Storage of A.A.S. 100 mg
6. Contents of the pack and other information

1. What A.A.S. 100 mg is and what it is used for

A.A.S. 100 mg is indicated for the prevention of blood clots and for reducing the risk of blockage of your arteries, because:

• you have previously had a myocardial infarction or angina pectoris.
• you have had a non-hemorrhagic stroke, either transient or permanent.
• you have undergone a surgical procedure such as coronary angioplasty or coronary bypass.

2. What you need to know before starting A.A.S. 100 mg

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

• If you are allergic to acetylsalicylic acid or to any of the other ingredients of this medicine (listed in section 6).
• If you have mastocytosis (usually characterized by hives), as severe hypersensitivity reactions (severe allergic reactions with flushing, hypotension, tachycardia, and vomiting) may occur.
• If you have or have had gastric, duodenal ulcers, or recurrent gastric discomfort.
• If you have experienced asthma-type allergic reactions (difficulty breathing, suffocation, bronchospasm, and in some cases coughing or wheezing) when taking anti-inflammatory drugs, acetylsalicylic acid, other analgesics, or when consuming tartrazine dye.
• If you have or have had asthma or nasal polyps associated with asthma induced or worsened by acetylsalicylic acid, rhinitis, or urticaria.
• If you have hemophilia or other blood coagulation disorders that predispose you to internal bleeding, or any other bleeding disorder or risk of bleeding.
• If you are being treated with medications to improve blood circulation (oral anticoagulants) (see "Taking A.A.S. 100 mg with other medicines").
• If you are being treated with methotrexate at doses exceeding 20 mg/week (see "Taking A.A.S. 100 mg with other medicines").
• 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 of age, unless specifically instructed by a doctor, as the use of acetylsalicylic acid has been associated with Reye's syndrome, a rare but serious illness.
• If you are in your third trimester of pregnancy (more than 24 weeks of gestation) and taking doses exceeding 100 mg/day (see "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

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

• You have kidney, heart, or liver disease.

• You have mild or moderate liver impairment (in case of severe liver failure, it is contraindicated; see "Do not take A.A.S. 100 mg").

• You have blood coagulation disorders or are undergoing anticoagulant therapy.

• You have gout. Acetylsalicylic acid alters serum uric acid levels at analgesic doses.

• You experience uterine bleeding outside the menstrual period, metrorrhagia, or menorrhagia (prolonged and increased menstrual bleeding).

• You are scheduled for surgery, including dental surgery. In such cases, 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 tinnitus or noises in the ears, reduced hearing, or dizziness.

• If you have glucose-6-phosphate dehydrogenase deficiency due to the risk of hemolysis (see "Possible adverse effects").

• Concomitant treatment with levothyroxine (used to treat hypothyroidism) and salicylates should be avoided (see "Taking A.A.S. 100 mg with other medicines").

• If you are taking anti-inflammatory drugs or other medications, as certain medicines may interact with A.A.S. 100 mg and cause unwanted effects (see "Taking A.A.S. 100 mg with other medicines").

• You have hypertension.

• With daily doses ≥ 500 mg/day, female fertility may be impaired due to effects on ovulation; this effect is reversible upon discontinuation of treatment.

• You should avoid alcohol, as it increases gastrointestinal adverse effects of acetylsalicylic acid and is a triggering factor for chronic irritation caused by acetylsalicylic acid (see "Taking A.A.S. 100 mg with food, drinks, and alcohol").

• In patients treated with nicorandil and acetylsalicylic acid, there is an increased risk of serious complications such as gastrointestinal ulcer, perforation, and hemorrhage (see "Taking A.A.S. 100 mg with other medicines").

• History of gastroduodenal ulcer, gastrointestinal bleeding, or gastritis. Avoid concomitant use with other medications that may increase the risk of bleeding. Consult your doctor.

• Patients with asthma: asthma attacks may be related to allergy to non-steroidal anti-inflammatory drugs or acetylsalicylic acid. In such cases, 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 influenza) who are taking acetylsalicylic acid. Therefore, acetylsalicylic acid should only be administered to these children and adolescents under medical advice, when other measures have failed. If persistent vomiting, loss of consciousness, or abnormal behavior occurs, treatment with acetylsalicylic acid must be discontinued.

• This medicine contains acetylsalicylic acid. Other medicines also contain it; do not take them simultaneously to avoid exceeding the recommended daily dose.

• Regular use of analgesics, especially when analgesics are combined, may cause persistent kidney damage with risk of renal 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 occurred in the past.

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

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine, including over-the-counter medicines, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one or more 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 (a medicine used for cancer and rheumatoid arthritis treatment).
• Other analgesics or non-steroidal anti-inflammatory drugs (medicines used to treat pain and/or muscle inflammation).
• Anticoagulants (medicines used to thin the blood and prevent clot formation), thrombolytics (to dissolve clots), antiplatelet agents, and other medicines associated with bleeding risk.
• Medicines that lower blood sugar levels (oral antidiabetics and insulin).
• Barbiturates (medicines used to treat sleep disorders, 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 (a 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 to treat infections).
• Interferon alpha.
• Zidovudine (used in the treatment of AIDS).
• Metamizole (another analgesic/antipyretic medicine).
• Acetazolamide (a diuretic).
• Varicella vaccine (do not take salicylates within 6 weeks after vaccination).
• Levothyroxine (thyroid hormone).
• Tenofovir (used in the treatment of AIDS).
• Nicorandil (used in the treatment of heart diseases) (see "Warnings and precautions").
• Pemetrexed: increased risk of pemetrexed toxicity.
• 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 scheduled for any diagnostic tests (including blood and urine tests), inform your doctor that you are taking this medicine, as A.A.S. 100 mg may alter test results.

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

Take this medicine after meals or with food.

If you regularly consume alcohol (three or more alcoholic drinks—beer, wine, spirits, 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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Taking this medicine during the first and second trimesters of pregnancy may be harmful 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 less than six months pregnant, 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. 100 mg").

Breastfeeding

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

Fertility

Acetylsalicylic acid may affect fertility by altering ovulation. This effect is reversible after discontinuation of the medicine.

Driving and using machines

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

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

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

A.A.S. 100 mg contains sodium

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

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

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

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

• For the prevention of embolism caused by a blood clot (infarction, angina pectoris, biological heart valve prosthesis, bypass, inflammation of a blood vessel due to a blood clot, and risk of clot formation in the circulatory system), the recommended average dose is 1 to 3 tablets of A.A.S. 100 mg 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 the treatment prematurely. Under no circumstances should you modify or discontinue the prescribed treatment without consulting your doctor.

Use in children and adolescents

A.A.S. 100 mg must not be given to children under 16 years of age.

Use in elderly patients

Elderly individuals should not take this medicine without consulting their doctor, as they are more likely to experience adverse effects.

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

The main symptoms of moderate overdose include: headache, confusion, dizziness, tinnitus, sensation of deafness, blurred vision, sweating, nausea, vomiting, and occasionally diarrhea. These may be controlled by reducing the dose.

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

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

Overdose with salicylates is particularly significant in elderly patients and especially in young children, and may lead to severe hypoglycemia and potentially fatal intoxication.

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

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

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

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 will experience them.

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

Blood disorders:

• Impaired blood coagulation when administered at high doses (hypoprothrombinemia).

Respiratory system disorders:

• Rhinitis, difficulty breathing.
• Sensation of breathlessness.

Gastrointestinal disorders: nausea and vomiting.

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

Blood disorders:

• Anaemia.

Liver disorders:

• Liver toxicity.

General disorders:

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

The following adverse effects have been observed after prolonged treatment with acetylsalicylic acid, but their frequency cannot be accurately determined:

• Haemorrhagic syndromes: bruising, urogenital bleeding, nosebleeds, bleeding gums, appearance of red spots on the skin. If an injury or cut occurs, bleeding may take slightly longer than normal to stop.

• Fixed eruption, itching, fluid accumulation in the skin and mucous membranes, skin reactions.

• Non-cardiogenic pulmonary oedema (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 haemorrhage, which may be fatal, especially in elderly patients.

• Tinnitus, deafness (see “If you take more A.A.S. 100 mg than you should”).

• Gastrointestinal disorders:

• Inflammation of the oesophagus, duodenum and gastric mucosa, oesophageal ulcers, 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 may be visible in stools or cause vomiting of blood.

• Blood disorders: thrombocytopenia (decreased platelet levels), pancytopenia (decreased white blood cells, red blood cells and platelets), bicytopenia (decreased levels of two types of blood cells), aplastic anaemia, bone marrow failure, agranulocytosis (decreased granulocytes: a type of white blood cell), neutropenia (decreased neutrophils: a type of white blood cell) and leucopenia (decreased white blood cells). Haemolytic anaemia 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 conditions, influenza or chickenpox) (see “Warnings and precautions”).

• Kidney inflammation and other renal problems.

• Haematospermia (presence of blood in semen).

• Sweating, headache, dizziness and confusion may occur with prolonged high doses.

• Haemorrhage, which may be fatal, vasculitis including Henoch-Schönlein purpura.

• Simultaneous occurrence of cardiac events and allergic reactions (Kounis syndrome).

• Oedema (fluid accumulation) with high (anti-inflammatory) doses of acetylsalicylic acid.

• Hypersensitivity reactions, anaphylactic reactions (severe allergic reaction with breathing difficulty and even loss of consciousness).

If you notice any of the following:

• Stomach discomfort or pain, gastrointestinal bleeding, or black stools.
• Skin disorders such as rashes or redness.
• Difficulty breathing.
• Unexpected changes 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 these may indicate adverse effects requiring 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 not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of A.A.S. 100 mg

Store below 25°C.

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of A.A.S. 100 mg

• The active substance is acetylsalicylic acid. Each tablet contains 100 mg of acetylsalicylic acid.
• The other components (excipients) are: sodium saccharin, mannitol (E 421), maize starch, gum arabic, orange flavour, and colouring Yellow No. 10 (E 104) and Orange Yellow S colouring (E 110).

Appearance of the medicine and contents of the pack

A.A.S. 100 mg is presented as round, biconvex, scored tablets, yellow to orange in colour. Each pack contains 30 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 most recent revision of this leaflet: October 2022

Other sources of information

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