Acetylsalicylic acid

Acid acetilsalicilic

Each tablet contains acetylsalicylic acid 500 mg.

Indication: As an analgesic and antipyretic: relief of mild to moderate pain (headache, myalgia, lumbago, rheumatic articular and periarticular pain, neuralgia, toothache, sore throat, dysmenorrhoea), and of pain and fever associated with influenza or the common cold.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
− Hypersensitivity to the active substance, other salicylates or to any of the excipients listed in section 6.1;
− Active gastric or duodenal ulcer, gastrointestinal bleeding or perforation;
− Haemorrhagic diathesis;
− History of bronchial asthma induced by administration of salicylates or medicinal products with a similar action, in particular non-steroidal anti-inflammatory drugs;
− Last trimester of pregnancy;
− Severe heart failure;
− Severe hepatic impairment;
− Severe renal impairment;
− Concomitant use with methotrexate at doses ≥15 mg/week (see section 4.5).
− Concomitant use of acetylsalicylic acid with anticoagulants in patients with a history of gastroduodenal ulcers − increased risk of bleeding (see section 4.5).
− Children and adolescents under 18 years of age.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use
Acetylsalicylic acid may be used in the following cases only after careful assessment of the potential risk/therapeutic benefit ratio:
− Hypersensitivity to other analgesics, non-steroidal anti-inflammatory drugs, antirheumatic agents and other allergens.
− Patients with an allergic background: in cases of bronchial asthma and other chronic obstructive bronchopulmonary diseases, pollen allergy, allergic rhinitis, nasal polyps, allergic reactions to other medicinal products (e.g. analgesics or antirheumatic agents) or foods (e.g. preservatives) − treatment should be initiated only on a doctor's recommendation and under medical supervision, since asthma attacks, skin rashes (particularly urticaria) or angioedema (Quincke's oedema) may occur (more frequently than in other patients).
− Gastrointestinal disorders.
− Inflammatory or ulcerative conditions of the gastrointestinal tract […]