Aspirin Pain Inflammation 20 Tablets 500mg

INDICATIONS

Symptomatic treatment of fever and/or mild to moderate pain, such as headache, flu syndrome, toothache, muscle pain.

ACTIVE INGREDIENTS

Each tablet contains 500 mg of acetylsalicylic acid. Excipients with known effect: one coated tablet contains 3.12 mmol (or 71.7 mg) sodium. For the full list of excipients, see section 6.1.

EXCIPIENTS

Tablet core: Colloidal silicon dioxide, Sodium carbonate. Coating: Carnauba wax, Hypromellose, Zinc stearate.

CONTRAINDICATIONS AND SIDE EFFECTS

• Hypersensitivity to acetylsalicylic acid or other salicylates, or to any of the excipients listed in section 6.1, • history of asthma or hypersensitivity reactions (e.g. urticaria, angioedema, severe rhinitis, shock) induced by the administration of salicylates or substances with a similar action, in particular non-steroidal anti-inflammatory drugs (NSAIDs), • active peptic ulcer, • diathesis hemorrhagic, • severe renal failure (GFR< 30 ml/min/ 1.73 m²), • severe hepatic failure, • severe uncontrolled heart failure, • concomitant administration of methotrexate in doses exceeding 15 mg per week, for anti-inflammatory doses of acetylsalicylic acid, or for analgesic or antipyretic doses (see section 4.5), • concomitant administration of oral anticoagulants for anti-inflammatory doses of acetylsalicylic acid, or for analgesic or antipyretic doses and in patients with history of gastroduodenal ulcers (see section 4.5), • from the beginning of the 6th month of pregnancy (beyond the twenty-fourth week of amenorrhea) (see section 4.6), • children and young people under 16 years of age.

DOSAGE

Dosage Adults and children (from 16 years onwards): 1 to 2 tablets for each dose to be repeated as needed after a minimum period of 4 hours. The maximum daily dose should not exceed 6 tablets. Elderly (from 65 years): 1 tablet for each dose to be repeated as needed after a minimum period of 4 hours. The maximum daily dose should not exceed 4 tablets. Acetylsalicylic acid should not be taken for more than 3 days (in case of fever) or 3 - 4 days (in case of pain) unless otherwise indicated by the doctor. Pediatric population: Acetylsalicylic acid should not be used in children and adolescents under 16 years of age without a medical prescription. Acetylsalicylic acid should be used with caution in patients with abnormal liver or kidney function or circulatory problems. Method of administration For oral use. The tablets should be taken with an adequate quantity of water. To open the strip, tear from the edge at any position.

CONSERVATION

Do not store above 30°C. Store in the original packaging to protect from light and humidity.

WARNINGS

In case of combination with other medicinal products, to avoid any risk of overdose, check that acetylsalicylic acid is absent from the composition of these other medicines. • Reye's syndrome, a very rare and potentially fatal disease, has been described in children with symptoms of viral infections (particularly chickenpox and flu episodes) with or without taking acetylsalicylic acid. Consequently, acetylsalicylic acid should be administered to children in these conditions only after medical advice and when other measures have proven ineffective. In case of persistent vomiting, changes in consciousness or abnormal behavior, treatment with acetylsalicylic acid should be discontinued. • In case of prolonged administration of high-dose analgesics, the headache attack should not be treated with higher doses. • Regular use of analgesics, particularly a combination of analgesics, may result in permanent kidney damage, with risk of renal failure. • The medicine must be used with particular caution in the following cases: patients with mild to moderate renal function impairment (GFR ≥ 30 to < 90 ml/min/ 1.73 m²) or patients with impaired cardiovascular circulation (e.g. renal vascular disease, congestive heart failure, volume depletion, major surgery, sepsis or major bleeding events) as acetylsalicylic acid may further increase the risk of renal impairment and acute renal failure. • In some severe forms of G6PD deficiency, high doses of acetylsalicylic acid can cause hemolysis. In case of G6PD deficiency, acetylsalicylic acid should be administered under medical supervision. • Treatment monitoring should be intensified in the following cases: • in patients with a history of gastric or duodenal ulcer, gastrointestinal bleeding, or gastritis; • in patients with renal failure; • in patients with liver failure; • in patients with asthma: the occurrence of an asthma attack, in some patients, may be linked to an allergy to non-steroidal anti-inflammatory drugs or to acetylsalicylic acid; in this case, this medicinal product is contraindicated (see section 4.3); • in patients with metrorrhagia or menorrhagia (risk of an increase in the volume and duration of the cycle). • Gastrointestinal bleeding or ulcers/perforations may occur at any time during treatment, without necessarily having any warning signs or history in the patient. The relative risk increases in elderly subjects, in subjects with low body weight, and in patients receiving anticoagulants or platelet aggregation inhibitors (see section 4.5). In case of gastrointestinal bleeding, treatment should be stopped immediately. • Given the inhibitory effect of acetylsalicylic acid on platelet aggregation, which occurs even at very low doses and persists for several days, the patient should be aware of the risk of bleeding in the event of surgical interventions, even minor ones (e.g. tooth extraction). • In analgesic or antipyretic doses, acetylsalicylic acid inhibits the excretion of uric acid; in the doses used in rheumatology (anti-inflammatory doses), acetylsalicylic acid has a uricosuric effect. • The use of this medicine is not recommended during breastfeeding (see section 4.6). The administration of acetylsalicylic acid is not recommended with: • Oral anticoagulants with analgesic or antipyretic doses of acetylsalicylic acid (≥500 mg per administration and/or < 3 g per day) and in patients without a history of gastroduodenal ulcers (see section 4.5); • Other non-steroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory doses of acetylsalicylic acid (≥ 1g per administration and/or ≥ 3g per day) or with analgesic or antipyretic doses of acetylsalicylic acid (≥500 mg per administration and/or < 3 g per day) (see section 4.5); • Low molecular weight heparins (and related molecules) and unfractionated heparins with therapeutic doses or in elderly patients (>65 years) regardless of the heparin dose, and for anti-inflammatory doses of acetylsalicylic acid (≥ 1g per administration and/or ≥ 3g per day) or with analgesic or antipyretic doses of acetylsalicylic acid (≥500 mg per administration and/or < 3 g per day) (see section 4.5); • Clopidogrel (beyond the approved indications for this combination in patients with acute coronary disease) (see section 4.5); • Ticlopidine (see section 4.5); • Uricosurics (see section 4.5); • Glucocorticoids (except hydrocortisone replacement therapy) for anti-inflammatory doses of acetylsalicylic acid (≥ 1g per administration and/or ≥ 3g per day) (see section 4.5); • Pemetrexed in patients with mildly to moderately reduced renal function (creatinine clearance between 45 ml/min and 80 ml/min) (see section 4.5); • Anagrelide: increased risk of bleeding and decreased antithrombotic effect (see paragraph 4.5). Important information about some excipients This medicinal product contains 71.7 mg sodium per dose equivalent to 3.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

INTERACTIONS

In the following text, the following definitions apply: - anti-inflammatory doses of acetylsalicylic acid are defined as “≥ 1g per administration and/or ≥ 3g per day”; - Analgesic or antipyretic doses of acetylsalicylic acid are defined as “≥500 mg per administration and/or <3 g per day”. Various substances give rise to interactions, due to their platelet aggregation inhibitor properties: abciximab, acetylsalicylic acid, cilostazol, clopidogrel, epoprostenol, eptifibatide, iloprost, iloprost trometamol, prasugrel, ticlopidine, Tirofiban, ticagrelor. The risk of bleeding increases with the use of multiple platelet aggregation inhibitors as well as with their use in combination with heparin or related molecules, oral anticoagulants or other thrombolytics, and must be evaluated through constant clinical monitoring. Contraindicated combinations (see section 4.3): • Methotrexate in doses higher than 15 mg per week, with anti-inflammatory doses of acetylsalicylic acid, or with analgesic or antipyretic doses of acetylsalicylic acid: increased toxicity of methotrexate, in particular haematological toxicity (due to reduced renal elimination of methotrexate caused by acetylsalicylic acid). • Oral anticoagulants with anti-inflammatory doses of acetylsalicylic acid, or with analgesic or antipyretic doses of acetylsalicylic acid and in patients with a history of gastroduodenal ulcers: increased risk of hemorrhage. Combinations not recommended: • Oral anticoagulants with analgesic or antipyretic doses of acetylsalicylic acid and in patients without a history of gastroduodenal ulcers: increased risk of haemorrhage. • Other non-steroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory doses of acetylsalicylic acid, or with analgesic or antipyretic doses of acetylsalicylic acid: increased risk of gastrointestinal ulcers and haemorrhage. • Low molecular weight heparins (and related molecules) and unfractionated heparins at curative doses, or in elderly patients (≥65 years) regardless of the heparin dose, and for anti-inflammatory doses of acetylsalicylic acid or analgesic or antipyretic doses of acetylsalicylic acid: increased risk of hemorrhage (inhibition of platelet aggregation and aggression of the gastroduodenal mucosa by the acid acetylsalicylic). Another anti-inflammatory drug, or another analgesic or antipyretic should be used. • Clopidogrel (outside the approved indication for this combination in patients with acute coronary syndrome): increased risk of bleeding. If concomitant administration cannot be avoided, clinical monitoring is recommended. • Ticlopidine: increased risk of haemorrhage. If concomitant administration cannot be avoided, clinical monitoring is recommended. • Uricosurics (benzbromarone, probenecid): reduction of the uricosuric effect due to competition for the elimination of uric acid in the renal tubules. • Glucocorticoids (excluding hydrocortisone replacement therapy) for anti-inflammatory doses of acetylsalicylic acid: increased risk of bleeding. • Pemetrexed in patients with mild to moderate reduction in renal function (creatinine clearance between 45 ml/min and 80 ml/min); increased risk of pemetrexed toxicity (due to decreased renal elimination of pemetrexed caused by acetylsalicylic acid) with anti-inflammatory doses of acetylsalicylic acid. • Anagrelide: increased risk of hemorrhage and decreased antithrombotic effect. If concomitant administration cannot be avoided, clinical monitoring is recommended. Combinations requiring precautions for use: • Diuretics, angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists, with anti-inflammatory doses of acetylsalicylic acid or with analgesic or antipyretic doses of acetylsalicylic acid: In dehydrated patients, acute renal failure may occur caused by the reduction in the glomerular filtration rate due to the decreased synthesis of renal prostaglandins. Furthermore, there may be a reduction in the antihypertensive effect. Ensure the patient is hydrated and renal function is monitored at the start of treatment. • Methotrexate in doses ≤ 15 mg per week, with anti-inflammatory doses of acetylsalicylic acid, or with analgesic or antipyretic doses of acetylsalicylic acid: increased toxicity of methotrexate, in particular haematological toxicity (due to reduced renal elimination of methotrexate caused by acetylsalicylic acid). Complete blood counts should be monitored weekly during the first few weeks of coadministration. Patients with reduced renal function (even mild) and elderly patients should be closely monitored. • Clopidogrel (in the approved indication for this combination in patients with acute coronary syndrome): increased risk of bleeding. Clinical monitoring is recommended. • Topical gastrointestinal treatments, antacids and activated charcoal: increased renal excretion of acetylsalicylic acid due to alkalinization of the urine. It is recommended to administer antacids and topical gastrointestinal treatments at least two hours after taking acetylsalicylic acid. • Pemetrexed in patients with normal renal function: increased risk of pemetrexed toxicity (due to decreased renal elimination of pemetrexed caused by acetylsalicylic acid) with anti-inflammatory doses of acetylsalicylic acid. Renal function should be monitored. Combinations that must be taken into consideration: • Glucocorticoids (excluding hydrocortisone replacement therapy) for analgesic and antipyretic doses of acetylsalicylic acid: increased risk of haemorrhage. • Deferasirox: with anti-inflammatory doses of acetylsalicylic acid, or with analgesic or antipyretic doses of acetylsalicylic acid: increased risk of gastrointestinal ulcers and haemorrhage. • Low molecular weight heparins (and related molecules) and unfractionated heparins in preventive doses in patients under 65 years of age: influencing hemostasis at various levels, concomitant administration increases the risk of hemorrhage. Therefore, in patients under 65 years of age, the concomitant administration of heparins (or related molecules) in preventive doses, and of acetylsalicylic acid in any dose, should be taken into consideration combined with clinical and laboratory monitoring as needed. • Thrombolytics: increased risk of haemorrhage. • Selective Serotonin Reuptake Inhibitors (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline): increased risk of bleeding.

SIDE EFFECTS

Frequencies: not known (cannot be estimated from available data) Blood and lymphatic system disorders Bleeding and tendency to haemorrhage (epistaxis, bleeding gums, purpura, etc.) with increased bleeding time. The risk of bleeding may persist for 4-8 days after stopping taking acetylsalicylic acid. It may cause an increased risk of bleeding during surgery. Intracranial and gastrointestinal hemorrhages may also occur. Immune system disorders Hypersensitivity reactions, anaphylactic reactions, asthma, angioedema Nervous system disorders Headache, dizziness, sensation of hearing loss, tinnitus, usually indicating an overdose. Intracranial hemorrhage Gastrointestinal disorders Abdominal pain Occult or overt gastrointestinal bleeding (hematemesis, melena, etc.) resulting in iron deficiency anemia. The risk of bleeding is dose related. Gastric ulcers and perforations Intestinal diaphragm disease (especially in long-term treatment) Renal and urinary disorders Renal impairment and acute kidney injury have been reported Hepatobiliary disorders Elevations of liver enzymes usually reversible upon discontinuation of treatment, liver damage, mainly hepatocellular in nature Pathologies of the skin and subcutaneous tissue Urticaria, skin rashes General disorders Reye's syndrome (see section 4.4) Reporting of side effects It is important to report side effects of the medicine after authorization. This allows continued monitoring of the risk-benefit ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reaction via the Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

OVERDOSE

Overdose can be harmful in elderly subjects and in particular in young children (therapeutic overdose or, more frequently, accidental intoxication) in which it can be fatal. Symptoms Moderate intoxication: Symptoms such as ringing in the ears, sensation of hearing loss, headache and dizziness are indicative of overdose and can be controlled by reducing the dosage. Severe intoxication: Symptoms include: Fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiovascular collapse, respiratory failure, severe hypoglycemia. In children, overdose can be fatal starting from a single dose of 100 mg/kg. Emergency management • Immediate transfer to a specialized hospital unit • Gastrointestinal lavage and administration of activated charcoal • Control of acid-base balance • Alkalinization of urine with monitoring of urinary pH • Hemodialysis in case of severe intoxication • Symptomatic treatment

PREGNANCY AND BREASTFEEDING

Pregnancy Inhibition of prostaglandin synthesis may have adverse effects on the course of pregnancy and/or embryo-foetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformations and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular malformations increased from no less than 1% to approximately 1.5%. The risk appears to increase with the dose and duration of treatment. In animals, it has been demonstrated that the administration of a prostaglandin synthesis inhibitor causes an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals administered a prostaglandin synthesis inhibitor during the organogenetic period of gestation. Unless absolutely essential, acetylsalicylic acid should not be administered during the first 24 weeks of amenorrhea. If acetylsalicylic acid is administered to women who wish to become pregnant or are pregnant during the first 24 weeks of amenorrhea, the dose should be as low as possible and the duration of treatment as short as possible. Beyond the 24th week of amenorrhea, all inhibitors of prostaglandin synthesis can expose the fetus to: • cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); • renal dysfunction, which can evolve into renal failure with oligohydramniosis; In the final phase of pregnancy, the mother and newborn may experience: • Prolongation of the bleeding time, due to the inhibition of platelet aggregation which can occur even at very low doses of acetylsalicylic acid; • inhibition of uterine contractions which determines the delay or prolongation of labor. Therefore, acetylsalicylic acid is contraindicated beyond the 5th month of pregnancy (beyond 24 weeks of amenorrhea) (see section 4.3). Breastfeeding Acetylsalicylic acid passes into breast milk: therefore the use of acetylsalicylic acid is not recommended during breastfeeding (see section 4.4) Fertility There is some evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may cause impaired female fertility due to an effect on ovulation. This effect is reversible upon discontinuation of treatment.

EFFECTS ON DRIVING ABILITY

Acetylsalicylic acid has no influence on the ability to drive and use machines.