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BAYER SPA

ASPIRIN PAIN INF*20CPR500MG

ASPIRIN PAIN INF*20CPR500MG

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EAN

041962034

MINSAN

041962034

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


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Therapeutic indications

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

Dosage and method of use

Posology Adults and children (from 16 years on) : 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 your doctor. Pediatric population : Acetylsalicylic acid should not be used in children and adolescents under 16 years of age without a 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 amount of liquid.

Contraindications

• Hypersensitivity to acetylsalicylic acid or other salicylates, or to any of the excipients listed in section 6.1, • history of asthma or hypersensitivity reactions (eg urticaria, angioedema, severe rhinitis, shock) induced by the administration of salicylates or with a similar action, especially non-steroidal anti-inflammatory drugs (NSAIDs), • active peptic ulcer, • bleeding diathesis, • severe renal insufficiency, • severe hepatic insufficiency, • severe uncontrolled cardiac insufficiency, • concomitant administration of methotrexate in doses greater than 20 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), • since the beginning of the 6th month of severe dancing (beyond the 24th week of amenorrhea) (see section 4.6), • children and young people under 16 years of age.

Side effects

Frequencies: not known (cannot be estimated from the available data) Blood and lymphatic system disorders Bleeding and bleeding tendency (epistaxis, bleeding gums, purpura, etc.) with increased bleeding time. The risk of bleeding may persist for 4 to 8 days after you stop taking acetylsalicylic acid. It can cause an increased risk of bleeding in case of surgery. Intracranial and gastrointestinal hemorrhages may also occur. Immune system disorders Hypersensitivity reactions, anaphylactic reactions, asthma, angioedema Nervous system disorders Headache, dizziness, feeling of hearing loss, tinnitus, usually indicating overdose. Intracranial haemorrhage Gastrointestinal disorders Abdominal pain Occult or overt gastrointestinal haemorrhage (haematemesis, melaena, etc.) resulting in iron deficiency anemia. The risk of bleeding is dose related. Gastric ulcers and perforations Hepatobiliary disorders Elevated liver enzymes usually reversible upon discontinuation of treatment, liver injury, mainly hepatocellular in nature Skin and subcutaneous tissue disorders Urticaria, rash General disorders Reye's syndrome (see section 4.4) Patient reporting side effects It is important to report side effects of the medicine after authorisation. This allows you to continue monitoring the benefit-risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the Website: www.agenziafarmaco.gov.it/it/responsabili.

Special 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 medicinal products. • Reye's syndrome, a very rare and potentially fatal disease, has been described in children with symptoms of viral infections (particularly chicken pox 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 proved ineffective. In case of persistent vomiting, changes in consciousness or abnormal behaviour, 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, especially a combination of analgesics, can lead to permanent kidney damage, with the risk of renal failure. • In some severe forms of G6PD deficiency, high doses of acetylsalicylic acid can cause haemolysis. 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 insufficiency • in patients with hepatic insufficiency • 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 increased volume and cycle length) • Gastrointestinal bleeding or ulcers/perforations may occur at any time during treatment, without that there is necessarily no premonition 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 haemorrhage in case of surgery, even minor ( eg tooth extraction). • In analgesic or antipyretic doses, acetylsalicylic acid inhibits the excretion of uric acid; in doses used in rheumatology (anti-inflammatory doses), acetylsalicylic acid has a uricosuric effect. • The use of this medicinal product 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 gastro-duodenal ulcers (see section 4.5 ) • Other non-steroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory doses of acetylsalicylic acid (≥ 1 g per administration and/or ≥ 3 g 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 ≥ 3 g 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 artery 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 (≥ 1 g per administration and/or ≥ 3 g per day) (see section 4.5) • Pemetrexed in patients with mildly to moderately impaired renal function (creatinine clearance between 45 ml/min and 80 ml/min) (see section 4.5) • Anagrelide: increased risk of haemorrhage and decreased antithrombotic effect (see section 4.5)

Pregnancy and breastfeeding

Pregnancy Inhibition of prostaglandin synthesis may have adverse effects on the course of pregnancy and/or the 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 the early stages of pregnancy. The absolute risk of cardio vascular malformations increased from no less than 1% to approximately 1.5%. The risk appears to increase with dose and duration of treatment. In animals, administration of a prostaglandin synthesis inhibitor has been shown to cause increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period of gestation. Unless absolutely essential, acetylsalicylic acid should not be given during the first 24 weeks of amenorrhea. If acetylsalicylic acid is administered to women attempting to conceive 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 prostaglandin synthesis inhibitors can expose the fetus to: • cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); • renal dysfunction, which can progress to renal failure with oligohydramniosis; In the final phase of pregnancy, the mother and the newborn can undergo: • Prolongation of the bleeding time, due to the inhibition of platelet aggregation which can also occur at very low doses of acetylsalicylic acid; • inhibition of uterine contractions which causes the delay or prolongation of labour. 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 fertility female due to an effect on ovulation. This effect is reversible upon discontinuation of treatment.

Expiration and conservation

Do not store above 30°C

Interactions with other drugs

In the text below, 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" Several substances cause interactions, due to their platelet aggregation inhibitory 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 by constant clinical monitoring. Contraindicated combinations (see section 4.3) : • Methotrexate in doses higher than 20 mg per week, with anti-inflammatory doses of acetylsalicylic acid, or with analgesic or antipyretic doses of acetylsalicylic acid: increased methotrexate toxicity, 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 haemorrhage. 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 bleeding. • Low molecular weight heparins (and related molecules) and unfractionated heparins at curative doses, or in elderly patients (≥65 years) regardless of heparin dose, and for anti-inflammatory doses of acetylsalicylic acid or analgesic or antipyretic doses of acetylsalicylic acid: increased risk of haemorrhage (inhibition of platelet aggregation and aggression of the gastroduodenal mucosa by acetylsalicylic acid). Another anti-inflammatory drug, or another pain reliever or antipyretic should be used. • Clopidogrel (outside the approved indication for this combination in patients with acute coronary syndrome): Increased risk of haemorrhage. 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 the 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 renal impairment (creatinine clearance between 45 ml/min and 80 ml/min); increased risk of pemetrexed toxicity (due to decreased renal elimination of pemetrexed by acetylsalicylic acid) with anti-inflammatory doses of acetylsalicylic acid. • Anagrelide: increased risk of haemorrhage 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 patients Dehydrated people may experience acute renal failure caused by decreased glomerular filtration rate due to decreased synthesis of renal prostaglandins. Furthermore, there may be a reduction in the antihypertensive effect. Ensure that the patient is hydrated and that renal function is monitored at the start of treatment. • Methotrexate in doses ≤ 20 mg per week, with anti-inflammatory doses of acetylsalicylic acid, or with analgesic or antipyretic doses of acetylsalicylic acid: Increased methotrexate toxicity, especially haematological toxicity (due to reduced renal elimination of methotrexate caused by acid acetylsalicylic). Blood counts should be monitored weekly during the first few weeks of co-administration. Patients with impaired renal function (even mildly) and elderly patients should be monitored closely. • Clopidogrel (in the approved indication for this combination in patients with acute coronary syndrome): Increased risk of haemorrhage. 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 the acetylsalicylic acid. • Pemetrexed in patients with normal renal function: Increased risk of pemetrexed toxicity (due to decreased renal elimination of pemetrexed by acetylsalicylic acid) with anti-inflammatory doses of acetylsalicylic acid. Renal function should be monitored. Combinations that must be taken into account : • 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 bleeding. • Low molecular weight heparins (and related molecules) and unfractionated heparins in preventive doses in patients under 65 years of age: by influencing haemostasis to various levels, concomitant administration increases the risk of haemorrhage. Therefore, in patients under 65 years of age, the concomitant administration of heparins (or related molecules) in preventive doses, and acetylsalicylic acid in any dose, should be considered, combined with clinical and laboratory monitoring as necessary. . • Thrombolytics: increased risk of haemorrhage. • Selective Serotonin Reuptake Inhibitors (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline): increased risk of haemorrhage.

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, feeling of hearing loss, headache and dizziness are indicative of an overdose and can be controlled by reducing the dosage. Severe intoxication : Symptoms include: Fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, circulatory collapse, respiratory failure, severe hypoglycemia. In children, overdose can be fatal 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 • Urine alkalization with urinary pH monitoring • Hemodialysis in case of severe intoxication • Symptomatic treatment

Active principles

Each tablet contains 500 mg of acetylsalicylic acid. For the full list of excipients, see section 6.1.

Excipients

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

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