ASPIRINA DOLOG INF 20CPR500MG

ASPIRINA PAIN AND INFLAMMATION 500 MG COATED TABLETS

active principles

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.

Exceptions

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

Therapeutic indications

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

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 (GFR ml/min/ 1.73 m²), • severe hepatic insufficiency, • severe uncontrolled cardiac insufficiency, • concomitant administration of methotrexate in doses higher than 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 a history of gastroduodenal ulcers (see section 4.5), • from the beginning of the 6th month of pregnancy (beyond the 24th week of amenorrhea) (see paragraph 4.6), • children and teenagers under 16 years of age.

Posology

Posology Adults and children (16 years and older): 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 water. To open the strip, tear from the edge in any position.

Storage

Do not store above 30°C. Store in the original package in order to protect from light and moisture.

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. • The medicinal product should be used with particular caution in the following cases: patients with mild to moderate renal impairment (GFR ≥ 30a) 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 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 breakthrough bleeding or menorrhagia (risk of increased volume and cycle length). • Gastrointestinal bleeding or ulcers/perforations may occur at any time during treatment, without necessarily any warning signs or patient history. 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 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 Important information on some of the excipients This medicinal product contains 71.7 mg sodium per dose equivalent to 3.6% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult.

Interactions

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

Effects

Frequencies: Not known (cannot be estimated from the 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 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 Pathologies of the nervous system Headache, dizziness, feeling of hearing loss, tinnitus, usually indicating an overdose. Intracranial hemorrhage Gastrointestinal pathologies Abdominal pain Occult or overt gastrointestinal bleeding (haematemesis, melaena, etc.) resulting in iron deficiency anemia. The risk of bleeding is dose related. Gastric ulcers and perforations Disease of the intestinal diaphragm (especially in long-term treatment) Renal and urinary disorders Renal impairment and acute kidney injury have been reported Hepatobiliary pathologies Elevated liver enzymes usually reversible upon discontinuation of treatment, liver injury, mainly of a hepatocellular nature Skin and subcutaneous tissue disorders Urticaria, rash General ailments Reye's syndrome (see section 4.4) Reporting of 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: 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, 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

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 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 mortality. 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 amenorrhoea, 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 occur even 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).

Feeding time

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 impairment of female fertility due to an effect on ovulation. This effect is reversible upon discontinuation of treatment.

Source: Farmadati