ASPIRINA DOLOG INF 8CPR 500MG

ASPIRINA DOLOGY AND INFIAMMATION 500 MG

active ingredients

Each tablet contains 500 mg of acetylsalicylic acid. Excipients with a known effect: a coated tablet contains 3,12 mmoli (or 71,7 mg) of sodium For the full list of excipients, see paragraph 6.1.

Excellent

Compressed core: Silicon colloidal dioxide, Sodium carbonate. Coating: Carnauba wax, Ipromellosa, Zinc stearate.

Therapeutic indications

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

Contraindications

• Hypersensitivity to acetylsalicylic acid or other salicylates, or to any of the excipients listed in paragraph 6.1, • asthma anamnesi 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 ml/min/ 1,73 m2), • severe liver failure, • uncontrolled severe heart failure, • concomitant metotrexate in doses greater than 15 mg per week, for antinflammatory doses of acetylcylic acid, or for analgesic or antipyretic doses (see paragraph 4.5), • concomitant administration of oral anticoagulants for antinflammatory doses of acetylcylic acid.

Population

Population Adults and boys (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. Seniors (from 65 years): 1 tablet for each dose to be repeated as required 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 to 4 days (in case of pain) unless otherwise indicated by the doctor. Pediatric population: Acetylsalicylic acid should not be used in children and children under 16 years 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 off the edge in any position.

Conservation

Do not store above 30°C. Store in the original package 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 not in 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 (especially chickenpox and flu-like 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, alterations in the state of consciousness or abnormal behaviour, treatment with acetylsalicylic acid should be stopped.• 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, may lead to permanent kidney damage, with risk of kidney failure.• The medicinal product should be used with particular caution in the following cases: patients with mild to moderate renal impairment (GFR ≥ 30 a ) or patients with impaired cardiovascular circulation (e.g. renal vascular disease, congestive heart failure, volume depletion, major surgery, sepsis or major haemorrhagic events) since 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 may 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 related to an allergy to nonsteroidal 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 duration of the cycle).• Gastrointestinal bleeding or ulcers/perforations may occur at any time during treatment, without necessarily any warning signs or history in the patient.The relative risk is increased 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 surgical interventions, even minor ones (e.g. 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 dose of heparin, 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 about some of the 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

Effects

Frequency: not known (can not be evaluated by available data) Diseases of blood and lymphatic system Blood and tendency to hemorrhages (epistaxis, bleeding of the gums, purple, etc.) with increased bleeding time. The risk of bleeding may persist for 4-8 days after the interruption of the intake of acetylsalicylic acid. It can cause an increase in the risk of hemorrhage in case of surgery. Intracranial and gastrointestinal bleeding may also occur. Immune system disorders Reactions of hypersensitivity, anaphylactic reactions, asthma, angioedema Diseases of the nervous system Cephalea, dizziness, feeling of hearing loss, tinnitus, which usually indicate an overdose. Intracranial hemorrhage Gastrointestinal diseases Abdominal pain Hidden or conclaimed gastrointestinal bleeding (ematemesis, melena, etc.) resulting in iron deficiency anemia. The risk of bleeding is related to the dose. Ulcere e perforazioni gastriche Disease of intestinal diaphragm (especially in long-term treatment) Kidney and urinary disorders Renal compromises and acute kidney damage have been reported Hepatobiliary pathologies Raising hepatic enzymes usually reversible with the interruption of treatment, liver damage, mainly of hepatocellular nature Pathologies of skin and subcutaneous tissue Skin rashes General disturbances Reye syndrome (see paragraph 4.4) Reporting of unwanted effects It is important to report the undesirable effects of the medicinal product after authorization. This allows to continue monitoring the risk report benefiting the medicinal product. Healthcare professionals are required to report any adverse reaction suspected through the Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

Overdose can be harmful in older subjects and especially in small children (therapeutic or, more frequently, accidental poisoning) in which it can be fatal. Synonyms Moderate intoxication: Symptoms such as buzz in the ears, hearing loss sensation, headache and dizziness are indicative of overdose and can be kept under control by reducing the dosage. Serious intoxication: Symptoms include: Fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiocircolatory collapse, respiratory failure, severe hypoglycemia. In children, overdose can be fatal from a dose of 100 mg/kg in single intake. Emergency management • Immediate transfer to a specialized hospital unit • Gastrointestinal washing and active carbon administration • Acid-base balance control • Alcalinization of urine with urinary pH monitoring • Emodilysis in case of severe intoxication • Syntomatic treatment

Pregnancy

The inhibition of the synthesis of prostaglandins may have adverse effects on the course of pregnancy and/or embryo-fetal development. The data from epidemiological studies suggest an increase in the risk of miscarriage, heart malformations and gastroschisis following the use of prostaglandin synthesis inhibitors in the early stages of pregnancy. The absolute risk of vascular cardio malformations has increased from no less than 1% to about 1.5%. The risk seems to increase with dose and duration of treatment. In animals, it has been shown that the administration of an inhibitor of the synthesis of prostaglandine causes an increase in the pre and post-system loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular malformations, was reported in animals to which an inhibitor of prostaglandin synthesis was given during the organogenetic period of gestation. Unless it is absolutely essential, acetylsalicylic acid should not be administered during the first 24 weeks of amenorrhea. If acetylsalicylic acid is administered in women who want a pregnancy or are pregnant during the first 24 weeks of amenorrhea, the dose must be as low as possible and the duration of treatment as short as possible. Over the 24th week of amenorrhea, all prostaglandin synthesis inhibitors can expose the fetus to: • cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); • kidney dysfunction, which can evolve in kidney failure with oligohydroamniosis; In the final phase of pregnancy, the mother and the newborn can meet: • Extension of hemorrhage time, due to the inhibition of piastrinic aggregation that can occur even at very low doses of acetylsalicylic acid; • inhibition of uterine contractions that determines the delay or protraction of labor. Therefore acetylsalicylic acid is contraindicated exceeded the 5th month of pregnancy (over 24 weeks of amenorrhea) (see paragraph 4.3).

Food

Acetylsalicylic acid passes into breast milk: therefore the use of acetylsalicylic acid is not recommended during breastfeeding (see paragraph 4.4) Fertility There are some evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may cause alteration of female fertility due to an effect on ovulation. This effect is reversible to the suspension of treatment.

Source: Farmadati