Aspirinaact 800 mg/480 mg - 10 effervescent tablets

Product Description

AspirinaAct is indicated for the symptomatic treatment of mild to moderate pain, in the common cold or flu symptoms for the symptomatic treatment of pain and fever.

Indications

For the symptomatic treatment of mild to moderate pain, e.g. headache, toothache, and menstrual pain. In the common cold or flu symptoms for the symptomatic treatment of pain and fever. Aspirinaact is indicated in adults and adolescents over 16 years of age.

Composition

Active substances

One effervescent tablet contains 800 mg of acetylsalicylic acid and 480 mg of ascorbic acid. Excipient with known effect: One effervescent tablet contains 438 mg of sodium. For the full list of excipients, see section 6.1.

Excipients

Sodium hydrogen carbonate (modified), citric acid, povidone, colloidal anhydrous silica.

Directions for use and Dosage

Dosage: 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.
Adults: 1 effervescent tablet as a single dose, which can be repeated at intervals of at least 4 hours if necessary. The maximum daily dose should not exceed 3 effervescent tablets, corresponding to a maximum daily dose of 2400 mg of acetylsalicylic acid. Paediatric population.
Adolescents (16 years and older): This medicine is for use only in adolescents weighing more than 53 kg. The lowest effective dose should be used. The recommended daily dose of acetylsalicylic acid in children is 60 mg/kg of body mass, divided into 2-3 doses, equal to 15 mg/kg every 6 hours. The maximum daily dose should not exceed 3 effervescent tablets, corresponding to a maximum daily dose of 2400 mg of acetylsalicylic acid. The dosage of Aspirinaact (800 mg of acetylsalicylic acid/480 mg of ascorbic acid) may not be suitable for the treatment of adolescents due to weight restrictions. Other products containing lower doses of acetylsalicylic acid are available for use in this population.
Children (under 16 years of age): Aspirinaact should not be used in children under 16 years of age. In case of accidental administration, see section 4.4 "Special warnings and precautions for use" and section 4.9 "Overdose".
Elderly patients (aged 65 years and over) and patients with low body weight: Acetylsalicylic acid should be used with caution in elderly patients due to possible comorbidities or low body weight (see sections 4.3 and 4.4). The lowest effective dose should be used.
Patients with hepatic impairment: Acetylsalicylic acid should be used with caution in patients with mild or moderate hepatic impairment (see section 4.4). Dose reduction or prolongation of dosing intervals is recommended. Acetylsalicylic acid is contraindicated in patients with severe hepatic impairment (see section 4.3).
Patients with renal insufficiency or impaired cardiovascular circulation: Acetylsalicylic acid should be used with caution in patients with mild or moderate renal insufficiency or impaired cardiovascular circulation (see section 4.4). Dose reduction or prolongation of dosing intervals is recommended. Acetylsalicylic acid is contraindicated in patients with severe renal insufficiency or severe, uncontrolled heart failure (see section 4.3).
Method of administration: For oral use. The effervescent tablet should be dissolved in a glass of water before taking. The effervescent tablet should not be taken on an empty stomach to reduce gastric irritation.

Warnings

Acetylsalicylic acid should be used with particular caution in the following cases: in case of combination with other medicines, to avoid any risk of overdose, check that acetylsalicylic acid is not in the composition of these other medicines. In case of long-term administration of analgesics at high doses, the onset of headache should not be treated with higher doses. Regular use of analgesics, especially combinations of analgesics, can lead to persistent renal damage, with the risk of renal failure.
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 or patients with compromised cardiovascular circulation (e.g., renal vascular disease, congestive heart failure, volume depletion, major surgery, sepsis, or major haemorrhagic events), as acetylsalicylic acid may further increase the risk of renal impairment and acute renal failure; 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 acetylsalicylic acid; in this case, this medicine is contraindicated (see section 4.3); in patients with metrorrhagia or menorrhagia (risk of increased volume and duration of the cycle); co-administration of anticoagulants (see section 4.5). Acetylsalicylic acid may accelerate bronchospasm and induce asthma attacks or other hypersensitivity reactions. Risk factors include the following pre-existing conditions: asthma, hay fever, nasal polyps, or chronic respiratory disease. This also applies to patients who have allergic reactions (e.g., skin reactions, itching, urticaria) to other allergens. Gastrointestinal bleeding or ulcers/perforations, some with fatal outcomes, can occur at any time during treatment, without necessarily having any warning signs or prior history. The relative risk increases with increasing doses, in patients with a history of gastrointestinal ulcers, particularly with complications of haemorrhage or perforation, in the elderly, in subjects with low body weight, and in patients taking anticoagulants or platelet aggregation inhibitors (see section 4.5). In the event of gastrointestinal bleeding or ulcers, treatment must be discontinued 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 the event of surgical procedures, even minor ones (e.g., tooth extraction). Acetylsalicylic acid reduces uric acid excretion. This can cause gout in patients who already have limited uric acid excretion.
Paediatric population: This medicine is not indicated for children and adolescents under 16 years of age. Reye's syndrome, a very rare and potentially fatal disease, has been described in children and adolescents with symptoms of viral infections (particularly chickenpox and influenza) who take acetylsalicylic acid. Therefore, acetylsalicylic acid should be administered to children and adolescents in these conditions only after medical advice, when other measures have proven ineffective. In case of persistent vomiting, altered consciousness, or abnormal behavior, acetylsalicylic acid treatment should be discontinued. The use of salicylates should be avoided for 6 weeks after vaccination against varicella virus. In some severe forms of G6PD deficiency, acetylsalicylic acid can cause haemolysis. Factors that may increase the risk of haemolysis include high doses, fever, or acute infections. In cases of G6PD deficiency, acetylsalicylic acid should be administered under medical supervision. Haemolysis has also been observed with high doses of ascorbic acid. The use of this medicine is not recommended during breastfeeding (see section 4.6). There is some evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may impair female fertility through an effect on ovulation. This is reversible upon discontinuation of treatment. Regarding ascorbic acid: Caution is advised in patients with hyperoxaluria, predisposition to calcium oxalate nephrolithiasis, or in patients with recurrent nephrolithiasis. Caution is also advised in patients with iron overload or iron utilization disorders (Mediterranean anemia, hemochromatosis, sideroblastic anemia). This medicine contains 438 mg sodium per effervescent tablet, equivalent to 21.9% of the WHO recommended maximum daily intake of 2 g sodium for adults.

Contraindications

The combination of acetylsalicylic acid with ascorbic acid should not be used in the following cases:

• hypersensitivity to the active substances acetylsalicylic acid, ascorbic acid or to any of the excipients listed in section 6.1, or to other non-steroidal anti-inflammatory drugs (NSAIDs) (cross-reactivity);
• patients with pre-existing mastocytosis, in whom the use of acetylsalicylic acid may be contraindicated; induce severe hypersensitivity reactions (including circulatory shock with flushing, hypotension, tachycardia and vomiting);
• history of asthma induced by the administration of acetylsalicylates or substances with a similar activity, in particular non-steroidal anti-inflammatory drugs;
• third trimester of pregnancy (beyond the twenty-fourth week of gestation) (see section 4.6);
• active peptic ulcer;
• acquired or congenital haemorrhagic diathesis;
• severe renal insufficiency;
• severe hepatic insufficiency;
• severe uncontrolled cardiac insufficiency;
• co-administration of methotrexate used in doses of 15 mg/week. or higher (see section 4.5);
• co-administration of oral anticoagulants with acetylsalicylic acid in patients with a history of gastroduodenal ulcers (see section 4.5);
• Nephrolithiasis or a history of nephrolithiasis;
• Hyperoxaluria;
• Haemochromatosis.

Undesirable effects

The following undesirable effects are based on spontaneous post-marketing reports for all Aspirin formulations, including short-term and long-term oral treatment. The frequencies of undesirable effects are classified as follows: very common (>=1/10); common (>=1/100 to < 1/10); uncommon (>=1/1000 to < 1/100); rare (>=1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Blood and lymphatic system disorders.
Not known: anaemia or iron deficiency anaemia with the respective laboratory and clinical signs and symptoms as a consequence of haemorrhage, haemolysis and haemolytic anaemia in patients with severe forms of glucose-6-phosphate dehydrogenase (G6PD) deficiency, thrombocytopenia. Immune system disorders. Not known: hypersensitivity reactions, anaphylactic reactions, asthma, angioedema. Hypersensitivity reactions with the respective laboratory and clinical manifestations include reactions affecting the skin, respiratory tract, gastrointestinal tract and cardiovascular system, particularly in patients with asthma. Symptoms include rash, urticaria, edema, pruritus, drop in blood pressure, asthma syndrome, dyspnea, rhinitis, nasal congestion, cardiorespiratory distress, and, very rarely, serious reactions, including anaphylactic shock or angioedema. Metabolism and nutrition disorders. Very rare: acetylsalicylic acid reduces uric acid excretion. This can cause gout in patients who already have a limited uric acid excretion; not known: hypoglycemia. Nervous system disorders. Not known: headache, dizziness, sensation of hearing loss, tinnitus, which usually indicate overdose. Intracranial and cerebral haemorrhage. Vascular disorders. Not known: haemorrhagic syndromes (epistaxis, bleeding gums, purpura, urogenital haemorrhages, etc.) with increased bleeding time. The risk of bleeding may persist for 4-8 days after stopping acetylsalicylic acid. It may cause an increased risk of haemorrhage during surgery. Intracranial and gastrointestinal haemorrhages may also occur. Intracranial haemorrhage can be fatal, especially when administered to the elderly. Serious haemorrhages and cerebral haemorrhage have been reported (especially in patients with uncontrolled hypertension and/or receiving concomitant anticoagulant therapy), which in individual cases could be life-threatening. Respiratory, thoracic and mediastinal disorders. Rare: symptoms of hypersensitivity reactions such as asthma syndrome, rhinitis, nasal congestion; not known: non-cardiogenic pulmonary edema with chronic use and in the context of a hypersensitivity reaction due to acetylsalicylic acid. Gastrointestinal disorders. Common: upper and lower gastrointestinal disorders such as dyspepsia, reflux, diarrhea, nausea, vomiting; Uncommon: Gastrointestinal and abdominal pain; Rare: Upper gastrointestinal disorders: esophagitis, erosive duodenitis, erosive gastritis, esophageal ulceration, perforation. Lower gastrointestinal disorders: ulcers of the small intestine (jejunum and ileum) and large intestine (colon and rectum), colitis; Very rare: occult or overt gastrointestinal bleeding (hematemesis, melaena, etc.) resulting in iron deficiency anemia. The risk of bleeding is dose-related. Gastric ulcers and gastrointestinal perforations. These reactions may or may not be associated with bleeding and may occur with any dose of aspirin in patients with or without warning symptoms or a previous history of serious gastrointestinal events. Not known: diarrhea with high doses of ascorbic acid, intestinal diaphragm disease (especially with long-term treatment). Hepatobiliary disorders. Not known: Increased liver enzymes (transaminases), hepatic impairment, liver injury, mainly hepatocellular. Skin and subcutaneous tissue disorders. Uncommon: Urticaria, rash, pruritus; not known: Skin reactions. Renal and urinary disorders. Not known: Renal impairment, acute renal failure, nephrolithiasis (calcium oxalate) due to ascorbic acid. General disorders and administration site conditions. Not known: Reye's syndrome (see section 4.4). Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdose

Acetylsalicylic acid: The risk of overdose can be harmful in elderly subjects and especially in young children (therapeutic overdose or, more frequently, accidental intoxication), in whom it can be fatal. Non-cardiogenic pulmonary edema may occur with acute and chronic overdose of acetylsalicylic acid (see section 4.8). Symptoms: Moderate intoxication: Symptoms such as ringing in the ears, sensation of hearing loss, sweating, nausea and vomiting, headache, and dizziness are indicative of an overdose and can be controlled by reducing the dose. Severe poisoning: 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; - Monitoring of acid-base balance; - Alkalinization of urine with monitoring of urinary pH; - Hemodialysis in cases of severe poisoning; - Monitoring of serum electrolytes and replacement of lost fluids; - Symptomatic treatment. Ascorbic acid: After single doses of ascorbic acid exceeding 3 g per day, osmotic diarrhea and gastrointestinal disturbances such as nausea or gastritis may occur. Acute or chronic overdose of the product may cause serious complications. Induce specific manifestations of vitamin C toxicity. General manifestations of vitamin C overdose may include gastrointestinal disturbances such as diarrhea, nausea, and vomiting. Clinical signs and symptoms, laboratory findings, and consequences of overdose depend on individual reactivity and related circumstances (e.g., dose, duration of use, time to diagnosis). If symptoms of overdose occur, use of the product should be discontinued immediately and a healthcare professional should be consulted. Acute or chronic vitamin C overdose (> 2 g/day in adults) can significantly increase urinary oxalate levels. In some cases, this leads to hyperoxaluria, calcium oxalate crystallization, kidney stone formation, calcium oxalate deposition, tubulointerstitial nephropathy, and acute kidney injury. Vitamin C overdose in individuals with glucose-6-phosphate dehydrogenase deficiency (> 3 g/day in children and > 15 g/day in adults) may cause renal failure. may cause red blood cell haemolysis.

Pregnancy and breastfeeding

Pregnancy: Inhibition of prostaglandin synthesis may have adverse effects on pregnancy and/or embryo-fetal development. Data from epidemiological studies suggest an increased risk of spontaneous abortion, cardiac malformations, and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. The risk appears to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation embryonic loss and embryo-fetal lethality. Additionally, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered a prostaglandin synthesis inhibitor during the organogenetic period of gestation. Except when absolutely necessary, aspirin should not be administered during the first 24 weeks of pregnancy. If aspirin is administered to a woman planning a pregnancy or who is pregnant during the first 24 weeks, the dose should be kept as low as possible and the duration of treatment as short as possible. Beyond the twenty-fourth week of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligohydramnios. In the late stages of pregnancy, the mother and newborn may experience: prolonged bleeding time, due to the inhibition of platelet aggregation that can occur after the administration of very low doses of acetylsalicylic acid; inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, acetylsalicylic acid is contraindicated in the third trimester of pregnancy (beyond the twenty-fourth week of gestation) (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: Given the limited amount of published data available, human studies do not show any relevant effect of acetylsalicylic acid on impairment of fertility and there is no conclusive evidence in animal studies.

Format

10 Effervescent Tablets