Descrizione Clinica
ASPIRINAACT 800 MG /480 MG COMPRESSE EFFERENCES WITH VITAMIN C
active ingredients
An effervescent tablet contains 800 mg of acetylsalicylic acid and 480 mg of ascorbic acid. Excipient with known effects: an effervescent tablet contains 438 mg sodium. For the full list of excipients, see paragraph 6.1.Excellent
Sodium hydrogencarbonate (modified), citric acid, povidone, colloidal silica anidra.Therapeutic indications
For symptomatic treatment of mild to moderate pain, e.g. headache, toothache and menstrual pain. In common cold or flu symptoms for symptomatic treatment of pain and fever. Aspirinaact is indicated in adults and adolescents aged 16.Contraindications
The acetylsalicylic acid association with ascorbic acid should not be used in the following cases: • hypersensitivity to the active ingredients acetylsalicylic acid, ascorbic acid or any of the excipients listed in paragraph 6.1, or to other nonsteroidal anti-inflammatory drugs (NSAID) (cross-reactivity); • patients with pre-existing mastocytosis, where the use of acetylsalicylic acid can induce severe hypersensitivity reactions (including circulatory shock with redness, hypotension, tachycardia and vomiting); • anamnesi 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 paragraph 4.6); • peptic ulcer in active phase; • acquired or congenital hemorrhagic diathesis; • severe kidney failure; • severe liver failure; • severe heart failure not controlled; • co-administration of metotrexate used in doses of 15 mg/sett. or higher (see paragraph 4.5); • co-administration of oral anticoagulants with acetylsalicylic acid in patients with gastroduodenal ulcer anamnes (see paragraph 4.5); • Nephrolysis or clinical history of nephrolysis; • Hyperossaluria; • Emocromatosis.Population
Population 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. Adults: 1 effervescent tablet as a single dose, which can be repeated at intervals of a minimum period of 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. Pediatric population Adolescents (ages 16 and older): This medicine should only be used in teenagers 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 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 indicated for the treatment of adolescents due to weight limits. Other products containing lower doses of acetylsalicylic acid are available for use in this population. Children (aged under 16): Aspirinaact should not be used in children under the age of 16. In case of accidental administration, see paragraph 4.4 “Special warnings and precautions of employment” and paragraph 4.9 “Soversage”. Senior Patients (ages 65 and over) and patients with low body weight Acetylsalicylic acid should be used with caution in elderly patients due to possible comorbility or low body weight (see paragraphs 4.3 and 4.4). The lowest effective dose should be used. Patients with liver failure: Acetylsalicylic acid must be used with caution in patients with mild or moderate liver failure (see paragraph 4.4). It is recommended to reduce dose or extend dose intervals. Acetylsalicylic acid is contraindicated in patients with severe liver failure (see paragraph 4.3). Patients with renal failure or compromised cardiovascular circulation: Acetylsalicylic acid must be used with caution in patients with mild or moderate kidney failure or with impaired cardiovascular circulation (see paragraph 4.4). It is recommended to reduce dose or extend dose intervals. Acetylsalicylic acid is contraindicated in patients with severe kidney failure or severe and uncontrolled heart failure. (see paragraph 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.Conservation
Do not store at temperature above 25 °C.Warnings
Acetylsalicylic acid should be used with particular caution in the following cases: • If combined with other medicines, to avoid any risk of overdose, check that acetylsalicylic acid is absent from the composition of these other medicines. • In case of long-term administration of high dose analgesics, the onset of headache should not be treated with higher doses. • Regular use of analgesics, in particular combinations of analgesics, can lead to persistent kidney injuries, with risk of kidney failure. Treatment monitoring should be intensified in the following cases: • in patients with gastric or duodenal ulcer anamnesi, gastrointestinal bleeding, or gastritis; • in patients with kidney failure or patients with impaired cardiovascular circulation (e.g. kidney vascular pathology, congestive heart failure, volemic depletion, important surgery, sepsis or major hemorrhagic events), since acetyllic acid can further increase the risk of kidney failure and acute kidney failure; • in patients with liver failure; • in patients with asthma: the occurrence of an asthma attack, in some patients, may be connected to an allergy to non-steroidal anti-inflammatory drugs or acetylsalicylic acid; in this case, this medicinal product is contraindicated (see paragraph 4.3); • in patients with metrorrhagia or menorrhagia (risk of increased volume and duration of the cycle); (see paragraph 4.5). Acetylsalicylic acid can accelerate bronchospasm and induce asthma attacks or other hypersensitivity reactions. Risk factors are represented by the following conditions: asthma, hay fever, nasal polyps or chronic respiratory disease. This also applies to patients with allergic reactions (e.g. skin, itching, hives) to other allergens. Gastrointestinal bleeding or ulcers/perforations, some with fatal outcome, may occur at any time during treatment, without necessarily having any premonitor or anamnesi signs in the patient. The relative risk increases with increased doses, in patients with gastrointestinal ulcers, in particular with hemorrhage or perforation complications, in elderly individuals, in subjects with low body weight and in patients taking anticoagulants or inhibitions of piastrinic aggregation (see paragraph 4.5). In case of gastrointestinal hemorrhage or ulcers, treatment must be immediately stopped. Given the inhibitory effect of acetylicylic acid on platelet aggregation, which is also manifested at very low doses and persists for several days, the patient should be aware of the risk of hemorrhage in case of surgery, even of small entities (e.g. dental extraction). Acetylsalicylic acid reduces uric acid excretion. This can cause gout in patients who already tend to a limited excretion of uric acid. Pediatric population This medicine is not suitable for children and adolescents under the age of 16. Reye's syndrome, a very rare and potentially mortal disease, has been described in children and adolescents with symptoms of viral infections (especially chickenpox and flu episodes) taking acetylsalicylic acid. As a result, acetylsalicylic acid should be administered to children and adolescents under these conditions only after medical advice, when other measures have proved ineffective. In case of persistent vomiting, alterations of the state of consciousness or abnormal behavior, treatment with acetylylylylylyl acid must be stopped. It should be avoided the use of salicylates for 6 weeks after vaccination against chickenpox virus. In some serious forms of G6PD deficiency, acetylsalicylic acid may cause haemolysis. Factors that can determine an increase in the risk of hemolysis are, for example, high dosage, fever or acute infections. In case of G6PD deficiency, acetylsalicylic acid should be administered under medical supervision. Hemolysis was also observed with high doses of ascorbic acid. The use of this medicine is not recommended during breastfeeding (see paragraph 4.6). There are some evidence that drugs that inhibit cycloxygenase/synthesis of prostaglandins can cause the impairment of female fertility through an effect on ovulation. This is reversible to the suspension of treatment. As for ascorbic acid: Precaution is recommended in patients with hyperoxluria, predisposition to calcium oxalate nephrolitisis or in patients with recurrent nephrolitisis. Caution is also recommended in patients with iron overload or iron use disorders (Mediterranean anemia, hemochromatosis, sideroblastic anemia). This medicine contains 438 mg sodium per effervescent tablet, equivalent to 21,9% of the maximum daily dose recommended by the WHO of 2 g sodium per adult.Interactions
Different substances are involved in interactions due to their inhibitory properties on platelet aggregation: abciximab, acetylsalicylic acid, chlopidogrel, epoprostenol, eptifibatide, iloprost and iloprost tromethylamolo, ticlopidine and thyrofiban. The use of multiple inhibitors of platelet aggregation increases the risk of hemorrhage, as well as their association with heparin or related molecules, oral anticoagulants or other trombolitics; the increase of risk must be taken into account by establishing regular clinical monitoring. Contraindicated combinations (see section 4.3): Metotrexate used at doses of 15 mg/week or higher: Increased metotrexate toxicity, in particular hematological toxicity (due to reduced renal elimination of metotrexate caused by acetylsalicylic acid). Oral anticoagulants in patients with gastroduodenal ulcer anamnesi: Increased hemorrhage risk. Unrecommended combinations: Oral anticoagulants in patients without anamnes of gastroduodenal ulcers: Increased hemorrhage risk. Other non-steroidal anti-inflammatory drugs (NSWERS): Increased risk of gastrointestinal ulcers and hemorrhage. Eparine with low molecular weight (and related molecules) and eparine not fractionated in therapeutic doses, or in elderly patients (age > 65 years) regardless of the dose of heparin: Increased risk of hemorrhage (inhibition of platelet aggregation and aggression of gastroduodenal mucosa by acetylsalicylic acid). Another anti-inflammatory drug should be used, or another analgesic or antipyretic. Clopidogrel (out of the approved indication for this combination in patients with acute coronary syndrome): Increased hemorrhage risk. If concurrent administration cannot be avoided, clinical monitoring is recommended. Resurrection (benzbromarone, probenecid): Reduction of the uric effect due to the competition for the elimination of uric acid in the renal tubules. Ticlopidine: Increased hemorrhage risk. If concurrent administration cannot be avoided, clinical monitoring is recommended. Combinations that require precautions of use: Metotrexate, used at doses less than 15 mg/week.Increased metotrexate toxicity, in particular hematological toxicity (due to reduced renal elimination of metotrexate caused by acetylsalicylic acid). The hemochrome should be monitored every week during the first weeks of concurrent administration. Patients with reduced kidney function (even mild) and older patients should be closely monitored. Clopidogrel (in the approved indication for this combination in patients with acute coronary syndrome): Increased hemorrhage risk. It is recommended to carry out clinical monitoring. Gastrointestinal topical treatments, antacids and activated carbon: Increased renal excretion of acetylsalicylic acid due to alcalinization of urine. It is recommended to administer gastrointestinal acid and topical treatments at least two hours from the intake of acetylsalicylic acid. Eparine with low molecular weight (and related molecules) and eparine not fractionated in preventive doses in patients under 65 years of age: Influencing hemostasis at various levels, concurrent administration increases the risk of hemorrhage. Therefore, in patients under 65 years of age, the concomitant administration of eparine (or related molecules) in preventive doses, and acetylsalicylic acid at any dose, should be taken into consideration by combining it with clinical and laboratory monitoring according to the need. Tromboliti, streptochinasi: Increased hemorrhage risk. Selective Serotonin Reuptake inhibitors (citalopram, escitalopram, fluoxetine, fluvoxamina, paroxetine, sertralin): Increased hemorrhage risk. Digoxin: Plasma concentrations of digoxin increase due to decreased excretion. Monitor the plasma concentration of digoxin and, if necessary, it is recommended to adjust the dose. Antidiabetics, e.g. insulin, sulphonluree: Increase of the hypoglycemic effect caused by high doses of acetylsalicylic acid through the hypoglycemic action of the latter and the smoothing of sulphonlurea from the sites of connection with plasma proteins. It is recommended to monitor blood sugar. Glucocorticoids (except hydrocortisone substitute therapy): Increased hemorrhage risk. Reduction of blood levels of salicylates during treatment with corticosteroid and risk of overdose from salicylates after the interruption of this treatment for the increase of the elimination of salicylates by corticosteroids. Diuretics, inhibitors of angiotensin conversion enzyme (ACE-inhibitionrs) and antagonists of angiotensin receptor II: In dehydrated patients, acute kidney failure can occur due to the reduction of glomerular filtration speed due to the decreased synthesis of kidney prostaglandins. Also, there may be a reduction of the antihypertensive effect. Make sure that the patient is hydrated and that the kidney function is monitored at the beginning of the treatment. Valproic acid: Increased toxicity of valproic acid due to smoothing from protein binding sites. Other: Increased damage to the gastrointestinal mucosa and prolonged bleeding time due to the additive effects of acetylsalicylic acid and alcohol.Co-administration should be avoided. Combinations to be taken into account: Deferasirox: Increased risk of gastrointestinal ulcers and hemorrhage. Deferoxamine: Concurrent use with ascorbic acid can increase tissue toxicity of iron, especially at the heart, causing heart failure. Iron and aluminium: The administration of ascorbic acid increases gastrointestinal absorption. This should be taken into account in patients with kidney failure, in case of iron replacement and the administration of antacids containing aluminum. Interactions with laboratory analysis: Acetylsalicylic acid and ascorbic acid in high doses can interfere with some laboratory analysis, e.g. occult blood test in feces and analysis of liver function. Since vitamin C is a reducing agent (i.e. an electron donor), it can cause chemical interference in laboratory investigations where oxide-reduction reactions are involved, such as glucose analysis, creatinine, carbamazepine, uric acid in urine, serum and occult blood research in feces. Vitamin C can interfere with the analyses that measure glucose in the urine and blood, leading to a falsified reading of the results, although it has no effect on blood glucose levels.Effects
The following undesirable effects are based on spontaneous post-marketing reports for all formulations of Aspirin, 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 1/100).Blood and lymphatic system disorders Not known: Anaemia or iron deficiency anaemia with 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 Do not note: Reactions of hypersensitivity, anaphylactic reactions, asthma, angioedema. Hypersensitivity reactions with the respective laboratory and clinical manifestations include reactions to the skin, respiratory tract, gastrointestinal tract and cardiovascular system, especially in patients with asthma. Symptoms include skin rash, hives, edema, itching, decrease in blood pressure, asthmatic syndrome, dispnea, rhinitis, nasal congestion, cardiorespiratory distress and, very rarely, serious reactions, including anaphylactic shock or angioedema. Disorders of metabolism and nutrition Very rare: Acetylsalicylic acid reduces uric acid excretion. This can cause gout in patients who already tend to a limited excretion of uric acid; Do not note: Hypoglycemia. Diseases of the nervous system Do not note: Cephalea, dizziness, feeling of hearing loss, tinnitus, which usually indicate an overdose. Intracranial and cerebral hemorrhage. Vascular diseases 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 the intake of acetylsalicylic acid.May cause an increased risk of haemorrhage in case of surgical interventions.Intracranial and gastrointestinal haemorrhages may also occur.Intracranial haemorrhage may be fatal, especially if the medicinal product is administered to the elderly.Serious haemorrhages and cerebral haemorrhage have been reported (especially in patients with uncontrolled hypertension and/or concomitant anticoagulant therapy), which in individual cases could be life-threatening. Respiratory, chest and mediastinic pathologies Rari: Symptoms of hypersensitivity reactions like asthmatic syndrome, rhinitis, nasal congestion; Do not note: Non cardiogenic lung edema with chronic use and in the context of a reaction from hypersensitivity due to acetylsalicylic acid. Gastrointestinal diseases Municipalities: Upper and lower gastrointestinal tract disorders such as dyspepsia, reflux, diarrhea, nausea, vomiting; Not common: Gastrointestinal and abdominal pains; Rari: Upper gastrointestinal tract disorders: esophagitis, erosive duodenitis, erosive gastritis, esophageal ulceration, perforation. Lower gastrointestinal tract disorders: ulcers of the small intestine ( fasting and ileum) and of the cranial intestine (colon and rectum), colitis; Very rare: Hidden or conclaimed gastrointestinal hemorrhage (ematemesis, melena, etc.) resulting in iron deficiency anemia. The risk of bleeding is related to the dose. Gastric ulcers and gastrointestinal perforations. These reactions may or may not be associated with hemorrhage, and may occur with any dose of acetylsalicylic acid in patients with or without premonitory symptoms or anamnesi pregress of serious gastrointestinal events. Do not note: Diarrhea with high doses of ascorbic acid, intestinal diaphragm disease (especially in long-term treatment). Hepatobiliary pathologies Do not note: Increased liver enzymes (transaminase), liver impairment, hepatic lesion mainly of hepatocellular type. Pathologies of skin and subcutaneous tissue Not common: Hives, rash, itching; Do not note: Skin reactions. Kidney and urinary disorders Do not note: Kidney failure, acute kidney failure, Nephrolithiasis (calcium bone) due to ascorbic acid. General pathologies and conditions for administration Do not note: Reye syndrome (see paragraph 4.4). Reporting of suspected adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction through 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 people and especially in small children (therapeutic or, more frequently, accidental intoxication) in which it can be fatal. With acute and chronic overdose of acetylsalicylic acid, non cardiogenic pulmonary edema may occur (see paragraph 4.8). Synonyms Moderate intoxication: Symptoms such as buzz in the ears, feeling of hearing loss, sweating, nausea and vomiting, 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 administration of activated coal; - Control of acid-base balance; - Alcalination of urine with urinary pH monitoring; - Hemodialysis in case of severe intoxication; - Control of serum electrolytes and reintegration of lost fluids; - Syntomatic treatment. Ascorbic acid: After individual doses of ascorbic acid greater than 3 g per day, osmotic diarrhea and gastrointestinal disorders such as nausea or gastritis can occur. Acute or chronic overdose of the product can induce specific manifestations of vitamin C toxicity. Generic manifestations of vitamin C overdose may include gastrointestinal disorders such as diarrhea, nausea and vomiting. Clinical signs and symptoms, laboratory results and overdose consequences depend on individual reactivity and related circumstances (such as dose, duration of use, time involved in diagnosis). If there are any overdose symptoms, the use of the product must be immediately interrupted and a healthcare provider must be consulted. Acute or chronic overdose of vitamin C (> 2g/day in adults) can significantly increase the levels of oxalates in the urine. In some cases, this involves hyperoxluria, crystallization of calcium oxalates, formation of kidney stones, deposit of calcium oxalate, piping nephropathy and acute kidney damage. Overdose of vitamin C in individuals with glucose deficiency 6 phosphate dehydrogenase (> 3 g/day in children and > 15 g/day in adults) can lead to erythrocytic haemolysis.Pregnancy
Inhibition of prostaglandin synthesis may have adverse effects on 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 cardiovascular malformations increased from less than 1% to about 1.5%. It seems that the risk increases with dose and duration of therapy. In animals, it has been shown that the administration of an inhibitor of the synthesis of prostaglandine causes an increase in the loss of pre and post-system embryo and embryo-fetal lethal. In addition, an increased incidence of various malformations, including cardiovascular malformations, was reported in animals to which an inhibitor of prostaglandin synthesis had been given during the organogenetic period of gestation. Except where it is absolutely necessary, acetylsalicylic acid should not be administered during the first 24 weeks of pregnancy. If you administer acetylsalicylic acid to a woman who plans a pregnancy or who is pregnant during the first 24 weeks, the dose must be as low as possible and the duration of treatment as short as possible. Over the 24th week of pregnancy, 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 oligoidramnios. In the last stages of pregnancy, the mother and the newborn can present: - prolongation of bleeding time, due to the inhibition of piastrinic aggregation that may occur after the administration of very low doses of acetylcylic acid; - inhibition of uterine contractions that determines the delay or protraction of labor. As a result, acetylsalicylic acid is contraindicated in the third trimester of pregnancy (beyond the twenty-fourth week of gestation) (see paragraph 4.3).Breastfeeding
Acetylsalicylic acid passes into breast milk. Therefore, the use of acetylsalicylic acid is not recommended during feeding (see paragraph 4.4).Fertility
Considered the limited number of published data available, human studies show no significant effect of acetylsalicylic acid on fertility impairment and there are no conclusive evidence in animal studies.Source: Farmadati
