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Aspirin C 20 Effervescent Tablets 400+240 mg
Aspirin C 20 Effervescent Tablets 400+240 mg

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PRODUCT NET WEIGHT
PRODUCT NET WEIGHT
EAN
EAN
004763330
MINSAN
MINSAN
004763330
ACTIVE INGREDIENTS
Active ingredients contained in Aspirin C 20 Effervescent Tablets 400+240 mg - What is the active ingredient in Aspirin C 20 Effervescent Tablets 400+240 mg?
Aspirin 400 mg effervescent tablets with vitamin C, one tablet contains active ingredients: acetylsalicylic acid 400 mg; ascorbic acid (Vitamin C) 240 mg. For the full list of excipients, see section 6.1.
EXCIPIENTS
Composition of Aspirin C 20 Effervescent Tablets 400+240 mg - What does Aspirin C 20 Effervescent Tablets 400+240 mg contain?
Excipients: monosodium citrate, sodium bicarbonate, sodium carbonate, citric acid.
DIRECTIONS
Therapeutic indications Aspirin C 20 Effervescent Tablets 400+240 mg - Why is Aspirin C 20 Effervescent Tablets 400+240 mg used? What is it used for?
Symptomatic treatment of feverish states and flu and cold syndromes. Symptomatic treatment of headache and toothache, neuralgia, menstrual pain, rheumatic and muscular pain.
CONTRAINDICATIONS
Contraindications Aspirin C 20 Effervescent Tablets 400+240 mg - When should Aspirin C 20 Effervescent Tablets 400+240 mg not be used?
/SECONDARY EFFECTS Aspirin effervescent tablets with vitamin C is contraindicated in case of: hypersensitivity to the active substances (acetylsalicylic acid and ascorbic acid), to other analgesics (painkillers)/antipyretics (feverkillers)/nonsteroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients; gastroduodenal ulcer; haemorrhagic diathesis; severe renal, cardiac or hepatic insufficiency; glucose-6-phosphate dehydrogenase (G6PD/favism) deficiency; concomitant treatment with methotrexate (at doses of 15 mg/week or more) or with warfarin (see section 4.5); history of asthma induced by the administration of salicylates or substances with similar activity, in particular nonsteroidal anti-inflammatory drugs; last trimester of pregnancy and breastfeeding (see section 4.6); children and adolescents under 16 years of age. Nephrolithiasis or previous history of nephrolithiasis; hyperoxaluria; hemochromatosis
DOSAGE
Quantity and method of taking Aspirin C 20 Effervescent Tablets 400+240 mg - How to take Aspirin C 20 Effervescent Tablets 400+240 mg?
Adults: 1-2 tablets as a single dose, repeating, if necessary, the dose at intervals of 4-8 hours up to 3-4 times a day. Aspirin C must always be dissolved before use (1 tablet in half a glass of water). The product is reserved for adult patients only. Always use the lowest effective dosage and increase it only if it is not sufficient to relieve the symptoms (pain and fever). Those most at risk of serious side effects, who can use the medicine only if prescribed by a doctor, must carefully follow the instructions (see section 4.4). Use the medicine for the shortest possible period. Do not take the product for more than 3 - 5 days without consulting a doctor. Consult your doctor if symptoms persist. Take the medicine preferably after main meals or, in any case, on a full stomach. Special populations. Paediatric population: Aspirin effervescent tablets with vitamin C are not indicated for use in the paediatric population (see section 4.4). Elderly: In elderly patients, use the lowest effective dosage. Patients with impaired hepatic function: Acetylsalicylic acid should be used with caution in patients with impaired hepatic function (see section 4.4). Patients with impaired renal function: Acetylsalicylic acid should be used with caution in patients with impaired renal function (see section 4.4).
CONSERVATION
Storage Aspirin C 20 Effervescent Tablets 400+240 mg - How to store Aspirin C 20 Effervescent Tablets 400+240 mg?
Store below 25 degrees C.
WARNINGS
Warnings Aspirin C 20 Effervescent Tablets 400+240 mg - About Aspirin C 20 Effervescent Tablets 400+240 mg it is important to know that:
Hypersensitivity reactions: acetylsalicylic acid and other NSAIDs may cause hypersensitivity reactions (including asthma attacks, rhinitis, angioedema or urticaria). The risk is higher in subjects who have already shown a hypersensitivity reaction after using this type of drug in the past (see section 4.3) and in subjects who have allergic reactions to other substances (e.g. skin reactions, itching, urticaria). In subjects with asthma and/or rhinitis (with or without nasal polyposis) and/or urticaria, reactions may be more frequent and severe. In rare cases, reactions may be very serious and potentially fatal. In the following cases, administration of the drug requires a doctor's prescription after careful evaluation of the risk/benefit ratio. Subjects at increased risk of hypersensitivity reactions (see above). Subjects at increased risk of gastrointestinal lesions: acetylsalicylic acid and other NSAIDs may cause serious gastrointestinal side effects (bleeding, ulcer, perforation). For this reason, these drugs should not be used by subjects suffering from gastrointestinal ulcers or gastrointestinal bleeding. It is also prudent that those who have suffered from gastrointestinal ulcers or gastrointestinal bleeding in the past should avoid their use. The risk of gastrointestinal lesions is a dose-related effect, as gastrolesivity is greater in subjects who use higher doses of acetylsalicylic acid. Subjects who are used to drinking large quantities of alcohol are also more exposed to the risk of gastrointestinal lesions (bleeding in particular) (see section 4.5). Subjects with coagulation defects or undergoing treatment with anticoagulants: in subjects suffering from coagulation defects or undergoing treatment with anticoagulants, acetylsalicylic acid and other NSAIDs can cause a serious reduction in haemostatic capacity, exposing them to the risk of haemorrhage. Subjects with impaired renal or cardiac or hepatic function: acetylsalicylic acid and other NSAIDs may cause a critical reduction in renal function and fluid retention; the risk is greater in subjects treated with diuretics. This can be particularly dangerous for the elderly and for subjects with impaired renal or cardiac or hepatic function. Subjects suffering from asthma: acetylsalicylic acid and other NSAIDs may cause an aggravation of asthma. Geriatric age (especially over 75 years): the risk of serious adverse effects is greater in geriatric subjects. Subjects over 70 years of age, especially in the presence of concomitant therapies, should use Aspirin only after consulting a doctor. Aspirin should not be used in the paediatric population (see section 4.3). Products containing acetylsalicylic acid should not be used in children and adolescents under 16 years of age with viral infections, regardless of whether or not fever is present. In certain viral infections, especially influenza A, influenza B and chickenpox, there is a risk of Reye's Syndrome, a very rare but life-threatening disease that requires immediate medical attention. The risk may be increased by concomitant intake of acetylsalicylic acid, although a causal relationship has not been demonstrated. Persistent vomiting in patients with these diseases may be a sign of Reye's Syndrome. Subjects with hyperuricaemia/gout: acetylsalicylic acid may interfere with the elimination of uric acid: high doses have a uricosuric effect while (very) low doses may reduce its excretion. It should also be considered that acetylsalicylic acid and other NSAIDs may mask the symptoms of gout, delaying its diagnosis. An antagonistic effect with uricosuric drugs is also possible (see section 4.5). Subjects with a predisposition to calcium-oxalate nephrolithiasis (kidney stones) or with recurrent nephrolithiasis. Aspirin effervescent tablets with vitamin C: Vitamin C (ascorbic acid) should be used with caution by subjects with a predisposition to calcium-oxalate nephrolithiasis (kidney stones) or with recurrent nephrolithiasis. Combinations of drugs not recommended or requiring special precautions or dosage adjustment: the use of acetylsalicylic acid in combination with certain drugs may increase the risk of serious side effects (see section 4.5). Do not use acetylsalicylic acid together with another NSAID or, in any case, do not use more than one NSAID at a time. If you are undergoing surgery (even a minor one, for example tooth extraction) and have used acetylsalicylic acid or another NSAID in the previous few days, you must inform the surgeon due to the possible effects on coagulation. Since acetylsalicylic acid can cause gastrointestinal bleeding, this must be taken into account if a search for occult blood is necessary. Before administering any medicine, all useful precautions must be taken to prevent unwanted reactions; particularly important is the exclusion of previous hypersensitivity reactions to this or other medicines and the exclusion of other contraindications or conditions that may expose you to the risk of potentially serious unwanted effects listed above. If in doubt, consult your doctor or pharmacist. Imperfect and prolonged storage of Aspirin C may cause variations in the colour of the tablet which in themselves do not affect either the activity or the tolerability of the active ingredient. In this case, it is advisable to ask the pharmacy to replace the package. The product must be taken on a full stomach. Information on excipients: this medicine contains 467 mg of sodium per effervescent tablet equivalent to 23% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult.
INTERACTIONS
Interactions Aspirin C 20 Effervescent Tablets 400+240 mg - Which medicines or foods can modify the effect of Aspirin C 20 Effervescent Tablets 400+240 mg?'
Contraindicated combinations (avoid concomitant use - see section 4.3). Methotrexate (doses greater than or equal to 15 mg/week): increased plasma levels and toxicity of methotrexate; the risk of toxic effects is greater if renal function is impaired. Warfarin: severely increased risk of haemorrhage due to increased anticoagulant effect. Combinations not recommended (the concomitant use of the two drugs requires a doctor's prescription after careful evaluation of the risk/benefit ratio - see section 4.4): Antiplatelet agents: increased risk of haemorrhage due to the addition of the antiaggregant effect. Thrombolytics or oral or parenteral anticoagulants: increased risk of haemorrhage due to increased pharmacological effect. NSAIDs (excluding topical use): increased risk of serious adverse effects. Methotrexate (doses less than 15 mg/week): the increased risk of toxic effects (see above) must also be considered for treatment with low-dose methotrexate. Selective serotonin reuptake inhibitors (SSRIs): increased risk of upper gastrointestinal bleeding due to a possible synergistic effect. Combinations requiring special precautions or dosage adjustment (the concomitant use of the two drugs requires a doctor's prescription after careful evaluation of the risk/benefit ratio - see paragraph 4.4). ACE inhibitors: reduction of the hypotensive effect; increased risk of renal impairment. Valproic acid: increased effect of valproic acid (risk of toxicity). Antacids: antacids taken simultaneously with other drugs may reduce their absorption; the excretion of acetylsalicylic acid increases in alkaline urine. Antidiabetics (e.g. insulin and oral hypoglycaemics): increased hypoglycaemic effect; the use of acetylsalicylic acid in subjects treated with antidiabetics must take into account the risk of inducing hypoglycaemia. Digoxin: increased plasma concentration of digoxin due to decreased renal elimination. Diuretics: increased risk of nephrotoxicity of acetylsalicylic acid and other NSAIDs; reduced effect of diuretics. Acetazolamide: reduced elimination of acetazolamide (risk of toxicity). Phenytoin: increased effect of phenytoin. Corticosteroids (excluding those for topical use and those used for the treatment of adrenal insufficiency): a) increased risk of gastrointestinal lesions; b) due to the increased elimination of salicylates induced by corticosteroids, plasma salicylate levels are reduced. Conversely, after stopping corticosteroid treatment, salicylate overdose may occur. Metoclopramide: increased effect of acetylsalicylic acid by increasing the rate of absorption. Uricosurics (e.g. probenecid, benzbromarone): decreased uricosuric effect. Zafirlukast: increased plasma concentration of zafirlukast. Deferoxamine. Aspirin effervescent tablets with vitamin C: concomitant use of ascorbic acid may cause increased tissue toxicity of iron, especially at cardiac level, and cause cardiac failure. Aspirin effervescent tablets with Vitamin C contain buffer systems that may reduce the effects of the thyroid hormone Levothyroxine. Alcohol (see section 4.4): the sum of the effects of alcohol and acetylsalicylic acid causes increased damage to the gastrointestinal mucosa and prolongation of bleeding time. However, it is advisable not to administer other oral medications within 1 or 2 hours of using the product. Interference with clinical laboratory tests. Vitamin C: since vitamin C is a reducing agent (i.e. an electron donor), it can cause chemical interference in laboratory tests that involve oxidation-reduction reactions, such as glucose, creatinine, carbamazepine, uric acid in urine, serum and occult blood in stool. Vitamin C can interfere with tests that measure urine and blood glucose leading to a false reading of the results even if it has no effect on blood glucose levels.
SIDE EFFECTS
Like all medicines, Aspirin C 20 Effervescent Tablets 400+240 mg can cause side effects - What are the side effects of Aspirin C 20 Effervescent Tablets 400+240 mg?
The most frequently observed side effects are those affecting the gastrointestinal system and may occur in approximately 4% of subjects taking acetylsalicylic acid as an analgesic-antipyretic. This percentage increases significantly in subjects at risk of gastrointestinal disorders. These disorders can be partially alleviated by taking the medicine on a full stomach. Most of the side effects are dependent on both the dose and the duration of treatment. The side effects observed with acetylsalicylic acid are generally common to other NSAIDs. Blood and lymphatic system disorders: prolonged bleeding time, anaemia due to gastrointestinal haemorrhage, reduction in platelets (thrombocytopenia) in extremely rare cases. Haemorrhagic/iron deficiency anaemia (due, for example, to occult microhaemorrhages) may occur following haemorrhage, with related alterations in laboratory parameters and related clinical signs and symptoms such as asthenia, pallor and hypoperfusion. Nervous system disorders: headache, dizziness. Rarely: Reye's syndrome (*). Rarely to very rarely: cerebral haemorrhage, especially in patients with uncontrolled hypertension and/or on anticoagulant therapy, which, in isolated cases, may be life-threatening. Ear and labyrinth disorders: tinnitus (buzzing/rustling/ringing/whistling in the ears). Respiratory, thoracic and mediastinal disorders: respiratory disease exacerbated by acetylsalicylic acid, asthma syndrome, rhinitis (profuse rhinorrhoea), nasal congestion (associated with hypersensitivity reactions). Epistaxis. Cardiac disorders: cardiorespiratory distress (associated with hypersensitivity reactions). Eye disorders: conjunctivitis (associated with hypersensitivity reactions). Gastrointestinal disorders: (occult) gastrointestinal bleeding, gastric disturbances, heartburn, gastrointestinal pain, gingival bleeding. Vomiting, diarrhoea, nausea, crampy abdominal pain (associated with hypersensitivity reactions). Rarely: gastrointestinal inflammation, gastrointestinal erosion, gastrointestinal ulceration, haematemesis (vomiting blood or material), melaena (passage of black, tarry stools), oesophagitis. Very rarely: haemorrhagic gastrointestinal ulcer and/or gastrointestinal perforation with associated clinical signs and symptoms and alterations in laboratory parameters. Frequency not known (especially in long-term treatment): intestinal diaphragm disease. Hepatobiliary disorders. Rarely: hepatotoxicity (usually mild and asymptomatic hepatocellular injury) manifested by increased transaminases. Skin and subcutaneous tissue disorders: rash, oedema, urticaria, pruritus, erythema, angioedema (associated with hypersensitivity reactions). Renal and urinary disorders: alteration of renal function (in the presence of conditions of altered renal haemodynamics) and acute renal injury, urogenital haemorrhages. Systemic disorders and conditions related to the site of administration: procedural haemorrhages, haematomas. Immune system disorders. Rarely: anaphylactic shock with related alterations of laboratory parameters and clinical manifestations. (*) Reye's syndrome (RS). RS initially manifests itself with vomiting (persistent or recurrent) and with other signs of encephalic suffering of varying degrees: from listlessness, drowsiness or personality changes (irritability or aggressiveness) to disorientation, confusion or delirium up to convulsions or loss of consciousness. The variability of the clinical picture must be taken into account: vomiting may also be absent or replaced by diarrhoea. If these symptoms occur in the days immediately following an episode of influenza (or flu-like or chickenpox or another viral infection) during which acetylsalicylic acid or other medicinal products containing salicylates were administered, the doctor's attention must immediately be drawn to the possibility of an RS. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continuous 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 of the Italian Medicines Agency at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
PREGNANCY AND BREASTFEEDING
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Aspirin C 20 Effervescent Tablets 400+240 mg.
Fertility: The use of acetylsalicylic acid, as with any drug inhibiting the synthesis of prostaglandins and cyclooxygenase, may interfere with fertility; female subjects, particularly women who have fertility problems or who are undergoing investigations of fertility, must be informed of this. Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations was increased from less than 1%, up to approximately 1.5%. It has been estimated that the risk increases with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. From the twentieth week of pregnancy onwards, the use of acetylsalicylic acid may cause oligohydramnios resulting from fetal renal dysfunction. This condition may be encountered soon after initiation of treatment and is usually reversible upon discontinuation of treatment. In addition, cases of constriction of the ductus arteriosus have been reported following treatment in the second trimester, most of which resolved after discontinuation of treatment. Therefore, during the first and second trimester of pregnancy, acetylsalicylic acid should not be administered unless clearly necessary. If acetylsalicylic acid is used by a woman planning to become pregnant, or during the first and second trimester of pregnancy, the lowest possible dose should be used for the shortest possible duration. Following exposure to acetylsalicylic acid for several days from the twentieth week of gestation onwards, antenatal monitoring for oligohydramnios and constriction of the ductus arteriosus should be considered. If oligohydramnios or constriction of the ductus arteriosus occurs, treatment with Aspirin with vitamin C should be discontinued. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction (see above); the mother and the unborn child, at the end of pregnancy, to: possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; inhibition of uterine contractions resulting in delay or prolongation of labor. Consequently, Aspirin with Vitamin C is contraindicated during the third trimester of pregnancy. Breastfeeding: Aspirin with Vitamin C is contraindicated during breastfeeding (see section 4.3)."
