A.MENARINI VIVIN C 330MG + 200MG THERAPY SYMPTOMATIC OF THE UNITED INFLUENZA AND COOLING FROM 20 EFFERVESCENT TABLETS

020096020

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Headache and toothache, neuralgia, period pains, rheumatic and muscular pain. Symptomatic treatment of fever and flu-like syndromes and cooling.

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Vivin C 330mg + 200mg

Symptomatic therapy States Of Influenza And From Cooling; 20 Effervescent Tablets


Active principles

Each tablet contains: Active ingredients: acetylsalicylic acid 0.330 g, 0.200 g ascorbic acid.

excipients

glycine, citric acid anhydrous, sodium hydrogen carbonate, sodium benzoate.

Therapeutic indications

Headache and toothache, neuralgia, period pains, rheumatic and muscular pain. Symptomatic treatment of fever and flu-like syndromes and cooling.

Contraindications

Hypersensitivity to the active substances, to salicylates or to any of the excipients, ascertained tendency to bleeding, gastric diseases (eg. Gastro-duodenal ulcers), asthma. History of gastrointestinal bleeding or perforation related to previous active treatments or history of peptic hemorrhage / ulcer recurrent (two or more distinct episodes of proven ulceration or bleeding). Severe heart failure. The use of this medicinal product is contraindicated in children and boys aged under 16 years. Dose> 100 mg / day during the third trimester of pregnancy

dosage

Adults: 1-2 tablets as needed up to 3-4 times a day. Dissolved in half a glass of still water one to two tablets of VIVIN C. Use of the product must take place on a full stomach. Do not exceed the recommended dose: in particular elderly patients should follow the minimum dosage mentioned above.

Warnings and Precautions

This medicinal product must not be used in children or adolescents under 16 years of age (see section 4.3). of Reye's syndrome they have been observed in children with viral infections (especially chicken pox and flu-like conditions) and treated with acetylsalicylic acid. Reye's syndrome is manifested by persistent vomiting and signs of progressive damage of the central nervous system (somnolence, until the onset of generalized convulsions and coma), signs of liver injury, and hypoglycemia. Individuals over the age of 70 years of age, especially in the presence of concomitant therapy, should use this medicine only after consulting a doctor. After three days of use at maximum dose or after 5-7 days of continuous employment, seek medical advice. It is recommended that a doctor be consulted by patients with glucose-6-phosphate dehydrogenase deficiency, chronic gastric and intestinal disorders or recurrent or compromised renal function. In the case of scheme sodium-free or low-salt is to keep in mind that each tablet product contains about 480 mg of sodium. The use of VIVIN C should be avoided in conjunction with NSAIDs, including selective COX-2. The side effects can be minimized by using the lowest effective dose for the shortest possible treatment duration necessary to control symptoms. Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2). Gastrointestinal bleeding, ulceration and perforation: during treatment with all NSAIDs at any time, with or without warning symptoms or a previous history of serious gastrointestinal events, were reported gastrointestinal bleeding, ulceration and perforation, which may be fatal. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (eg misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5). When GI bleeding or ulceration occurs in patients taking VIVIN C treatment should be discontinued. NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Caution should be exercised in patients with a history of hypertension and / or heart failure because, in association with NSAID therapy, have been reported fluid retention and edema. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients seem to be at higher risk: the onset of the reaction occurs in the majority of cases within the first month of treatment. VIVIN C should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

interactions

Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4). Anticoagulants: NSAIDs may enhance the effect of anticoagulants, such as warfarin (see section 4.4). Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4). The administration of acetylsalicylic acid, especially in case of prolonged therapy, may potentiate the side effects of methotrexate, the effects and the secondary manifestations of all non-steroidal antirheumatic, the effect of reducing blood sugar medications (sulfonylurea). Caution should be observed for substances such as spironolactone, furosemide and antigout prepared, whose activity is instead reduced by acetylsalicylic acid. Therefore, unless otherwise prescribed, VIVIN C should not be administered concurrently with the above-mentioned preparations.

Side effects

Gastrointestinal disorders The most commonly observed adverse events are gastrointestinal in nature. After administration of VIVIN C have been reported: • nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). • peptic ulcer, also perforated • Gastrointestinal bleeding, which can be manifested (haematemesis, melena), and sometimes fatal, or hidden and cause iron deficiency anemia. Such bleeding was more frequent with increasing dosage, particularly in elderly patients (see section 4.4). • Less frequently, gastritis has been observed. • Cardiac disorders Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Skin and subcutaneous tissue • bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis. Blood and lymphatic system • Haemorrhagic syndrome (epistaxis, gingival bleeding, thrombocytopenia purpura) with increased bleeding time. This effect persists for 4-8 days after discontinuation of acetylsalicylic acid. And 'because of bleeding risk in patients undergoing surgery. • High doses of vitamin C (> 1g) can increase hemolysis in patients with G6PDdeidrogenasi deficiency in the form of chronic haemolysis Immune system disorders • Hypersensitivity reactions: angioedema, Quincke's edema, urticaria, rash, asthma, anaphylactic reactions. Nervous system disorders • Ringing ear • Feeling of hearing loss • Headache, usually a sign of overdose of pregnancy conditions, puerperium and perinatal • childbirth delay kidney and urinary disorders • High doses of vitamin C (> 1g) can promote the formation of oxalate stones and uric acid in some individuals.

Pregnancy and lactation

- Low doses (up to 100 mg / day) Clinical studies indicate that doses up to 100 mg / day may be considered safe for limited use in obstetrics, which requires a specialized monitoring. Servings of 100-500 mg / day There are insufficient clinical data on the use of doses above 100 mg / day up to 500 mg / day. Therefore, the following recommendations reported for the doses of 500 mg / day and other, applies to this dose range. Servings of 500 mg / day and above Inhibition of prostaglandin synthesis may negatively affect pregnancy and / or the embryo / fetus. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor, in the early stages of pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1% to about 1.5%. E 'was estimated that the risk increases with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals to which the prostaglandin synthesis inhibitors were administered, during the organogenesis period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be given unless clearly necessary. If acetylsalicylic acid is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester 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 The mother and the neonate, at the end of pregnancy to: • possible prolongation of bleeding time and antiplatelet effect which may occur even at very low doses; • inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, acetylsalicylic acid at doses> 100 mg / day is contraindicated during the third trimester of pregnancy.

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