Vivin C 330 mg + 200 mg Acetylsalicylic Acid with Vitamin C 20 Effervescent Tablets

WARNINGS
This medicinal product should not be used in children and young people under the age of 16. Cases of Reye's syndrome have been observed in children with viral infections and treated with acetylsalicylic acid. Reye's syndrome is manifested by persistent vomiting and signs of progressive damage to the central nervous system (numbness, leading to generalized convulsions and coma), signs of liver injury and hypoglycemia. Individuals older than 70 years of age, especially in the presence of concomitant therapies, should use this medicine only after consulting a doctor. After three days of use at the maximum dose or after 5-7 days of continuous use, consult your doctor. It is advisable that patients with glucose-6-phosphate-dehydrogenase deficiency, chronic or recurrent gastric and intestinal disorders or impaired renal function be consulted by the doctor. In the case of a sodium-free or low-sodium regimen it should be noted that each tablet of the product contains about 480 mg of sodium. Concomitant use should be avoided with NSAIDs, including selective COX-2 inhibitors. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal haemorrhage, ulceration and perforation: Gastrointestinal haemorrhage, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events. Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin. When gastrointestinal bleeding or ulceration occurs in patients taking the drug, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. Caution should be exercised in patients with a history of hypertension and / or heart failure as fluid retention and edema have been reported in association with NSAID therapy. 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. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. The drug should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity '.
PHARMACOTHERAPEUTIC CATEGORY
Analgesics and antipyretics - salicylic acid and derivatives.
STORAGE
Do not store above 25 degrees C. Keep the tube tightly closed in order to protect the medicine from moisture.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active ingredients, to salicylates or to any of the excipients, ascertained tendency to bleeding, gastropathies (e.g. gastro-duodenal ulcer), asthma. History of gastrointestinal haemorrhage or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Severe heart failure. The use of this medicine is contraindicated in children and adolescents with a diet of less than 16 years. Dose> 100 mg / day during the third trimester of pregnancy.
NAME
VIVIN C 330 MG + 200 MG EFFERVESCENT TABLETS
EXCIPIENTS
Glycine, anhydrous citric acid, sodium hydrogencarbonate, sodium benzoate.
SIDE EFFECTS
Gastrointestinal disorders: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, ulcerative stomatitis, exacerbation of colitis and Crohn's disease. Peptic ulcer, even perforated. Gastrointestinal haemorrhage, which can be manifest (haematemesis, melaena) and sometimes fatal, or occult and cause iron deficiency anemia. Such bleeding is more frequent with increasing dosage, particularly in elderly patients. Less frequently, astrites have been observed. Cardiac disorders: Edema, hypertension and heart failure have been reported in association with NSAID treatment. Skin and subcutaneous tissue disorders: Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis. Blood and lymphatic system disorders: haemorrhagic syndromes (epistaxis, gingival haemorrhages, thrombocytopenia, purpura) with increased bleeding time. This effect persists for 4-8 days after discontinuation of the administration of acetylsalicylic acid. It causes bleeding risk in patients undergoing surgery. High doses of vitamin C (> 1g) may increase hemolysis in patients with G6PD dehydrogenase deficiency in the form of chronic hemolysis. Disorders of the immune system. Hypersensitivity reactions: angioedema, Quincke's edema, urticaria, erythema, asthma, anaphylactic reactions. Nervous system disorders: ringing in the ears. Feeling of reduced hearing. Headache, usually a sign of overdose. Pregnancy, puerperium and perinatal conditions: late delivery. Renal and urinary disorders: high doses of vitamin C (> 1g) may favor the formation of oxalate and uric acid calculations in some individuals.
PREGNANCY AND BREASTFEEDING
Low doses (up to 100 mg / day): clinical studies indicate that doses up to 100 mg / day can be considered safe for use in obstetrics, which requires specialist monitoring. Doses of 100-500 mg / day: there are insufficient clinical data regarding the use of doses above 100 mg / day up to 500 mg / day. Therefore, the recommendations below for doses of 500 mg / day and above also apply to this dose range. Doses of 500 mg / day and more: inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development. Findings from epidemiological studies suggest an increased risk of abortion and 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% 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 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 prostaglandin synthesis inhibitors were administered during the organogenetic period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be administered except in strictly necessary cases. 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 can expose the fetus to cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy to possible prolongation of the bleeding time and antiplatelet effect which can 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.
INDICATIONS
Headache and toothache, neuralgia, menstrual pain, rheumatic and muscle pain. Symptomatic therapy of feverish states and flu and cold syndromes.
INTERACTIONS
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding. Anticoagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. The administration of acetylsalicylic acid, especially in the case of prolonged therapy, can 'potentiate the undesirable effects of methotrexate, the secondary effects and manifestations of all non-steroidal antirheumatics, the effect of blood sugar-reducing drugs (sulphonylurea). Precaution should be observed for substances such as spironolactone, furosemide and antigout preparations, whose activity is instead reduced by acetylsalicylic acid. Therefore, unless otherwise prescribed, it should not be administered concomitantly with the above preparations.
DOSAGE
Adults: 1-2 tablets if necessary up to 3-4 times a day. Dissolve one or two tablets in half a glass of still water. The product must be taken on a full stomach. Do not exceed the recommended dosages: in particular elderly patients should follow the minimum dosages indicated above.
ACTIVE PRINCIPLES
Each tablet contains: acetylsalicylic acid 0.330 g, ascorbic acid 0.200 g.