VIVIN 500 MG TABLETS
Headache and toothache, neuralgia, menstrual pain, rheumatic and muscular pain. Symptomatic therapy of feverish states and flu and cold syndromes.
Dosage and method of use
Dosage1-2 tablets 2 - 3 times a day. Do not exceed the recommended doses: elderly patients in particular should stick to the minimum dosages indicated above.Method of administrationThe tablets should be swallowed with or without drinking (water).
Hypersensitivity to the active ingredient, to salicylates or to any of the excipients listed in paragraph 6.1, haemorrhagic diseases, gastropathies (e.g.: gastro-duodenal ulcerative disease), asthma, hypophosphatemia, renal failure. Last trimester of pregnancy. The use of this medicine is contraindicated in children and adolescents under the age of sixteen. Dose > 100 mg/day during the third trimester of pregnancy. History of gastrointestinal hemorrhage or perforation related to previous active treatment or history of recurrent peptic hemorrhage/ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). CARDIOVASCULAR SAFETY OF NSAIDs Severe heart failure.
During treatment, gastric disorders (pain, etc.) may occur, mostly in sensitive patients. In completely sporadic cases and in predisposed patients, bleeding episodes may occur (epistaxis, gingivorrhagia, gastrointestinal haemorrhages, etc.); rarely, hypersensitivity reactions may occur, such as bronchial spasms, skin manifestations, oto-vestibular disorders (buzzing) and, in extremely rare cases, reduction in platelets (thrombocytopenia) and delays in childbirth. Gastrointestinal: the most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). After administration of VIVIN the following have been reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4 - special warnings and precautions for use) . Less frequently, gastritis has been observed. SKIN SAFETY OF NSAIDs Bullous reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis (very rarely). CARDIOVASCULAR SAFETY OF NSAIDs Edema, hypertension and heart failure have been reported in association with treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatments) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) ( see Section 4.4).Reporting of suspected adverse reactionsReporting suspected adverse reactions that occur after authorization 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 at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
After three days of use at the maximum dose or after 5-7 days of continuous use, without appreciable results, consult your doctor. It is also advisable for patients with glucose-6-phosphate dehydrogenase deficiency, chronic or recurrent gastric and intestinal disorders or impaired renal function to consult their doctor. If prolonged vomiting and profound drowsiness appear during treatment, discontinue administration. This medicine must not be used in children and young people under 16 years of age (see contraindications). Subjects over 70 years of age, especially in the presence of concomitant therapies, should use this medicine only after consulting a doctor. The product must be taken on a full stomach. Pre-operative use may hinder intraoperative haemostasis. The use of VIVIN, like any drug that inhibits the synthesis of prostaglandins and cyclooxygenases, is not recommended in women who intend to become pregnant. The administration of VIVIN should be suspended in women who have fertility problems or who are undergoing fertility investigations. The use of VIVIN should be avoided in conjunction with selective COX-2 inhibitor NSAIDs. Side effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhages and perforations, which may be fatal (see section 4.2). Gastrointestinal haemorrhage, ulceration and perforation: during treatment with all NSAIDs, at any time Gastrointestinal haemorrhage, ulceration and perforation, which may be fatal, have been reported, with or without warning symptoms or previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), 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 (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or haemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking VIVIN, treatment should be discontinued. NSAIDs should be administered 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 undesirable effects). CARDIOVASCULAR SAFETY OF NSAIDs Caution is required in patients with a history of hypertension and/or heart failure since, in association with NSAID therapy, fluid retention, hypertension and edema have been reported. SKIN SAFETY OF NSAIDs 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 4.8). 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. VIVIN should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). Cardiovascular and cerebrovascular effects Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatments) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). There are currently insufficient data available to exclude a similar risk for acetylsalicylic acid when it is administered at a daily dose of 1-2 tablets 2 - 3 times a day. VIVIN contains less than 1 mmol (23 mg) ofsodiumper tablet, i.e. it is essentially “sodium-free”.
Pregnancy and breastfeeding
For use during breastfeeding and pregnancy, consult your doctor. Do not use in the last three months of pregnancy unless use is specifically prescribed by the doctor, since acetylsalicylic acid can cause hemorrhagic phenomena in the fetus and mother, delayed birth, and in the unborn child, premature closure of the Botallo duct.Pregnancy- Low doses (up to 100 mg/day) Clinical studies indicate that doses up to 100 mg/day can be considered safe limited to use in obstetrics, which requires specialist monitoring. - Doses of 100-500 mg/day There are insufficient clinical data relating to the use of doses higher than 100 mg/day up to 500 mg/day. Therefore, the recommendations below for doses of 500 mg/day and above also apply to this dosage range. - Doses of 500 mg/day and above The inhibition of prostaglandin synthesis can negatively affect pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of 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 the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, 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 unless strictly 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 inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo-hydramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, and anti-aggregating 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.
Expiration and conservation
This medicine does not require any special storage conditions.
Interactions with other drugs
The administration of acetylsalicylic acid, especially in the case of prolonged therapy, can enhance the activity of anticoagulant drugs (for example coumarin derivatives and heparin), the side effects of methotrexate, the risk of gastrointestinal bleeding in case of simultaneous treatment with corticosteroids, the effects and secondary manifestations of all non-steroidal antirheumatic drugs, the effect of blood sugar-reducing drugs (sulfonylurea). Precaution must be observed for substances such as spironolactone, furosemide and anti-gout preparations, whose activity is instead reduced by acetylsalicylic acid. Therefore, unless otherwise prescribed by a doctor, VIVIN should not be administered concomitantly with the aforementioned preparations. However, it is advisable not to administer other drugs orally within 1 or 2 hours of using the product. Corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4). Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4). Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal haemorrhage (see section 4.4). Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclooxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking VIVIN concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy. Metamizole may reduce the effect of acetylsalicylic acid on platelet aggregation, if taken simultaneously. Therefore, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection.
Symptoms of overdose include dizziness and tinnitus (ringing in the ears) which may be accompanied by nausea, vomiting and gastric disorders. In more serious cases, confusion, numbness, collapse, convulsions, respiratory and renal disorders and sometimes even bleeding are observed. In case of acute overdose, empty the stomach using emetics, or aspiration or gastric lavage. For milder intoxications, drink large quantities of liquids. In case of severe intoxication (plasma salicylate concentrations higher than 500 ug/ml in adults and 300 ug/ml in children), forced alkaline diuresis may be indicated and continued until a plasma salicylate concentration lower than 350 is reached. , ug/ml in adults. At this point the intravenous administration can be suspended and the patient invited to take liquids orally. Plasma electrolytes, especially potassium, as well as acid-base balance should be regularly monitored. Acidemia must be corrected by infusion of sodium bicarbonate before starting forced diuresis. In the presence of heart or kidney failure or very severe intoxication, hemodialysis or endoperitoneal dialysis may be necessary. Acute allergic reactions following the intake of acetylsalicylic acid can be treated, if necessary, with the administration of adrenaline, corticosteroids and antihistamines.
One tablet contains:Active principle: Acetylsalicylic acid 500 mg Excipients: for the complete list of excipients, see section 6.1.
Starch, sodium lauryl sulphate, colloidal silica.