VIVIN * 20CPR 500MG

VIVIN * 20CPR 500MG

Therapeutic indications

Headache and toothache, neuralgia, menstrual pain, rheumatic and muscle 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: in particular elderly patients should follow the minimum dosages indicated above.Method of administrationThe tablets should be swallowed with or without drink (water).

Contraindications

Hypersensitivity to the active substance, to salicylates or to any of the excipients listed in section 6.1, haemorrhagic diseases, gastropathies (e.g. gastro-duodenal ulcer disease), asthma, hypophosphataemia, renal failure. Last trimester of pregnancy. The use of this medicine is contraindicated in children and young people under the age of sixteen. Dose> 100 mg / day during the third trimester of pregnancy. History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). CARDIOVASCULAR SAFETY OF NSAIDs Severe heart failure.

Side effects

During the course of treatment, gastric disturbances (pains, etc.) may occur mostly in sensitive patients. In completely sporadic cases and in predisposed patients, bleeding episodes may occur (epistaxis, gingivorrhagia, gastrointestinal bleeding, etc.); hypersensitivity reactions, such as bronchial spasms, skin manifestations, oto-vestibular disturbances (buzzing) and, in extremely rare cases, reduction of platelets (thrombocytopenia) and delayed delivery may occur rarely. Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of VIVIN (see section 4.4 - special warnings and precautions for use) . Gastritis has been observed less frequently. 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 NSAID treatment. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatment) may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) ( see Section 4.4).Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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.

Special warnings

After three days of use at the maximum dose or after 5-7 days of continuous use, without noticeable results, consult your doctor. It is also advisable that patients with glucose-6-phosphate-dehydrogenase deficiency, chronic or recurrent gastric and intestinal disorders or impaired renal function be consulted with the doctor. If prolonged vomiting and profound drowsiness occur during treatment, discontinue administration. This medicine should not be used in children and young people under the age of 16 (see Contraindications). People older than 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. Preoperative use can hinder intraoperative haemostasis. The use of VIVIN, as with any prostaglandin and cyclooxygenase inhibitor drug, is not recommended in women intending to become pregnant. VIVIN administration should be discontinued 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 inhibitory NSAIDs. 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 (see section 4.2) Gastrointestinal bleeding, ulceration and perforation: during treatment with all NSAIDs, at any time Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported 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 (see section 4.3), the risk of gastrointestinal bleeding, 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 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 (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking VIVIN the 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 (see section 4.8 undesirable effects). CARDIOVASCULAR SAFETY OF NSAIDs Caution should be exercised in patients with a history of hypertension and / or heart failure as fluid retention, hypertension and edema have been reported in association with NSAID therapy. 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 signs of hypersensitivity. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see 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 treatment) may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). There are currently insufficient data to exclude a similar risk for acetylsalicylic acid when it is administered as a daily dose of 1-2 tablets 2-3 times a day. VIVIN contains less than 1 mmol (23 mg) ofsodiumper tablet, ie it is essentially “sodium-free”.

Pregnancy and breastfeeding

For use in breastfeeding and pregnant women consult your doctor. Do not use in the last three months of pregnancy unless the use is specifically prescribed by the doctor, since acetylsalicylic acid can cause haemorrhagic phenomena in the fetus and mother, delay in childbirth, and in the unborn child, early 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 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 over. Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage 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%. The risk has been estimated to increase 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 given prostaglandin synthesis inhibitors 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 can 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 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.

Expiry and retention

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 undesirable effects of methotrexate, the risk of gastrointestinal bleeding in case of simultaneous treatment with corticosteroids, secondary effects and manifestations of all non-steroidal antirheumatics, the effect of blood glucose-lowering drugs (sulfonylurea). Caution should be observed for substances such as spironolactone, furosemide and antigout preparations, whose activity is instead reduced by acetylsalicylic acid. Therefore, unless otherwise prescribed, VIVIN should not be administered concomitantly with the above preparations. However, it is advisable not to administer other drugs by mouth within 1 or 2 hours of using the product. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4). Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4). Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4). Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, 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 monitoring of renal function should be considered after initiation of concomitant therapy. Metamizole can reduce the effect of acetylsalicylic acid on platelet aggregation when taken at the same time. Therefore, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection.

Overdose

Symptoms of overdose are dizziness and tinnitus (ringing in the ears) which may be accompanied by nausea, vomiting and stomach upset. In severe cases, confusion, numbness, collapse, convulsions, respiratory and kidney disorders and sometimes even hemorrhages are observed. In case of acute overdose, empty the stomach by emetics, or by aspiration or gastric lavage. For milder intoxications, drink copious amounts of fluids. In case of severe intoxication (plasma concentrations of salicylate higher than 500, ug / ml in the adult and 300, ug / ml in the child), forced and continued alkaline diuresis may be indicated until a plasma concentration of salicylate below 350 is reached. , ug / ml in the adult. At this point the intravenous administration can be suspended and the patient invited to take liquids orally. Plasma electrolytes, especially potassium, as well as the acid-base balance must be checked regularly. Acidemia should be corrected by sodium bicarbonate infusion before starting forced diuresis. In the presence of cardiac or renal insufficiency 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.

Active principles

One tablet contains:Active principle: Acetylsalicylic acid 500 mg Excipients: for a full list of excipients, see section 6.1.

Excipients

Starch, sodium lauryl sulfate, colloidal silica.