VIVIN C * 20CPR EFF 330MG + 200MG

VIVIN C * 20CPR EFF 330MG + 200MG

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

Dosage.Adults: 1-2 tablets if necessary up to 3-4 times a day. Dissolve one or two VIVIN C tablets in half a glass of still water. The product should be taken on a full stomach. Do not exceed the recommended dose. After three days of use at the maximum dose or after 5 days of continuous use, consult your doctor. Special populations.Pediatric population: VIVIN C is not indicated for use in the pediatric population (see section 4.3)Elderly people: Elderly patients should adhere to the minimum dosages indicated above.

Contraindications

VIVIN C is contraindicated in case of: Hypersensitivity to the active substances, (acetylsalicylic acid and ascorbic acid) or to other analgesics (painkillers) / antipyretics (feverproof) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients listed in section 6.1 ; Hemorrhagic diathesis; Gastropathies (eg gastro-duodenal ulcer); Asthma; 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); Severe kidney, heart or liver failure; Concomitant treatment with methotrexate (at doses of 15 mg / week or more) or with warfarin (see section 4.5). The use of this medicine is contraindicated in children and young people under the age of 16. Dose> 100 mg / day during the third trimester of pregnancy. Breastfeeding (see section 4.6).

Side effects

Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. Most of the undesirable effects are dependent on both the dose and the duration of treatment. Following administration of VIVIN C, the following 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, 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 (see section 4.4). - Gastritis has been observed less frequently.Cardiac pathologies: - 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.Disorders of the blood and lymphatic system: - Haemorrhagic syndromes (epistaxis, gingival haemorrhages, thrombocytopenia, purpura) with increased bleeding time. This effect persists for 4-8 days after discontinuation of acetylsalicylic acid administration. 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 hemolysisDisorders of the immune system: - Hypersensitivity reactions: angioedema, Quincke's edema, urticaria, erythema, asthma, anaphylactic reactions.Nervous system disorders: - Ear buzz; - Feeling of reduced hearing; - Headache, dizziness, usually a sign of overdose.Pregnancy, puerperium and perinatal conditions: - Delay in childbirth.Renal and urinary disorders: - High doses of vitamin C (> 1g) may promote the formation of oxalate and uric acid stones in some individuals.Respiratory, thoracic and mediastinal disorders: Rhinitis, dyspnoea. Rarely bronchospasm, asthma attacks.Reporting of suspected adverse reactions. Reporting 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

This medicinal product should not be used in children and young people under the age of 16 (see section 4.3). Cases of Reye's syndrome have been observed in children with viral infections (particularly chicken pox and flu-like conditions) and treated with acetylsalicylic acid. Reye's syndrome is a very rare, but life-threatening disease that requires immediate medical attention. It is manifested by persistent vomiting and signs of progressive damage to the central nervous system (numbness, up to the onset of generalized convulsions and coma), signs of liver injury and hypoglycemia. G6PD deficiency, high doses of acetylsalicylic acid can cause hemolysis. In case of G6PD deficiency, acetylsalicylic acid should only be administered under medical supervision.Elderly people:elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. These patients should start treatment with the lowest available dose (see section 4.2). People older than 70 years of age, especially in the presence of concomitant therapies, should use this medicine only after consulting a doctor.Crohn's disease, ulcerative colitis:acetylsalicylic acid, like NSAIDs in general, is a risk factor for the clinical relapse of the disease, it can favor the onset of diverticular complications such as perforation, fistulization and abscesses. It is advisable that patients with gastric and intestinal disorders or impaired renal function (mild to moderate) be consulted with the physician. The use of VIVIN C should be avoided concomitantly 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. 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 (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. Patients being treated with VIVIN C should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. When gastrointestinal bleeding or ulceration occurs in patients taking VIVIN C the treatment should be stopped and not restarted without consulting your doctor. Acetylsalicylic acid and other NSAIDs can cause hypersensitivity reactions (including asthma attacks, rhinitis, angioedema or urticaria). In subjects with asthma and / or rhinitis (with or without nasal polyposis) and / or urticaria the reactions may be more frequent and severe. Acetylsalicylic acid modifies uricaemia (acetylsalicylic acid increases uric acid in the analgesic dose by inhibiting the excretion of uric acid, at the doses used in rheumatology, acetylsalicylic acid has a uricosuric effect). Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, selective serotonin reuptake inhibitor (SSRI) anticoagulants or antiplatelet agents such as aspirin (50 mg to 375 mg acetylsalicylic acid) per day). Low molecular weight heparins and fractionated heparins (see section 4.5). In diabetic patients, being treated with e.g. sulfonylureas, salicylics may increase the hypoglycemic effect of sulfonylureas. (see section 4.5). 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 acetylsalicylic acid therapy, as well as with other NSAIDs. The risk is greater in subjects being treated with diuretics. The medicinal product is contraindicated in severe renal, cardiac or hepatic insufficiency (see section 4.3). The sodium content per effervescent tablet (485 mg) should be taken into account in the case of a low salt / sodium diet in patients with heart failure, high blood pressure and renal insufficiency. 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 appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. VIVIN C should be discontinued at the first appearance of rash, mucosal lesions or any other signs of hypersensitivity.Surgery: If you have to undergo surgery (even a minor one, for example tooth extractions) and have used acetylsalicylic acid or another NSAID in the previous days, there is an increased risk of bleeding and you should inform the surgeon. for the possible effects on coagulation. People with a habit of drinking high quantities of alcohol are at increased risk of gastrointestinal injury (bleeding in particular) (see section 4.5).Metrorrhagia or menorrhagia:the concomitant intake of acetylsalicylic acid may increase the risk of greater intensity and duration of the bleeding.Pregnancy and lactation (see section 4.6).This medicinal product contains 485 mg of sodium per tablet equivalent to 24.25% of the WHO recommended maximum daily intake of 2 g of sodium per adult. This medicinal product contains 48 mg of sodium benzoate per tablet equivalent to 48 mg / 3500mg.

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. 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.Feeding time: Acetylsalicylic acid in small quantities passes into breast milk: VIVIN C must not be taken during breastfeeding.

Expiry and retention

Do not store above 25 ° C. Keep the tube tightly closed to protect from moisture. For storage conditions after first opening see section 6.3.

Interactions with other drugs

The following interactions should be considered when prescribing VIVIN C: Methotrexate(doses greater than or equal to 15 mg / week): increase in plasma levels and methotrexate toxicity; the risk of toxic effects is greater if renal function is impaired. Concomitant use should be avoided (see section 4.3). Administration of acetylsalicylic acid, therefore, may potentiate the undesirable effects of methotrexate and the secondary effects and manifestations of all non-steroidal antirheumatics.Analgesics:avoid concomitant administration of other salicylates or other NSAIDs (including topical formulations) due to increased risk of serious side effects.Corticosteroids:increased risk of gastrointestinal ulceration or bleeding (see section 4.4).Anticoagulants: increased risk of bleeding due to thrombocyte inhibition, risk of lesions of the duodenal mucosa, enhancement of the pharmacological effect and displacement of oral anticoagulants from their plasma protein binding sites (see section 4.4).Warfarin:severe increased risk of bleeding due to potentiation of the anticoagulant effect. Avoid concomitant use (see section 4.3)Low molecular weight heparins and unfractionated heparins:the joint use of medicines that act at different levels of haemostasis increases the risk of bleeding.Antiplatelet agents(e.g. clopidogrel and dipyridamole) and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).Anagrelide: increased risk of bleeding and decreased antithrombotic effect. If concomitant administration cannot be avoided, clinical monitoring is recommended.Pemetrexedin patients with mild to moderate decreased renal function (creatinine clearance between 45 ml / min and 80 ml / min); increased risk of pemetrexed toxicity (due to decreased renal elimination of pemetrexed by acetylsalicylic acid) with anti-inflammatory doses of acetylsalicylic acid.Antidiabetic(eg insulin and oral hypoglycemic agents): increase in the hypoglycemic effect;Diuretics and antihypertensives: NSAIDs may reduce the antihypertensive effects of diuretics and other antihypertensive agents. As with other NSAIDs, concomitant administration of acetylsalicylic acid with antihypertensives (eg ACE inhibitors) or diuretics increases the risk of acute renal failure due to impaired glomerular filtration due to impaired renal synthesis of prostaglandins.Valproic Acid: Acetylsalicylic acid has been reported to reduce the binding of valproate to serum albumin, thereby increasing its steady-state free plasma concentrations.Urine alkalizers(eg antacids, citrates): antacids taken at the same time as other drugs can reduce their absorption; excretion of acetylsalicylic acid increases in alkalized urine.Digoxin and lithium: acetylsalicylic acid significantly reduces the renal excretion of digoxin and lithium, resulting in an increase in their plasma concentrations.Carbonic anhydrase inhibitors(acetazolamide): reduced elimination of acetazolamide which can cause severe acidosis and increased toxicity to the central nervous system.Phenytoin: increased effect of phenytoinMetoclopramide and domperidone: increase in the effect of acetylsalicylic acid by increasing the absorption rate.Uricosurics(eg: probenecid and sulfinpyrazone): decrease in the uricosuric effect.Chickenpox vaccine: It is recommended not to administer salicylates to patients who have received varicella vaccination for a period of six weeks after vaccination. Cases of Reye's syndrome have occurred as a result of the use of salicylates during chickenpox infection.Zafirlukast: increased plasma concentration of zafirlukast.Alcohol: increased risk of intestinal bleeding. At doses above 2 g per day of vitamin C, ascorbic acid can interfere with the following tests: blood and urine creatinine and glucose measurements. 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

Salicylate toxicity (a dose greater than 100 mg / kg / day for 2 consecutive days can induce toxicity), may be the consequence of chronic overdose, or acute overdose, which is potentially life-threatening and includes even accidental ingestion in children. Overdose in children can be fatal starting at 100 mg / kg / day in a single dose. Symptoms: -Moderate intoxicationRinging in the ear, a feeling of reduced hearing acuity, headache, dizziness are the hallmarks of overdose and can be controlled by reducing the dosage. -Severe poisoning: Symptoms include fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiovascular collapse, respiratory failure, severe hypoglycemia. Emergency guide: - Immediate transfer to a specialized hospital, - gastric lavage and repeated administration of activated charcoal, - control of acid-base balance, - forced alkaline diuresis to obtain a urinary pH between 7.5 and 8, possibility hemodialysis in severe poisonings, - compensate for dehydration with adequate fluid intake - supportive symptomatic treatment. In the event of an overdose, contact a poison control center or the nearest hospital immediately. Acetylsalicylic acid is dialyzable.

Active principles

Each tablet contains:Active principles: acetylsalicylic acid 0.330 g, ascorbic acid 0.200 g. Excipient with known effects: sodium, sodium benzoate. For the full list of excipients, see section 6.1

Excipients

Glycine, anhydrous citric acid, sodium hydrogencarbonate, sodium benzoate.