Vivin C 20 Effervescent Tablets

VIVIN C 330 MG / 200 MG EFFERVESCENT TABLETS

Therapeutic indications

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

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 non-carbonated water. The product must 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 must 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 (antipyretics)/non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients listed in paragraph 6.1 ; Hemorrhagic diathesis; Gastropathies (e.g. gastro-duodenal ulcer); Asthma; 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); Severe kidney, heart or liver failure; Concomitant treatment with methotrexate (at doses of 15 mg/week or more) or warfarin (see section 4.5). The use of this medicine is contraindicated in children and adolescents under 16 years of age. 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 side effects are dependent on both the dose and duration of treatment. After 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 bleeding, which can be manifest (hematemesis, melena) 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). - Less frequently, gastritis has been observed.Cardiac diseases: - Edema, hypertension and heart failure have been reported in association with treatment with NSAIDs.Pathologies of the skin and subcutaneous tissue: - Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.Pathologies of the blood and lymphatic system: - Hemorrhagic syndromes (epistaxis, gingival hemorrhages, thrombocytopenia, purpura) with increased bleeding time. This effect persists for 4-8 days after stopping the administration of acetylsalicylic acid. It causes bleeding risk in patients undergoing surgery. - High doses of vitamin C (>1g) can increase hemolysis in patients with G6PD-dehydrogenase deficiency in the form of chronic hemolysisImmune system disorders: - Hypersensitivity reactions: angioedema, Quincke's edema, urticaria, erythema, asthma, anaphylactic reactions.Nervous system disorders: - Ringing in the ears; - Sensation of reduced hearing; - Headache, dizziness, usually a sign of overdose.Pregnancy, puerperium and perinatal conditions: - Delayed birth.Renal and urinary disorders: - High doses of vitamin C (>1g) can promote the formation of oxalate and uric acid stones in some individuals.Respiratory, thoracic and mediastinal disorders: Rhinitis, dyspnea. Rarely bronchospasm, asthma attacks.Reporting of suspected adverse reactions. Reporting 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

This medicine must not be used in children and young people under 16 years of age (see section 4.3). Cases of Reye's syndrome have been observed in children suffering from viral infections (in particular chickenpox and influenza-like conditions) and treated with acetylsalicylic acid. Reye's syndrome is a very rare, but life-threatening disease that requires immediate medical intervention. It manifests itself with persistent vomiting and signs of progressive damage to the central nervous system (stunness, up to the appearance 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). Subjects over 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, constitutes a risk factor for the clinical recurrence of the disease and can favor the appearance of diverticular complications such as perforation, fistulization and abscesses. It is advisable for patients with gastric and intestinal disorders or reduced renal function (mild to moderate) to consult their doctor. The use of VIVIN C should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. Side effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms. Gastrointestinal haemorrhage, ulceration and perforation: Gastrointestinal haemorrhage, ulceration and perforation, which may be fatal, have been reported during treatment with all NSAIDs, at any time, 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. 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, treatment should be stopped and not restarted without consulting the doctor. Acetylsalicylic acid and other NSAIDs may 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 serious. Acetylsalicylic acid modifies uric acid (in the analgesic dose acetylsalicylic acid increases uric acid by inhibiting the excretion of uric acid, at the doses used in rheumatology, acetylsalicylic acid has a uricosuric effect). Caution should be used 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 (acetylsalicylic acid 50 mg to 375 mg per day). Low molecular weight heparins and fractionated heparins (see section 4.5). In diabetic patients treated with sulfonylureas, for example, salicylics can increase the hypoglycaemic effect of sulfonylureas. (see paragraph 4.5). Caution is required in patients with a history of hypertension and/or heart failure since, in association with therapy with acetylsalicylic acid, as with other NSAIDs, water retention and edema have been reported. The risk is greater in subjects treated with diuretics. The medicine is contraindicated in severe renal, cardiac or hepatic insufficiency (see section 4.3). The sodium content per effervescent tablet (485 mg) must be taken into consideration in the case of a low-sodium/low-salt diet in patients with heart failure, high blood pressure and renal failure. 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 skin rash, mucosal lesions or any other sign of hypersensitivity.Surgery: If you have to undergo surgery (even a small one, for example tooth extractions) and you have used acetylsalicylic acid or another NSAID in the previous days, there is an increased risk of bleeding and you should inform your surgeon. due to possible effects on coagulation. Subjects with a habit of drinking large quantities of alcohol are more exposed to the risk of gastrointestinal lesions (bleeding in particular) (see section 4.5).Metrorrhagia or menorrhagia:the simultaneous intake of acetylsalicylic acid may increase the risk of greater intensity and duration of bleeding.Pregnancy and breastfeeding (see section 4.6).This medicinal product contains 485 mg sodium per tablet equivalent to 24.25% of the WHO recommended maximum daily intake of 2 g sodium per adult. This medicine contains 48 mg 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 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: 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 administered prostaglandin synthesis inhibitors 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 prostaglandin synthesis inhibitors 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 newborn, at the end of pregnancy, are exposed 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.Feeding time: Acetylsalicylic acid passes into breast milk in small quantities: VIVIN C should not be taken during breastfeeding.

Expiration and conservation

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

Interactions with other drugs

The following interactions should be taken into consideration when prescribing VIVIN C: Methotrexate(doses greater than or equal to 15 mg/week): increase in plasma levels and toxicity of methotrexate; the risk of toxic effects is greater if renal function is compromised. Avoid concomitant use (see section 4.3). The administration of acetylsalicylic acid, therefore, can potentiate the side effects of methotrexate and the effects and secondary manifestations of all non-steroidal antirheumatic drugs.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 haemorrhage (see section 4.4).Anticoagulants: increased risk of bleeding due to inhibition of thrombocytes, risk of lesions of the duodenal mucosa, potentiation of the pharmacological effect and displacement of oral anticoagulants from their binding sites with plasma proteins (see section 4.4).Warfarin:serious increase in the risk of haemorrhage due to enhancement of the anticoagulant effect. Avoid concomitant use (see section 4.3)Low molecular weight heparins and unfractionated heparins:the joint use of medicines acting at different levels of hemostasis 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 hemorrhage and decreased antithrombotic effect. If concomitant administration cannot be avoided, clinical monitoring is recommended.Pemetrexedin patients with mild to moderate reduction in renal function (creatinine clearance between 45 ml/min and 80 ml/min); increased risk of pemetrexed toxicity (due to decreased renal elimination of pemetrexed caused by acetylsalicylic acid) with anti-inflammatory doses of acetylsalicylic acid.Antidiabetics(e.g. insulin and oral hypoglycemics): increased 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 (e.g. ACE inhibitors) or diuretics increases the risk of acute renal failure due to reduced glomerular filtration due to reduced 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(e.g. antacids, citrates): antacids taken at the same time as other drugs can reduce their absorption; the excretion of acetylsalicylic acid increases in alkalinized 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 central nervous system toxicity.Phenytoin: increased effect of phenytoinMetoclopramide and domperidone: increase in the effect of acetylsalicylic acid due to an increase in the speed of absorption.Uricosurics(e.g. probenecid and sulfinpyrazone): decrease in the uricosuric effect.Chickenpox vaccine: It is recommended not to administer salicylates to patients who have received chickenpox vaccination for a period of six weeks after vaccination. Cases of Reye's syndrome have occurred following the use of salicylates during chickenpox infection.Zafirlukast: increased plasma concentration of zafirlukast.Alcohol: increased risk of intestinal bleeding. At doses greater than 2 g per day of vitamin C, ascorbic acid may interfere with the following tests: creatinine and glucose measurements in blood and urine. 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.

Overdose

Salicylate toxicity (a dosage exceeding 100 mg/kg/day for 2 consecutive days can induce toxicity) can be the consequence of a chronic intake of excessive doses, or of acute overdose, potentially life-threatening and including also accidental ingestion in children. Overdose in children can be fatal from 100 mg/kg/day in a single dose. Symptoms: -Moderate intoxication: Ringing 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 guidance: - 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 of hemodialysis in severe poisoning, - compensate for dehydration with adequate fluid intake - symptomatic supportive treatment. In case of 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 hydrogen carbonate, sodium benzoate.