Vivin C 20 effervescent tablets 330mg + 200mg

Vivin C is a non-prescription drug based on acetylsalicylic acid 330 mg and ascorbic acid 200 mg. Vivin C has antipyretic, anti-inflammatory and analgesic action useful for treating and alleviating flu symptoms such as: cough, fever, runny nose, sore throat, feeling of general malaise, joint and muscle pain typical of the flu.

Vivin C tablets 330mg + 200mg, due to its analgesic action, can also be used in case of headache, toothache, neuralgia, menstrual pain, rheumatic and muscular pain.

ACTIVE INGREDIENTS

Active ingredients contained in Vivin C 20 effervescent tablets 330mg + 200mg - What is the active ingredient of Vivin C 20 effervescent tablets 330mg + 200mg?

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

EXCIPIENTS

Composition of Vivin C 20 effervescent tablets 330mg + 200mg - What does Vivin C 20 effervescent tablets 330mg + 200mg contain?

Glycine, anhydrous citric acid, sodium hydrogen carbonate, sodium benzoate.

DIRECTIONS

Therapeutic indications Vivin C 20 effervescent tablets 330mg + 200mg - Why is Vivin C 20 effervescent tablets 330mg + 200mg used? What is it used for?

Headache and toothache, neuralgia, menstrual pain, rheumatic and muscular pain; symptomatic therapy of feverish states and flu and cold syndromes.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Vivin C 20 effervescent tablets 330mg + 200mg - When should Vivin C 20 effervescent tablets 330mg + 200mg not be used?

VIVIN C is contraindicated in case of: hypersensitivity to the active substances (acetylsalicylic acid and ascorbic acid) or to other analgesics (painkillers)/antipyretics (feverkill)/nonsteroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients listed in paragraph 6.1; haemorrhagic diathesis; gastropathies (e.g. gastroduodenal ulcer); asthma; history of gastrointestinal haemorrhage or perforation related to previous active treatments or history of recurrent peptic haemorrhage/ulcer (two or more distinct episodes of proven ulceration or bleeding); severe renal, cardiac or hepatic insufficiency; concomitant treatment with methotrexate (at doses of 15 mg/week or more) or with warfarin (see paragraph 4.5). The use of this medicinal product 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).

DOSAGE

Quantity and method of taking Vivin C 20 effervescent tablets 330mg + 200mg - How to take Vivin C 20 effervescent tablets 330mg + 200mg?

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 must be taken on a full stomach. Do not exceed the recommended doses. After three days of use at the maximum dose or after 5 days of continuous use, consult your doctor. Special populations. Paediatric population: VIVIN C is not indicated for use in the paediatric population (see section 4.3). Elderly: elderly patients should adhere to the minimum dosages indicated above.

CONSERVATION

Storage Vivin C 20 effervescent tablets 330mg + 200mg - How to store Vivin C 20 effervescent tablets 330mg + 200mg?

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

WARNINGS

Warnings Vivin C 20 effervescent tablets 330mg + 200mg - About Vivin C 20 effervescent tablets 330mg + 200mg it is important to know that:

This medicinal product should not be used in children and adolescents under 16 years of age (see section 4.3). Cases of Reye's syndrome have been observed in children with viral infections (particularly chickenpox 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 manifests itself with persistent vomiting and signs of progressive damage to the central nervous system (numbness, up to generalized convulsions and coma), signs of liver damage and hypoglycaemia. G6PD deficiency, high doses of acetylsalicylic acid may cause haemolysis. In case of G6PD deficiency, acetylsalicylic acid should only be administered under medical supervision. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. These patients should start treatment with the lowest available dose (see section 4.2). Patients over 70 years of age, especially in the presence of concomitant therapies, should use this medicinal product only after consulting a doctor. Crohn's disease, ulcerative colitis: acetylsalicylic acid, like NSAIDs in general, constitutes a risk factor for clinical relapse of the disease, may favor the onset of diverticular complications such as perforation, fistulization and abscesses. It is advisable to consult a doctor by patients with gastric and intestinal disorders or reduced renal function (mild to moderate). The use of VIVIN C should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3). Patients taking VIVIN C should report any unusual GI symptoms (especially GI bleeding), particularly in the initial stages of treatment. When GI bleeding or ulceration occurs in patients taking VIVIN C, treatment should be discontinued and not restarted without consulting a 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, reactions may be more frequent and severe. Acetylsalicylic acid modifies uricemia (in the analgesic dose, acetylsalicylic acid increases uricemia by inhibiting the excretion of uric acid; at doses used in rheumatology, acetylsalicylic acid has a uricosuric effect). Caution should be exercised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants, selective serotonin reuptake inhibitors (SSRIs) or antiplatelet agents such as aspirin (acetylsalicylic acid 50 mg to 375 mg daily). Low molecular weight heparins and fractionated heparins (see section 4.5). In diabetic patients, treated with e.g. sulfonylureas, salicylics may increase the hypoglycaemic effect of sulfonylureas. (see section 4.5). Caution is required in patients with a history of hypertension and/or heart failure since, in association with acetylsalicylic acid therapy, as with other NSAIDs, fluid retention and oedema have been reported. The risk is increased in subjects 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 sodium/low salt 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). Patients appear to be at higher risk in the early stages of therapy: 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 are to undergo surgery (even minor surgery, for example tooth extraction) and you have used acetylsalicylic acid or another NSAID in the previous few days, there is an increased risk of haemorrhage and you should inform your surgeon because of the possible effects on coagulation. Subjects who are used to drinking large quantities of alcohol are more exposed to the risk of gastrointestinal lesions (bleeding in particular) (see section 4.5). Metrorrhagia or menorrhagia: concomitant intake of acetylsalicylic acid may increase the risk of greater intensity and duration of haemorrhage. Pregnancy and breast-feeding (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 for an adult. This medicinal product contains 48 mg sodium benzoate per tablet equivalent to 48 mg/3500 mg.

INTERACTIONS

Interactions Vivin C 20 effervescent tablets 330mg + 200mg - Which medicines or foods can modify the effect of Vivin C 20 effervescent tablets 330mg + 200mg?'

The following interactions should be taken into account when prescribing VIVIN C. Methotrexate (doses greater than or equal to 15 mg/week): increased plasma levels and toxicity of methotrexate; the risk of toxic effects is greater if renal function is impaired. Avoid concomitant use (see section 4.3). Therefore, the administration of acetylsalicylic acid may potentiate the adverse effects of methotrexate and the effects and secondary manifestations of all nonsteroidal antirheumatic drugs. Analgesics: avoid concomitant administration of other salicylates or other NSAIDs (including topical formulations) due to increased risk of serious adverse effects. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4). Anticoagulants: increased risk of bleeding due to inhibition of platelets, risk of duodenal mucosal injury, potentiation of the pharmacological effect and displacement of oral anticoagulants from their plasma protein binding sites (see section 4.4). Warfarin: severely increased risk of haemorrhage due to potentiation of the anticoagulant effect. Avoid concomitant use (see section 4.3). Low molecular weight heparins and unfractionated heparins: the combined use of medicinal products acting 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 haemorrhage (see section 4.4). Anagrelide: increased risk of haemorrhage and decreased antithrombotic effect. If concomitant administration cannot be avoided, clinical monitoring is recommended. Pemetrexed in patients with mild to moderate renal impairment (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 hypoglycaemics): increased hypoglycaemic; 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 by 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 alkalinizers (e.g. antacids, citrates): Antacids taken concomitantly with other drugs may reduce their absorption; acetylsalicylic acid excretion increases in alkalinized urine. Digoxin and lithium: Acetylsalicylic acid significantly reduces the renal excretion of digoxin and lithium, resulting in increased plasma concentrations of these drugs. Carbonic anhydrase inhibitors (acetazolamide): Reduced elimination of acetazolamide which may cause severe acidosis and increased central nervous system toxicity. Phenytoin: Increased plasma concentrations of phenytoin. Metoclopramide and domperidone: Increased plasma concentrations of acetylsalicylic acid due to increased absorption rate. Uricosurics (eg, probenecid and sulfinpyrazone): decrease in uricosuric activity. Varicella vaccine: it is recommended that salicylates not be administered to patients who have received varicella vaccination for a period of six weeks after vaccination. Cases of Reye's syndrome have occurred following the use of salicylates during varicella infection. Zafirlukast: increase in plasma concentrations of zafirlukast. Alcohol: increase in the 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 platelet aggregation if taken concomitantly with acetylsalicylic acid. Therefore, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection.

SIDE EFFECTS

Like all medicines, Vivin C 20 effervescent tablets 330mg + 200mg can cause side effects - What are the side effects of Vivin C 20 effervescent tablets 330mg + 200mg?

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. After administration of VIVIN C the following have been reported: nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4); peptic ulcer, including perforated; gastrointestinal bleeding, which may be manifest (haematemesis, melaena) and sometimes fatal, or occult and cause iron deficiency anaemia. Such bleeding is more frequent with increasing dosage, particularly in elderly patients (see section 4.4). Less frequently, gastritis has been observed. Cardiac disorders: oedema, hypertension and cardiac failure have been reported in association with treatment with NSAIDs. 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 cessation of acetylsalicylic acid administration. It causes a risk of haemorrhage in patients undergoing surgery. High doses of vitamin C (>1g) may increase haemolysis in patients with G6PD-dehydrogenase deficiency in the form of chronic haemolysis. Immune system disorders: Hypersensitivity reactions: angioedema, Quincke's edema, urticaria, erythema, asthma, anaphylactic reactions. Nervous system disorders: Tinnitus; Sensation of reduced hearing; headache, dizziness, usually a sign of overdose. Pregnancy, puerperium and perinatal conditions: delayed delivery. 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 suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continued 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.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Vivin C 20 effervescent tablets 330mg + 200mg.

Low doses (up to 100 mg/day): Clinical studies indicate that doses up to 100 mg/day can be considered safe for obstetric use only, which requires specialist monitoring. Doses of 100-500 mg/day: There are insufficient clinical data on 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 dosage range. Doses of 500 mg/day and above: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results from epidemiological studies suggest an increased risk of miscarriage and of 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%, up to approximately 1.5%. The risk was estimated to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-foetal 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 trimesters of pregnancy, acetylsalicylic acid should not be administered unless clearly 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 may expose the fetus to: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligo-hydroamniosis. The mother and the newborn, at the end of pregnancy to: possible prolongation of bleeding time and antiaggregant 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. Breastfeeding: acetylsalicylic acid in small quantities passes into breast milk: VIVIN C should not be taken during breastfeeding.