VIVIN C 20CPR EFF 330MG+200MG

VIVIN C 330 MG / 200 MG COMPRESSE EFFERENCES

active ingredients

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

Excellent

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

Therapeutic indications

Headache and teeth, nerves, menstrual pain, rheumatic and muscle pain. Symptomatic therapy of fever states and flu and cooling syndromes.

Contraindications

VIVIN C is contraindicated in case of: Hypersensitivity to active ingredients (acetylsalicylic acid and ascorbic acid) or to other analgesics (antidolorphic)/antipyretics (antifebbril)/non-steroidal anti-inflammatory drugs (NSAID) or any of the excipients listed in paragraph 6.1; Hemorrhagic diathesis; Gastropathy (e.g. gastro-duodenal ulcer); Asthma; History of gastrointestinal hemorrhage or perforation related to previous active treatments or history of hemorrhage/recurring peptic ulcer (two or more separate episodes of proven ulceration or bleeding); Renal, heart or hepatic insufficiency; Concurrent treatment with metotrexate (at doses of 15 mg/week or more) or with warfarin (see paragraph 4.5). The use of this medicine is contraindicated in children and children under the age of 16. Dose >100 mg/die during the third trimester of pregnancy. Nursing (see paragraph 4.6).

Population

Population. . Adults: 1-2 tablets if necessary up to 3-4 times a day. Dissolve in half a glass of water not gassed one or two tablets of VIVIN C. Intake of the product must take place 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. Pediatric population: VIVIN C is not indicated for use in the pediatric population (see paragraph 4.3) Seniors: Older patients must comply with the minimum doses mentioned above.

Conservation

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

Warnings

This medicine should not be used in children or children under 16 (see paragraph 4.3). Reye syndrome cases have been observed in children suffering from viral infections (particularly chickenpox and flu-like conditions) and treated with acetylsalicylic acid. Reye syndrome is a very rare disease, but dangerous for life, requiring immediate medical intervention. It manifests with persistent vomiting and signs of progressive damage of the central nervous system (torpor, until the appearance of generalized and coma seizures), signs of liver injury and hypoglycemia. G6PD Deficit, high doses of acetylsalicylic acid may cause haemolysis. In case of G6PD deficiency, acetylsalicylic acid should only be administered under medical supervision. Seniors: elderly patients have an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal. These patients must begin treatment with the lowest dose available (see paragraph 4.2). Subjects over 70 years of age, especially in the presence of concomitant therapies, must use this medicine only after consulting a doctor. Crohn's disease, ulcerative colitis: acetylsalicylic acid, such as NSAIDs in general, is a risk factor for the clinical relapse of the disease, can promote the appearance of diverticular complications such as drilling, fistolization and ascesis. It is recommended that patients with gastric and intestinal disorders or reduced kidney function (from mild to moderate). The use of VIVIN C must be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible duration of treatment needed to control symptoms. Gastrointestinal hemorrhage, ulceration and drilling: during treatment with all NSAIDs, at any time, with or without symptoms of notice or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see paragraph 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increased doses of NSAID. Patients in treatment with VIVIN C must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. When bleeding or gastrointestinal ulcer occurs in patients taking VIVIN C the treatment must be stopped and no longer resumed without consulting the doctor. Acetylsalicylic acid and other NSAIDs can cause hypersensitivity reactions (including asthma, rhinitis, angioedema or urticaria). In subjects with asthma and/or rhinitis (with or without nasal polyposes) and/or urticaria reactions can be more frequent and severe. Acetylsalicylic acid changes urine (in the analgesic dose acetylsalicylic acid increases uricemy by inhibiting the excretion of uric acid, at the doses used in rheumatology, acetylsalicylic acid has an uric effect). You should use caution in patients taking concomitant medications that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, selective anti-agulants of serotonin reuptake (SSRI) or anti-aggregating agents such as aspirin (acetylsalicylic acid from 50 mg to 375 mg per day). Eparine with low molecular weight and fractional eparine (see paragraph 4.5). In diabetic patients, in treatment with es solfoniluree, salicylics can increase the hypoglycemic effect of sulphonluree. (see paragraph 4.5). Precaution is needed in patients with a history of hypertension and/or heart failure since, in association with acetylsalicylic acid therapy, as well as with other NSAIDs, water retention and edema were reported. The risk is greater in subjects treated with diuretics. The medicinal product is contraindicated in severe kidney, heart or liver failure (see paragraph 4.3). The sodium content per effervescent tablet (485 mg) must be considered in the case of a hypoxodic/poor diet of salt in patients with heart failure, high blood pressure and kidney failure. Severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis, have been reported very rarely in association with the use of NSAIDs (see paragraph 4.8). In the early stages of therapy patients seem to be at higher risk: the onset of reaction occurs in most cases within the first month of treatment. VIVIN C must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Surgery: If you have to be subjected to surgery (even of small entities, e.g. dental extractions) and in previous days you have made use of acetylsalicylic acid or another NSAID, there is an increased risk of hemorrhage and you need to inform the surgeon for possible effects on coagulation. Persons with a habit of taking high amounts of alcohol are more exposed to the risk of gastrointestinal lesions (particularly bleeding) (see paragraph 4.5). Metrorragia or menorragia: simultaneous intake of acetylsalicylic acid can increase the risk of increased intensity and duration of bleeding. Pregnancy and nursing (see paragraph 4.6). This medicine contains 485 mg of sodium per tablet equivalent to 24,25% of the maximum daily intake recommended by WHO which corresponds to 2 g of sodium per adult. This medicine contains 48 mg of benzoate sodium per tablet equivalent to 48 mg / 3500mg.

Interactions

The following interactions should be taken into account when prescribing VIVIN C: Methodology (doses greater or equal to 15 mg/week): increase in plasma levels and toxicity of metotrexate; the risk of toxic effects is greater if the kidney function is compromised. Avoid concomitant use (see paragraph 4.3) The administration of acetylsalicylic acid, therefore, can enhance the undesirable effects of metotrexate and the side effects and manifestations of all non-steroidal anti-reumatics Analgesics: avoid concurrent administration of other salicylates or other NSAIDs (including topical formulations) for increased risk of serious side effects. Corticosteroids: increased risk of gastrointestinal ulceration or hemorrhage (see paragraph 4.4). Antiagulants: increased risk of bleeding due to the inhibition of thrombocytes, at the risk of injury of the duodenal mucosa, to the strengthening of the pharmacological effect and to the smoothing of oral anticoagulants from their sites of connection with plasma proteins (see paragraph 4.4). Warfarin: severe increase in the risk of hemorrhage for strengthening the anticoagulant effect. Avoid concomitant use (see paragraph 4.3) Eparine with low molecular weight and un fractional eparine: joint use of medicines that act at different levels of hemostasis increases the risk of bleeding. Anti-platelet aggregates (e.g. chlopidogrel and dipyridamol) and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage (see paragraph 4.4). Anagrelide: increased risk of hemorrhage and decreased antithrombotic effect. If concurrent administration cannot be avoided, clinical monitoring is recommended. Pemetrex in patients with mild to moderate renal function reduction (cancer crystalrance between 45 ml/min and 80 ml/min); increase of the risk of toxicity from pemetrexed (due to the decreased renal elimination of pemetrexed caused by acetylsalicylic acid) with anti-inflammatory doses of acetylsalicylic acid. Antidiabetics (e.g. insulin and oral hypoglycemics): increase of 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 (e.g., ACE inhibitors) or diuretics increases the risk of acute renal failure due to reduced glomeral filtration due to reduced renal synthesis of prostaglandins. Valproic acid: it has been reported that acetylicylic acid reduces the bond of valproate with sierica albumin, thus increasing its free plasma concentrations to the stationary state. Alkalinizing urine (e.g. antacids, citrates): antacids taken at the same time to other drugs can reduce their absorption; the excretion of acetylsalicylic acid increases in alkalineized urine. Digoxin and lithium: acetylsalicylic acid significantly reduces renal excretion of digoxin and lithium, resulting in increased plasma concentrations. Carbon dioxide inhibitors (acetazolamide): reduced elimination of acetazolamide which can cause severe acidosis and increased toxicity at the central nervous system level. Fenitoin: increased effect of phenytoin Metoclopramide and domperidone: an increase in the effect of acetylsalicylic acid by increase in absorption speed. Resurrection (e.g. probenecid and sulfinpirazone): decrease in the uric effect. Vaccine against chickenpox: it is recommended not to administer salicylates to patients who received vaccination against chickenpox for a period of six weeks after vaccination. Reye syndrome cases occurred as a result of the use of salicylates during chickenpox infection. Zafirlukast: increased plasma concentration of zafirlukast. Other: 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 concomitantly.Therefore, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection.

Effects

Gastrointestinal diseases: The most commonly observed adverse events are gastrointestinal. Most side effects are dependent on both dose and duration of treatment. After administration VIVIN C were reported: - nausea, vomiting, diarrhea, flatulence, constipation, despair, abdominal pain, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4); - peptic ulcer, even perforated; - Gastrointestinal hemorrhage, which can be manifested (ematemesis, melena) and sometimes fatal, or occult, and cause sideropenic anemia. These bleedings are more frequent with increased dose, especially in older patients (see paragraph 4.4). - Less often gastritis were observed. Heart disease: - Edema, hypertension and heart failure were reported in association with NSAID treatment. Pathologies of skin and subcutaneous tissue: - Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis. Emolinfopoietic system pathologies: - Hemorrhagic syndromes (epistaxis, gum bleeding, thrombocytopenia, purple) with increased bleeding time. This effect persists for 4-8 days after the interruption of the administration of acetylsalicylic acid. It is caused by hemorrhagic risk in patients suffering from surgery. - High doses of vitamin C (>1g) can increase hemolysis in patients with deficiency of G6PD-Dedrogenase in the form of chronic hemolysis Immune system disorders: - Reactions of hypersensitivity: angioedema, edema of Quincke, hives, erythema, asthma, anaphylactic reactions. Diseases of the nervous system: - Auricular hub; - Hearing reduction sensation; - Cephalea, chief, usually a sign of overdose. Pregnancy, Puerperio and PerinataliChildbirth. Kidney and urinary pathologies: - High doses of vitamin C (>1g) can encourage the formation of oxalate and uric acid stones in some individuals. Respiratory, chest and mediastinic pathologies: Rinite, dispnea. Rarely bronchospasm, asthma attacks. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The toxicity from salicylates (a dosage greater than 100 mg/kg/day for 2 consecutive days can induce toxicity), can be the result of chronic intake of excessive doses, or acute overdose, potentially dangerous for life and also includes accidental ingestion in children. Overdose in children can be fatal from 100 mg/kg/day in a single dose. Symptoms:- Moderate intoxication: Ear buzz, a feeling of reduced hearing acuity, headaches, dizziness are the distinctive signs 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 lavender and repeated administration of activated carbon, - acid-base balance control, - forced alkaline diuresis to obtain a urinary pH between 7.5 and 8, possibility of hemodilysis in severe poisoning, - compensate for dehydration with adequate fluid intake - syntomatic support treatment. In case of overdosing, please contact a poison center or the nearest hospital immediately. Acetylsalicylic acid is dialysable.

- Low doses (up to 100 mg/day): Clinical studies indicate that doses of up to 100 mg/die can be considered safe only for obstetric use, requiring specialist monitoring. -Dosis of 100-500 mg/die: There are insufficient clinical data related to the use of doses greater than 100 mg/die up to 500 mg/die. Therefore, the recommendations below for doses of 500 mg/die and beyond also apply to this dosage range. -Dosis of 500 mg/die and beyond: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis, in the early stages of pregnancy. The absolute risk of heart failure had increased from less than 1% to about 1.5%. It has been estimated that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in pre- and post-system loss and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disease, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second quarter of pregnancy, acetylsalicylic acid should not be administered if not in strictly necessary cases. If acetylsalicylic acid is used by a woman waiting for conception, or during the first and second trimester of pregnancy, the dose and duration of treatment must be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose Fetus a: • cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); • kidney dysfunction, which can progress in kidney failure with oligo-idroamnios. The mother and the newborn, at the end of pregnancy to: • possible prolongation of bleeding time and anti-aggregating effect that can also take place at very low doses; • inhibition of uterine contractions resulting in delay or extension of labor. Consequently, acetylsalicylic acid at doses> 100 mg/die is contraindicated during the third trimester of pregnancy.

Food

: Acetylsalicylic acid in small amounts passes into breast milk: VIVIN C should not be taken during lactation.

Source: Farmadati