VITAMIN C TEVA
Therapeutic indications
Ascorbic acid deficiency states (pregnancy, breastfeeding, increased vitamin requirements).
Dosage and method of use
DosageAdminister 1 to 3 tablets per day in a glass of water.Method of administrationFor oral use. Dissolve an effervescent tablet in a glass of water and drink the resulting solution immediately.
Contraindications
Hypersensitivity to the active ingredient, to other closely related substances from a chemical point of view or to any of the excipients listed in paragraph 6.1. The administration of ascorbic acid orally is contraindicated in case of diarrhea or other gastrointestinal disorders.
Side effects
Ascorbic acid is generally well tolerated. High doses can cause diarrhea and calcium oxalate kidney stone formation. Nausea and stomach cramps may occur. Hypersensitivity reactions may occur in predisposed individuals. At doses higher than recommended, headaches and gastrointestinal disorders have been reported.Reporting of suspected adverse reactionsReporting 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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Special warnings
Ascorbic acid should be administered with caution in patients with hyperoxaluria. Vitamin C should be used with caution by subjects who suffer, or have suffered in the past, from nephrolithiasis (kidney stones) and by those suffering from G6PD (glucose-6-phosphate dehydrogenase) deficiency, hemochromatosis, thalassemia or sideroblastic anemia. Ascorbic acid can alter, at high doses, the results of the most common diagnostic tests, in particular for glycosuria, with non-specific means, giving false positive results. It is therefore advisable to suspend the intake of the product a few days before proceeding with the measurement of glucose in the urine. Do not use for prolonged treatments. This medicine contains: •sucrose; Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. • approximately 12.5 mmol (or 287 mg) ofsodiumper effervescent tablet. To be taken into consideration in people with reduced kidney function or who follow a low sodium diet. •aspartame: a source of phenylalanine. May be harmful to patients with phenylketonuria. •dye E 110 (sunset yellow) and dye E 102 (tartrazine): may cause allergic reactions.
Pregnancy and breastfeeding
Administration during pregnancy and breastfeeding is among the therapeutic indications. Unless otherwise prescribed by a doctor, it is recommended not to exceed a dose of 1 g/day.
Expiration and conservation
Keep the container tightly closed in order to protect the medicine from moisture. In fact, effervescent tablets are sensitive to humidity and in the container cap there is a desiccant substance which serves to protect the tablets from humidity that could penetrate them. Store below 25°C.
Interactions with other drugs
Ascorbic acid may increase the apparent half-life of paracetamol. Concomitant administration of aluminum-containing antacids may increase the excretion of aluminum in the urine. Concomitant administration of antacids and ascorbic acid is not recommended, especially in patients with renal insufficiency. Concomitant administration of ascorbic acid and deferoxamine increases urinary iron excretion. Cases of cardiomyopathy and congestive heart failure have been reported in patients with idiopathic hemochromatosis and thalassemia, treated with deferoxamine, subsequently treated with ascorbic acid. In these patients ascorbic acid should be used with caution and their cardiac function should be monitored.
Overdose
If ascorbic acid is administered in quantities exceeding the body's requirements, the unused portion is eliminated in the urine: there is therefore no danger of overdose. Nonetheless, occasionally very high quantities of ascorbic acid can cause mild gastrointestinal disorders consisting mainly of laxative-type phenomena. In such cases it is advisable to interrupt treatment. Ascorbic acid can cause acidosis or hemolytic anemia in some individuals with glucose-6-phosphate dehydrogenase deficiency. In case of massive overdose of ascorbic acid, renal failure may occur.
Active principles
Each effervescent tablet contains:Active principle: ascorbic acid 1000 mg.Excipients with known effects: sucrose, sodium, aspartame, color E 110 (sunset yellow) and color E 102 (tartrazine). For the full list of excipients, see section 6.1.
Excipients
Each tablet contains: Excipients: sodium bicarbonate, sucrose, tartaric acid, citric acid, leucine, citronjus flavour, sodium chloride, sodium saccharin, aspartame, color E 110 (sunset yellow), color E 102 (tartrazine).