Vit.C-GAP Package Insert

SCHEDULING STATUS:

Not Scheduled

PROPRIETARY NAME AND DOSAGE FORM:

VIT C-GAP Effervescent tablet

COMPOSITION:

Each tablet contains:
Vitamin C 1000 mg
Preservative: Sodium benzoate 0,005 % m/m
List of Excipients: Citric acid anhydrous, colour yellow, orange flavour, polyethylene glycol, povidone, simethicone, sodium bicarbonate, sodium lauryl sulphate, sorbitol, sucralose

PHARMACOLOGICAL CLASSIFICATION:

D 22.2 Vitamins, Others

PHARMACOLOGICAL ACTION:

Ascorbic acid (vitamin C) functions in a number of biochemical reactions, mostly involving oxidation. Thus, it is required for or facilitates the conversion of certain proline residues in collagen to hydroxyproline in the course of collagen synthesis, the oxidation of lysine side chains in proteins to provide hydroxytrimethyllysine for caritine synthesis, the synthesis of steroids by adrenal cortex, conversion of folic acid to folinic acid, microsomal drug metabolism and tyrosine drug metabolism. At the tissue level, a major function of ascorbic acid is related to the synthesis of collagen, proteoglycans, and other organic constituents of the intercellular matrix in such diverse tissues as tooth, bone and capillary endothelium1.

INDICATIONS:

VIT C-GAP is used to assist in the maintenance of vitamin C levels.

CONTRAINDICATIONS:

VIT C-GAP tablet is contra-indicated for individuals allergic or sensitive to any of the listed ingredients.

WARNINGS AND SPECIAL PRECAUTIONS:

VIT C-GAP tablet has not been evaluated by the Medicine Control Council. This product is intended only to complement health or supplement the diet. Do not exceed the recommended daily dosage.

INTERACTIONS:

Ascorbic acid has an effect on various medicines which include hormonal contraceptives, fluphenazine and warfarin. Omeprazole may affect the bioavailability of dietary vitamin C and ascorbic acid may increase the absorption of iron in iron deficiency states.

PREGNANCY AND LACTATION:

Safety during pregnancy has not been established. Vitamin C is excreted into breast milk and thus supplied to breast-fed infants. Please consult your healthcare practitioner prior to use.

DOSAGE AND DIRECTIONS FOR USE:

Adults: Drop one tablet in half a glass of cold water. The tablet dissolves producing an effervescent drink. Drink the mixture as soon as the effervescing has stopped. Do not exceed the recommended daily dosage.

SIDE-EFFECTS:

Larger doses of ascorbic acid are reported to cause diarrhoea and other gastrointestinal disturbances. It has also been stated that larger doses may result in hyperoxaluria and the formation of renal calcium oxalate calculi. Ascorbic acid should therefore be given with care to patients with hyperoxaluria.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

Larger doses of ascorbic acid are reported to cause diarrhoea and other gastrointestinal disturbances. Treatment of overdosage should be symptomatic and supportive.

IDENTIFICATION:

VIT C-GAP are light orange, round, flat, bevelled edge effervescent tablets

PRESENTATION:

VIT C-GAP effervescent tablets are foil wrapped and packed in a plastic tube with a tamper proof plastic closure in packs of 10s. The tubes are packed into cardboard carton.

STORAGE INSTRUCTIONS:

Store in a cool place at or below 25 oC. Protect from moisture.

KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:

VIT C-GAP tablet has not been evaluated by the Medicine Control Council. This product is intended only to complement health or supplement the diet.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:

Adcock Ingram Limited
1 New Road
Erand Gardens
Midrand
1685
www.adcock.com

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

To be allocated

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