Summary of Product Characteristics (SmPC) - Linus Vitamin C powder
1 NAME OF THE MEDICINAL PRODUCT
LINUS Vitamin C Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ascorbic Acid BP 100%
3 PHARMACEUTICAL FORM
Powder
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Scurvy and all other manifestations of vitamin C deficiency.
Prophylaxis of scurvy.
Adjunct in the treatment of anaemia, infections, wounds and fractures.
4.2 Posology and method of administration
Adults: As an accompaniment to the treatment of infections, anaemia, wounds and fractures:
200 to 500 mg daily (1/8 to 1/6 teaspoon) in water or a drink such as orange juice or blackcurrant juice, preferably after a meal.
For the treatment of scurvy:
1 g (1/3 teaspoon) two or three times daily in water or a drink such as orange juice or blackcurrant juice, preferably after a meal.
Children: 6 to 12 years: Half the adult dose.
Under 5 years: Quarter of the adult dose.
Elderly: As for the adult dose.
4.3 Contraindications
Renal calcium oxalate calculi.
4.4 Special warnings and precautions for use
Should be given with care to patients with hyperoxaluria.
4.5 Interaction with other medicinal products and other forms of interaction
Ascorbic acid could interfere with the laboratory estimations of blood or urine creatinine, glucose, uric acid, liver enzymes and bilirubin. Ascorbic acid increases the apparent half-life of some drugs undergoing sulphate conjugation but the clinical significance of this is not known.
4.6 Fertility, Pregnancy and lactation
May be used in pregnancy and lactation. Doses greater than 1 gram daily should not be taken because the effect of large doses on the foetus is not known.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Large doses may cause diarrhoea. In some individuals with deficiency of glucose-6-phosphate dehydrogenase, Vitamin C may cause haemolytic anaemia.
4.9 Overdose
Overdose is not serious and no special treatment is recommended.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Ascorbic acid is essential for the synthesis of collagen and intercellular material. It is involved in the conversion of folic acid to folinic acid, in electron transport processes, and in the healing of wounds, and is believed to be involved in the metabolism of tyrosine.
5.2 Pharmacokinetic properties
Ascorbic Acid is absorbed from the gastro-intestinal tract and widely distributed in the body tissues, the concentration being highest in leucocytes and platelets and lowest in the erythrocytes and plasma.
Any Ascorbic Acid in excess of the body’s requirements is rapidly eliminated in the urine accompanied by mild diuresis.
Plasma concentrations fall with increasing age.
Ascorbic Acid is partly metabolised to the sulphate and can modify the transformation of drugs similarly metabolised. Ascorbic-3-sulphate is a metabolite of Ascorbic Acid.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Nil.
6.2 Incompatibilities
Not known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store below 25ºC.
Keep in well closed containers.
Protect from light and metals.
Keep out of reach of children.
6.5 Nature and contents of container
High density polystyrene containers with polythene lids, or polypropylene containers with polypropylene or polythene lids.
Pack sizes: 60, 100, 250,500, 1000 and 5000 grams.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
11 Boumpoulinas Street,
3rd Floor, 1060 Nicosia
Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 33414/0155
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
1972 / 8th February 1999
10 DATE OF REVISION OF THE TEXT
16/01/2015