Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Ennogen Pharma Limited, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS
Prevention and treatment of scurvy.
Prophylactic: 25–75 mg daily.
Note: This unit dosage form is unsuitable for prophylactic use.
Therapeutic: Not less than 250mg daily in divided doses. Maximum of 1000mg daily.
This unit dosage form is unsuitable for children under 6 years.
As for other adults. As the dietary intake of vitamin C may be less in the elderly, they have greater risk of presenting with vitamin C deficiency.
For oral administration.
At doses of over 3g per day unabsorbed ascorbic acid is mainly excreted unmetabolised in the faeces. Absorbed ascorbic acid additional to the body’s needs is rapidly eliminated. Large doses of ascorbic acid may cause diarrhoea and the formation of renal oxalate calculi. Symptomatic treatment may be required.
Ascorbic acid may cause acidosis or haemolytic anaemia in certain individuals with a deficiency of glucose 6-phosphate dehydrogenase. Renal failure can occur with massive ascorbic acid overdosage.
Gastric lavage may be given if ingestion is recent otherwise general supportive measure should be employed as required.
Plastic containers: 3 years.
Blister packs: 2 years.
Plastic containers: Keep the container tightly closed to protect from light and moisture.
Blister packs: Keep the blister in the outer carton to protect from light and moisture.
1. Opaque plastic containers (securitainers) fitted with plastic caps with a packaging inclusion of a silica gel desiccant pack.
Pack sizes are 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 or 1000 tablets.
2. Opaque plastic containers composed of either high density polypropylene or high density polyethylene with a tamper-evident or child-resistant tamper-evident closure composed of high density polyethylene with a packing inclusion of standard polyether foam or polyethylene or polypropylene-made filler and a silica desiccant pack.
Pack sizes are 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 or 1000 tablets.
3. Blister packs of aluminium/opaque PVC/PVDC packed in printed boxboard cartons.
Pack sizes are 28, 30, 56, 60, 84, 90 and 112 tablets.
Not all pack sizes may be marketed.
No special instructions.
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