Ascorbic Acid 50mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ascorbic Acid 50mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg of ascorbic acid.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white convex tablets engraved with logo on one side and A009 on the other side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Prevention and treatment of scurvy.
4.2 Posology and method of administration
Route of Administration:
Oral
Dose
Adults (including the elderly) and children over 6 years: Prophylactic: 25 - 75 mg daily.
Therapeutic: Not less than 250mg daily in divided doses.
Children under 6 years:
This unit dosage form is unsuitable for children under 6 years.
4.3 Contraindications
Hypersensitivity to ascorbic acid.
4.4 Special warnings and precautions for use
Increased intake of ascorbic acid over a prolonged period may result in an increase in renal clearance of ascorbic acid and deficiency may result if it is withdrawn rapidly. Large doses are associated with the formation of renal calcium oxalate calculi. Ascorbic acid should be given with care to patients with hyperoxaluria.
The administration of therapeutic doses may interfere with Clinistix test for glucosuria giving a false negative result.
4.5 Interaction with other medicinal products and other forms of interaction
Concomitant administration of aluminium-containing antacids may increase urinary aluminium elimination. Concurrent administration of antacids and ascorbic acid is not recommended, especially in patients with renal insufficiency.
Concurrent use of ascorbic acid with barbiturates or primidone may increase the urinary excretion of ascorbic acid.
Concurrent use with cellulose sodium phosphate may result in metabolism of ascorbic acid to oxalate.
Concurrent use of desferrioxamine with ascorbic acid enhances tissues iron toxicity especially in the heart. Cases of cardiomyopathy and congestive heart failure have been reported in patients with idiopathic haemochromatosis and thalassaemias receiving desferrioxamine who were subsequently given ascorbic acid. Ascorbic acid should be used with caution in these patients and cardiac function monitored.
Concurrent use of disulfiram with ascorbic acid especially with chronic use or in high doses may interfere with the disulfiram-alcohol interaction.
Marked acidification of urine resulting from use of large doses of ascorbic acid may accelerate the renal excretion of mexiletine if administered concurrently.
Concurrent use of salicylates with ascorbic acid may increase the urinary excretion of ascorbic acid.
Ascorbic acid may interfere with biochemical determinations of creatinine, uric acid and glucose in samples of blood and urine.
4.6 Fertility, Pregnancy and lactation
Ascorbic acid in doses greater than 1g should not be administered during pregnancy as the effect of large doses on the foetus is not known.
No problems are anticipated with the administration of ascorbic acid tablets during lactation.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Ascorbic acid is usually well tolerated. High doses may result in diarrhoea, flushing or redness of the skin, headache, increased urination, nausea, vomiting, stomach cramps and occasionally back pain. Ascorbic acid may cause haemolytic anaemia in certain individuals with a deficiency of glucose-6-phosphate dehydrogenase.
4.9 Overdose
Adverse effects are not normally expected from an acute overdose of the water soluble vitamin.
Renal failure can occur with massive ascorbic acid overdosage.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Vitamins - Ascorbic acid (vitamin C), plain ATC code: A11G A
Ascorbic acid is a water-soluble vitamin essential for the synthesis of collagen and intercellular material. It is involved in some oxidation-reduction reactions. It is also involved in metabolism of phenylalanine, tyrosine, folic acid and iron; utilisation of carbohydrate; synthesis of lipids and proteins; and preservation of blood vessel integrity.
5.2
Pharmacokinetic properties
Ascorbic acid is readily absorbed from the gastro-intestinal tract mainly the jejunum. Large quantities limit the absorption. Binding to plasma proteins is low, approximately 25%. It is widely distributed in the body tissues. Biotransformation occurs in the liver.
The amount of ascorbic acid in the body in health is about 1.5g. The concentration is higher in leucocytes and platelets than in erythrocytes and plasma. In deficiency states the concentration in leucocytes declines later and at a slower rate than the concentration in plasma.
It is reversibly oxidised to dehydroascorbic; some is metabolised to ascorbate-2-sulphate, which is inactive, and oxalic acid which is excreted in the urine. Ascorbic acid in excess of the body’s need is also rapidly eliminated in the urine. Ascorbic acid crosses the placental barrier and is distributed in breast milk. It is removed by haemodialysis.
5.3 Preclinical safety data
There are no other preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Microcrystalline cellulose Magnesium stearate Lactose monohydrate Maize starch
Pregelatinised maize starch Syrup
6.2 Incompatibilities
None.
6.3 Shelf life
Plastic containers: 3 years
Blister packs: 2 years.
6.4 Special precautions for storage
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.
6.5 Nature and contents of container
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 packed in printed boxboard cartons.
Pack sizes are 28, 30, 56, 60, 84, 90 and 112 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special instructions.
7 MARKETING AUTHORISATION HOLDER
Ennogen Pharma Limited Unit G4,
Riverside Industrial Estate,
Riverside Way,
Dartford DA1 5BS
8 MARKETING AUTHORISATION NUMBER(S)
PL 40147/0004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11 May 2004
10 DATE OF REVISION OF THE TEXT
26/05/2012