SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Ascorbic Acid 500mg Tablets BP

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Each tablet contains Ascorbic Acid 500mg

For excipients, see 6.1

3    PHARMACEUTICAL FORM

Tablet

White uncoated bi-convex tablets with tablet markings “500”.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For use in treating Vitamin C deficiency including the treatment and prevention of scurvy.

4.2.    Posology and Method of Administration

For oral administration. The tablets are to be chewed before being swallowed. Adults, the elderly and children over 12years:

One to five tablets daily in divided doses.

Children 4 - 12 years

Half to two and a half tablets daily in divided doses

Note: As the dietary intake of vitamin C may be less in the elderly, they are at greater risk of being deficient in this vitamin.

4.3.    Contra-indications

Hypersensitivity to ascorbic acid or any of the other ingredients.

Ascorbic acid supplements should not be given to patients with hyperoxaluria.

4.4.    Special Warnings and Precautions for Use

Vitamin C may interfere with tests and assays for urinary glucose, giving false negative results with methods utilising glucose oxidase with indicator (eg. Labstix, Testape) and false positive results with neocuproin methods. Estimation of uric acid by phosphotungstate or by uricase with copper reduction and measurement of creatinine in non-deproteinised serum may also be affected. High doses of vitamin C may give false negative readings in faecal occult blood tests.

Patients with rare hereditary problems of fructose or galactose intolerance, the LAPP lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine as it contains lactose and sucrose.

4.5.    Interactions with other Medicinal Products and other forms of Interaction

Large doses of ascorbic acid may cause acidification of the urine which could alter the rate of renal excretion of some drugs. Ascorbic acid may increase the oral absorption of iron. It may also increase iron excretion when used in conjunction with desferrioxamine in the treatment of iron overload.

4.6.    Pregnancy and Lactation

There is inadequate evidence of the safety of ascorbic acid in human pregnancy but it has been in wide use for many years without apparent ill consequences, animal studies having shown no hazard. Ascorbic acid crosses the placenta. The established medical principal of only administering drugs in early pregnancy when considered absolutely necessary should be observed. Ascorbic acid is excreted in breast milk but there is no evidence of any hazard.

4.7. Effects on Ability to Drive and Use Machines

None.

Undesirable Effects

Large doses of ascorbic acid may cause diarrhoea. Patients known to be at risk of hyperoxaluria should not ingest ascorbic acid in doses exceeding 1 gram daily, as there may be increased urinary oxalate excretion. However, such a risk has not been demonstrated in normal, non-hyperoxaluric individuals. Ascorbic acid has been implicated in precipitating haemolytic anaemia in certain individuals with a deficiency of glucose-6-phosphate dehydrogenase. 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 the intake is reduced or withdrawn rapidly. Doses of more than 600mg daily have a diuretic effect.

4.9. Overdose

At doses of over 3 grams per day unabsorbed ascorbic acid is chiefly 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 oxylate calculi. Symptomatic treatment may be required.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

A11G A01 - Ascorbic Acid (Vit C), Plain

Ascorbic acid coupled with dehydroascorbic acid to which it is reversibly oxidised, has a variety of functions in cellular oxidation processes. Vitamin C is required in several important hydroxylations, including the conversion of proline to hydroxyproline (and thus in collagen formation eg. for intercellular substances during wound healing); the formation of the neurotransmitters 5-hydroxytryptamine from tryptophan and noradrenaline from dopamine; and the biosynthesis of carnitine from lysine and methionine. Vitamin C appears to have an important role in metal ion metabolism, including the gastrointestinal absorption of iron and its transport between plasma and storage organs. There is also evidence that vitamin C is required for normal leukocyte function and that it participates in the detoxification of numerous foreign substances by the hepatic microsomal system.

Deficiency in vitamin C leads to scurvy, which may be manifested by weakness, fatigue, dyspnoea, aching bones, perifollicular hyperkeratoses, petechiae and ecchymoses, swelling and bleeding of gums, hypochromic anaemia and other haematopoietic disorders, together with reduced resistance to infection (and impaired wound healing).

5.2. Pharmacokinetic Properties

Ascorbic acid is well absorbed from the gastro-intestinal tract, and is widely distributed to all tissues. Body stores of ascorbic acid normally are about 1.5 grams. The concentration is higher in leukocytes and platelets than in erythrocytes and plasma. Ascorbic acid additional to the body’s needs (generally amounts above 200mg daily) is rapidly eliminated; unmetabolised vitamin C and its inactive metabolic products are chiefly excreted in the urine. The amount of ascorbic acid excreted unchanged in the urine is dose dependent and may be accompanied by mild diuresis.

5.3. Preclinical Safety Data

No data of relevance which is additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose

Pregelatinised Maize Starch

Syrup

Talc

Microcrystalline Cellulose Stearic Acid

6.2. Incompatibilities

Not applicable.

6.3. Shelf Life

3 years.

6.4.    Special Precautions for Storage

Do not store above 25°C. Keep the container tightly closed. Store in the original container.

6.5.    Nature and Contents of Container

Polypropylene containers with low density polyethylene caps of 28, 50, 100 or 500 tablets.

Not all packs may be marketed.

6.6.    Instruction for Use/Handling Not applicable.

7.    MARKETING AUTHORISATION HOLDER

Dalkeith Laboratories Ltd

2 Park Street

Woburn Bedfordshire MK17 9PG

8.    MARKETING AUTHORISATION NUMBER(S)

PL 17496/0015

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

09/01/2007

10    DATE OF REVISION OF THE TEXT

09/01/2007