VITAMIN C TABLETS 500MG

Active substance: ASCORBIC ACID

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Vitamin C Tablets 500mg

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ascorbic Acid 500mg.

3.

PHARMACEUTICAL FORM
Tablet.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
Treatment of vitamin C deficiency.

4.2.

Posology and method of administration
Adults:
Half of one tablet daily.
Children 6-12 years:
Not recommended.
Children under 6 years:
Not recommended.
Route of administration:
Oral.

4.3.

Contraindications
None.

4.4.

Special warnings and precautions for use
None.

4.5.

Interactions with other medicinal products and other forms of interaction
The following interactions are recorded in Martindale, the Extra
Pharmacopoeia, London The Pharmaceutical Press, 29th Edition, 1989 but
appear to be of slight clinical significance as they are not included in
Appendix 1, Interactions of the National Formulary, Number 23 (March
1992), London, British Medical Association and Royal Pharmaceutical
Society of Great Britain.
1.

2.
3.
4.
5.

4.6.

Ascorbic Acid has been reported to increase urinary iron excretion in patients being
treated for iron overload with desferrioxamine. It has been recommended that
vitamin C should be given with extreme caution to patients with excess iron.
Ingestion of high doses of ascorbic acid may cause raised plasma concentrations of
ethinyloestradiol in women taking that substance.
A case has been reported of reduced fluphenazine efficacy in a patient with steady
state fluphenazine concentrations who was given ascorbic acid.
Occasional reports of vitamin C reducing the efficacy of warfarin have been
reported.
Ascorbic Acid interferes with laboratory tests involving oxidation and reduction
reactions e.g. tests for glucose in urine may give false readings.

Pregnancy and lactation
Ascorbic acid crosses the placenta and is distributed in breast milk. It appears
to be reasonably safe in pregnancy in therapeutic doses.

4.7.

Effects on ability to drive and use machines
None.

4.8.

Undesirable effects
1.

2.

Large doses of ascorbic acid are reported to cause diarrhoea and other
gastrointestinal disturbances and are associated with renal calcium oxalate calculi.
Ascorbic acid should be given with care to patients with hyperoxaluria
There is a report of an allergic reaction to ascorbic acid in 3 patients presenting as
eczema, uticaria or asthma.

4.9.

Overdose

Ascorbic Acid in excess of the body’s needs is rapidly excreted in urine.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
Ascorbic acid is a water soluble vitamin that is essential for the synthesis of
collagen and intercellular material.

5.2.

Pharmacokinetic properties
Ascorbic Acid is readily absorbed from the gastrointestinal tract and is widely
distributed in the body tissues. It is reported to be about 25% bound to plasma
proteins. The concentration is higher in leucocytes and platelets than in
erythrocytes and plasma.
ASCORBIC acid is reversibly oxidised to dehydroascorbic acid, some is
metabolised to Ascorbate-2-sulphate and oxalic acid which is excreted in the
urine. Ascorbic acid in excess of the body’s needs is also rapidly excreted in
the urine.

5.3.

Preclinical safety data
No relevant data.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
Calcium phosphate tribasic.
Lactose.
Starch.
Providone. 30.

Sodium starch glycol late.
Talc.
Stearic Acid
Magnesium Stearate.
Gum acacia 1968.

6.2.

Incompatibilities
Ascorbic acid is incompatible with oxidising agents, ferric salts and salts of
heavy metals, particularly copper.

6.3.

Shelf life
36 months.

6.4.

Special precautions for storage
In well closed containers in a dry place protected from light. Contact with
metals to be avoided.

6.5.

Nature and contents of container
High impact polystyrene white or polystyrene amber co-plastic bottles. Pack
size 30 tablets.
Polypropylene securitainers. Pack size 100 tablets.
Polythene bag enclosed in lever lid tin. Pack size 1000 tablets.

6.6

Special precautions for disposal
None.

7.

MARKETING AUTHORISATION HOLDER
Nutrition Warehouse Ltd
Head Office Address
Samuel Ryder House
Townsend Drive
Nuneaton
CV11 6XW

8.

MARKETING AUTHORISATION NUMBER(S)
PL 14010/0002

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
1 October 1999

10.

DATE OF (PARTIAL) REVISION OF THE TEXT
November 1998

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Source: Medicines and Healthcare Products Regulatory Agency

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