ASCORBIC ACID TABLETS BP 100MG

Active substance: ASCORBIC ACID

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Ascorbic Acid Tablets BP 100 mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100.0 mg of ascorbic acid.

3

PHARMACEUTICAL FORM
Tablet.
Ascorbic Acid Tablets BP 100 mg are presented as white to off-white normal
convex tablets engraved with company logo on one side and A010 on the other
side.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Prevention and treatment of scurvy.

4.2

Posology and method of administration
Adults and children over 6 years:
Prophylactic: 25 - 75 mg daily.
Note: this unit dosage form is unsuitable for prophylactic use.
Therapeutic: not less than 250 mg daily in divided doses.
Children under 6 years:
This unit dosage form is unsuitable for children under 6 years.
Elderly:
Dosage same as for adults.

Route of administration
Oral.

4.3

Contraindications
Hypersensitivity to ascorbic acid or to any of the excipients.
Hyperoxaluria.

4.4

Special warnings and precautions for use
Excessive use of chewable ascorbic acid tablets may cause breakdown of enamel and
increased incidence of caries.
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renal clearance of ascorbic acid and deficiency may result if it is withdrawn rapidly.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.
The administration of therapeutic doses of ascorbic acid may interfere with Clinistix
test for glucosuria giving a false negative result.

4.5

Interaction with other medicinal products and other forms of interaction
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 tissue iron toxicity
especially in the heart. Concurrent administration of ascorbic acid with
desferrioxamine enhances urinary iron excretion. Cases of cardiomyopathy and
congestive heart failure have been reported in patients with idiopathic
haemochromotosis 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.
Concomitant administration of aspirin and ascorbic acid may interfere with
absorption of ascorbic acid. Concurrent use of salicylates with ascorbic acid may
increase the urinary excretion of ascorbic acid. However, renal excretion of salicylate
is not affected and does not lead to reduced anti-inflammatory effects of aspirin.
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.
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 crosses the placental barrier and is excreted in breast milk. Studies in
animals and humans have not been conducted. Problems have not been documented
with the intake of normal daily requirements during pregnancy and lactation.
However, ingestion of large quantities during pregnancy may result in increased
requirements and scurvy in the neonate. Ascorbic acid in doses greater than 1 g
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 (greater than 1 g per day) may
result in diarrhoea. Other effects are flushing or redness of the skin, headache, mild
increase in urination with doses greater than 600 mg per day, 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 watersoluble vitamin.
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
measures should be employed as required.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Vitamins - Ascorbic acid (vitamin C), plain ATC
code: AHGA
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 1.5 g. The
concentration is higher in leucocytes and platelets than in erythrocytes and
plasma. In deficiency states the concentration in leucocytes decline later and at
a slower rate than the concentration in plasma.
It is reversibly oxidised to dehydroascorbic; some is metabolised to ascorbate2-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 into breast
milk. It is removed by haemodialysis.

5.3

Preclinical safety data
There are no pre-clinical 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
Components of special lactose granules:

Lactose
Maize starch
Pregelatinised maize starch
Syrup

6.2

Incompatibilities
None.

6.3

Shelf life
Plastic
containers:
Blister packs:

36 months (3 years), as packaged for sale
24 months (2 years), as packaged for sale

6.4

Special precautions for storage
Keep out of the reach of children.
Protect from heat, 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 packaging inclusion of standard polyether
foam or polyethylene or polypropylene made filler and a silica gel
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 or 112 tablets.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special instructions for use/handling.

7

MARKETING AUTHORISATION HOLDER
Crescent Pharma Ltd
Units 3 & 4, Quidhampton Business Units
Polhampton Lane
Overton
Hampshire
RG25 3ED

8

MARKETING AUTHORISATION NUMBER(S)
PL 20416/0190

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
12 January 2004

10

DATE OF REVISION OF THE TEXT
25/03/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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