Summary of Product Characteristics (SmPC) - Ascorbic tablets BP 50 mg
1 NAME OF THE MEDICINAL PRODUCT
Ascorbic Acid Tablets BP 50mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active mg/tablet
Ascorbic Acid BP 50.0mg
3 PHARMACEUTICAL FORM
Uncoated tablets for oral administration
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The indications for Ascorbic Acid are the treatment of scurvy. Prophylactically in cases where deficiency might be expected to occur.
4.2 Posology and method of administration
Children, Adults, & the elderly:
Two tablets three times a day
Prophylactic dose: One tablet twice daily
4.3 Contraindications
No significant contra-indications
4.4 Special warnings and precautions for use
Use with care in patients with hyperoxaluria. Doses above 600mg daily may have a diuretic effect. Large doses may cause diarrhoea.
4.5 Interaction with other medicinal products and other forms of interaction
May adversely affect the action of warfarin in very high doses.
4.6 Fertility, pregnancy and lactation
Doses greater than 1g daily should not be taken during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
None
4.8 Undesirable effects
None
4.9 Overdose
Diarrhoea is a symptom of high doses/overdose and in cases showing symptoms discontinue vitamin C
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Ascorbic acid is essential for the synthesis of collagen and intercellular material involved in conversion of folic acid to folinic acid.
5.2 Pharmacokinetic properties
Ascorbic acid is well absorbed from the gastro-intestinal tract, and is widely distributed in body tissues. Excess material is readily excreted in the urine.
5.3 Preclinical safety data
None stated
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose BP, Potato Starch BP, Syrup BP, Colloidal Silicon Dioxide USNE, Talc BP, Stearic Acid BPC
6.2 Incompatibilities
None known
6.3 Shelf life
3 years
6.4 Special precautions for storage
Tablets should be stored in a cool dry place below 20°C
6.5 Nature and contents of container
The tablets are available in Securitainers or Tampertainers in packs of 100, 500 or 1000 tablets.
Specification for Securitainers and Tampertainers: High density polypropylene containers with low density polyethylene caps. The tablets are also available in blister packs of 28 tablets. Specification details of blister packs:
- PVC (rigid, PVdC coated): 286.6 microns ± 5%
- Aluminium foil (hard tempered): 30 ± 2 microns
- Primer: 1 ± 0.4gsm
- Heat seal lacquer: 7 ± 1.5gsm
6.6 Special precautions for disposal
Always read instructions on the label and the Patient Information Leaflet (PIL) enclosed
Keep all medicines out of the reach of children Do not use after the expiry date
7 MARKETING AUTHORISATION HOLDER
Noumed Life Sciences Limited
Noumed House,
Shoppenhangers Road,
Maidenhead,
Berkshire,
SL6 2RB,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 44041/0106
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/09/2005
10 DATE OF REVISION OF THE TEXT
20/02/2018