SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Gregovite ‘C’ Tablets Vitamin C Chewable Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Ingredients    mg/tablet

Sodium Ascorbate SA99    176.74

(equivalent to Ascorbic Acid    155.54)

Ascorbic Acid C97    148.93

(equivalent to Ascorbic Acid    144.46)

Excipients: Lactose, Sucrose

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Chewable tablet.

Yellow, circular, biconvex, lemon flavoured chewable tablet.

4.    CLINICAL PARTICULARS

4.1    Therapeutic Indications

For use as a Vitamin C supplement during cold and influenza infections.

4.2 Posology and method of administration

For oral use.

Adults:    Swallow whole, suck or chew 1 tablet every six

hours.

Elderly:    As adult dose.

Children aged 12 and over: Swallow whole, suck or chew 1 tablet every

eight hours.

Not recommended for children under 12 years old.

Contraindications

Hypersensitivity to the active substances or to any of the excipients.

Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.4    Special warnings and precautions for use

If symptoms worsen or do not improve after 7 days, a doctor should be contacted.

4.5    Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6    Pregnancy and lactation

Vitamin C may be taken by pregnant and lactating women under the supervision of a doctor.

4.7    Effects on ability to drive and use machines

This product has no influence on the ability to drive and use machines.

4.8. Undesirable Effects

No undesirable effects have been reported.

4.9 Overdose

No cases of overdose have been reported.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Ascorbic acid (vitamin C), plain, ATC code: A11G A

Ascorbic acid (vitamin C) cannot be synthesised by man, therefore a dietary source is necessary.

Ascorbic acid (vitamin C) acts as a cofactor in numerous biological processes including the hydroxylation of proline to hydroxyproline. In deficiency, the formation of collagen is therefore impaired.

Ascorbic acid (vitamin C) is important in the hydroxylation of dopamine to noradrenaline and in hydroxylations occurring in steroid synthesis in the adrenals.

Ascorbic acid (vitamin C) is a reducing agent in tyrosine metabolism and by acting as an electron donor in the conversion of folic acid to tetrahydrofolic acid is directly involved in the synthesis of purine to thymine.

Ascorbic acid (vitamin C) is also necessary for the incorporation of iron into ferritin.

Ascorbic acid (vitamin C) increases the phagocytic function of leucocytes; it possesses anti-inflammatory activity and promotes wound healing.

Deficiency can produce scurvy. Features include swollen inflamed gums, petechial haemorrhages and subcutaneous bruising.

The deficiency of collagen leads to development of thin watery ground substances in which blood vessels are insecurely fixed and readily ruptured. The supportive components of bone and cartilage are also deficient causing bones to fracture easily and teeth to become loose. Anaemia commonly occurs probably due to the role of ascorbic acid (vitamin C) in iron metabolism.

5.2 Pharmacokinetic Properties

Ascorbic acid (vitamin C) is a water soluble vitamin which is readily absorbed from the gastro-intestinal tract and is widely distributed in the body tissues.

Ascorbic acid (vitamin C) is reversibly oxidised to dehydroascorbic acid; some is metabolised to ascorbate-2-sulphate, which is inactive, and oxalic acid which are excreted in the urine. Ascorbic acid (vitamin C) in excess of the body's needs is also rapidly eliminated unchanged in the urine.

5.3 Pre-clinical 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.

6.1    List of excipients

Compressible Sugar    (Microtal)

Lemon Flavour E2954 (includes Maltodextrin, Acacia, Lactose)

Magnesium Stearate

Quinoline Yellow Lake 19248 (E104)

Saccharin Sodium 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.

6.5    Nature and contents of container

The product is presented in press through blisters containing six Uniflu tablets with six Gregovite C tablets or six Olbas Powerflu tablets with six Vitamin C Chewable tablets. The blister pack has a lidding material of 30 micron embossed lacquered aluminium foil, with a heat seal lacquer for sealing to PVC/PVDC and a base material of 250 micron/35 micron (60g/m²) PVC/PVDC.

The product is available in two pack sizes:

(i)    12 tablet box containing 1 blister strip

(ii)    24 tablet box containing 2 blister strips

6.6 Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

G. R. Lane Health Products Limited Sisson Road

Gloucester

GL2 0GR

United Kingdom

Tel: +44 (0)1452 524012

Fax: +44 (0)1452 507930

Email: info@laneshealth.com

8.    MARKETING AUTHORISATION NUMBER(S)

PL 01074/0226

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 3 October 2005.

10 DATE OF REVISION OF THE TEXT

19/02/2009