SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Gluco-Lyte Powders

Glucal Powders

Glucohalal Powders

Boots Oral Rehydration Treatment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium chloride 200.0mg Potassium chloride 300.0mg Sodium bicarbonate 300.0mg Glucose 8.0g

3    PHARMACEUTICAL FORM

Powder

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the treatment of diarrhoea and fluid loss due to diarrhoea in infants, children and adults

4.2 Posology and method of administration

For oral administration.

Adults, the elderly and children over 12 years

One or two reconstituted sachets after each loose bowel movement.

Children 1 - 12 years

One reconstituted sachet after each loose bowel movement.

Infants

Substitute equivalent volume of reconstituted solution in place of feeds or give appropriate volume before breast feeding.

Directions for reconstitution

1.    Pour the contents of a sachet into a glass.

2.    Add 200ml of fresh drinking water. For infants and where drinking water is not available,use freshly boiled and cooled water. Stir until the powder is completely dissolved.

3.    Use within one hour of reconstitution, or within 24 hour stored in a refrigerator.

4.    Do not boil the solution after mixing.

4.3 Contraindications

Cardiac failure, renal impairment or kidney diseases, or patients with very severe vomiting, diarrhoea and dehydration requiring fluid therapy. Patients with dextrose malsorption. It should not be used when there is peripheral or pulmonary oedema or toxaemia of pregnancy.

4.4 Special warnings and precautions for use

i)    It is very important to dissolve Gluco-Lyte in water of the correct volume. A weak solution will not contain optimum glucose and electrolyte concentration and a strong solution may give rise to electrolyte imbalance.

ii)    Diarrhoea can have very serious consequences in children under 3 years old. Immediate medical advice should be sought.

iii)    In other age groups, if symptoms persist for more than 24 - 48 hours, consult your doctor.

iv)    If nausea and vomiting are present with the diarrhoea, small and frequent amounts of Gluco-Lyte should be drunk first.. In infants, immediate medical assistance should be obtained.

v)    Keep out of the reach of children.

vi)    Use within one hour of reconstitution, or within 24 hours if stored in a refrigerator.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

Can be used during pregnancy and lactation.

4.7 Effects on ability to drive and use machines

No effects.

4.8 Undesirable effects

None known.

4.9 Overdose

Iso-osmotic overload is managed by sodium, potassium and water restriction plus measures to increase renal sodium, potassium and water loss such as “loop diuretics” e.g. Frusemide.

5.1 Pharmacodynamic properties

The reconstituted solution of Gluco-Lyte contains a mixture of sodium and potassium salts along with glucose, which facilitates the absorption of sodium and potassium from the intestine. Water is drawn from the bowel by the osmotic effect. As well as “drying-up” the stools, the dehydration and loss of electrolytes caused by the diarrhoea is corrected by the water and electrolytes absorbed.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

None.

Incompatibilities

None known.

6.3 Shelf life

36 months unopened.

24 hours after reconstitution or when the container is opened for the first time, if appropriate

6.4 Special precautions for storage

Store the sachets in a cool, dry place.

6.5 Nature and contents of container

8.8g sachets packed in a carton.

The sachets are constructed of paper/polythene/foil/polythene laminate Pack sizes: 6 and 20

6.6 Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

AYRTON SAUNDERS LIMITED NORTH WAY

WALWORTH INDUSTRAIL ESTATE

ANDOVER

SP10 5AZ

UNITED KINGDOM

8    MARKETING AUTHORISATION NUMBER(S)

PL 16431/0051

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15 July 1986 / 2 December 1998

DATE OF REVISION OF THE TEXT

14/01/2008