Boots Oral Rehydration Treatment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Oral Rehydration Treatment
|
2 QUALITATIVE AND QUANTITATIVE COMPOSITION | |
|
Sodium Chloride |
200.0 mg |
|
Potassium Chloride |
300.0 mg |
|
Sodium Bicarbonate |
300.0 mg |
|
Glucose |
80g |
|
For excipients, see 6.1. | |
3 PHARMACEUTICAL FORM
Powder for oral solution.
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
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
1. It is very important to dissolve oral rehydration salts 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.
2. Diarrhoea can have very serious consequences in children under 3 years old. Immediate medical advice should be sought.
3. In other age groups, if symptoms persist for more than 24 - 48 hours, consult your doctor.
4. If nausea and vomiting are present with the diarrhoea, small and frequent amounts of oral rehydration salts should be drunk first. In infants, immediate medical assistance should be obtained.
5. Keep out of the reach of children.
6. 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
None known
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 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Oral rehydration salt formulations, ATC code: A07CA
The reconstituted solution 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
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None
6.2 Incompatibilities
None known
6.3 Shelf life
36 months unopened.
After reconstitution, one hour or 24 hours if stored in a refrigerator.
6.4 Special precautions for storage
Do not store above 25°C. Store in a dry place.
6.5 Nature and contents of container
6 sachets comprised of a laminate made up of:
2 2 2 40g/m gloss coated paper; 12g/m polythene; 8p aluminium; 23g/m polythene; each
containing 8.8g of powder packed in a carton.
6.6 Special precautions for disposal
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 200 ml 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 hours if stored in a refrigerator.
4. Do not boil the solution after mixing.
7 MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd 9 Arkwright Road
Astmoor Industrial Estate
Runcorn
Cheshire
WA7 1NU
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0118
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25th April 1995, 24th April 2000, 24th April 2005
10 DATE OF REVISION OF THE TEXT
05/03/2011