Rehydration Treatment Granules For Oral Solution
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rehydration Treatment Granules for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains dextrose (glucose) monohydrate BP 3.58g, sodium chloride BP 0.47g, potassium chloride BP 0.30g, sodium citrate dihydrate BP 0.39g and anhydrous citric acid BP 0.128g.
3 PHARMACEUTICAL FORM
Granules for oral solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of acute diarrhoea; and for the treatment and prevention of dehydration by replacing fluids and electrolytes lost through diarrhoea.
4.2 Posology and method of administration
The contents of each sachet should be dissolved in 200ml (7 fluid ounces) of fresh drinking water (for both adults and children). Freshly boiled and cooled water should be used for infants and when fresh water is not available. The solution should be made up immediately before use and used within 1 hour. If refrigerated the solution may be kept for up to 24 hours.
Adults, the elderly and children over 12 years: The contents of one or two sachets should be reconstituted and taken after each loose motion.
Children 1 to 12 years: The contents of one sachet should be reconstituted and taken after each loose motion.
Infants under 1 year: Not to be given unless instructed by your doctor, in which case 1 to 1/ times the usual 24 hour feed volume should be given. See Special Warnings and Special Precautions for Use, sub-section 4.4.
During the first 24 hours of illness Rehydration Treatment should replace normal feeds in bottle fed babies, gradually resuming normal feeds as the baby gets better. In breast fed babies, firstly the recommended amount of Rehydration Treatment should be given and then breast feed until satisfied.
4.3 Contraindications
Contraindicated in patients with phenylketonuria or those with hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Care is advised if used in patients with impaired liver or kidney function.
Rehydration Treatment should not be given to children under 1 year except on medical advice. The doctor should be consulted if symptoms persist for longer than 36 hours and in all cases of infant diarrhoea.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Pregnancy and lactation
May be used during pregnancy and lactation as there are no known adverse effects.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
None stated.
4.9 Overdose
If significant overdosage occurs, serum electrolytes should be evaluated. Corrective measures should be carried out and levels monitored until a return to normal level is achieved.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The product consists of physiological salts and glucose which are used synergistically in solution to aid rehydration. The pharmacodynamic effect is to counter the drop in the extracellular fluid volume and electrolytes in mild to moderate diarrhoea.
5.2 Pharmacokinetic properties
None relevant.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Colloidal anhydrous silica BP, aspartame (Nutrasweet*), and blackcurrant flavourings.
6.2 Incompatibilities
None stated.
6.3 Shelf life
The granules have a 2 year shelf life.
The reconstituted solution should be discarded after 1 hour or 24 hours if stored in a refrigerator.
6.4 Special precautions for storage
Store below 25°C in a dry place.
6.5 Nature and contents of container
Single dose foil laminate sachets enclosed in a cardboard outer containing 6, 10, 20, 50
& 100 sachets.
Also in a Travel Pack with Tillomed’s Loperamide Hydrochloride 2mg pack of 6 capsules,
Richmond Antiseptic Cream 50g and Eastern’s Ibuprofen 200mg 12 tablets.
6.6 Special precautions for disposal
Reconstitution: The contents of each sachet should be dissolved in 200ml (7 fluid ounces) of fresh drinking water (for both adults and children). Freshly boiled and cooled water should be used for infants and when fresh water is not available. The solution should be made up immediately before use and used within 1 hour. If refrigerated the solution may be kept for up to 24 hours.
Solutions other than water should not be used for reconstituting the product and each sachet should be dissolved in the correct volume as above.
* trade mark
7 MARKETING AUTHORISATION HOLDER
East Midlands Pharma Limited
16 Rancliffe Avenue Nottingham NG12 5HY United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 22958/0007
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
7th April 2003
10 DATE OF REVISION OF THE TEXT
28/07/2011