Rehydration Treatment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rehydration Treatment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Citrate Dihydrate BP 0.39g
Citric Acid Anhydrous BP 0. 128g
3. PHARMACEUTICAL FORM
Granules to be reconstituted for oral administration.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
For the treatment of acute diarrhoea by preventing and treating the associated dehydration due to fluid and electrolyte loss.
4.2. Posology and Method of Administration
Adults, the elderly and children over 12 years: The contents of one or two sachets to be taken after each loose motion up to a maximum of 16 sachets in 24 hours.
Children 2 to 12 years of age: The contents of one sachet to be taken after each loose motion, up to a maximum of 12 sachets in 24 hours.
Infants under 2 years: (See Special Warnings and Precautions).
Bottle/breast fed infants: One to one and a half times the usual 24 hour feed volume should be given.
During the first 24 hours of illness the solution should replace normal feeds in bottle fed babies, gradually resuming normal feeds as the baby gets better. In breast fed babies, firstly give the recommended amount of solution and then breast feed until satisfied.
Older infants: The contents of one sachet to be taken after each loose motion, up to a maximum of 12 sachets in 24 hours.
Reconstitution: Reconstitute only with water and ensure the correct amount is used. The contents of each sachet should be dissolved in 200m 1 (7 fluid ounces) of fresh drinking water (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.
4.3 Contra-indications
Contraindicated in patients with phenylketonuria or those with hypersensitivity to any of the ingredients.
Oral treatment is inappropriate in such conditions as severe dehydration, which requires parenteral fluid therapy or intestinal obstruction.
4.4 Special warnings and precautions for use
Medical supervision is necessary in the presence of renal disease, including anuria or prolonged oliguria; severe and persistent diarrhoea and vomiting; or inability to drink or retain oral fluids.
The use of this product in patients with liver disease or patients on low potassium or low sodium diets or in patients with diabetes should be supervised by a physician.
The label will state:
Infants with severe diarrhoea and/or vomiting should be seen by a doctor as soon as possible.
If symptoms persist for more than 36 hours, seek medical advice.
This product contains dextrose. Patients with rare glucose-galactose malabsorption should not take this medicine.
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; breastfeeding may be continued as normal.
None stated.
4.8. Undesirable Effects
None stated.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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 levels 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 Pre-clinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
PHARMACEUTICAL PARTICULARS
6.
6.1 List of Excipients
Colloidal Anhydrous Silica, Aspartame (Nutrasweet) which contains Phenylalanine Blackcurrant flavourings
6.2 Incompatibilities
None stated.
6.3 Shelf-Life
The granules have a two 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 250C in a dry place.
6.5 Nature and Contents of Container
Single dose foil laminate sachets enclosed in outer carton.
6.6 Instructions for Use/Handling
None stated.
Galpharm Healthcare Limited
Wrafton
Braunton
Devon
EX33 2DL
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 16028/0015
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22 September 1997
10 DATE OF REVISION OF THE TEXT
01/02/2016