SALIO

Posology Adults, the elderly and children over 12 years:

The contents of one or two sachets to be taken after each loose motion.

Children 1 to 12 years:

The contents of one sachet to be taken after each loose motion.

Infants under 1 year:

Not to be given unless instructed by a doctor, in which one to one and a half times the usual 24 hour feed volume should be given. 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 fed until satisfied. 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.

A doctor should be consulted if symptoms persist for longer than 24 – 48 hours.

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.

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Severe and persistent diarrhoea should be treated under medical supervision. If symptoms persist for more than 24 — 48 hours, medical advice should be sought. Inability to drink or retain fluids requires medical supervision. Children • Rehydration treatment should only be given to children under 1 year of age on medical advice.

• If a young child (particularly one under 6 months of age) has diarrhoea and/or vomiting advice should be sought from a pharmacist, doctor or other health care professional. If the diarrhoea and/or vomiting is severe the child should be seen by a doctor as soon as possible.

Renal Impairment • Medical supervision is necessary in patients with renal disease, including anuria and prolonged oliguria.

Hepatic Impairment:

Low potassium or Sodium diets: Diabetes • Treatment should be supervised by a physician. This medicinal product contains dextrose. Patients with rare-glucose-galactose malabsorption should not take this medicine. 82% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

94mg potassium per sachet . To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

1. • Oral treatment is inappropriate in such conditions as severe dehydration, which requires parenteral fluid therapy or intestinal obstruction. • Contraindicated in patients with phenylketonuria.