sanofi-aventis

Dioralyte Blackcurrant Powder for Oral Solution.

Dioralyte Citrus Powder for Oral Solution.

Dioralyte Natural Powder for Oral Solution.

Each sachet contains:

Sodium Chloride 0.47g

Potassium Chloride 0.30g

Glucose 3.56g

Disodium Hydrogen Citrate 0.53g

Excipients:

Dioralyte Blackcurrant: Also includes ethanol, less than 100mg per dose.

Dioralyte Citrus: Also includes sulphur dioxide (E220)

For a full list of excipients, see section 6.1.

Powder for oral solution.

White, homogeneous, granular powder with an odour and taste of blackcurrant.

White, homogeneous, granular powder with an odour and taste of lemon and lime.

White, homogeneous, granular powder.

In the oral correction of fluid and electrolyte loss and in the management of watery diarrhoea.

The basic unit of dosage is the content of a single sachet reconstituted in 200ml (approximately 7 fluid ounces) of drinking water. Use fresh drinking water for adults and children. For infants where drinking water is unavailable the water should be freshly boiled and cooled. The solution should be made up immediately before use. If refrigerated, the solution may be stored for up to 24 hours, otherwise any solution remaining an hour after reconstitution should be discarded.

The solution must not be boiled after reconstitution.

Daily intake may be based on a volume of 150ml/kg body weight for infants and 20-40 mg/kg body weight for adults and children. A reasonable approximation is:

Infants – One to one and a half times the usual feed volume. For infants under 12 months, use only under medical advice.

Children – One sachet after every loose motion.

Adults including elderly – One or two sachets after every loose motion. More may be required initially to ensure early and full volume repletion.

There are no known contra-indications to Dioralyte.

Special labelling requirements.

The solution must not be reconstituted except with water at the volume stated.

Solutions of greater concentration may result in hypernatraemia. Those of greater dilution may result in inadequate replacement.

If there is no improvement within 24-36 hours the physician should be consulted.

For infants under 12 months use only on medical advice.

If nausea and vomiting are present with the diarrhoea, small but frequent amounts of dioralyte should be drunk at first.

For use in the elderly no specific precautions are necessary. However, care should be taken when administering glucose-electrolyte solutions in cases of severe renal or hepatic impairment or other conditions where the normal electrolyte balance may be distributed.

None

Dioralyte is not contra-indicated in pregnancy or lactation.

None.

None stated.

In the event of significant overdose, serum electrolytes should be evaluated as soon as possible, appropriate steps taken to correct any abnormalities and levels monitored until return to normal levels is established. This is particularly important in the very young and in cases of severe hepatic or renal failure.

Dioralyte is an oral rehydration therapy. The combination of electrolytes stimulates water and electrolyte absorption from the gastro-intestinal tract and therefore prevents dehydration in diarrhoea.

Sodium and glucose are actively transported via the membrane into the enterocytes. Sodium is then extruded into the intercellular spaces and the resulting osmotic gradient causes water and electrolytes to be drawn from the gut and then into the circulation.

None.

Dioralyte Blackcurrant

Colloidal Anhydrous Silica

Saccharin Sodium

Blackcurrant flavour

(contains ethanol)

Dioralyte Citrus

Colloidal Anhydrous Silica

Saccharin Sodium

Citrus flavour

(contains sulphur dioxide)

Dioralyte Natural

Colloidal Anhydrous Silica

Saccharin Sodium

Not applicable.

2 years.

Do not store above 25°C. The reconstituted solution should be used immediately but may be stored for up to 24 hours in a refrigerator at 2-8°C.

Foil/polyethylene laminate sachets containing powder for reconstitution packed in outer cartons.

Pack sizes: 3, 6, 7, 10, 14, 20, 30 Sachets.

Not all pack sizes may be marketed.

The solution should be prepared immediately before use.

The contents of each sachet should be dissolved in 200 ml (approximately 7 fluid ounces) of drinking/cooled boiled water where relevant. Dioralyte should only be prepared with water and to the volume stated.

The solution must not be boiled after reconstitution.

sanofi-aventis Ireland Ltd.,

Citywest Business Campus,

Dublin 24.

PA 540/98/1

PA 540/98/2

PA 540/99/1

3rd June 1992 / 3rd June 2007

3rd June 1992 / 3rd June 2007

13th July 1989/3^rd June 2007

July 2007.