Section 4.2          Posology and Method of Administration

Amended as follows:-

The contents of each sachet should be dissolved in 200ml (approximately 7 fluid ounces) of drinking water. 

Daily intake may be based on a volume of 150ml/kg body weight for infants up to the age of 24 months and 20-40 mgml/kg body weight for adults and children

Infants under 24 months              Use only under medical advice.

One to one and a half times the usual 24 hour feed volume.

Children over 24 months              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.

Special population

No specific dose adjustment for the use of Dioralyte in elderly patients is recommended.

For patients with renal or hepatic impairment see section 4.4.

4.3 Contraindications

Amended as follows:-

Hypersensitivity to the active substances or to any of the excipients.

4.4 Special Warnings and Special Precautions for Use

Amended as follows:

Dioralyte should not be used for treatment in infants below the age of 24 months without medical supervision.

Dioralyte should not be used for self-treatment by patients with:

-              Chronic or persistent diarrhoea

-              Liver or kidney disease

-              Diabetes

-              On low potassium or sodium diets

-              Intestinal obstruction

The use of Dioralyte in patients with these conditions should be supervised by a doctor.

A weaker solution than recommended will not contain the optimal glucose and electrolyte concentration and a stronger solution than recommended may give rise to electrolyte imbalance.

4.6 Pregnancy and Lactation

Amended as follows:-

Medical supervision is recommended for use during pregnancy and lactation.

SmPC – Update to section 4.8 to include HPRA adverse event reporting details.