This information is intended for use by health professionals

1. Name of the medicinal product

Dioralyte Relief Blackcurrant

Dioralyte Relief Blackcurrant & Raspberry

Dioralyte Relief Raspberry & Blackcurrant

Dioralyte Double Action Blackcurrant

(See section 6.5 for pack details)

2. Qualitative and quantitative composition

Active ingredients per sachet:

Pre-cooked Rice Powder6g
Sodium Citrate PhEur580mg
Sodium Chloride PhEur 350mg
Potassium Chloride PhEur300mg
3. Pharmaceutical form

Sachet containing powder for mixing with water prior to administration.

4. Clinical particulars
4.1 Therapeutic indications

For the treatment of fluid and electrolyte loss associated with acute diarrhoea.

4.2 Posology and method of administration

Posology

Adults and children:

One sachet after every loose motion up to a maximum of 5 sachets per day for 3-4 days.

Infants from 3 months to one year under medical advice:

In the event of diarrhoea and depending on the extent of dehydration (loss of weight assessed at less than 10%) 150 to 200 ml/kg/24 hours of preparation may be given.

• half the volume is to be given during the first 8 hours, and the other half during the next 16 hours.

• in the event of vomiting accompanying the diarrhoea, the amount administered can be divided up (5 to 10 ml every 5 minutes) and this may be gradually increased until the infant can drink normally.

Method of Administration

Pour the contents of one sachet into a large glass. Add 200ml of drinking water Mix well until the liquid has a milky appearance and drink the whole glassful. Ensure that no solid is remaining at the bottom of the glass and do not use extra water to rinse out the glass. For infants and where drinking water is not available, the water should be freshly boiled and cooled. The solution should be made up immediately before use.

4.3 Contraindications

Dioralyte Relief Blackcurrant should not be used in patients with phenylketonuria. However, there may be a number of conditions where treatment with Dioralyte Relief Blackcurrant may be inappropriate, e.g. intestinal obstruction requiring surgical intervention, cases of severe renal or hepatic impairment.

4.4 Special warnings and precautions for use

For oral administration only. Dioralyte Relief should not be reconstituted in diluents other than water.

Each sachet should always be dissolved in 200ml water.

Dioralyte Relief should not be administered to infants under 3 months and for those aged 3 months to 1 year, administered under medical advice.

Infants under the age of 2 with diarrhoea should be seen by the physician as soon as possible.

If diarrhoea persists unremittingly for longer than 36 hours the patient should be reassessed by the physician.

No specific precautions are necessary in the elderly. However, care should be taken when administering Dioralyte Relief solution in cases of severe renal or hepatic impairment or other conditions where normal electrolyte balance may be disturbed. Dioralyte Relief should not be used for self-treatment by patients on low potassium or sodium diets. The use of Dioralyte Relief in patients with these conditions should be supervised by a physician.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

Dioralyte Relief is not contraindicated in pregnancy or lactation but should be used on medical advice.

4.7 Effects on ability to drive and use machines

Dioralyte Relief could not be expected to affect the ability to drive or use machines.

4.8 Undesirable effects

None known.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Dioralyte Relief contains a balanced amount of electrolytes, starch and proteins in water. Oral rehydration therapy with Dioralyte Relief enables a dehydrated subject to be rehydrated rapidly. The presence of pre-cooked rice in the formulation enables watery stools to return to normal more rapidly.

The advantages of Dioralyte Relief are bound with its composition.

Water: the appropriate amount is essential to correct dehydration.

Starch: low osmotic capacity (unlike pure glucose) thus preventing any additional loss of fluid through the stools. Rice starch contains 20% amylose and 80% amylopectin.

Proteins: specific nutritional properties.

Electrolytes: essential for restoring the ionic equilibrium. The role of citrate is to correct the acidosis that occurs as a result of diarrhoea. Citrate also enhances the absorption of Na+ and is more stable than bicarbonate.

5.2 Pharmacokinetic properties

Content of electrolytes in the reconstituted preparation:

Na+ 60 mmol/l
Cl-50 mmol/l
K+20 mmol/l
Citrate 10 mmol/l (or 30 meq/l)
Osmolarity140 mosm/l
5.3 Preclinical safety data

Not applicable.

6. Pharmaceutical particulars
6.1 List of excipients

Blackcurrant Flavour Firmenich 501017

Hypromellose

Aspartame

Ethanol 96%

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf life

A shelf life of 36 months is given for unopened sachets of the product when stored under the conditions given in section 6.4. Once reconstituted, any solution should be used within one hour, or within 24 hours if stored in a refrigerator.

6.4 Special precautions for storage

Store in a dry place under 25°C.

6.5 Nature and contents of container

Carton containing paper/PVDC sachets of Dioralyte Relief Blackcurrant powder. Dioralyte Relief Blackcurrant is available in packs of 6 or 20 sachets.

Dioralyte Relief Blackcurrant & Raspberry is available as a pack of 6 sachets containing:

4 sachets blackcurrant flavour, 2 sachets raspberry flavour*

Dioralyte Relief Raspberry & Blackcurrant is available as a pack of 6 sachets containing:

4 sachets raspberry flavour*, 2 sachets blackcurrant flavour

(*, raspberry formulation PL 04425/0280).

6.6 Special precautions for disposal and other handling

See section 4.2 for instructions on reconstitution.

7. Marketing authorisation holder

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

or trading as:-

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8. Marketing authorisation number(s)

PL 04425/0273

9. Date of first authorisation/renewal of the authorisation

9 February 2009

10. Date of revision of the text

27 February 2014

Legal classification

GSL