This information is intended for use by health professionals

1. Name of the medicinal product

Dioralyte Relief Blackcurrant Sachets

Dioralyte Double Action Blackcurrant Sachets

2. Qualitative and quantitative composition

Active ingredients per sachet:

Pre-cooked Rice Powder

6g

Sodium Citrate PhEur

580mg

Sodium Chloride PhEur

350mg

Potassium Chloride PhEur

300mg

For excipients, see 6.1.

3. Pharmaceutical form

Sachet containing powder for mixing with water prior to administration.

4. Clinical particulars
4.1 Therapeutic indications

Oral correction of fluid and electrolyte loss in infants aged 3 months upwards, children and adults.

Treatment of watery diarrhoea of various aetiologies including gastroenteritis in all age groups from 3 months upwards.

Dioralyte Relief is particularly recommended in the case of too loose or frequent stools where it enables over-loose stools to revert to normal.

4.2 Posology and method of administration

Method of Use

Pour the contents of one sachet into a large glass of drinking water (200ml). Mix well and drink the whole glassful. 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.

Adults and children:

5 sachets per day for 3 to 4 days following a loose motion.

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.

4.3 Contraindications

Dioralyte Relief should not be used in patients with phenylketonuria.

However, there may be a number of conditions where treatment with Dioralyte Relief 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 under medical advice.

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.

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

The information below lists reported adverse reactions, ranked using the following frequency classification:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Immune system disorders

Not known: Hypersensitivity

Reporting of suspected adverse reactions

Reporting suspected adverse reaction 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

ATC code: Electrolytes with carbohydrates A07C.

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)

Osmolarity

140 mosm/l

5.3 Preclinical safety data

Not applicable.

6. Pharmaceutical particulars
6.1 List of excipients

Blackcurrant Flavour

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 Sachets powder.

Dioralyte Relief Blackcurrant Sachets is available in packs of 5, 6, 10, 15 or 20 sachets.

6.6 Special precautions for disposal and other handling

See section 4.2 for instructions on reconstitution.

7. Marketing authorisation holder

Aventis Pharma Limited, trading as Sanofi

410 Thames Valley Park Drive,

Reading,

Berkshire,

RG6 1PT,

United Kingdom.

8. Marketing authorisation number(s)

PL 04425/0272

9. Date of first authorisation/renewal of the authorisation

3 March 2009

10. Date of revision of the text

01 October 2019