Dioralyte Rebalance Citrus Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium chloride; Potassium chloride; Glucose; Disodium hydrogen citrate

Available from:

Opella Healthcare France SAS T/A Sanofi

ATC code:

A07CA

INN (International Name):

Sodium chloride; Potassium chloride; Glucose; Disodium hydrogen citrate

Dosage:

0.47/0.30/3.56/0.53 gram(s)

Pharmaceutical form:

Powder for oral solution

Therapeutic area:

Oral rehydration salt formulations

Authorization date:

2020-02-14

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
DIORALYTE REBALANCE NATURAL/CITRUS/BLACKCURRANT POWDER FOR ORAL
SOLUTION
glucose, sodium chloride, potassium chloride, disodium hydrogen
citrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING DIORALYTE
REBALANCE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any side effects not
listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel
worse after 24-36 hours.
IN THIS LEAFLET:
1. What Dioralyte Rebalance is and what it is used for
2. What you need to know before you take Dioralyte Rebalance
3. How to take Dioralyte Rebalance
4. Possible side effects
5. How to store Dioralyte Rebalance
6. Contents of the pack and other information
1. WHAT DIORALYTE REBALANCE IS AND WHAT IT IS USED FOR
Dioralyte Rebalance is an oral rehydration therapy containing a
balanced combination of electrolytes
which include glucose, sodium chloride, potassium chloride and
disodium hydrogen citrate.
It is recommended for the replacement of essential water and salt loss
which can happen for various
reasons including when you have diarrhoea.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIORALYTE REBALANCE
DO NOT TAKE DIORALYTE REBALANCE AND TALK TO YOUR DOCTOR OR PHARMACIST
IF:
• You are allergic (hypersensitive) to glucose, sodium chloride,
potassium chloride and
disodium hydrogen citrate or any of the other ingredients of Dioralyte
Rebalance (see
Section 6: Contents of the pack and other information) Signs of an
allergic reaction include: a
rash, swallowing or breathing problems, swelling of your lips, face,
throat or tongue
• Your bowel is partially or fully blocked (called ‘intestinal
obstruction’)
Do not take this medicine

Summary of Product characteristics

Health Products Regulatory Authority
28 March 2023
CRN00CRGL
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dioralyte Rebalance Citrus Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
Sodium Chloride 0.47g
Potassium Chloride 0.30g
Glucose 3.56g
Disodium Hydrogen Citrate 0.53g
Excipient(s) with known effect
Includes sulphur dioxide (E220).
Each sachet contains 278.4 mg sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
White, homogeneous, granular powder with an odour and taste of lemon
and lime.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dioralyte Rebalance is indicated for use in infants, children and
adults for the oral correction of fluid and electrolyte loss of
gastrointestinal origins and in the management of watery diarrhoea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The contents of each sachet should be dissolved 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 up to the age of 24 months and 20-40 ml/kg body
weight for adults and children. A reasonable approximation is:
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 stool.
Adults including elderly
One or two sachets after every loose stool.
More may be required initially to ensure early and full volume
repletion.
If diarrhoea persists for longer than 24 to 36 hours the patient
should be seen by a doctor.
Do not exceed the maximum d