Dioralyte Citrus Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Glucose; Sodium chloride ; Disodium hydrogen citrate; Potassium chloride

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

A07CA

INN (International Name):

Glucose; Sodium chloride ; Disodium hydrogen citrate; Potassium chloride

Dosage:

3.56 g/0.47g/0.53g/0.30 gram(s)

Pharmaceutical form:

Powder for oral solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Oral rehydration salt formulations

Authorization status:

Marketed

Authorization date:

1992-06-03

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
DIORALYTE NATURAL/CITRUS/BLACKCURRANT POWDER FOR ORAL SOLUTION
glucose, sodium chloride, potassium chloride, disodium hydrogen
citrate
IS THIS LEAFLET HAD TO SEE OR READ? PHONE [phone] FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING DIORALYTE
BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
Always take this medicine exactly as described in this leaflet or as
our 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 IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIORALYTE
3. HOW TO TAKE DIORALYTE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DIORALYTE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DIORALYTE IS AND WHAT IT IS USED FOR
Dioralyte 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
Do not take Dioralyte and talk to your doctor or pharmacist if:
•
You are allergic (hypersensitive) to glucose, sodium chloride,
potassium chloride and disodium hydro-
gen citrate or any of the other ingredients of Dioralyte (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 if any of the above apply to you. If you are
no

Summary of Product characteristics

Health Products Regulatory Authority
22 April 2021
CRN009L6P
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dioralyte Citrus Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
Sodium Chloride Ph. Eur.
0.47
g
Potassium Chloride Ph. Eur.
0.30
g
Glucose Ph. Eur.
3.56
g
Disodium Hydrogen Citrate B.P.
0.53
g
Excipients: Also includes sulphur dioxide (E220)
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 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 daily dose of 14 sachets.
The product