Dioralyte Citrus Powder for Oral Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

POTASSIUM CHLORIDE, DISODIUM HYDROGEN, CITRATE, GLUCOSE, SODIUM CHLORIDE

Available from:

Opella Healthcare France SAS T/A Sanofi 157 avenue Charles de Gaulle, 92200 Neuilly-sur-Seine , France

ATC code:

A07CA

INN (International Name):

POTASSIUM CHLORIDE 0.30 g DISODIUM HYDROGEN CITRATE 0.53 g GLUCOSE 3.56 g SODIUM CHLORIDE 0.47 g

Pharmaceutical form:

POWDER FOR ORAL SOLUTION

Composition:

POTASSIUM CHLORIDE 0.30 g DISODIUM HYDROGEN CITRATE 0.53 g GLUCOSE 3.56 g SODIUM CHLORIDE 0.47 g

Prescription type:

OTC

Therapeutic area:

ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

Authorization status:

Withdrawn

Authorization date:

2005-10-28

Patient Information leaflet

421457 (alt 421291) GMID 832388 (alt 817984) PB Dioralyte Irland
Pantone Reflex Blue/Pantone 354/Pantone 123/Pantone 259
150 x 192 mm
geflaz
min 8pt A.Schmitz Code 113 Version 0
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 HARD 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 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 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 li

Summary of Product characteristics

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
0.47g
Potassium Chloride
0.30g
Glucose
3.56g
Disodium Hydrogen Citrate
0.53g
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 should not be used for more than 5 days.
Special population
No specific dose adjustment for the use of D