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Document: leaflet MAH BRAND 3_PL 16431-0051 change

PATIENT INFORMATION LEAFLET

GLUCOHALAL POWDERS

Please read this leaflet carefully before you start using this product. If you have any questions or are unsure about anything, ask your doctor or pharmacist.

Glucohalal Powders contains the following active ingredients:

Sodium Chloride 200mg Potassium Chloride 300mg Sodium Bicarbonate 300mg Glucose 8mg

The powder is available in individual sachets in cartons of 6 or 20 sachets.

PRODUCT TYPE

Glucohalal Powders is a powder for the treatment of diarrhoea and fluid loss due to diarrhoea in infants, children and adults.

MA HOLDER

Ayrton Saunders Ltd, 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire, WA7 1NU.

MANUFACTURER

Simco Ltd, Braye Road Industrial Estate, Vale, Guernsey USES

For the treatment of diarrhoea and fluid loss due to diarrhoea in infants, children and adults.

BEFORE USING GLUCOHALAL POWDERS

The following information should be read before using this medicine:

1.    Do not use this product if you are sensitive to any of the ingredients listed at the beginning of this leaflet.

2.    Make sure this product is suitable for you - ask your doctor or pharmacist.

3.    Seek immediate medical attention for children under 3 years old. In other age groups, if symptoms persist for more than 24-48 hours or worsen consult your doctor.

4.    It is very important to dissolve Glucohalal Powders in water of the correct volume. A weak or strong solution will not be effective.

5.    If nausea and vomiting are present with the diarrhoea, Glucohalal Powders should be given in small frequent amounts. In infants seek medical attention immediately

6.    After dissolving in water, use within 1 hour, or within 24 hours if the solution is kept in the fridge.

7.    Keep out of the reach of children

WHEN SHOULD YOU NOT USE GLUCOHALAL POWDERS?

1.    It should not be used when there is peripheral and pulmonary oedema (swellings) or toxaemia of pregnancy (blood poisoning).

2.    It should not be used by patients with dextrose malabsorption/ intolerance.

3.    It should not be used by patients with very severe vomiting, diarrhoea and dehydration requiring fluid therapy.

4.    It should not be used by patients with a history of heart failure, kidney problems or diseases.

DIRECTIONS FOR USE

For oral administration

Adults, the elderly and children over 12 years:

1 or 2 reconstituted sachets after each loose bowel movement.

Children 1-12 years:

1 reconstituted sachet after each loose bowel movement.

Infants:

Substitute equivalent volume of reconstituted solution in place of feeds or give the appropriate volume before breast feeding.

How to prepare the medicine

1.    Pour the contents of a sachet into a glass.

2.    Add 200 ml of fresh drinking water. For infants and where drinking water is not available use freshly boiled and cooled water. Stir in the powder until completely dissolved.

3.    Use within 1 hour reconstitution, or within 24 hours if refrigerated.

4.    Do not boil the solution after mixing.

If you swallow too much of this product contact your doctor or pharmacist.

SIDE EFFECTS

No side effects have been reported following use of this product:

If you experience any form of reaction following the use of this product, the please report this to your doctor or pharmacist who will advise you on the necessary action to take.

STORING THIS PRODUCT

This product has a three year shelf life if unopened; its expiry date is given on the tube and carton. Store the sachets in a cool dry place.

Do not use Glucohalal Powders after the expiry date shown.

Glucohalal Powders should be stored out of the reach of children.

Date of revision: March 2013