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Boots Oral Rehydration Treatment

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Document: leaflet MAH BRAND_PL 16431-0118 change

Boots Oral Rehydration Treatment

PATIENT INFORMATION LEAFLET

Please read this leaflet carefully because it contains important information for you. If you have further questions, please ask your doctor or pharmacist.

Boots Oral Rehydration Treatment contains the following active ingredients:

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

Pharmaceutical Form

A white free-flowing crystalline powder contained in sachets of 8.8g in a printed carton. There are 6 sachets in a carton.

Product Type

The reconstituted solution contains a mixture of Sodium and Potassium salts along with Glucose which facilitates the absorption of Sodium and Potassium from the intestine. Water is drawn from the bowel by osmotic effect. As well as drying up the stools the dehydration and loss of electrolyte caused by the diarrhoea is corrected by the water and electrolytes absorbed.

Product Licence Holder

Ayrton Saunders Ltd

9 Arkwright Road

Astmoor Industrial Estate

Runcorn

Cheshire

WA7 1NU

Manufacturer Cupal Limited King Street Blackburn Lancashire BB2 2DX

Uses:

For the treatment of diarrhoea and fluid loss due to diarrhoea in infants, children and adults. BEFORE USING BOOTS ORAL REHYDRATION TREATMENT

The following information should be read before using this medicine:

1.    Do not use this product if you suffer from kidney disease or heart disease.

2.    Do not use this product if you are suffering from severe vomiting, diarrhoea or dehydration which require fluid therapy. If in doubt, consult your doctor or pharmacist.

3.    Do not use this product if you have problems with products containing glucose (dextrose).

4.    This product should not be used if you are suffering from toxaemia of pregnancy, or peripheral or pulmonary oedema.

5.    It is very important to dissolve Boots Oral Rehydration Treatment in water of the correct volume. A weak solution will not contain the optimum glucose and electrolyte concentration and a strong solution may give rise to electrolyte imbalance.

6.    Consult your doctor before administering this product to children under three years of age.

7.    If symptoms persist for more than 48 hours seek medical advice.

8.    Make sure Oral Rehydration Treatment is suitable for you to use - ask your doctor or pharmacist.

DIRECTIONS FOR USING BOOTS ORAL REHYDRATION TREATMENT

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.

Directions for reconstitution:

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 until the powder is completely dissolved.

3.    Use within one hour of reconstitution, or within 24 hours if stored in a refrigerator.

4.    Do not boil the solution after mixing.

Following accidental ingestion of large amounts of Oral Rehydration Treatment, medical advice should be immediately sought.

UNDESIRABLE EFFECTS

No undesirable effects have been reported following use of this product.

If you experience any reactions following use of this product, then discontinue it’s use immediately, and please report this to your doctor or pharmacist, who will advise you on the necessary action to take.

SHELF-LIFE

This product has a 3 year shelf-life which is given on the label on the sachet.

Do not use Boots Oral Rehydration Treatment after the expiry date shown on the label.

Do not store above 25oC.

Keep out of the reach and sight of children.

Date of revision: January 2011 PL 16431/0118