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Boots Oral Rehydration Treatment

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PATIENT INFORMATION LEAFLET

ORAL REHYDRATION SALTS LEMON & LIME FLAVOUR

Please read this leaflet carefully as it contains important information regarding this medicine. If you have any questions or queries regarding this product, please ask your doctor or pharmacist.

Each sachet of ORAL REHYDRATION SALTS LEMON & LIME FLAVOUR contains the following active ingredients:

Sodium Chloride BP    200 mg

Potassium Chloride BP    300 mg

Sodium Bicarbonate BP    300 mg

Glucose BP    8 g

They also contain the following inactive ingredient:

Flavour 610477E

The Medicine

A white free-flowing crystalline powder contained in sachets in a printed carton. There are six sachets in a carton.

Oral Rehydration Salts Lemon & Lime Flavour act by drying up the stools, helping to stop diarrhoea, and by replacing lost water and electrolytes.

Product Licence Holder

Ayrton Saunders Ltd

9 Arkwright Road

Astmoor Industrial Estate

Runcorn

Cheshire

WA7 1NU

Manufacturer

Cupal Ltd King Street Blackburn BB2 2DX

Uses

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

BEFORE USING ORAL REHYDRATION SALTS

The following information should be read before using this medicine:

Do not use this medicine if you suffer from any of the following: -

1.    Kidney Disease, heart disease or cirrhosis of the liver.

2.    Problems with your pituitary gland, in particular when associated with low ACTH levels, or low cortisol levels.

3.    Increased body potassium levels.

4.    Breathing difficulties.

5.    Problems with the amount of some salts (electrolytes) in your body, eg: sodium, potassium, calcium, chloride levels (which may be too high or too low).

6.    Difficulty in passing water.

7.    Oedema, (swelling of the limbs due to fluid retention).

8.    Toxaemia of pregnancy, (pre-eclampsia or high blood pressure in pregnancy) or any swelling due to water retention.

9.    High blood pressure including during pregnancy.

10.    Severe or regular vomiting, diarrhoea or fluid loss.

11.    If you have problems with products containing glucose (dextrose).

Do not use this medicine if you are taking any of the following: -

1.    Diuretics or water tablets.

2.    Any medicine or tablet containing potassium.

3.    Corticosteroids, NSAIDs or Carbenoxolone.

If you are taking and other medicines or tablets, consult your doctor before using this product.

If you are pregnant or breast feeding do not use this product unless advised to do so by your doctor.

Use with caution if suffering from heat cramps.

Make sure Oral Rehydration Salts Lemon & Lime Flavour are suitable for you to use - if in doubt ask your doctor or pharmacist.

DIRECTIONS FOR USING ORAL REHYDRATION SALTS LEMON & LIME FLAVOUR

Adults and children over 12 years

One or two sachets made up in the correct amount of water after each loose bowel movement.

The elderly

Normal adult dose. However, care should be taken in the elderly as potassium excretion may be reduced. The doctor may want to monitor Potassium levels in elderly patients Children 1 - 12 years

One sachet made up in the correct amount of water after each loose bowel movement Infants

Administer with care to infants. Bottle Fed

Substitute an equivalent volume of made up solution Breast Fed

Before breast feeding give an appropriate volume of made up solution in place of the breast milk normally taken.

Warning

It is very important to dissolve Oral Rehydration Salts Lemon & Lime Flavour in the correct amount of water. A weak solution will not contain the right amount of glucose and electrolytes (salts), and a strong solution may give rise to an electrolyte imbalance, (too much salt).

Diarrhoea can have very serious consequences in children under 3 years old. Immediate medical advice should be sought.

In other age groups, if symptoms persist for more than 24 - 48 hours, consult your doctor.

If nausea (feeling sick), and vomiting (being sick), are present with the diarrhoea, small and frequent amounts of Oral Rehydration Salts Lemon & Lime Flavour should be drunk first. In infants, immediate medical assistance should be obtained.

INSTRUCTIONS FOR MAKING UP THE SOLUTION

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 deliberate or accidental ingestion of more than the stated dose of Oral Rehydration Salts Lemon & Lime Flavour, medical advice should be immediately sought.

SIDE EFFECTS

The following undesirable effects have been reported in some patients but usually following excessive use of the product: - Swelling of the limbs, sickness, diarrhoea, stomach pains, thirst, dry mouth, sweating, fever, kidney failure, breathing difficulties, headache, dizziness, restlessness, irritability, weakness, muscle twitching, fits, loss of consciousness, stomach ulcers, high blood pressure, flatulence (wind), increased heart rate, excess tear production, increased sodium and potassium levels.

If you experience and of the reactions named above or any other reaction following use of this product, then stop using it immediately, and please report this to your doctor or pharmacist, who will advise you on the necessary action to take.

STORING YOUR MEDICINE

This product has a three year shelf life which is stated on the sachet and carton.

Do not use these sachets after the expiry date should on the sachet or carton.

Oral Rehydration Salts Lemon & Lime Flavour should be stored below 25oC in a dry place out of the reach of children.

Date of leaflet preparation: January 2011