Rehydration Treatment

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you take this medicine because it contains important information you need to know.

This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice.

1.    What is this medicine and what is it used for?

This medicine contains:

*    dextrose monohydrate

*    sodium chloride

*    potassium chloride

*    sodium citrate dihydrate

*    citric acid anhydrous

They are a combination of salts and sugars which when used together help replace fluids and salts lost through diarrhoea.

These sachets are used for the treatment of acute diarrhoea and for the treatment and prevention of dehydration (loss of fluids) resulting from diarrhoea.

2.    Is this medicine suitable for you?

Do not take this medicine if you:

*    are allergic to dextrose monohydrate, sodium chloride, potassium chloride, sodium citrate dihydrate, citric acid anhydrous or any of the other ingredients

*    have a bowel that is partially or fully blocked (called ‘intestinal obstruction')

*    are severely dehydrated

*    suffer with phenylketonuria, a rare inherited, metabolic disorder.

Children under 1 year of age should not be given this medicine unless advised to do so by a doctor. If a young child (particularly one under 6 months of age) has diarrhoea and/or vomiting advice should be sought from a pharmacist, doctor or other health care professional. If the diarrhoea and/or vomiting is severe the child should be seen by a doctor as soon as possible.

Please see your doctor or pharmacist before taking this medicine if you:

•    suffer from liver or kidney disease, including difficulty with passing water (urinating)

•    are unable to drink or retain fluids

•    have diabetes

•    have an intolerance to some sugars

•    are on a low potassium or low sodium diet (please see below)

•    have symptoms that persist for more than 24 -48 hours, you should consult your doctor or pharmacist as other treatment may be needed. Severe and persistent diarrhoea and/or vomiting should be treated under medical supervision.

Other important information:

Pregnancy and breast feeding:

You may take this product during pregnancy or when breast feeding.

Information about some of the ingredients in this medicine:

Each sachet contains 3.58 g of glucose (sugar).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This should be taken into account in patients with diabetes.

Contains aspartame (E951), a source of phenylalanine. May be harmful for people with phenylketonuria.    Please turn over ^

Each sachet contains 276 mg of sodium. To

be taken into consideration by patients on a controlled sodium diet.

Each sachet contains 157 mg of potassium.

To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

3. How to take this medicine

Mix the contents of 1 sachet with 200 ml (7 fluid ounces) of fresh drinking water and drink immediately. When fresh drinking water is not available, freshly boiled and cooled water should be used.

For infants under 1 year, use freshly boiled and cooled water only.

The medicine should be used within 1 hour, but if refrigerated, can be kept for up to 24 hours.

Adults, the elderly and children over 12 years:

1 or 2 sachets after each loose motion, as required. Children 1 to 12 years:

1 sachet after each loose motion.

Infants under 1 year:

Not to be given unless instructed by your doctor.

In such cases, it is usual to give 1 to 1% times the usual 24 hour feed volume of the infant. Ask your doctor or pharmacist for advice if you are not sure how much to give.

During the first 24 hours of illness, this treatment should replace normal feeds in bottle fed babies, gradually resuming normal feeds as the baby gets better.

In breast fed babies, firstly give the amount of this medicine recommended and then breast feed until satisfied.

Do not exceed the stated dose. If your symptoms persist for longer than 24 - 48 hours, or worsen, you must see a doctor or pharmacist.

If you take too many sachets by mistake, contact your doctor or pharmacist straight away.

4.    Possible side effects

Most people do not have any side effects while taking this medicine. However, if you experience any side effects, or anything unusual happens, stop taking the medicine immediately, and see your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store your medicine

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date printed on the pack.

Store below 25°C, in a dry place.

6.    What is in this medicine?

Each 4.97 g sachet of granules contains the active ingredients: dextrose monohydrate 3.58 g, sodium chloride 470 mg, potassium chloride 300 mg, sodium citrate dihydrate 390 mg and citric acid anhydrous 128 mg.

When dissolved in 200 ml of water, each 4.97 g sachet of granules will produce a blackcurrant flavoured solution giving the equivalent of: glucose 90 mmol/L, sodium 60 mmol/L, potassium 20 mmol/L, chloride 60 mmol/L and citrate 10 mmol/L.

The other ingredients are: colloidal anhydrous silica, blackcurrant flavour and aspartame (E951),

This product is available in a pack size of 6 sachets.

7.    Who makes this medicine?

The Marketing Authorisation holder and manufacturer is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, United Kingdom. Text revised: April 2015.

PL 12063/0046    2747804