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Rehydration Treatment

Document: leaflet MAH BRAND_PL 16028-0015 change

REHYDRATION TREATMENT

PATIENT INFORMATION LEAFLET

Read this leaflet carefully because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You should contact a doctor if your symptoms worsen or do not improve within 24 hours.

IN THIS LEAFLET:

1.    What this medicine is for

2.    Before you take the medicine

3.    How to take the medicine

4.    Possible side effects

5.    Storing the medicine

6.    Further information

1.    WHAT THIS MEDICINE IS FOR

Rehydration Treatment are sachets which contain a powder which contains salt and glucose. This must be dissolved in the right amount of water, making a blackcurrant flavoured drink.

The solution is taken to replace fluids and body salts lost through diarrhoea, so preventing dehydration.

2.    BEFORE YOU TAKE THE MEDICINE Do not take this medicine if:

•    You suffer from phenylketonuria, which is a severe form of mental illness (see also ‘Important information about some of the ingredients of this medicine’ below).

•    You are allergic to any of the ingredients listed in Section 6.

•    Your bowel is partially or fully blocked (called ‘intestinal obstruction’).

•    You if have severe dehydration and you are unable to drink or retain fluids.

Check with your doctor before taking this medicine if:

•    You suffer from liver or kidney problems, including difficulty in urinating.

•    You are unable to drink or retain fluids.

•    You have severe and persistent diarrhoea and vomiting.

•    You are pregnant or breastfeeding (unless instructed by your doctor).

•    You are on a low potassium or a low sodium diet.

•    You have diabetes.

Important information about some of the ingredients of this medicine:

•    The sachet powder contains aspartame (E951) a source of phenylalanine. This may be harmful for people with phenylketonuria.

•    The sachets contain glucose; if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

HOW TO TAKE THE MEDICINE

3.


Adults, the elderly and children over 12 years_

How to take:

The sachet powder should be dissolved in water as described overleaf before drinking.

Dose and how often to take:

After the first loose stool (bowel motion) drink the solution made from the contents of 1 rehydration sachet (200 ml solution) or 2 sachets (400ml solution).

After each further loose stool, take a further 1 or 2 sachets._

Further doses of sachets can be taken after each loose stool, up to a maximum of 16 sachets in 24 hours, if necessary.

   Do not give to children under 12 years of age.

•    Do not take more than 16 sachets in any 24 hours.

•    Do not take the sachets for more than 24 hours unless advised by a doctor.

•    If symptoms persist for more than 24 hours consult your doctor.

   DO NOT EXCEED THE STATED DOSE.


IF YOU TAKE TOO MUCH: If you take more sachets than you should, tell your doctor or pharmacist.

Making up the sachet solution for drinking

Dissolve the contents of each sachet in 200 ml (7 fluid ounces) of fresh drinking water. When fresh water is not available, use 200 ml of freshly boiled and cooled water.

ONLY use water to make up the solution; and always make sure that each sachet is dissolved in the correct amount of water (i.e. 200 ml), so that that the solution is at the correct concentration for rehydration.

The solution should be made up immediately before use and used within 1 hour, or may be kept for up to 24 hours in a fridge.

4. POSSIBLE SIDE EFFECTS

Side effects do not usually occur with the rehydration solution, but as with all medicines, side effects may occur occasionally.

Allergic reaction:

Stop taking the medicine and contact your doctor immediately if you notice:

•    skin rashes or other signs of allergic reaction such as itching, swelling of the lips, tongue or throat, or difficulty in breathing.

Other side effects are:

•    Stomach pains

•    Tiredness

•    Dizziness

•    Dry mouth

If you experience any side effect which is troublesome, or not listed in this leaflet, stop taking the medicine and tell your pharmacist or doctor.

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.    STORING THE MEDICINE

Do not store above 25°C. Store in the original packaging.

Do not use the sachets after the expiry date shown on the pack.

Keep all medicines out of the reach and sight of children.

6.    FURTHER INFORMATION What is in this medicine:

The active ingredients in the sachets are: Glucose Monohydrate 3.58 g, Sodium Chloride 0.47 g, Potassium Chloride 0.30 g, Sodium Citrate 0.39 g, Citric Acid Anhydrous 0.128 g; The other ingredients in the sachets are: Colloidal Anhydrous Silica, Aspartame (E951) [containing Phenylalanine] and Blackcurrant flavourings. Each sachet contains 0.276 g of Sodium; to be taken into consideration by patients on a controlled sodium diet.

Contents of the pack:

The pack contains six Rehydration Sachets.

Marketing Authorisation Holder:

Galpharm Healthcare Ltd., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom

Manufacturer: Galpharm International Ltd., Elmhirst Park, Middle Field Road, Barnsley, South Yorkshire, S75 4LS, United Kingdom

Text revised: 04/01/2015