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REHYDRATION TREATMENT GRANULES FOR ORAL SOLUTION

Active substance(s): CITRIC ACID ANHYDROUS / DEXTROSE MONOHYDRATE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM CITRATE DIHYDRATE / CITRIC ACID ANHYDROUS / DEXTROSE MONOHYDRATE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM CITRATE DIHYDRATE

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PACKAGE LEAFLET - INFORMATION FOR THE USER

3. How to take Rehydration Treatment
Check that the sachet is intact before use. 1. Pour the contents of the sachet into a glass. 2. Add 200 ml (7 fl oz.) of fresh drinking water. For infants and where fresh drinking water is not available use freshly boiled cooled water. Stir until the powder is completely dissolved. 3. Use within 1 hour of reconstitution or within 24 hours if stored in a refrigerator 4. Do not use solution other than water to make up the contents of the sachet and always make sure that each is dissolved in the correct amount of water (i.e. 200ml). This is important to ensure that the solution provides the correct concentration for salt and water absorption. Adults, the elderly and children over 12 years: Take one or two reconstituted sachets after each loose bowel movement, up to a maximum of 12 sachets in 24 hours. Children 1 to 12 years: Take one reconstituted sachet after each loose bowel movement, up to a maximum of 12 sachets in 24 hours. Infants under 1 year: Not to be given unless instructed by a doctor, in which case give one to a half times the usual 24 feed volume. During the first 24 hours of illness, Rehydration Treatment should replace normal feeds in bottle-fed infants, gradually resuming normal feeds as the infant gets better. In breast-fed infants, firstly give the same volume of this medicine as the bottle-fed infant and then put to the breast until satisfied. DO NOT EXCEED THE STATED DOSE. If diarrhoea continues for more than 36 hours, talk to your doctor. If you take more Rehydration Treatment than you should If you or someone else has taken a large number of extra dose contact your doctor or hospital accident and emergency department straight away. Take your medicine with you. If you forget to take Rehydration Treatment If you forget to take a dose, just take the next dose at the usual time. Do not take a double dose.

Rehydration Treatment Granules for Oral Solution
3.58g/470mg/300mg/390mg/128mg Dextrose (glucose) monohydrate, sodium chloride, potassium chloride, sodium citrate dihydrate, citric acid anhydrous

BLACKCURRANT FLAVOUR
(referred to as 'Rehydration Treatment' in this leaflet) Read all of this leaflet carefully because it contains important information for you. This medicine is available without a prescription, for you to treat a mild illness without a doctor's help. Nevertheless you still need to use Rehydration Treatment carefully to get the best results from it. Keep this leaflet. You may need to read it again Ask your pharmacist if you need more information or advice You must see a doctor if your symptoms worsen or do not improve. In this leaflet 1. What Rehydration Treatment is and what it is used for 2. Before you take Rehydration Treatment 3. How to take Rehydration Treatment 4. Possible side effects 5. How to store Rehydration Treatment 6. Further information

1. What Rehydration Treatment is and what it is used for
This product belongs to group of medicines called oral rehydration products. It can be used for the treatment of acute diarrhoea, by the treatment and prevention of dehydration, by replacing fluids and body salts lost through diarrhoea.

2. Before you take Rehydration Treatment
Do not take if: you are allergic to any of the ingredients shown previously (see section 6) you suffer from phenylketonuria (PKU) you suffer from liver disease you suffer from kidney disease or have difficulty in urinating you want to give this treatment to a baby under 1 year Tell your doctor or pharmacist before you take this medicine if: you are diabetic you require low sodium diet you require low potassium diet Taking with food and drink Do not drink alcohol when taking Rehydration Treatment as it will dehydrate you further. Pregnancy and breast-feeding It is safe to take Rehydration Treatment if you are pregnant or breast-feeding. Driving and using machines Your ability to drive or use machines will be not affected while you take Rehydration Treatment. Important information about Rehydration Treatment Rehydration Treatment contains sodium. This may be harmful to people on low sodium diet. Sodium content per sachet is 276 mg. This preparation may be harmful to people on a low potassium diet. Consult your doctor if diarrhoea and vomiting are persistent and severe, or if you are unable to drink or retain oral fluids. Consult your doctor as soon as possible for infants under the age of 1 year with severe diarrhoea and/or vomiting. Taking other medicines Tell your doctor or pharmacist if you are taking any other medicines, including those you have bought yourself.

4. Possible side effects
Like all medicines, Rehydration Treatment may have side effects although not everyone gets them. If you experience any unpleasant effects which you think are caused by Rehydration Treatment you must tell your doctor or pharmacist for advice.

5. How to store Rehydration Treatment
Store below 25C in a dry place, in the original package. Keep out of the reach and sight of children. Do not take them after the expiry date shown on the pack.

6. Further information
What does each Rehydration Treatment contain? Each sachet of granules contains: Citric Acid Anhydrous 0.128g, Dextrose Monohydrate 3.58g, Potassium Chloride 0.30g, Sodium Chloride 0.47g, Sodium Citrate Dihydrate 0.39g, which are the active ingredients. Other ingredients are colloidal anhydrous silica, blackcurrant flavourings and aspartame (E951, which contains phenylalanine). Additional information: Sodium content per sachet: 276 mg. Each 200 ml of reconstituted solution contains: 12mmol Sodium (Na+) 4 mmol Potassium (K+), 12 mmol Chloride (Cl+), 2 mmol Citrate and mmol Glucose. What is in the pack? Rehydration Treatment are supplied in sachets of 6,10, 20, 50 and 100.* Who supplies these Rehydration Treatment sachets? Rehydration Treatment is manufactured by Norbrook Laboratories Ltd, Factory 4, Newry, County Down, BT35 6QQ, for the Marketing Authorisation holder, East Midlands Pharma Ltd., 16 Rancliffe Avenue, Keyworth, Notts NG12 5HY. Date of preparation: February 2011 * not all pack sizes may be marketed PL 22958/0007

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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