Rehydration Treatment
PACKAGE LEAFLET - INFORMATION FOR THE USER Rehydration Treatment Granules for Oral Solution
Read all of this leaflet carefully before you start taking this medicine 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.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 24 to 48 hours.
What is in this leaflet
1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. What this medicine is and what it is used for
This medicine contains Glucose and various salts which belong to group of medicines called oral rehydration products.
It can be used for the treatment of acute diarrhoea, and for the treatment and prevention of dehydration (loss of fluids), resulting from diarrhoea.
2. What you need to know before you take this medicine Do not take if:
• you are allergic to active substances or any of the other ingredients of this medicine (listed in section 6)
• you suffer from phenylketonuria (PKU), a rare inherited, metabolic disorder
• you are severely dehydrated
• you have a bowel that is partially or fully blocked.
Warnings and precautions
Talk to your doctor or pharmacist before you take this medicine if:
• you have liver problems
• you have kidney problems, including producing little or no urine
• you are unable to drink or retain fluids
• you 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
• you have diabetes
• you are on a low potassium or low sodium diet (please see below).
Children
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.
Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
You can take this medicine if you are pregnant or breast-feeding.
Driving and using machines
Your ability to drive or use machines will be not affected while you are taking this medicine.
Important information about some of the ingredients of this medicine This medicine contains glucose (sugar)
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains aspartame (E951), a source of phenylalanine
May be harmful for people with phenylketonuria.
This medicine contains sodium
To be taken into consideration by patients on a controlled sodium diet.
This medicine contains potassium
To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
2. How to take this medicine To prepare the medicine
1. Mix the contents of each sachet with 200 ml (7 fluid ounces) of fresh drinking water. For adults, when fresh drinking water is not available use freshly boiled and cooled water.
2. For infants use only freshly boiled and cooled water at all times.
3. Prepare the sachet only as needed and drink within one hour once made up. If required the refrigerated solution may be kept for 24 hours.
4. Only use water to make up the contents of the sachet. Make sure you use the right amount of water (i.e. 200 ml for one sachet, 400 ml for two sachets). This is to make sure the salt and water can be absorbed into the body correctly.
5. Drink the solution.
Adults, the elderly and children over 12 years:
Take one or two sachets dissolved in water after each loose bowel movement.
Children 1 to 12 years:
Take one sachet dissolved in water after each loose bowel movement.
Infants under 1 year:
Do not give this medicine unless a doctor tells you to. Over the first 24 hours give one to one and a half times the normal feed volume that your baby takes at each feed. Ask your doctor or pharmacist for advice if you need more information.
Bottle fed infants:
During the first 24 hours of illness, give this medicine at normal feed times only.
As diarrhoea improves re-introduce normal diet.
Breast fed infants:
Give the recommended amount of this medicine at normal feed times only. Then breastfeed until the infant is no longer hungry.
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 more of this medicine than you should
If you or someone else has taken too many sachets contact your doctor or hospital accident and emergency department straight away. Take your medicine with you.
If you forget to take this medicine
If you forget to take a dose, just take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.
4. Possible side effects
Most people do not have any side effects while taking this medicine. However, if you experience any side effects, 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 this medicine
• Keep out of the sight and reach of children.
• Store below 25°C in a dry place.
• Do not use this medicine after the expiry date which is stated on the carton after (EXP). The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What does this medicine contains
• Each sachet 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).
What is in the pack
• This medicine is supplied in sachets of 6, 10, 20, 50 or 100 packed in a carton. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road, Berkhamsted, HP4 1EG, United Kingdom. Telephone: 0044 (0) 1442 200922 Fax: 0044 (0) 1442 873717
Email: info@bristol-labs.co.uk
Manufacturer
Norbrook Laboratories Ltd,
Factory 4,
Newry, County Down,
BT35 6QQ.
This leaflet was last revised in March 2015.
Rehydration Treatment Granules for Oral Solution; PL 17907/0462
To request a copy of this leaflet in Braille, large print or audio format then please contact the licence holder at the address (or telephone, fax, email) above.
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