Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Potassium chloride, Sodium chloride, Glucose, Disodium hydrogen citrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for The name of your medicine is Dioralyte Natural/ Citrus/Blackcurrant (called Dioralyte throughout this leaflet). Dioralyte works by replacing the water and salts lost from your body when you have diarrhoea. It contains glucose and salts (these are sodium chloride, potassium chloride and disodium hydrogen citrate). The powder is mixed with water before taking. 2. Before you take Dioralyte Do not take Dioralyte and talk to your doctor or pharmacist if:
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▲ You have chronic or persistent diarrhoea ▲ You are on a low potassium or low sodium diet ▲ You have liver or kidney disease ▲ You have diabetes If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Dioralyte. If nausea and vomiting are present with the diarrhoea, small but frequent amounts should be drunk at first. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Dioralyte can affect the way some other medicines work. Also some medicines can affect the way Dioralyte works. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding. This includes if you are planning to get pregnant or think that you might be pregnant. Important information about some of the ingredients of Dioralyte This medicine contains glucose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine. This medicine contains approximately 300 mg sodium (main component of cooking/table salt) in each sachet. This is equivalent to 15% of the recommended maximum daily dietary intake of sodium for an adult.
Dioralyte If you are not sure how to take this medicine, check with your doctor or pharmacist Preparing this medicine Dioralyte must be mixed with water before taking.
1. Empty the contents of 1 sachet into a glass 2. Add 200 ml (7 fl oz) of water 3. Stir until the powder dissolves When your medicine is fully dissolved, the drink will be a colourless solution.
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Do not use more or less than 200 ml of water. If you do, the drink will become too weak or too strong. It will not work as well. You may also upset the balance of salts in your body. How many sachets to take
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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Dioralyte Keep out of the sight and reach of children. Do not use Dioralyte after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month. Store below 25°C. Store in the original package in order to protect from moisture. The drink should be made up just before it is going to be taken. Throw away any remaining drink after 1 hour (or 24 hours if stored in a refrigerator). Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further information What Dioralyte contains
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Dioralyte Citrus Sachets (GSL) comes as sachet. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Dioralyte Citrus Sachets (GSL) is potassium chloride, sodium chloride, glucose, disodium hydrogen citrate.
Medicines with the same active substance, strength and form include: Dioralyte Blackcurrant Sachets (GSL), Dioralyte Blackcurrant Sachets (P), Dioralyte Citrus Sachets (P). In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Dioralyte Citrus Sachets (GSL), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For treatment of fluid and electrolyte loss associated with acute diarrhoea.
Route of administration: Oral
RECONSTITUTION
The contents of each sachet should be dissolved in 200ml (approx. 7fl oz) of drinking water. Use fresh drinking water for adults and children. For infants, and where drinking water is unavailable, the water should be freshly boiled and cooled. The solution should be made up immediately before use and may be stored for up 24 hours in a refrigerator, otherwise any solution remaining an hour after reconstitution should be discarded. The solution itself must not be boiled.
A basic principle of treatment of diarrhoea is to replace lost fluid and electrolytes and then to maintain sufficient fluid intake to replace fluid loss from stools. The amount of reconstituted Dioralyte administered should be adapted to the age and weight of the patient and the stage and severity of the condition.
Severe dehydration may need to be corrected by parenteral fluids initially, followed by oral maintenance if indicated. If the loss of fluid in the diarrhoea is excessive, medical advice should be sought.
Daily intake may be based on a volume of 150ml/kg body weight for infants up to the age of 2 and 20-40ml/kg body weight for adults and children. A reasonable approximation is:
Infants up to the age of 2: One to one and a half times the usual 24 hour feed volume.
Children: One sachet dissolved in 200ml of water after every loose motion.
Adults (including the elderly): One or two sachets after every loose motion. Each sachet should be dissolved in 200ml of water.
More may be required initially to ensure early and full volume repletion.
In the initial stages of treatment of diarrhoea all foods, including cow's or artificial milk, should be stopped. However breast milk need not be withheld. In breast fed infants it is suggested that the infant is given the same volume of Dioralyte as the bottle fed baby and then put to the breast until satisfied. Expression of residual milk from the breasts may be necessary during this period. After 24 - 48 hours, when symptoms have subsided, the normal diet should be resumed but this should be gradual to avoid exacerbation of the condition.
When vomiting is present with the diarrhoea it is advisable that small amounts of Dioralyte be taken frequently. However, it is important that the whole of the required volume of Dioralyte be taken. Where the kidneys are functioning normally, it is difficult to over-hydrate by mouth and where there is doubt about the dosage, more rather than less should be taken. If no improvement is seen within 24-48 hours it is recommended that the patient be seen by a physician.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
There are no known contraindications to Dioralyte. However, there may be a number of conditions where treatment with Dioralyte will be inappropriate e.g. intestinal obstruction requiring surgical intervention.
For oral administration only. Dioralyte should not be reconstituted in diluents other than water. Each Sachet should always be dissolved in 200ml of water. A weaker solution than recommended will not contain the optimal glucose and electrolyte concentration and a stronger solution than recommended may give rise to electrolyte imbalance. If diarrhoea persists for longer than 24-48 hours the patient should be seen by a physician. Dioralyte should not be used for the self treatment of chronic or persistent diarrhoea except under medical supervision. Dioralyte shall not be used for treatment in infants below the age of 24 months without medical supervision. Infants under the age of 2 years with diarrhoea should be seen by a physician as soon as possible. No specific precautions are necessary in the elderly.
Dioralyte should not be used for self-treatment by patients:
• with chronic or persistent diarrhea.
• with liver or kidney disease.
• with diabetes.
• on low potassium or sodium diets.
• with an intestinal obstruction.
The use of Dioralyte in patients with these conditions should be supervised by a physician.
If nausea and vomiting are present with the diarrhoea, small but frequent amounts should be drunk at first.
Excipients
This medicinal product contains approximately 300 mg sodium per sachet, equivalent to 15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
None stated
Dioralyte is not contra-indicated in pregnancy or lactation.
Medical supervision is recommended for use during pregnancy and lactation.
Dioralyte could not be expected to affect the ability to drive or use machines.
None stated
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In the event of significant overdose, serum electrolytes should be evaluated as soon as possible, appropriate steps taken to correct an abnormalities and levels monitored until return to normal levels is established. This is particularly important in the very young and in cases of severe hepatic of renal failure.
Ask anything about Dioralyte Citrus Sachets (GSL). The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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