Dioralyte Relief Raspberry & Blackcurrant
Package leaflet: Information for the user
Dioralyte Double Action Blackcurrant Dioralyte Double Action Raspberry 6.0g/580mg/350mg/300mg, Powder for oral solution
Pre-cooked rice powder, sodium citrate, sodium chloride, potassium chloride
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Dioralyte Double Action Blackcurrant/Raspberry 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 contact a doctor if your symptoms worsen or do not improve after using this medicine for 36 hours.
•If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:
1. What Dioralyte Double Action is and what it is used for
2. Before you take Dioralyte Double Action
3. How to take Dioralyte Double Action
4. Possible side effects
5. How to store Dioralyte Double Action
6. Further information
1. What Dioralyte Double Action is and what it is used for
The name of your medicine is Dioralyte Double Action Blackcurrant/Raspberry (called Dioralyte Double Action throughout this leaflet). Dioralyte Double Action works by replacing the water and salts lost from your body when you have diarrhoea. It helps the watery stools return to normal.
It contains pre-cooked rice powder and salts (these are sodium citrate, sodium chloride and potassium chloride). The powder is mixed with water before taking.
2. Before you take Dioralyte Double Action
Do not take Dioralyte Double Action and talk to your doctor or pharmacist if:
•You are allergic (hypersensitive) to pre-cooked rice powder, sodium citrate, sodium chloride, potassium chloride or any of the other ingredients of Dioralyte Double Action (see Section 6: Further information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
•Your bowel is partially or fully blocked (called 'intestinal obstruction')
•You have severe kidney or liver disease
•You have something called 'phenylketonuria' (a rare illness passed on in families)
•The child taking the medicine is under 3 months old
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Dioralyte Double Action.
Take special care with Dioralyte Double Action
Check with your doctor or pharmacist before taking this medicine if:
•You have something called an 'electrolyte imbalance' (unusual levels of salts in your body) •You are on a low potassium or low sodium diet •The child taking the medicine is under 1 year old
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Dioralyte Double Action.
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 Double Action can affect the way some other medicines work. Also some medicines can affect the way Dioralyte Double Action works.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. This includes if you are planning to get pregnant or think you that you might be pregnant.
Important information about some of the ingredients of Dioralyte Double Action
Dioralyte Double Action contains a source of phenylalanine (aspartame). This may be harmful to people with something called 'phenylketonuria'.
Dioralyte Double Action contains 2.5 vol % ethanol (alcohol). One dose contains 191 mg of ethanol, which is about the same amount of alcohol as 4 ml of beer or 1.7 ml of wine. This can be harmful to people with a drink problem. Also take this into account if you are pregnant, breast-feeding or giving this to a child, have liver disease or epilepsy.
3. How to take Dioralyte Double Action
If you are not sure how to take this medicine, check with your doctor or pharmacist Preparing this medicine
Dioralyte Double Action must be mixed with water before taking.
•Prepare just before the medicine is going to be taken. Do not make in advance. If you are giving it to a baby over the course of the day, you can keep the drink in a refrigerator for up to 24 hours
•Only dissolve the powder in water. Do not dissolve it in anything else
•Use fresh drinking water for adults and children over 1 year old. If fresh water is not
available, use water which has been freshly boiled and cooled
•Always use water which has been freshly boiled and cooled for babies aged 3 months to 1 year
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 look milky
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
Adults (including the elderly) and children over 1 year •One sachet after each loose stool
•You can take up to 5 sachets each day, for up to 3 to 4 days. Do not take more than 5 sachets in 24 hours
Babies aged 3 months to 1 year (to be given under the guidance of a doctor)
•The amount depends on how much the baby weighs. The usual dose is 150-200 ml of the drink for each kg of the baby's weight, each day. This can be given over 24 hours •Give half the drink during the first 8 hours and the other half during the next 16 hours •Ask your doctor or pharmacist if you are not sure how much to give •If your baby is being sick, you can give 5-10 ml (one or two teaspoons) every 5 minutes.
This can be gradually increased until they are able to drink normally.
If you take more Dioralyte Double Action than you should
Dioralyte Double Action is not normally harmful if you take more than you should. However, if large amounts are taken, you should talk to a doctor or go to a hospital straight away. This is particularly important if it is a child or baby. Take the medicine pack with you.
If you forget to take your Dioralyte Double Action
Do not take a double dose to make up for a forgotten dose. Take the next dose when you need to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Dioralyte Double Action can cause side effects, although not everybody gets them.
However, if you notice anything unusual, talk to your doctor or pharmacist. You should not normally have any side effects.
Stop taking Dioralyte Double Action and see a doctor or go to a hospital straight away if:
•You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
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 Dioralyte Double Action
Keep out of the reach and sight of children.
Do not use Dioralyte Double Action 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 in a dry place below 25°C.
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 Double Action contains
•The active substances are pre-cooked rice powder, sodium citrate, sodium chloride and potassium chloride
•The other ingredients are hypromellose, aspartame, blackcurrant flavour 501017 or raspberry flavouring 611417E, purified water and ethanol 96%
What Dioralyte Double Action looks like and contents of the pack
Dioralyte Double Action is available in pack sizes of 6. Packs of 6 may contain:
•6 sachets of one flavour
•4 sachets of blackcurrant flavour and 2 of raspberry (Blackcurrant & Raspberry)
•4 sachets of raspberry flavour and 2 of blackcurrant (Raspberry & Blackcurrant)
Each sachet contains enough powder to make a drink up with 200 ml (7 fl oz) of water.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 0845 372 7101
Email:uk-medicalinformation@sanofi.com
Manufacturers Sanofi-Aventis Sp. z o.o.,
52, Lubelska Str., 35-233 Rzeszow, Poland
A Nattermann & Cie. GmbH Nattermannallee 1 D-50829 Cologne, Germany
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in {02/2014}. © Sanofi, 1995-2014
Reference: 80161 1.3.1.3 - Leaflet Text - MOD 1 - 300mg, 6g, 350mg, 580mg - 2014-01-28 - Double Action (GSL)-Updated AE
report & site transfer - 04425/0273, 04425/0280 0.8