Dioralyte Relief Raspberry & Blackcurrant
PACKAGE LEAFLET:
INFORMATION FOR THE USER Dioralyte Relief Blackcurrant Dioralyte Relief Raspberry 6.0g/580mg/350mg/300mg,
Powder for oral solution
Pre-cpoked rice powder, spdium citrate, sodium chloride, potassium chloride
SANOFltd
Is this leaflet hard to see or read? Phone 0845 372 7101 for help
SRead all of this leaflet carefully because it contains Important Information for yon.
This medicine is available without prescription.
However, you still need to use Dioralyte Relief Relief
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 3G hours.
• If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Dioralyte Relief is and what it is used for
2. Before you take Dioralyte Relief
3. How to take Dioralyte Relief
4. Possible side effects
5. How to store Dioralyte Relief
6. Further information
1. What Dioralyte Relief is and what it is used for_
The name of your medicine is Dioralyte Relief Blackcurrant/Raspberry (called Dioralyte Relief throughout this leaflet). Dioralyte Relief 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 Relief
Do not take Dioralyte Relief and talk to your doctor or pharmacist if:
x You are allergic (hypersensitive) to pre-cooked rice powder, sodium citrate, sodium chloride, potassium chloride or any of the other ingredients of Dioralyte Relief (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 x Your bowel is partially or fully blocked (called ‘intestinal obstruction') x You have severe kidney or liver disease
X You have something called ‘phenylketonuria’ (a rare illness passed on in families) x 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 Relief.
Take spedal care with Dioralyte Relief 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 Relief.
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
Erescription, including herbal medicines. This is ecause Dioralyte Relief can affect the way some other medicines work. Also some medicines can affect the way Dioralyte Relief works.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. This indudes if you are planning to get pregnant or think you that you might be pregnant.
Important information about some of the Ingredients of Dioralyte Relief
Dioralyte Relief contains a source of phenylalanine (aspartame). This may be harmful to people with something called 'phenylketonuria'.
Dioralyte Relief 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. Howto take Dioralyte Relief
If you are not sure how to take this medicine, check with your doctor or pharmacist
Preparing this medicine
Dioralyte Relief 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 tne 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
use of
side effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more
Markstins Authorisation Holder
Sanoti
One Onslow Street
Guildford
Surrey
GU1 4YS, UK
Tel: 0845 372 7101
Manufacturer
ANattermann &Cie. GmbH Nattermannallee 1 D-50829 Cologne, Germany.
This leaflet was last revised in {01/2014}.
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 first8 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 Relief than you should
Dioralyte Relief 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 chilo or baby. Take the medicine pack with you.
If you forget to take your Dioralyte Relief
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 iis product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Dioralyte Relief 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 Relief 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
5, How to store Dioralyte Relief
Keep out of the reach and sight of children.
Do not use Dioralyte Relief 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 Relief 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 Relief looks like and contents of
the pack
Dioralyte Relief is available in pack sizes of 6. Packs
of 6 may contain:
• 6 sachets of ore 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
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
© Sanofi, 1995-2014
417263-01.14-UK
Dioralyte Relief blackcurrants Raspberry Pantone Reflex Blue/Pantone 214/ Pantone 259 size 148x210mm
Font: Ocean Sans/min. size of text 8 pt
PM code: 545637
Laetus code 49
Version 01/01.2014
Plant Rzeszow
Dioralyte Relief Blackcurrant Dioralyte Relief Raspberry 6.0g/580mg/350mg/300mg,
Powder for oral solution
Pre-cpoked rice powder, spdium citrate, sodium chloride, potassium chloride
SANOFI
Is this leaflet hard to see or read? Phone 0845 372 7101 for help
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 Relief
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 Relief is and what it is used for
2. Before you take Dioralyte Relief
3. How to take Dioralyte Relief
4. Possible side effects
5. How to store Dioralyte Relief
6. Further information
The name of your medicine is Dioralyte Relief Blackcurrant/Rasp berry (called Dioralyte Relief throughout this leaflet). Dioralyte Relief 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.
Do not take Dioralyte Relief and talk to your doctor or pharmacist if:
x You are allergic (hypersensitive) to pre-cooked rice powder, sodium citrate, sodium chloride, potassium chloride or any of the other ingredients of Dioralyte Relief (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’) x You have severe kidney or liver disease
x You have something called ‘phenylketonuria’(a rare illness passed on in families) x The child taking the medicine is under3 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 Relief.
Take special care with Dioralyte Relief 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 yearold If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Dioralyte Relief.
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 Relief can affect the way some other medicines work. Also some medicines can affect the way Dioralyte Relief 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 planningto get pregnant or think that you might be pregnant.
Important information about some of the ingredients of Dioralyte Relief
Dioralyte Relief contains a source of phenylalanine (aspartame). This may be harmful to people with something called ‘phenylketonuria’.
Dioralyte Relief 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.
If you are not sure how to take this medicine, check with your doctor or pharmacist
Preparing this medicine
Dioralyte Relief must be mixed with water before
taking.
• Prepare just before the medicine is going to betaken. 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 Relief than you should
Dioralyte Relief 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 Relief
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.
Like all medicines, Dioralyte Relief 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 Relief 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.m h ra.gov.u k/ye 11 owca rd By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not use Dioralyte Relief 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 betaken. 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 howto dispose of medicines no longer required. These measures will help to protect the environment.
What Dioralyte Relief contains
* The active substances are pre-cooked rice powder, sodium citrate, sodium chloride and potassium chloride
* The other ingredients are hypromellose, aspartame, blackcurrant flavour 50101 / or raspberry flavouring 611417E, purified water and ethanol 96%
What Dioralyte Relief looks like and contents of
the pack
Dioralyte Relief 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 (Blackcurrants Raspberry)
* 4 sachets of raspberry flavour and 2 of blackcurrant (Raspberry & Blackcurrant)
Each sachet contains enough powderto 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: 08453727101
e m a i I: u k- m ed ica I i n fo rm atio n @sa n ofi.co m
Manufacturer
Sanofi-Aventis Sp. z o.o.,
52, Lubelska Str., 35-233 Rzeszow, Poland
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 01/2014.
© Sanofi, 1995-2014 g
s