Dioralyte Relief Blackcurrant Sachets P

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 Sachets 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

Do not take Dioralyte Relief 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 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’)
• 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 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 year old

Infants under the age of 2 with diarrhoea should be seen by a health care provider as soon as possible.

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 planning to get pregnant or think that you might be pregnant.

Important information about some of the ingredients of Dioralyte Relief

Dioralyte Relief contains 50 mg of aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

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.

This medicine contains 190 mg sodium (main component of cooking/table salt) in each sachet. This is equivalent to 10 % of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 156 mg potassium per sachet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

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 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.

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

Yellow Card scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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, purified water and ethanol 96%

What Dioralyte Relief looks like and contents of the pack

Dioralyte Relief is available in pack sizes of 20. 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

Manufacturer