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PATIENT INFORMATION LEAFLET

Actidose-Aqua® Advance

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

In this leaflet:

1.    What Actidose-Aqua Advance is and what it is used for

2.    Before you are given Actidose-Aqua Advance

3.    How Actidose-Aqua Advance is given to you

4.    Possible side effects

5.    How to store Actidose-Aqua Advance

6.    Further information

1. WHAT ACTIDOSE-AQUA ADVANCE IS AND WHAT IT IS USED FOR

Actidose-Aqua Advance contains activated charcoal together with some other ingredients, to give it a more pleasant taste. Please see section 6. for a list of these ingredients. Activated charcoal is not a drug but is a simple chemical substance that takes up and binds many other chemicals. It prevents the absorption of many poisons from the stomach into the blood stream and helps to eliminate some poisons from the body even after they have been absorbed.

Actidose-Aqua Advance is used for the emergency treatment of poisoning or drug overdose involving many substances.

2. BEFORE YOU ARE GIVEN ACTIDOSE-AQUA ADVANCE

•    Actidose-Aqua Advance should not be given unless the patient is fully conscious

•    Tell the doctor or hospital staff if you have diabetes or any form of sugar intolerance, eg hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency

If Actidose-Aqua Advance is being given to your child then of course this information will apply to him/her.

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If you know what poison has been taken, please tell the hospital staff at once. Actidose-Aqua Advance is effective in most cases, but is not usually used if the poison is one of the following:

•    Alcohol

•    Turpentine

•    Corrosives such as alkalis, bleach and strong acids

•    Petrol

•    Paint thinner and other solvents

•    Cleaning Fluid

•    Furniture polish

•    Iron salts

•    Insecticides such as malathion and DDT

If you can say how much has been taken this will help in deciding the correct dose of Actidose-Aqua Advance.

A laxative is often administered with Actidose-Aqua Advance to hasten the removal of the poison and charcoal. This may result in diarrhoea.

Taking other medicines

Please tell your doctor or hospital staff if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Actidose-Aqua Advance will absorb most medicines and other chemical substances, and may therefore interfere with any medicines taken by mouth.

Pregnancy and breast feeding

Please tell the doctor or hospital staff if you are pregnant, planning to become pregnant or are breast feeding, Actidose-Aqua Advance is generally regarded as safe, although the doctor may prefer a different treatment to be given under these circumstances.

Important information about some of the ingredients of Actidose-Aqua Advance

Actidose-Aqua Advance contains the following ingredients:

•    Sucrose which is a sugar. Take special care if you have diabetes. You should not take it if you have a sugar intolerance. Each 240ml bottle contains 116g of sucrose.

•    Propylene glycol which may cause alcohol-like symptoms

•    Glycerol which may cause headache, stomach upset and diarrhoea

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3. HOW ACTIDOSE-AQUA ADVANCE IS GIVEN TO YOU

Actidose-Aqua Advance is usually given by mouth but may also be given by stomach tube. The normal dose is as follows:

Adults (including the elderly) and children over 12 years of age:

For single dose therapy, one to two large bottles (240 - 480 ml) taken as soon as possible after ingestion of the poison.

For multiple dose therapy, 120 - 240 ml every 4 to 6 hours.

Children aged 1-12 years of age:

Are usually given half the adult dose

Children under one year of age:

The dose is calculated according to body weight

If you are concerned about your dose of Actidose-Aqua Advance

Speak to the doctor or hospital staff. As this medicine is administered by a healthcare professional it is unlikely that you will be given too much or miss a dose.

4. POSSIBLE SIDE EFFECTS

The most common side-effect associated with Actidose-Aqua Advance is black faeces (stools).

Multiple dose use of the medicine has been reported to cause obstruction of the bowel with abdominal pain.

Accidental inhalation of the medicine into the lungs can cause Lung damage

Other possible side effects associated with Actidose-Aqua Advance are stomach/ intestinal problems including sickness, constipation and diarrhoea.

Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet 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 ACTIDOSE-AQUA ADVANCE

Keep out of the reach and sight of children. The product should not be used after the expiry date printed on the Label Store at 15 - 30°C. Do not refrigerate.

6. FURTHER INFORMATION

Each 5ml of solution contains 1.04g of Activated Charcoal. Actidose-Aqua Advance also contains Sucrose, Propylene glycol. Glycerol, Citric Acid and Purified Water.

Each 240ml bottle contains 116g of sucrose.

What Actidose-Aqua Advance looks like and contents of pack

Actidose-Aqua Advance is provided in bottles containing 120ml, or 240ml and tubes containing 120mL Not all pack sizes and types may be marketed.

Marketing Authorisation Holder

Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK.

Manufacturer

Pharmaserve Limited Wynne Avenue, Swinton Manchester, M27 8FF

Actidose-Aqua is a registered trademark of Paddock Laboratories Inc.and is used under licence by Alliance Pharmaceuticals Limited.

This leaflet was last revised December 2014

For oral or gastroenteral administration in the emergency treatment of poisoning.

This product contains sucrose, propylene glycol and glycerol.

Shake well before use.

Keep out of reach and sight of children.

Store at 15 - 30 °C. Do not refrigerate.

See leaflet for further information.

MA Holder: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK.

PL 16853/0119    ___

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