teva UK Ref: 231-30-87840-C HANGER CHARCODOTE ORAL SUS 250ML PLIVA	Version: 4	23 June 2015

PACKAGE LEAFLET: INFORMATION FORTHE USER

Cuuicudwe (Activated Charcoal)

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

•    Keep this leaflet. You may need to read it again

•    If you have any further questions, ask your doctor or pharmacist

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What Charcodote is and what it is used for

2.    Before you are given Charcodote

3.    How you are given Charcodote 4 Possible side effects

5.    How to store Charcodote

6.    Further information

Q What Charcodote is and what it is used for

Charcodote is suspension containing the active ingredient activated charcoal. Charcodote is taken by mouth as an emergency antidote for the treatment of poisoning or drug overdose. It can be used either before or after gastric lavage (stomach pump). Charcodote adsorbs toxic substances and reduces or prevents them entering the bloodstream.

Q Before you are given Charcodote Anyone can be given Charcodote.

Take special care with Charcodote (and tell your doctor) if:

•    you have been poisoned by caustic (such as bleach) or corrosive (such as acid) substances. Charcodote is not very effective for these substances and may make damage to the oesophagus (gullet) difficult to see

•    you have been poisoned by any of the following: cyanide, lithium salts, ethanol, methanol, ethylene glycol, iron salts, salt, lead, boric acid, other mineral acids and

petrol. Charcodote is not very effective for these substances

•    you have taken another oral antidote, e.g. methionine for paracetamol poisoning; Charcodote will reduce the effectiveness of this antidote

Precaution should be taken to prevent inhalation of Charcodote as it may damage the lungs.

Charcodote should only be given to unconscious patients if they have an endotracheal tube in place (a flexible tube that protects the airway).

Taking other medicines Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. This is especially important of the following substances as they may interact with your Charcodote:

•    Ipecac syrup: Charcodote should not be used at the same time as ipecac syrup (a substance used to cause vomiting) because Charcodote will prevent the ipecac syrup from working. If ipecac syrup and Charcodote are used, Charcodote should only be given after vomiting has finished

It may still be all right for you to be given Charcodote and your doctor will be able to decide what is suitable for you.

Taking Charcodote with food and drink Ice cream or other foods should not be mixed with Charcodote because they will reduce its effectiveness.

Pregnancy and breast-feeding There is no reason why Charcodote cannot be used in pregnany or breast-feeding women. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines Charcodote should not affect your ability to drive or operate machines.

TEVA UK Ref: 231-30-87840-C HANGER CHARCODOTE ORAL SUS 250ML PLIVA	Version: 3	19 June 2015

0 How you are given Charcodote

Dosage

Charcodote is given by mouth. The usual dose for adults is one bottle (250 ml; 50 g activated charcoal) as soon as possible after poisoning or suspected poisoning. Charcodote can also be given after vomiting or gastric lavage (stomach pump). Your doctor may repeat the treatment.

The usual dose for children under 12 years is half of one bottle (125 ml; 25 g of activated charcoal) unless a large amount of poison has been taken and there is a risk of death.

Duration of treatment The treatment may be repeated every four hours for poisoning with the following substances: phenobarbital, carbamazepine (treatments for epilepsy) theophylline (for asthma), quinine (for malaria or muscle cramps), dapsone (for leprosy and skin infections) or salicylate (for skin conditions) when it is possible to monitor the patient.

If you believe you have received more Charcodote than you should Charcodote will be given to you by a doctor or nurse who is familiar with this type of treatment. If you have any questions about the amount of medicine you have been given or any other questions about your treatment, please ask you doctor or nurse for more information.

0 Possible side effects

Like all medicines, Charcodote can cause side effects, although not everybody gets them. The following side effects have been reported:

•    bezoar formation (a ball of material in the stomach that is not passed out)

•    intestinal obstruction (blockage of the digestive system)

•    intestinal perforation (a hole in the digestive tract) after several treatments (rare)

Charcodote will colour stools black, which is harmless.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

0 How to store Charcodote

Do not store above 25 °C. Do not freeze. Use immediately upon opening.

Any remaining unused Charcodote should be discarded after the first use.

Keep Charcodote out of the reach and sight of children.

Do not use Charcodote after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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.

0 Further information

What Charcodote contains:

The active substance is activated charcoal 200 mg/ml

The other ingredient is purified water.

What Charcodote looks like and contents of the pack

Plastic bottles with screw cap. Each bottle contains 250 ml (50 g activated charcoal). Marketing Authorisation Holder Teva UK Limited, Eastbourne, BN22 9AG. Manufacturer:

Cabot Norit Nederland B.V.,

Mr. Ovingkanaal O.Z.3,

7891 EV Klazienaveen,

The Netherlands.

This leaflet was last revised in June 2015 PL 00289/1489    1    l/| I®

Teva Pharmaceuticals Europe B.V 1.3.2 mockup-pil-uk-pl-00289-1489-charcodote-200mg-ml-suspension

Approvals

Signed by	Meaning of Signature	Server Date
Vivekananda Bhatlapenumar	Regulatory Affairs Approval	24-Jun-2015 08:41:20 PM

REG0046883 Version 1.4 Approved Page 3 of 3