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Cafcol

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Document: leaflet MAH BRAND_PL 33414-0017 change

PATIENT INFORMATION LEAFLET

CAFCOL

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF CAFCOL IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION

What is in your medicine?

The name of this medicine is CAFCOL and it contains the active ingredient Chloramphenicol. It is available as a white opaque capsule in a strength of 250 mg.

CAFCOL capsules also contain pregelatinised maize starch, sodium starch glycollate, magnesium stearate, gelatin and titanium dioxide.

CAFCOL Capsules are available in pots of 100 and 500.

How does CAFCOL work?

CAFCOL belongs to a group of medicines known as antibiotics and which are used for the treatment of infections.

If you are not sure why you are being prescribed CAFCOL, then please ask you doctor.

The Manufacturer is: DDSA Pharmaceuticals Ltd., Chatfield Road, off York Road, London SW11 3SE.

The Product Licence holder is: Chelonia Healthcare Limited 11 Boumpoulinas Street, 3rd Floor, 1060 Nicosia, Cyprus

What is CAFCOL for?

CAFCOL is reserved for the treatment of infections caused by haemophilus influenzae and typhoid fever.

Check before you take CAFCOL

Before taking this medicine tell your doctor if you have ever had any unusual or allergic reactions to Chloramphenicol or any of the other ingredients of CAFCOL, or any other antibiotic.

Also tell your doctor or pharmacist if you are allergic to any other substances such as foods, preservatives or dyes.

Do not use CAFCOL if you are pregnant, or likely to become pregnant, unless your doctor considers it essential. Tell your doctor or pharmacist if you are breast feeding. The presence of other medical problems may affect the use of this medicine.

Make sure, therefore, to tell your doctor if you have any other medical problems, especially a history of:

•    Liver disease

•    Kidney disease

•    Any form of anaemia, for example depression of white blood cells, depression of blood cells known as thrombocytes. Depression of bone marrow causing a condition known as aplastic anaemia.

Can you take CAFCOL with other medicines?

You can take CAFCOL with other medicines, but it is important to tell your doctor or pharmacist about all the medicines which you are taking, whether prescribed by your doctor or bought without a prescription from the pharmacy or elsewhere.

The following medicines may interact with CAFCOL:

•    Paracetamol

•    Rifampicin (another antibiotic)

•    Coumarin anticoagulants (blood thinners)

•    Sulphonylureas (for diabetes)

•    Phenytoin and phenobarbital (for epilepsy)

•    Ciclosporin and tacrolimus (cancer drugs)

Use in pregnancy and lactation

Do not use during pregnancy unless your doctor considers it imperative. Do not use during breast feeding.

When and how to take CAFCOL

Adults and elderly: 500 mg (2 capsules) every 6 hours to be taken by mouth.

Children: Not recommended excepting for meningitis known as pyogenic meningitis when the dosage is 50-100 mg per kg bodyweight taken every 6 hours.

Take this medicine by mouth and only in the doses prescribed by your doctor. Do not take more of it, and do not take it more often or for a longer time than your doctor ordered.

What to do if too many capsules are taken at the same time

If you accidentally take more capsules than recommended, then contact your doctor or nearest hospital casualty department at once, taking the medicine with you to show the doctor

What to do if you miss a dose

If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not take two doses at once.

If at any time you feel that this medicine is not working as well as you would expect do not increase the dose, instead check with your doctor.

What side effects can CAFCOL have?

Along with its needed effects the medicine may cause some unwanted effects such as depression of the bone marrow and certain blood conditions recognised by a sore throat and bruising, yellowing of the skin and whites of the eyes (jaundice). Inflammation of the nerves in the arms and legs, inflammation of the mouth and tongue, inflammation of the gut,

inflammation of the nerves of the eyes, nausea, vomiting, diarrhoea. Because of the various blood conditions that may be caused by Chloramphenicol, it is essential that periodic blood counts be undertaken during treatment.

Storing your medicine

You must keep the medicine in a safe place where children cannot get it. Your medicine could harm them.

Store you medicine below 25°C, in a dry place. Keep the container closed.

On the label you will find the words "Expiry Date" followed by numbers indicating the day, month and year. This is the date when the medicine is no longer fit for use. Do not use the medicine after this date, but return it to your doctor or pharmacist.

A reminder

REMEMBER this medicine is for you. Never give it to someone else, even if their symptoms are the same as yours.

This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.

Product Licence number PL 33414/0017.

This leaflet was revised in November 2008.