PATIENT INFORMATION LEAFLET

TAXOL™ CONCENTRATE

FOR INFUSION

Paclitaxel

This leaflet gives a summary of information about your medicine.

If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

Q. WHAT IS IN TAXOL CONCENTRATE FOR INFUSION?

A. Each 5ml vial contains 30mg of paclitaxel in a 6mg/ml solution. The other ingredients are dehydrated alcohol and polyethoxylated castor oil. Paclitaxel is a member of a group of compounds referred to as the taxanes, which are anti-cancer agents.

UK PRODUCT LICENCE: PL11184/0026

Held By: Bristol-Myers Squibb Pharmaceuticals Limited,

141 –149 Staines Road, Hounslow TW3 3JA

IRELAND PRODUCT AUTHORISATION: PA V59/1

Held By: Bristol-Myers Squibb Pharmaceuticals Limited,

Dublin, Ireland

MANUFACTURER

Bristol-Myers Squibb Company, Stz 7, Tr Rd 114, Km 3.1

Mayaguez, Puerto Rico 00708

Q. WHAT IS THIS MEDICINE FOR?

A. TAXOL is used to treat ovarian cancer which has not responded to treatment with a platinum-containing medicine.

TAXOL is also used to treat breast cancer in patients who have not responded to standard treatment using a medicine belonging to the group known as anthracyclines, or for whom such treatment should not be used.

BEFORE YOUR MEDICINE IS ADMINISTERED

Q. What should my doctor know before I receive TAXOL?

A. Tell your doctor if you are allergic to any of the ingredients in TAXOL or similar medicines as you should not receive TAXOL if you are. Your doctor should have checked that the results of your last blood test mean that you can receive your course of treatment. Also, make sure that your doctor knows if you have any liver disease, or if you are receiving treatment for fungal/ infections with a medicine containing ketoconazole.

Q. What if I am pregnant or think I might be pregnant ?

A. Make sure you tell your doctor immediately, as you should not receive TAXOL during pregnancy.

Q. What if I am breast feeding?

A. You should not breast feed while you are being treated with TAXOL. Do not restart breast feeding until your doctor tells you it is safe to do so.

Q. Can I take other medicines?

A. Not unless these have been discussed with your doctor or pharmacist. These include medicines bought at a pharmacy or elsewhere, e.g. supermarket.

Q. Is it all right to drive?

A. There is no reason why you cannot continue driving between courses of TAXOL but you should remember that this medicine contains some alcohol and it may be unwise to drive.

immediately after a course of treatment. As in all cases, you should not drive if you feel dizzy or lightheaded.

Q. Is it all right to drink alcohol?

A. There is no known interaction between TAXOL and alcohol. However, you should check with your doctor whether drinking is advisable for you.

ADMINISTRATION OF YOUR MEDICINE

Q. How is TAXOL given and what is the usual dose ?

A. TAXOL is given into a vein from an intravenous drip usually over about 3 hours. The dose you receive will be based on your body surface area and the result of blood tests carried out before treatment. The usual dose is 175mg/m2, body surface area.

Q. Will | need to receive any other medicine ?

A. You will be asked to take a steroid tablet 12 hours and 6 hours before receiving TAXOL. You will also be given two injections of different types of antihistamine approximately 30-60 minutes before you receive TAXOL.

Q. How often will I receive TAXOL ?

A. TAXOL is usually given every 3 weeks. This may vary, depending on the results of regular blood tests.

UNDESIRABLE EFFECTS

Q. Are there any unwanted effects of TAXOL ?

A. All medicines may cause some unwanted or "side" effects. The most common ones with TAXOL are: allergic reactions such as flushing, skin rash, dizziness, fast heart beat; abnormal heart beat; blood disorders (hence the need for regular blood tests); numbness, tingling and muscle pain; pain and swelling of the joints; hair loss; stomach upsets including sickness and diarrhoea; liver disorders; soreness of the mouth and tongue; swelling of the hands, feet and ankles; pain, inflammation and possibly skin discoloration at the site of injection. Most of these will occur during your treatment. If you notice any of these, or any other effects, between courses or after treatment has finished, tell your doctor.

LOOKING AFTER YOUR MEDICINE

This medicine will be stored in the pharmacy and made up in a special area before the doctor or nurse gives it to you.

DATE OF LAST REVISION

August 1995