Mitoxantrone (Mitozantrone) 2 mg / ml Sterile Concentrate Mitoxantrone (Mitozantrone) (Hospira UK Ltd)

This leaflet contains important information about your medicine; read it carefully.

Keep this leaflet; you may want to read it again.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

MITOXANTRONE (MITOZANTRONE) 2 mg/ml STERILE CONCENTRATE

• The active substance is mitoxantrone hydrochloride


• The other ingredients are acetic acid, sodium acetate, sodium chloride, sodium metabisulphite (E223) and Water for Injections.

The manufacturer and marketing authorisation holder is

Faulding Pharmaceuticals Plc

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

United Kingdom

What Mitoxantrone Sterile Concentrate is and what it is used for

Mitoxantrone Sterile Concentrate is an anti-cancer medicine, in the form of a concentrate for solution for infusion (concentrated solution which is diluted to make a solution which can be given as a slow injection via a drip). Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.

The medicine is presented in glass containers called vials. Each millilitre (ml) of Mitoxantrone Sterile Concentrate contains 2 milligrams (mg) of mitoxantrone hydrochloride. Each 10 ml vial contains 20 mg of mitoxantrone hydrochloride. It is available in packs containing 1 vial.

Mitoxantrone Sterile Concentrate is used in the treatment of a number of different types of cancer such as breast cancer, liver cancer and leukaemia.

Before Mitoxantrone Sterile Concentrate is used

Mitoxantrone Sterile Concentrate should not be used:

• if you have shown signs of hypersensitivity (severe allergy) to mitoxantrone hydrochloride or similar drugs on previous occasions


• if you are pregnant or trying to become pregnant


• if you are breast feeding

Special care will be taken:

• if you are already receiving treatment for breast cancer


• if you have myelosuppression (your bone marrow is not working properly)


• if your body condition is poor


• if you have certain heart problems


• if you have liver disease


• you are to have radiotherapy or any other anti-cancer medicines

Do not drive or use machines:

• if you feel drowsy


• if you experience any other effect which may impair your ability to drive or use machines

Important information about one of the ingredients of Mitoxantrone Sterile Concentrate:

This medicine contains sodium metabisulphite, which can cause an allergic type reaction (skin rash, swelling of eyelids, face or lips, or difficulty in breathing). This is rare but you may be more at risk if you suffer from allergies or asthma.

During treatment with Mitoxantrone Sterile Concentrate:

Please tell your doctor if you are taking, or have recently taken, any other medicines, including ones you have bought yourself.

Vaccinations are not recommended whilst you are undergoing treatment with Mitoxantrone Sterile Concentrate.

Men and women undergoing treatment with Mitoxantrone Sterile Concentrate should use effective contraception during treatment and for at least 6 months after treatment has stopped.

How Mitoxantrone Sterile Concentrate is used

The dose of medicine given to you and how often you are given it will depend upon your medical condition, whether other drugs are being used at the same time, the general state of your health and your body surface area. Your doctor will be able to explain exactly what drugs you will be given and when.

This medicine will be diluted with a solution such as sodium chloride 0.9% before it is given to you. It will be given to you as a slow injection via a drip into a vein.

During treatment blood samples may be taken and heart tests performed.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell you doctor or pharmacist if you have any concerns.

Possible side effects.

Like all medicines Mitoxantrone Sterile Concentrate can have side effects.

If any of the following happen, tell the doctor immediately:

• breathing difficulties


• chest pain


• severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.

These are very serious side effects. You may need urgent medical attention. All of these very serious side effects are rare.

If you experience any of the following tell your doctor as soon as possible:

• weakness, fatigue


• fever


• nausea and vomiting


• inflammation of lining of your mouth or nasal passages


• loss of hair, this should grow back when your treatment has finished


• skin rash


• your skin and nails may become pigmented (paler or darker patches)


• loosening of the nails


• the whites of the eye temporarily turning blue in colour


• conjunctivitis (inflammation of the eye)


• shortness of breath


• diarrhoea, constipation, severe weight loss, black stools or blood in your urine or stools


• stomach pain


• changes to the way food and drink tastes


• women may find that their periods will stop


• confusion, sleepiness, anxiety


• swelling or soreness where the injection was given


• pins and needles

Please note that your urine may turn a blue-green colour for up to 24 hours after your medicine has been given, this is an expected reaction.

Alterations in the blood may also occur – your doctor will monitor for these (low white cells and, less frequently, anaemia and/or low platelets, abnormal levels of uric acid, calcium, potassium and phosphate). Alteration in your liver enzymes or kidney function will also be monitored.

If you notice any side-effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Storing Mitoxantrone Sterile Concentrate

Keep out of reach of children

Do not store above 25°C. Do not refrigerate or freeze

Do not use after the expiry date printed on the carton and vial label

Date of preparation

24^th January, 2002