Daunorubicin (sanofi-aventis)

DAUNORUBICIN 20MG POWDER FOR I.V. INJECTION

daunorubicin hydrochloride

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 nurse



• 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 any of the side effects gets serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist



• Your doctor may have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect

In this leaflet:

• 1. What daunorubicin is and what it is used for


• 2. Before you are given daunorubicin


• 3. How you will be given daunorubicin


• 4. Possible side effects


• 5. How to store daunorubicin


• 6. Further information

What Daunorubicin Is And What It Is Used For

The name of your medicine is Daunorubicin 20mg Powder for I.V. Injection (called daunorubicin in this leaflet). It belongs to a group of medicines used to treat acute leukaemia.

Daunorubicin works by attacking and destroying the abnormal white blood cells which are present in a person with leukaemia.

Information about Leukaemia

Leukaemia is the name for a number of diseases of the white blood cells, which form part of your blood. These cells are produced in your bone marrow. In leukaemia, the white blood cells multiply in an uncontrolled and abnormal way.

The most common signs of leukaemia are:

• Increased number of white cells in the blood. This causes easy bruising and nose bleeds


• Feeling tired, faint, dizzy, having pale skin. These could be symptoms of anaemia


• Extreme tiredness (exhaustion), and headaches


• Bone and joint pain


• Severe infection and fever

Before You Are Given Daunorubicin

Before treatment, you should discuss the risks and benefits of this medicine with your doctor.

Do not have daunorubicin if:

• You are sensitive to or allergic to daunorubicin or any of the other ingredients of daunorubicin
  (listed in Section 6 below)
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue




• You have chicken pox or shingles, or you have been in recent contact with anyone who has chicken pox or shingles


• You have an infection, fever or high temperature


• You have any heart problems


• You are pregnant or breast-feeding


• You have a lot of mouth ulcers

Do not have daunorubicin if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist.

Take special care with daunorubicin

Check with your doctor, nurse or pharmacist before you are given daunorubicin if:

• You have had radiation treatment to the chest


• You have had any other medicines to treat leukaemia (or cancer)


• You have or have ever had gout


• You have or have ever had kidney stones or any other kidney problems


• You have any liver problems

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before being given daunorubicin.

Pregnancy and breast-feeding

Do not have daunorubicin if:

• You are pregnant, might become pregnant or think you might be pregnant


• You are breast-feeding or planning to breast-feed

Ask your doctor, nurse or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.

Driving and using machines

There is no information available about how daunorubicin might affect your ability to drive or use machines.

How You Will Be Given Daunorubicin

How daunorubicin is given

• Daunorubicin is a medicine used in hospitals


• It will be given to you by a doctor or nurse as an injection into one of your veins


• It will be given over about 20 minutes (this is called an intravenous infusion)


• It should never be given as a single injection under the skin or into a muscle


• The site of injection should not be covered or bandaged

Tell your doctor or nurse straight away if:

• You have any pain, swelling or warmth around the vein where daunorubicin is being injected



• You notice that your face is red while the injection is being given to you. This may be a sign that the injection is being given too quickly

How much daunorubicin will be given

• The exact dose will be determined by your doctor. It will depend on your age, height, weight and your general medical condition. The usual dose for a person weighing 70kg (12 stone) would be about 80mg



• Your course of treatment may be altered, depending on how your body reacts to the medicine



• Daunorubicin may be given alone or in combination with other medicines to treat or prevent side effects

Tests while having daunorubicin

Your condition will be closely monitored during treatment. This may involve blood, urine tests or heart monitoring (called ECG).

If you have any questions about your course of treatment ask your doctor, pharmacist or nurse.

Daunorubicin (sanofi-aventis) Side Effects

Like all medicines, daunorubicin can cause side effects, although not everybody who is given this medicine will be affected in the same way. If you are worried about side effects you should discuss them with your doctor, who will explain the risks and benefits of your treatment.

Some of the side effects can be lessened or treated by other medicines or therapy.

Tell your doctor, nurse or pharmacist straight away if:

• You have pain, swelling or warmth in or around the vein where daunorubicin is being injected



• You have a red face while daunorubicin is being injected. This may be a sign that the injection is being given too quickly



• You get fevers, chills or other signs of infection



• You have difficulty in breathing



• You have swelling of the feet or legs



• You have an uneven or fast heart beat



• You have black or tarry bowel motions



• You are being sick (vomiting) and bring up blood or dark brown coffee-coloured granules



• You notice any unusual bleeding or bruising

Tell your doctor, nurse or pharmacist if you notice any of the following side effects:

• You feel sick (nausea) or are sick (vomit)


• You have diarrhoea


• You have a skin rash


• You have sores in the mouth or on the lips

Other side effects include:

• Daunorubicin can make your urine turn red for a couple of days after each dose



• Medicines like daunorubicin often cause temporary loss of hair. After your treatment finishes your hair should grow back

Tell your doctor, nurse or pharmacist if any of the side effects gets serious, lasts longer than a few days, or if you notice any side effects not listed in the leaflet.

After stopping treatment

After you have finished your course of treatment, you may still get side effects. Tell your doctor, nurse or pharmacist straightaway if:

• You have difficulty in breathing


• You have swelling of the feet or legs


• You get an uneven or fast heart beat

How To Store Daunorubicin

• Keep this medicine in a safe place out of the reach and sight of children.



• Daunorubicin should not be used after the expiry date which is stated on the carton. The
  expiry date refers to the last day of the month.



• The vials of powder should be kept at room temperature and protected from light.



• The daunorubicin solutions made up from the powder should be stored at between 2 - 8°C, protected from light and used within 24 hours.



• Following the injection, daunorubicin will be disposed of carefully by the doctor or nurse.



• Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Daunorubicin 20mg Powder for I.V. Injection contains

The active ingredient is daunorubicin hydrochloride. Each vial contains 20mg of daunorubicin.

Each vial also contains mannitol.

What Daunorubicin 20mg Powder for I.V. Injection looks like and contents of the pack

Daunorubicin 20mg Powder for I.V. Injection comes as a vial containing a red powder. The solution prepared with this powder is also red.

The vials are available in packs of 1 and 10 vials.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder

Winthrop Pharmaceuticals

PO Box 611

GU1 4YS

UK

Manufacturer

Laboratories Thissen S.A.

Braine-l’Alleude

Belgium

This leaflet was last revised in September 2007.

Winthrop is a registered trademark.

© 2007 Winthrop Pharmaceuticals.