• 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 signs of illness are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

1. What Epirubicin is and what it is used for
2. What you need to know before you use Epirubicin
3. How to use Epirubicin
4. Possible side effects
5. How to store Epirubicin
6. Contents of the pack and other information

• if you are allergic (hypersensitive) to epirubicin, similar medicines (called anthracyclines or anthracenediones - see below) or any of the other ingredients of Epirubicin hydrochloride 2 mg/ml, solution for injection (listed in section 6)
• if you have been treated with high doses of some other anticancer drugs including doxorubicin and daunorubicin which belong to the same group of drugs as epirubicin (called anthracyclines and anthracenediones). They have similar side-effects (including those effects on the heart)
• if you have suffered or are currently suffering heart problems
• if you are breast-feeding
• if you have a low blood count. Your doctor will check this
• if you are suffering from severe liver impairment
• if you have an acute severe infection
• if you have pain and swelling of the lining of the mouth or digestive system (mucositis)

When administered intravesically (directly into the bladder), epirubicin solution for injection/intravesical use should not be used if:

• the cancer has penetrated the bladder wall
• you have an infection in your urinary tract
• you have pain or inflammation in your bladder
• your doctor has problems inserting a catheter (tube) into your bladder
• there is blood in your urine
• you have a large amount of urine left in your bladder after emptying it
• you have a contracted bladder

Talk to your doctor or pharmacist before using Epirubicin:

• if you are elderly because of the higher risk of serious cardiovascular side effects. The way your heart is working will be studied before and after treatment with epirubicin
• if you have a history of heart problems or are suffering from heart problems. Tell your doctor as your epirubicin dose may need to be adjusted. Your doctor will check this regularly
• if you have been previously treated with anticancer drugs, or if you have received radiotherapy as the risk of cardiovascular side effects are greater. This can have an impact on the dosing of epirubicin
• if you have liver or kidney disease as this may increase the risk of side effects
• if you suffer from infections or bleeding. Epirubicin may affect the bone marrow. The number of white blood cells in your blood will be reduced, making you more susceptible to infections (leukopenia). Bleeding can occur more easily (thrombocytopenia).These side effects are transient. Reduction of white blood cell count is highest 10-14 days after administration and usually return to normal 21 days after administration
• if you have recently had or plan to have a vaccination
• if you have severe inflammation or sores in your mouth
• if you have received or will receive radiotherapy on the chest area
• if you notice a burning sensation of discomfort redness, pain or swelling close to or at the place of injection during the infusion (possible leakage of epirubicin into the surrounding tissue). Tell your doctor immediately.

During treatment your doctor will be making regular checks of your:

• Blood - to check for low blood cell counts that may need treatment
• Heart function - heart damage can occur when high doses of epirubicin are given. This may not be detected for several weeks, so regular tests may be required during this period
• Liver - using blood tests to check that this medicine is not affecting the way it functions in a harmful way
• Blood uric acid levels - epirubicin may increase uric acid levels in the blood which might cause gout. Another medicine may be given if your uric acid levels are too high

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:

• other medicines that may affect the bone marrow for example, other cancer treatments, sulphonamide, chloramphenicol (used to treat infection), diphenylhydantoin (used to treat epilepsy), amidopyrine-derivative (used to relieve pain), antiretroviral agents (used to treat HIV infection) may alter the formation of blood cells
• paclitaxel and docetaxel (drugs used in some cancers)
• dexverapamil (a drug used to treat some heart conditions), when used in combination with epirubicin can have a negative effect on bone marrow
• interferon alpha-2b (a drug used in some cancers and lymphomas and for some forms of hepatitis)
• quinine (drug used for treatment of malaria and for leg cramps), can increase the distribution of epirubicin in the body, which may have a negative effects on the red blood cells
• dexrazoxane (a drug sometimes used with doxorubicin to reduce the risk of heart problems), the period which epirubicin is present in the body can be reduced, which may lead to the effect of epirubicin being reduced
• cimetidine (a medicine that reduces stomach acid), can make the effects of epirubicin stronger, which can lead to increased side effects.
• products that cause heart failure
• products that affect liver function, the metabolism of epirubicin may be affected, which may mean that efficacy is reduced, or that undesirable effects are increased
• live and attenuated vaccines, the response to vaccines may be reduced and leave you susceptible to infection

If you being given this medicine directly into your bladder (intravesical administration), you should not drink any fluid for 12 hours prior to dosing to avoid undue dilution with urine

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Epirubicin may cause births defects, so it is important to tell your doctor if you think you are pregnant. You must not use epirubicin during pregnancy unless clearly indicated by your doctor. Avoid becoming pregnant while you or your partner is taking epirubicin and for 6 months after treatment. If pregnancy occurs during treatment with Epirubicin, genetic counselling is recommended.

Lactation

You must discontinue breast-feeding before and during therapy with epirubicin.

Fertility

If you are sexually active, you are advised to use effective birth control to prevent pregnancy during treatment, whether you are male or female.

Epirubicin may cause premature menopause in premenopausal women.

Men who wish to father children in the future should seek advice about freezing sperm before treatment with epirubicin is started.

No studies on the effects on the ability to drive and use machines have been performed with epirubicin.

The medicine may be given directly into the bladder using a catheter. If this route is used, you should not drink any fluids for 12 hours before treatment so that your urine will not dilute the drug too much.

The dose will depend upon the type of bladder cancer.

The solution should be kept in your bladder for 1-2 hours after instillation. You will be rotated occasionally to ensure even exposure of all parts of the bladder to the drug.

Care should be taken to ensure that the contents of the bladder, when emptied, do not come into contact with the skin. In case of skin contact, thoroughly wash the affected area with soap and water but do not scrub.

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

Epirubicin needs to be given on a fixed schedule. Be sure to keep all appointments. If you miss a dose, you should discuss this with your doctor. Your doctor will decide when you should be given your next dose of epirubicin.

Stopping your treatment with epirubicin may stop the effect on tumour growth. Do not stop treatment with epirubicin unless you have discussed this with your doctor.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is 2 mg/ml epirubicin hydrochloride.
• The other ingredients are sodium chloride, water for injection and hydrochloric acid used as a pH adjuster.

A clear red solution for injection.

This medicinal product is available in glass packaging with a rubber stopper, called vials, with 10 mg (5 ml), 20mg (10 ml),50 mg (25 ml), 100 mg (50 ml) and 200 mg (100 ml) epirubicin hydrochloride.

Pack sizes:

Glass vials containing 5ml, 10ml, 25ml, 50ml and 100ml supplied in the following pack sizes:

1 x 5 ml,1 x 10 ml, 1 x 25 ml, 1 x 50 ml, 1 x100 ml.

Not all pack sizes may be marketed.