Pharmorubicin

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Epirubicin hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Pharmorubicin RD.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of using Pharmorubicin RD against the benefits it is expected to have for you.

If you have any concerns about this medicine, ask your doctor or pharmacist.

Keep this leaflet.

You may need to read it again.

What Pharmorubicin RD is used for

Pharmorubicin RD is used in the treatment of various types of cancer. It may be used alone or with other medicines.

Ask your doctor if you have any questions about why Pharmorubicin RD has been prescribed for you.

Your doctor may have prescribed it for another purpose.

Pharmorubicin RD is only available with a doctor's prescription. It is not addictive.

Before you are given Pharmorubicin RD

When you must not be given it

Do not use Pharmorubicin RD if you have ever had an allergic reaction to epirubicin (the active ingredient in Pharmorubicin RD), other medicines to treat cancer or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Do not use the medicine for injection into a vein if you have:

a low number of red blood cells, white blood cells or platelets in your blood

sore, red mouth from previous treatment or radiation therapy

an infection

severe liver problems

heart problems or have ever had heart problems

already received the highest dose allowed for medicines such as mitozantrone, mitomycin C, doxorubicin or daunorubicin.

Do not use the medicine for injection into the bladder if you have:

cancer that has gone into the bladder wall

kidney or urinary tract infection

swollen or inflamed bladder

problems with a catheter (a tube in your bladder)

blood in the urine.

Do not use Pharmorubicin RD if you are pregnant.

Pharmorubicin RD may harm the unborn child.

Do not use Pharmorubicin RD if you are breastfeeding.

You should not breastfeed while taking Pharmorubicin RD.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

Before you are given it

You must tell your doctor if you:

have heart problems or have ever had heart problems

have liver problems

have kidney problems

have had radiation therapy previously or are having radiation therapy

have been treated previously with medicines to treat cancer

you are going to be vaccinated (have an injection to prevent a certain disease)

are planning to have children.

Pharmorubicin RD may decrease the fertility of men and women. You should seek advice from your doctor on preserving fertility before starting treatment with Pharmorubicin RD.

If you have not told your doctor about any of the above, tell your doctor before you start using Pharmorubicin RD.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Pharmorubicin RD may interfere with each other. These include:

medicines used to treatment cancer such as:

5-fluorouracil

cyclophosphamide

cisplatin

paclitaxel

docetaxel

trastuzumab

other medicines to treat cancer.

medicines used to treat angina or high blood pressure such as:

nifedipine

verapamil

diltiazem

felodipine

amlodipine

lercanidipine

propranolol.

cimetidine ( a medicine used to treat heartburn or stomach ulcers).

You may need to take different amounts of your medicines or you may need to use different medicines. Your doctor will advise you.

How Pharmorubicin RD is given

Treatment will normally take place in a hospital. Pharmorubicin RD is usually given as a slow injection or a drip (infusion) into a vein. It might also be injected into the bladder.

Do not drink fluids for 12 hours before treatment if Pharmorubicin RD is to be used in the bladder.

Pharmorubicin RD may be given alone or in combination with other medicines.

Your doctor will decide the dose of Pharmorubicin RD to be given. Treatment is usually given every 3 to 4 weeks, in cycles of therapy. However, your doctor may give Pharmorubicin RD more or less frequently.

Treatment will not be repeated until your blood counts have returned to acceptable levels and any unwanted effects have been controlled.

Your doctor may change your dose during treatment.

Your doctor will let you know how many cycles of treatment you will need.

Ask your doctor if you have any questions about the dose of Pharmorubicin RD and how it is given.

If you are given too much (overdose)

As Pharmorubicin RD is likely to be given to you in hospital under the supervision of a doctor, it is unlikely that you will receive too much.

However, immediately tell your doctor or telephone the Poisons Information Centre on 13 11 26 for advice, or go to Accident and Emergency at your nearest hospital if you have side effects after being given Pharmorubicin RD.

You may need urgent medical attention.

Symptoms of overdose with Pharmorubicin RD include the side effects below in the 'Side Effects' section, but they are usually of a more severe nature.

While you are using Pharmorubicin RD

Things you must do

Tell your doctor or nurse immediately if the injection stings or hurts while it is being given.

The injection may need to be stopped and injected into a different vein.

Make sure you follow your doctor's instructions and keep all appointments.

Your doctor will regularly check the function of your heart, liver and kidneys. You will also need to have blood tests.

Use contraception (birth control) to prevent pregnancy while you or your partner are being treated with Pharmorubicin RD.

Pharmorubicin RD may cause birth defects if either the male or female is being treated with Pharmorubicin RD. Men being treated with Pharmorubicin RD must use effective contraceptive methods during treatment and for at least 3.5 months after treatment. Women being treated with Pharmorubicin RD must use effective contraceptive methods during treatment with Pharmorubicin RD and at least 6.5 months after treatment.

Tell your doctor immediately if you become pregnant while taking Pharmorubicin RD.

Tell your doctor if you have an infection or fever.

Pharmorubicin RD lowers your ability to fight infection.

Tell your doctor if you would like to take medicine to prevent or treat nausea (feeling sick) or vomiting.

Pharmorubicin RD may cause nausea and vomiting,

Tell any doctor, dentist or pharmacist who treats you that you are being treated with Pharmorubicin RD.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are being treated with Pharmorubicin RD.

Things to be careful of

Be careful driving, operating machinery or doing jobs that require you to be alert, until you know how Pharmorubicin RD affects you.

PHARMORUBICIN RD may make some people feel tired or dizzy.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are being treated with Pharmorubicin RD.

All medicines can have unwanted side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Medicines can affect people in different ways.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

nausea (feeling sick) or vomiting

diarrhoea

sore mouth or tongue, mouth ulcers, redness of mouth, sore vagina or rectum

redness of the skin or vein at the site of the injection

hair loss, beard stops growing

dehydration (thirsty, dry mouth, dry skin, loss of body fluid)

sore oesophagus (food pipe), pain on swallowing or difficulty with swallowing

stomach pain or burning feeling in stomach

skin rash, itchy skin, hives, sensitive skin, blisters

change in colour of skin or nails

increased sensitivity to the sun

itchy eye, crusty eyelid, sore red eye, blurred vision, conjunctivitis

loss of appetite

absence of menstrual bleeding (temporary loss of periods)

hot flushes

weakness, tiredness, dizziness, confusion, depression

tingling or numbness of hands or feet; pins and needles

gout

red coloured urine.

Pharmorubicin RD is red and may cause the urine to be a red colour for one or two days after treatment. There is no cause for alarm.

Tell your doctor immediately if you get any of the following side effects:

stinging, swelling or pain at the site of injection

flushing of face while the injection is being given

an infection or chills, fever, sore throat, swollen glands, shock

heart problems, fast or irregular heartbeat, shortness of breath

swelling of ankles, feet, legs or hands

bleeding or bruising under the skin

cough, difficulty breathing, chest pain, coughing up blood

swelling, pain, tenderness and redness of the leg.

The above side effects may be serious. You may need urgent medical attention.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above, such as leukaemia, may also occur in some patients.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After using Pharmorubicin RD

Tell your doctor immediately if you notice any of the following side effects, even if they occur several months or years after stopping treatment with Pharmorubicin RD:

heart problems, fast or irregular heartbeat, shortness of breath

swelling of ankles, feet, legs or hands, swelling in the stomach

fever or other signs of infection.

Leukaemia may occur after treatment with Pharmorubicin RD and other medicines to treat cancer. It is rare.