Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I being given Pharmorubicin RD?
Pharmorubicin RD contains the active ingredient epirubicin hydrochloride. Pharmorubicin
RD is used to treat different types of cancers. It may be used alone or with other
medicines.
2. What should I know before I am given Pharmorubicin RD?
You should not be given this medicine if you have ever had an allergic reaction to
Pharmorubicin RD, other medicines to treat cancer or any of the ingredients listed
at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Pharmorubicin RD and affect how it works.
4. How is Pharmorubicin RD given?
Pharmorubicin RD is usually given as a slow injection or a drip (infusion) into a
vein. It might also be injected into the bladder. It must only be given by a doctor
or nurse. Your doctor will decide what dose, how often and how long you will receive
it. More instructions can be found in Section
4. How is Pharmorubicin RD given? in the full CMI.
5. What should I know while being given Pharmorubicin RD?
|
Things you should do
|
Do not drink fluids for 12 hours before treatment if Pharmorubicin RD is to be used
in the bladder.
Tell your doctor or nurse immediately if the injection stings or hurts while it is
being given.
Remind any doctor or dentist you visit that you are being given Pharmorubicin RD powder
for injection.
Tell your doctor immediately if you become pregnant while being treated with Pharmorubicin
RD. If you have the potential to fall pregnant, you must use effective contraception
during treatment. If you are male and your partner has the potential to fall pregnant,
you must use effective contraception during your treatment.
Tell your doctor if you experience any signs of infection, such as sinusitis, tooth
abscess, sore red mouth, fever, sore throat, unusual bleeding or bruising, swollen
joints, nausea, vomiting, especially if it lasts for 24 to 48 hours.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how Pharmorubicin RD affects
you. It may make some people feel tired or dizzy.
|
6. Are there any side effects?
Common side effects of this medicine may include: 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 and gout.
Active ingredient(s): epirubicin hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Pharmorubicin RD. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Pharmorubicin RD.
Where to find information in this leaflet:
1. Why am I being given Pharmorubicin RD?
Pharmorubicin RD contains the active ingredient epirubicin hydrochloride and belongs
to a group of anticancer medicines known as cytotoxic anthracycline antibiotics.
Epirubicin hydrochloride works by stopping cancer cells from growing and multiplying.
It is used to treat many types of cancers.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
2. What should I know before I am given Pharmorubicin RD?
Warnings
You should not be given Pharmorubicin RD if:
you are allergic to medicines from the same group (anthracyclines or anthracenediones)
you have an allergy to epirubicin or any of the ingredients listed at the end of this
leaflet
you have a low blood count following chemotherapy or radiotherapy
you have sore, red mouth from previous treatment or radiation therapy
you have an infection
you have severe liver problems
you have heart disease or heart problems, have recently had a heart attack or experienced
chest pain or have a severe form of irregular heartbeats (arrhythmia)
if you have previously received the total permissible dose of epirubicin or another
medicine from the anthracycline group.
You should not be given Pharmorubicin RD 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.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
You should not be given this medicine if you or your partner are pregnant or planning
to become pregnant.
You should not be given this medicine if you are breastfeeding or plan to breastfeed.
It is not known whether epirubicin passes into breast milk. Therefore, breastfeeding
is not recommended during treatment with epirubicin.
Contraception
Use contraception (birth control) to prevent pregnancy while you or your partner are
being treated with Pharmorubicin RD.
Women of childbearing potential should use effective contraception during treatment
with epirubicin and for at least 28 weeks after the final dose. Male patients being
treated with epirubicin must use effective contraception during treatment and for
at least 14 weeks after the final dose if your partner is of childbearing potential.
You should seek advice on fertility preservation before treatment.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and epirubicin may interfere with each other. These include:
medicines used to treat 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
propranolol.
cimetidine (a medicine used to treat heartburn or stomach ulcers).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect
Pharmorubicin RD.
4. How is Pharmorubicin RD given?
How much and how long is it given
Pharmorubicin RD is given in a clinical setting (e.g. hospital) by a nurse or doctor.
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 what dose, how often and how long you will receive it. This
depends on your condition and other factors, such as your weight and height, age,
blood tests, how well your liver is working and whether or not other medicines are
being given at the same time.
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 too much Pharmorubicin RD is given
Since Pharmorubicin RD is given in a hospital or clinic under the supervision of a
doctor, it is very unlikely that you will be given too much of the medicine. Your
doctor or nurse will be monitoring your progress and checking the medicine that you
are given.
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.
5. What should I know while being given Pharmorubicin RD?
Things you should 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.
Tell your doctor immediately if you become pregnant while being treated with 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 are having or have had radiotherapy.
Tell your doctor if you are having or have had treatment with other anticancer medicines.
Tell your doctor if you have liver problems or kidney problems.
You should not be given this medicine if you have severe liver or kidney problems.
Your doctor may need to monitor your liver or kidney function and adjust the epirubicin
dose if necessary.
Tell your doctor if you have or have had heart disease or have high blood pressure.
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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Pharmorubicin
RD affects you.
Pharmorubicin RD may make some people feel tired or dizzy.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Leukaemia may occur after treatment with Pharmorubicin RD and other medicines to treat
cancer. It is rare.
Do not be alarmed by this list of possible side effects.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Pharmorubicin RD contains
|
Active ingredient
(main ingredient)
|
Epirubicin hydrochloride
|
|
Other ingredients
(inactive ingredients)
|
lactose
methyl hydroxybenzoate
|
Do not take this medicine if you are allergic to any of these ingredients.
What Pharmorubicin RD looks like
Pharmorubicin RD is a red-orange powder in a clear glass vial
Australian Registration Numbers
50 mg per vial - AUST R 40220
Who distributes Pharmorubicin RD
Pfizer Australia Pty Ltd
SYDNEY, NSW.
Toll Free Number: 1800 675 229.
This leaflet was prepared in November 2024