Skip to Content

PHARMORUBICIN RAPID DISSOLUTION 10MG 20MG 50MG 150MG

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PATIENT INFORMATION LEAFLET
Pharmorubicin® Rapid Dissolution 10 mg, 20 mg, 50 mg and 150 mg
Powder for Solution for Injection for Infusion
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you personally and you should 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
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Pharmorubicin is and what it is used for
2. Before you are given Pharmorubicin
3. How Pharmorubicin is given to you
4. Possible side effects
5. How to store Pharmorubicin
6. Further information
1. What Pharmorubicin is and what it is used for
- Pharmorubicin is an injection that contains epirubicin hydrochloride. It belongs to a
group of medicines called cytotoxics used for chemotherapy. Pharmorubicin causes
cells that are actively growing, such as cancer cells to slow or stop their growth and
increases the likelihood that they die. This medicine helps to selectively kill the
cancer tissue rather than normal, healthy tissue.
- Pharmorubicin is used to treat a variety of cancers, either alone or in combination
with other drugs. The way in which it is used depends upon the type of cancer that is
being treated.
- It has been found to be particularly useful in the treatment of cancers of the breast,
ovaries, stomach, bowel and lung. In addition, this medicine can be given to treat
cancers of the blood forming tissues such as malignant lymphomas, leukaemias and
multiple myeloma.
- Pharmorubicin can also be put directly into the bladder through a tube. This is
sometimes used to treat abnormal cells or cancers of the bladder wall. It can be used
after other treatments to try and prevent such cells from growing again.

2. Before you are given Pharmorubicin
Do not use Pharmorubicin if you have:
- an allergy (hypersensitivity) to epirubicin or any of the other ingredients of
Pharmorubicin (a list of ingredients can be found in Section 6).
- low blood cell counts, as it can lower them further.
- previously been treated with Pharmorubicin or similar chemotherapy drugs as
previous treatment with these similar medicines can increase the risk of side effects
with this medicine.
- suffered from severe heart trouble in the past, or are presently receiving treatment
for this.
Take special care with Pharmorubicin:
Tell your doctor if:
- your liver or kidneys are not working properly.
- you have had or if you are due to have any vaccination
This will help your doctor decide if this medicine is suitable for you
Taking other medicines:
Please tell your doctor or pharmacist if you have recently taken any other medicines,
even those not prescribed, particularly the following:
- Cimetidine (a drug usually used to treat stomach ulcers and heartburn). Cimetidine
can make the effects of Pharmorubicin stronger.
- Calcium Channel blockers (medicines for the heart)
- Quinine (antimalaria drug)
- Antibiotics such as sulphonamide and chloramphenicol
- Antiretroviral - drugs used to treat infection by HIV
- Diphenylhydantoin - a drug used to treat epilepsy
- Painkillers such as amidopyrine derivate
- Trastuzamab therapy for treatment of cancer
- Dexrazoxane (used to prevent chronic cumulative cardiotoxicity caused by
epirubicin).
Pregnancy
Avoid becoming pregnant while you or your partner is being treated with this
medicine. If you are sexually active, you are advised to use effective birth control to
prevent pregnancy during treatment, whether you are male or female. Pharmorubicin
may cause birth defects, so it is important to tell your doctor if you think you are
pregnant.
Breast feeding
You should stop breast feeding before starting treatment with this medicine as some
of the drug may get into your milk and possibly harm your child.
Ask your doctor or pharmacist for advice before taking any medicine whilst breast
feeding.

Driving and using machinery
There are no special precautions, as long as you feel fully recovered following your
hospital treatment, and you have discussed this with your doctor.
Important information about some of the ingredients of Pharmorubicin
This medicine contains methyl hydroxybenzoate. This may cause allergic reactions
(possibly delayed) and exceptionally, bronchospasm.
3. How Pharmorubicin is given to you
If you are prescribed Pharmorubicin it will only be given to you by doctors or nurses
experienced in giving chemotherapy.
This medicine will normally be given to you by a doctor or nurse through a drip
(infusion) into a vein. Your doctor will decide what dose to give and the number of
days treatment you will receive depending on your condition.
The dose is decided by taking into account the condition you have, your height and
weight. From your height and weight the doctor will work out your body surface
area; and it is this that your dose is calculated from.
Pharmorubicin made into a solution can also be put directly into the bladder to treat
bladder cancer, or to help prevent it returning. The dose depends on the type of
bladder cancer you have. When this medicine is injected directly into the bladder, you
will be instructed not to drink any fluid for 12 hours before treatment to avoid dilution
of the medicine with urine in your bladder.
While one course of treatment may sometimes be enough, more often your doctor will
advise further courses in three or four weeks time. It may take several courses before
your illness is under control and you feel better.
Regular checks by your doctor during Pharmorubicin treatment
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 Pharmorubicin 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 – Pharmorubicin 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.
If you receive high doses of Pharmorubicin:
High doses can worsen side effects like sores in the mouth or may decrease the
number of white blood cells (which fight infection) and platelets (these help the blood

to clot) in the blood. Should this happen, you may need antibiotics or blood
transfusions. Mouth ulcers can be treated to make them less uncomfortable as they
heal.
4. Possible side effects
Like all medicines Pharmorubicin can have side effects, although not everybody gets
them.
Please contact your doctor or nurse immediately if you notice any of the
following side effects. Although they are very rare (these may affect < 1 in 10,000
people), these symptoms can be serious:
 Feeling dizzy, feverish, short of breath with a tight chest or throat or have an itchy
rash,. This type of allergic reaction can be very serious.
Very common possible side effects (these may affect between 1 in 10 people)
 White blood cell counts (which fight infection) can drop which increases the
chance of infections and fever .
 A low red blood cell count (anaemia) that can leave you feeling tired and
lethargic.
 Hair loss is common and may be quite severe. Beard growth may stop in men.
Hair normally re-grows when your treatment course ends.
 Red discolouration of urine, (which is normal and related to the colour of the
medicine). You should inform your doctor if it does not stop in a few days or you
think there is blood in your urine.
Common possible side effects (these may affect between 1 in 100 to 1 in 10
people)
 Infection
 Loss of appetite
 Feeling thirsty (dehydration)
 Hot flushes
 Soreness or ulcers in the mouth, which may not appear until 3-10 days after
treatment.
 Heartburn, nausea (feeling sick), vomiting (being sick) or diarrhoea.
 Irritation of the bladder or damage to the bladder wall (called necrosis).
 Pain, burning or stinging sensation at the injection site.
Uncommon possible side effects (these may affect between 1 in 1,000 to 1 in 100
people)
 Platelets (cells that help the blood to clot) can be affected which could make you
bruise or bleed more easily. It is important to seek medical advice if this happens.
 Swelling, redness, leg pain which can be associated with blood clots.

Rare possible side effects (these may affect between 1 in 10,000 to 1 in 1,000
people)
 When given in combination with other anti-cancer drugs, some patients have
developed a rare leukaemia (cancer of white blood cells) after completing
treatment.
 Tiredness, weakness and feeling cold.
 Low sperm count
 Absence of menstruation
 Gasping for air, shortness of breath, swelling of abdomen, legs or ankles, fluid in
lungs (signs of congestive heart failure).
 ECG abnormalities, irregular heartbeat, heart muscle disease
 Changes in liver enzyme levels
 Increase uric acid levels in the blood which might cause gout.
Not known (cannot be estimated from the available data)
 Blood infection
 Pneumonia
 Internal bleeding
 Inflammation to the eye (conjunctivitis)
 Shock
 Discolouration of skin and nails,
 Sensitive to light
If you get any of the above side effects, or notice any other unusual side effects
not listed in this leaflet, tell your doctor at once.
5. How to store Pharmorubicin
 The unopened vials should be stored in the original container until ready for use.
 Keep out of the reach and sight of children.
 This medicine should not be used after the expiry date printed on the box and on
the vial. The pharmacist will check this when your medicine is prepared for you. If
the solution is cloudy after preparation, the pharmacist will dispose of it safely.
6. Further Information
What Pharmorubicin contains
The active substance is epirubicin hydrochloride. The other ingredients are lactose
monohydrate and methyl hydroxybenzoate.
What Pharmorubicin looks like and contents of the pack
Pharmorubicin is a freeze-dried powder in single glass vials containing 10mg, 20mg
50mg or 150mg of the active ingredient, epirubicin hydrochloride.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

Pharmacia Limited
Ramsgate Road,
Sandwich, Kent,
CT13 9NJ, UK

Manufacturer:

Actavis Italy S.p.A
10 Viale Pasteur
20014 Nerviano (MI)
Italy

Company Contact address:
If you have any comments on the way this leaflet is written, please contact Medical
Information at Pfizer Limited in Walton Oaks, Tadworth, Surrey, Tel :01304 616161
This leaflet was last updated 10/2012.
Document Reference: United Kingdom PM 8_1

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide