Epirubicin Hydrochloride Injection

Do not use Epirubicin Hydrochloride Powder for Solution for Injection or Infusion if you:

Are allergic (hypersensitive) to epirubicin hydrochloride, any of the other ingredients of Epirubicin Hydrochloride Powder for Solution for Injection or Infusion
Are allergic (hypersensitive) to drugs belonging to the group anthracenediones (including drugs used to treat cancer)are breast-feeding.
Epirubicin should not be injected into a vein (intravenous use) if you
are aware your blood counts are low, caused by previous treatment with other anti-tumour drugs or by previous radiotherapy have been treated with other chemotherapy at maximum dose such as epirubicin and/or other
anthracyclines (such as doxorubicin or daunorubicin), and anthracenediones, which can increase the risk of side effects.
Suffer with or have suffered with problems with your heart.
Suffer from an acute severe infection have severe liver problems.

Epirubicin should not be injected into the bladder if:
You suffer from urinary tract infection (including your kidneys, bladder and urethra) there are tumours which penetrate the bladder,there are problems placing the tube into the bladder, you have an inflammation of the bladder,
you have blood in the urine (hematuria)

Take special care with Epirubicin Hydrochloride Powder for Solution for Injection or Infusion if you:

Have some kidney or liver problems.
You should inform your doctor before treatment as he/she needs to take special care.
Your doctor will also be making regular checks so that your blood cell counts will not be too low to control the levels of uric acid and other factors in the blood to see that your heart and liver are working normally.
If you have or are to have radiotherapy to the area around the heart.
You should inform your doctor in case you experience swelling and pain in your mouth or mucous
membrane.
You should tell your doctor if you are about to have a vaccination, as it may cause side effects if used with epirubicin.
It is possible that the urine will have a red colour for one or two days after administration.

Pregnancy and breast-feeding

Fertility
There is a risk of sterility due to therapy with Epirubicin.
Male patients should consider storage of sperm before treatment.
Epirubicin may cause absence of menstruation or premature menopause in premenopausal women.

Pregnancy
Epirubicin may cause birth defects when used during pregnancy, it is important to tell your doctor if you are pregnant or if you become pregnant during treatment.
You must not use Epirubicin during pregnancy unless clearly indicated by your doctor.
If you or your partner are being teated with Epirubicin, effective birth control to prevent pregnancy is advised.
If pregnancy occurs during treatment or if you desire to have children after completion of therapy, genetic counselling is recommended.

Breast-feeding
Epirubicin may be harmful to nursing infants, therefore women must stop breast-feeding before starting treatment with this product.

Driving and using machines
Epirubicin may cause episodes of nausea and vomiting, which can temporarily lead to an impairment of the ability to drive or use machines.

Important information about some of the ingredients of Epirubicin Hydrochloride Powder for Solution for Injection or Infusion:-
This medicinal product contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.

How to use Epirubicin Hydrochloride Powder for Solution for Injection or Infusion
Epirubicin will be given to you by a doctor or nurse, either into a vein or directly into your bladder.
Your doctor will decide the correct dose and the number of days treatment you receive.
The dose will depend on the type of cancer you have, your health, height, weight, how well your liver is working and any other treatment you may receive.

By injection or infusion into a vein

Epirubicin Hydrochloride Powder for Solution for Injection or Infusion may be given as an injection into a vein over 3-5 minutes.
It may also be diluted before it is infused slowly, usually via a drip into a
vein over 30 minutes.

By being put into the bladder

If the injection is given into the bladder, you should not drink any fluids for 12 hours before treatment so that your urine will not dilute the drug too much. The solution should be kept in your bladder for 1-2 hours after installation.
You will need to turn occasionally to make sure all parts of the bladder are
exposed 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.
Your doctor will regularly check your blood for any unwanted effects.
To detect any possible heart damage your doctor will also monitor your heart for several weeks after the treatment.

Possible side effects
Like all medicines, Epirubicin Hydrochloride Powder for Solution for Injection or Infusion can cause side effects, although not everybody gets them.

If any of the following side effects happen when epirubicin is given by infusion into a vein tell you doctor immediately, as these are very serious side effects. You may need urgent medical attention:
– redness, pain or swelling at the injection site; tissue damage may occur after accidental injection
outside a vein
– symptoms of heart problems such as chest pain, shortness of breath, swelling of your ankles
(these effects may occur up to several weeks after finishing treatment with epirubicin)
– severe allergic reaction, symptoms include faintness, skin rash, swelling of the face and difficulty in breathing or wheeze . In some cases collapse may occur.

If you experience any of the following tell your doctor as soon as possible:

Very common (occur in more than 1 in 10 people):

• Bone marrow suppression (which leads to low blood cell count)
• hair loss (usually reversible)
• reduced growth of beard hair
• red coloured urine for 1 to 2 days after being given the medicine

Common (occur in less than 1 in 10 people):

• Severe loss of appetite leading to weight loss (anorexia)
• loss of fluid from the body (dehydration)
• feeling or being sick (nausea or vomiting)
• diarrhoea (which can result in dehydration)
• loss of appetite
• abdominal pain
• inflammation of the gullet (oesophagitis)
• high levels of pigments in the mouth
• swelling and pain in your mouth
• ulcers involving the lips and/or tongue and/or under the
  tongue
• hot flushes
• fever or infections
• redness
• pain or swelling at the injection site
• tissue damage may occur after accidental injection outside a vein
• allergic reactions or inflammation of the bladder
  (sometimes with bleeding) after injection of the medicine into the bladder.

Uncommon (occur in less than 1 in 100 people):

• Low levels of blood platelets (thrombocytopenia) often causing unusual bruising or bleeding
• headache
• high levels of pigments in the skin and nails
• skin redness
• sensitivity of the skin to light (in
  case of radiotherapy)
• vein inflammation including blood clotting (thrombophlebitis).

Rare (occur in less than 1 in every 1,000 people):

• Increased blood levels of uric acid (hyperuricaemia) possibly leading to gout
• fever and/or chills
• dizziness
• absence of menstrual periods (amenorrhea)
• lack of sperm
• changes in liver function(changes in transaminase levels)
• heart failure (shortness of breath, oedema, enlargement of the liver ,pulmonary oedema which can cause respiratory failure and swelling of the abdomen)
• abnormal heartrhythm
• Weaker heart with lower pumping rate which can result in, feeling generally unwell and feeling of weakness.

Not known (frequency cannot be estimated from the available data)

• Infection of the lungs (pneumonia)
• infection of the blood (sepsis)
• septic shock (severe complication of sepsis)
• bleeding and lack of oxygen in body tissues
• redness
• dryness and swelling of the eyes
• shock
• blockage of a blood vessel by a clot (e.g., in the lungs)
• skin rash, itching, skin changes, flushes(reddening of the skin)
• Infected area of the skin can become sore, swollen, red and hot, caused by severe cellulitis
• Decreased ability of the heart to pump blood (asymptomatic drops in left ventricular ejection fraction)
• Colour changes, bleeding, pain, sores, ulcers or burning sensation inside the mouth
• If epirubicin hydrochloride is injected directly into the bladder you may experience pain or difficulty when passing urine
• Blood may also be seen in your urine