Epirubicin Hydrochloride 2mg/ml solution for injection
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, ask your doctor.
This medicine has been prescribed for you. Do 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.
In this leaflet:
- 1. What Epirubicin is and what it is used for
- 2. Before you use Epirubicin
- 3. How to use Epirubicin
- 4. Possible side effects
- 5. How to store Epirubicin
- 6. Further information
What Epirubicin Is And What It Is Used For
Epirubicin is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy, Epirubicin is part of a group of medicines called antrhacyclines. These act upon cells that are actively growing, to slow or stop their growth and increase the chance that the cells die.
Epirubicin is used to treat a variety of cancers. The way in which it is used depends upon the type of cancer that is being treated.
When injected into the bloodstream, Epirubicin is used to treat cancers of the breast, stomach and lung as well as advanced ovarian cancer.
When injected into the bladder through a tube, Epirubicin is used to treat cancers of the bladder wall. It can also be used after other treatments for prevention of such cells from growing again.
Before You Use Epirubicin
Do not use Epirubicin if you:
- are allergic (hypersensitive) to epirubicin hydrochloride or any of the other ingredients of Epirubicin
- are aware your blood counts are low, as Epirubicin can lower them further
- have been treated with other chemotherapy such as doxorubicin or daunorubicin 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
- have severe inflammation in the mouth, pharynx, oesophagus and gastro-intestinal tract
- are breast-feeding.
Epirubicin should not be injected into the bladder if:
- you suffer from urinary infection
- there are tumours which penetrate the bladder
- there are problems placing the tube
- you have an inflammation of the bladder
- you have large volume of urine left in your bladder after you attempt to empty
- your bladder is contracted.
Take special care with Epirubicin if you:
- have some kindney 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 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. It is possible that the urine will have a red colour for one or two days after administration.
Using other medicines
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
- Cimetidine (used to reduce the acid in the stomach).
- Paclitaxel and docetaxel (used in some cancers).
- Interferon alfa-2b (used in some cancers and lymphoma and for some yellow fever).
- Quinine (used for treatment of malaria and for leg cramps).
- Dexrazoxane (sometimes used with doxorubicin in order to decrease the risk of heart problems).
- Dexverapamil (used to treat some heart conditions).
- Other medicines that may affect your liver and/or heart.
- Live vaccines.
- Other medicines that may affect the bone marrow (such as other medicines to treat cancer, sulphonamide and cloramphenicol (antibacterial medicines), diphenylhydantoin (antiepileptic), amidopyrine derivatives (some medicines to treat e.g. pain and fever) and some antiviral medicines).
Pregnancy and breast-feeding
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 treated with Epirubicin, effective birth control to prevent pregnancy during treatment and for 6 months after treatment is advised. If pregnancy occurs during treatment, genetic counsellation is recommended.
There is a risk of sterility due to therapy with Epirubicin. Male patients should consider storage of sperm before treatment.
Epirubicin may be harmful to nursing infants, therefore women must stop breast-feeding before starting treatment with Epirubicin.
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
This medicine contains less than 1mmol sodium (23mg) per ml, i.e. essentially ‘sodium free’.
How To Use Epirubicin
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 number of days treatment you receive, this 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 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.
If you receive more Epirubicin than you should:
You may notice sores in your mouth, however as this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much. Please tell your doctor if you have any concerns.
Possible Side Effects
Like all medicines, Epirubicin 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):
Hair loss, reduced growth of beard hair.
Common (occur in less than 1 in 10 people):
Allergic reactions, feeling or being sick, 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, changes in blood cells causing bleeding, fever or infections.
Uncommon (occur in less than 1 in 100 people):
Headache, high levels of pigments in the skin and nails, skin redness, sensitivity to light (in case of radiotherapy), vein inflammation including blood clotting (thrombophlebitis).
Rare (occur in less than 1 in every 1,000 people):
Hives (urticaria), fever and/or chills, dizziness, absence of menstrual periods (amenorrhea), lack of sperm, gout, changes in heart or liver function.
Your urine may be red in colour for a couple of days after being given epirubicin, which is a normal occurrence related to the colour of the medicine.
Longterm effect is a certain type of leukaemia (acute myeloid leukaemia) which has been rarely reported.
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.
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.
How To Store Epirubicin
Keep out of the reach and sight of children.
Store in a refrigerator (2° - 8°C). Keep the vial in the outer carton in order to protect from light.
Do not use Epirubicin after the expiry date which is printed on the label and carton after EXP. The expiry date refers to the last day of that month.
Do not use Epirubicin if you notice any visible signs of deterioration.
Medicines should not be disposed of via wastewater or houshold waste.
Ask your pharmacist how to dispose medicines no longer required. These measures will help to protect the environment.
Further Information
What Epirubicin contains
- The active substance is epirubicin hydrochloride. Each millilitre of solution for injection contains 2mg epirubicin hydrochloride.
- The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment) and water for injection.
What Epirubicin looks like and contents of the pack
Epirubicin Hydrochloride 2mg/ml solution for injection is a clear red solution.
Pack sizes:
1 x 5ml vial (10mg/5ml)
1 x 10ml vial (20mg/10ml)
1 x 25ml vial (50mg/25ml)
1 x 50ml vial (100mg/50ml)
1 x 100ml vial (200mg/100ml)
One 5ml vial of Epirubicin Hydrochloride 2mg/ml solution for injection contains 10mg epirubicin hydrochloride equivalent to 9.35mg epirubicin.
One 10ml vial of Epirubicin Hydrochloride 2mg/ml solution for injection contains 20mg epirubicin hydrochloride equivalent to 18.7 mg epirubicin.
One 25ml vial of Epirubicin Hydrochloride 2mg/ml solution for injection contains 50mg epirubicin hydrochloride equivalent to 46.75mg epirubicin.
One 50ml vial of Epirubicin Hydrochloride 2mg/ml solution for injection contains 100mg epirubicin hydrochloride equivalent to 93.5mg epirubicin.
One 100ml vial of Epirubicin Hydrochloride 2mg/ml solution for injection contains 200mg epirubicin hydrochloride equivalent to 187mg epirubicin.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
DK Epirubicin Actavis
AT Epirubicin Actavis 2 mg/ml Injektionslösung
BE Epirubicin Actavis Group 2 mg/ml Oplossing voor injectie
DE Epirubicin-Actavis 2 mg/ml Injektionslösung
ES Epirubicina Actavis 2 mg/ml solución inyectable
FI Epirubicin Actavis
IE Epirubicin 2 mg/ml solution for injection
IS Epirubicin Actavis
IT Epirubicina cloridrato Actavis
PT Epirrubicina Actavis
This leaflet was last revised in February 2008
If you would like a leaflet with larger text, please contact 01271 311257.
SINPL009
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