2 mg / ml injection / concentrate for infusion solution 
epirubicin hydrochloride

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, nurse, or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, nurse, or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Epirubicin Ebewe is and what it is used for 
2. What you need to know before you get Epirubicin Ebewe 
3. How to get Epirubicin Ebewe 
4. Possible side effects 
5. How to store Epirubicin Ebewe 
6. Contents of the packaging and other information 

What Epirubicin Ebewe is and what it is used for

Epirubicin Ebewe is a cancer medicine that belongs to a group of medicines called anthracyclines. These work by damaging the cells’ genome, the damage prevents the cell from growing and multiplying. Epirubicin Ebewe can be used alone or in combination with other anticancer medicines.

Epirubicin Ebewe can be used to treat breast and bladder cancer.

Epirubicin contained in Epirubicin Ebewe may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Epirubicin Ebewe

Do not use Epirubicin Ebewe

  • if you are allergic to epirubicin or any of the other ingredients of this medicine (listed in section 6).
  • if you are breast-feeding

Also, Epirubicin Ebewe should not be given to you:

by injection ( intravenously ):

  • if you have a sharp decrease in the number of blood cells (myelosuppression) or severe infection and sores in the mouth caused by cancer drugs or radiation therapy
  • if you have pronounced impairment of liver function
  • if you have severe heart failure, recent heart attack, or severe arrhythmias in the heart
  • if you have been given the maximum lifetime dose of the group of medicines to which Epirubicin Ebewe belongs ( anthracyclines ) or of anthracenediones
  • if you have a serious infection
  • if you have angina ( unstable angina pectoris)
  • if you have a heart muscle disease

directly in the bladder (intravesical):

  • if you have a urinary tract infection
  • if you have a tumor in the bladder that has penetrated the bladder wall
  • if you have inflammation of the bladder
  • have blood in the urine
  • if your doctor has difficulty inserting the catheter into your bladder

Warnings and cautions

Talk to your doctor or nurse before receiving Epirubicin Ebewe.

  • If you have persistent side effects from previous rounds of treatment such as general infection or sores and mouth infection.
  • If you have heart vascular disease
  • If you have impaired liver or kidney function
  • If you have or should receive radiation therapy in the chest region
  • If you have been given epirubicin or similar anticancer medicines to treat cancer before
  • If you experience discomfort or pain in or around the injection site during infusion. Tell your doctor immediately. There may be leakage to surrounding tissue.

Your doctor will make regular check-ups before and during treatment that your heart and liver are functioning normally and blood tests will be taken to check that the number of blood cells in your blood is satisfactory.

The urine may turn red for 1-2 days after administration of Epirubicin Ebewe.

Other medicines and Epirubicin Ebewe

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.

Epirubicin Ebewe can affect or be affected by other medicines such as:

  • Cimetidine (medicine that reduces the acid in the stomach)
  • Other anticancer medicines such as paclitaxel, trastuzumab, cyclophosphamide, 5-fluorouracil, and docetaxel
  • Calcium – antagonistic s (cardiovascular drugs)
  • Interferon α2b (for certain cancers and liver diseases)
  • Quinine (for seizures or malaria )
  • Dexverapamil (medicines that increase the effectiveness of certain cancer medicines)
  • Sulfonamides (diuretics),
  • Chloramphenicol ( antibiotics ),
  • Phenytoin (for epilepsy ),
  • Amidopyrine derivatives (used to treat pain),
  • Antiretroviral agents (medicines used to treat viral illness)
  • Dexrazoxane (other medicines used to treat cancer)
  • Other medicines that can cause similar side effects on the heart, bone marrow, and/or liver such as Epirubicin Ebewe

If Epirubicin Ebewe is given with other anticancer medicines, the side effects of these medicines may be more severe.

Vaccination with live vaccine should be avoided in patients receiving Epirubicin Ebewe.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.

Epirubicin Ebewe can cause birth defects if used during pregnancy. You must tell your doctor if you are pregnant or become pregnant during treatment. You should not use Epirubicin Ebewe during pregnancy unless your doctor specifically recommends it.

If you or your partner are being treated with Epirubicin Ebewe, effective contraception is recommended to avoid pregnancy during treatment. If you or your partner becomes pregnant during treatment, you should contact your doctor.

There is a risk that treatment with Epirubicin Ebewe will cause damage to sperm production. Male patients should consider freezing sperm before starting treatment.

Epirubicin Ebewe can cause missed periods or premature menopause in women who have not yet experienced menopause.

Epirubicin Ebewe can be harmful to breast-fed babies. Therefore, mothers must stop breast-feeding before starting treatment.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor, pharmacist, or nurse.

Epirubicin Ebewe contains sodium

This medicine contains 9 mg sodium per ml. This should be considered by patients on a low-salt diet.

3. How to get Epirubicin Ebewe

Epirubicin Ebewe is given to you by a doctor or nurse, either directly into the bloodstream or into the bladder. The doctor will decide the right dose and treatment time for you. How large a dose you receive is affected by the type of cancer you have, your health, height, weight, liver function, and any other treatment you receive.

Breast cancer

Epirubicin Ebewe can be given as an injection into a vein for 5-15 minutes. It can also be diluted and then given slowly as a drip into a vein, usually for 30-60 minutes. Doseone in one treatment cycle can be given as a single dose or divided into 2-3 days. The usual time interval between treatments is 3 weeks.

Bladder cancer

In the treatment of bladder cancer, Epirubicin Ebewe is injected into the bladder via a catheter (tube), usually 8 times a week.

The solution should be kept in the bladder for at least 1 hour after it has been injected. You need to turn around a few times during treatment to make sure that all parts of the bladder come in contact with the medicine.

If you take more Epirubicin Ebewe then you should

You will be given this medicine in a hospital and it is unlikely that you will be given too much epirubicin. If you are worried that you have been given too high a dose or if you have any questions about the dose you have been given, talk to your doctor or nurse who will give you the medicine.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, tell your doctor or healthcare professional immediately:

  • Redness, pain, or swelling at the injection site. This can occur if the drug leaks outside the blood vessel and injection should then be stopped
  • Rapid pulse, shortness of breath, or swelling of the ankles. These symptoms may appear several weeks after the end of treatment and indicate cardiac effects
  • Difficulty breathing, wheezing, swelling of the face, difficulty swallowing, reddening of the skin, may indicate a severe allergic reaction
  • Chest pain, pain when breathing, cough, and shortness of breath. It may indicate a blood clot in the lung

The following side effects have been reported:

Very common (may affect more than 1 user in 10):

  • Decreased production of blood cells in your bone marrow (myelosuppression)
  • Decreased amounts of white blood cells
  • Anemia
  • Hair loss
  • Red urine for 1 to 2 days after administration

Common (may affect up to 1 in 10 people):

  • Infection is
  • Loss of appetite
  • Dehydration
  • Hemorrhoids
  • Nausea
  • Vomiting
  • Diarrhea
  • Inflammation of the gastrointestinal tract, esophagus, and mouth (mucositis, esophagitis, stomatitis )
  • Redness at the injection or infusion site
  • Inflammation of the bladder after dosing directly to the bladder
  • Burning/burning sensation and frequent bladder emptying after dosing directly to the bladder

Uncommon (may affect up to 1 in 100 people):

  • Reduced platelet count
  • Inflammation of blood vessels with or without concomitant blood clots

Rare (may affect up to 1 in 1,000 people):

  • Blood cancer ( leukemia )
  • Severe allergic reactions (anaphylaxis / anaphylactoid reactions)
  • Very slow pulse with a tendency to faint
  • Increased amounts of uric acid in the blood
  • Dizziness
  • Heart failure ( chronic heart failure )
  • Adverse reactions to the heart (cardiotoxicity) such as irregular heartbeat or heart muscle disease
  • Fast or slow pulse
  • Hives
  • Absence of menstruation
  • Absence of sperm in the semen
  • Fever, chills, malaise, weakness.
  • Changed liver values

Has been reported (occurs in an unknown number of users):

  • Blood poisoning with or without shock.
  • Pneumonia
  • Bleeding and lack of oxygen to tissue due to impaired bone marrow function.
  • Inflammation of the eye (conjunctivitis, keratitis )
  • Shock
  • Blood clots that may include blood clots in the lung
  • Damage to tissue at the injection site such as rash, itching, skin changes, redness
  • Increased pigmentation of skin and nails
  • Hypersensitivity to light
  • Radiation-recall reaction
  • Reduction of left ventricular capacity without any symptoms
  • Hard and less elastic veins (phlebosclerosis), pain, severe tissue inflammation ( cellulite ), tissue death after accidental injection into the surrounding tissue.
  • Cold sores, pain in the mouth, bleeding in the mouth, burning sensation in the mucous membranes, and sores on the oral mucosa.
  • Pigmentation of the oral mucosa.

5. How to store Epirubicin Ebewe

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2 ° C-8 ° C).

Do not use this medicine after the expiry date which is stated on the carton after EXP. Dat or EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is epirubicin hydrochloride 2 mg/ml.
  • The other ingredients are sodium chloride, hydrochloric acid, water for injections

What the medicine looks like and the contents of the pack

Clear red solution.

Pack sizes: 5 ml, 5 x 5 ml, 25 ml, 50 ml and 100 ml in vial .

Marketing Authorization Holder and Manufacturer

Ebewe Pharma Ges.mbH Nfg KG

Mondseestrasse 11

A-4866 Unterach

Austria

Muhammad Nadeem

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