2 mg / ml injection solution 
doxorubicin 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 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 or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Doxorubicin Ebewe is and what it is used for 
2. What you need to know before using Doxorubicin Ebewe 
3. How to use Doxorubicin Ebewe 
4. Possible side effects 
5. How to store Doxorubicin Ebewe 6. Contents of the pack 
and other information 

What Doxorubicin Ebewe is and what it is used for

Doxorubicin Ebewe, which contains the active substance doxorubicin, belongs to a group of medicines called anthracyclines and is an anti-cancer medicine. The drug works by slowing down or stopping the growth of cancer cells. Doxorubicin Ebewe is often used in combination with other anticancer medicines.

Doxorubicin Ebewe can be used in the treatment of, among other things, the following cancers:

  • breast cancer
  • cancer of connective tissue, ligaments, bones, and muscles ( sarcoma )
  • lung cancer
  • lymph node cancer ( Hodgkin’s disease and malignant non-Hodgkin’s lymphoma)
  • cancer of the blood ( acute leukemia )
  • bone marrow ( myeloma )
  • cancer of the prostate or testicles
  • thyroid cancer
  • cancer of the ovaries or uterus
  • bladder cancer
  • cancer of the head/neck
  • stomach cancer
  • the tumor is in children such as neuroblastoma, rhabdomyosarcoma, Wilms tumor

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

What you need to know before using Doxorubicin Ebewe

Do not use Doxorubicin Ebewe

  • if you are allergic to doxorubicin, similar substances ( anthracyclines or anthracenediones), or any of the other ingredients of this medicine (listed in section 6)
  • if you are pregnant or breastfeeding

You should not receive Doxorubicin Ebewe in a blood vessel ( intravenously ):

  • if you have bone marrow inhibition one with reduced production of red blood cells
  • if you have severe hepatic impairment
  • if you have impaired heart function or severe arrhythmias (irregular heartbeat)
  • if you have had a heart attack before
  • if you have previously received the maximum lifetime dose of doxorubicin or similar medicines ( anthracyclines or anthracenediones)

Also, if you are going to receive Doxorubicin Ebewe via a catheter (thin flexible tubing) to your bladder, you should not have:

  • a cancerous tumor that has grown into the bladder
  • urinary tract infection
  • inflammation of the bladder
  • problems inserting the catheter

Warnings and cautions

Talk to your doctor or pharmacist before taking Doxorubicin Ebewe.

Before treatment, tell your doctor if you have or have had:

  • reduced production of blood cells are in bone marrow a
  • cardiac vessel -sjukdom
  • hepatic impairment
  • received doxorubicin or similar anticancer medicines ( anthracyclines or anthracenediones) for the treatment of cancer
  • received radiation treatment in the upper part of the body

Before starting treatment with Doxorubicin Ebewe, your doctor will perform the following tests:

  • count of your blood cells
  • test of your heart and liver function

Tell your doctor immediately if you:

  • feel a stinging or burning pain at the injection site. Such pain can occur if the drug leaks outside the blood vessel and injection should then be stopped

Your doctor will monitor your heart function during treatment due to:

  • doxorubicin can damage the heart muscle
  • doxorubicin may lead to heart failure after a certain cumulative dose has been administered (addition of all individual doses )
  • the risk of heart damage is greater if you have previously been treated with drugs that can damage your heart or if you have received radiation therapy in the upper part of the body

The level of uric acid (indicating that cancer cells are being destroyed) in your blood may be high during treatment. Your doctor will tell you if you need to take any medicine to control this.

Talk to a doctor if you have a sore mouth or any discomfort in your mouth.

Men and women treated with doxorubicin should use contraception.

Other symptoms that you may also experience and need to be aware of are described in the introduction to section 4 Possible side effects.

Other medicines and Doxorubicin Ebewe

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

Other medicines may affect the effect of doxorubicin and be affected by doxorubicin.

You must tell your doctor if you are taking or have recently taken:

  • drugs that can damage the heart or increase toxicity (such as certain anticancer medicines like cyclophosphamide, docetaxel, rituximab, trastuzumab, zosuquidar, or paclitaxel)
  • medicines for high blood pressure (such as verapamil)
  • drugs that can damage the liver (such as methotrexate)
  • drugs that affect the activity of your immune system (cyclosporine)
  • medicines to treat stomach ulcers (cimetidine and ranitidine)
  • antibiotics for tuberculosis (rifampicin)
  • sedatives ( barbiturates )

Pregnancy and breastfeeding

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

Pregnancy

Doxorubicin should not be given if you are pregnant. Doxorubicin can cause severe birth defects if given during pregnancy. If you are pregnant, your doctor will only give you doxorubicin if the benefits of treatment outweigh the potential risks to the unborn baby. Tell your doctor immediately if you are pregnant or think you may be pregnant.

Women of childbearing potential should use effective contraception during treatment with Doxorubicin Ebewe and for up to 12 weeks after stopping treatment.

Men treated with doxorubicin should use contraception.

Breast-feeding

Do not breast-feed while you are being treated with Doxorubicin Ebewe. The medicine can be passed on to the baby via breast milk.

Driving and using machines

It is not known if Doxorubicin Ebewe affects your ability to drive or use machines. Do not drive or use machines until you are sure how Doxorubicin Ebewe affects you.

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 or pharmacist.

Doxorubicin Ebewe contains sodium

This medicine contains 0.15 mmol (2.3 mg) sodium per ml. A vial with 5 ml containing 0.76 mmol (11.5 mg) of sodium and 25 ml containing 3.84 mmol (57.6 mg) sodium. This should be considered by patients on a low-salt diet.

3. How to use Doxorubicin Ebewe

Doxorubicin will be given to you under the supervision of a doctor who has experience in cancer treatment.

The recommended dose is:

Your doctor will decide what dose you will receive, usually, one dose is calculated based on body surface area.

Doxorubicin Ebewe will be given to you by a drip into your arm ( intravenous infusion ), or it will be given directly into the bladder via a catheter (if you have bladder cancer) by healthcare professionals.

If you use more Doxorubicin Ebewe then you should

Your doctor will ensure that the correct dose for your illness is given.

In case of overdose, you may get increased side effects. Inhibition of bone marrow, inflammation of the mucous membranes of the mouth and intestines ( mucositis ), and heart problems can occur.

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

4. Possible side effects

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

Tell your doctor immediately if you experience any of the following:

  • a stinging, burning redness, or swelling at the injection site. Such pain can occur if the drug leaks outside the blood vessel and injection should then be stopped
  • difficulty breathing, wheezing, swelling of the face lips, tongue or throat, difficulty swallowing, reddening of the skin, this may indicate a severe allergic reaction
  • 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
  • sore throat, cold sores, fever, chill,s or muscle aches, this may be a sign of infection
  • bleeding or bruising
  • bloody or black stools, this may be a sign of bleeding in the gastrointestinal tract.
  • ulcers in the mucous membranes of the mouth that remain until the next round of treatment ( mucositis )

Reported side effects are:

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

  • inhibition of blood cell formation in the bone marrow (myelosuppression) which can lead to anemia, lack of white blood cells and platelets, fever, and increased risk of infection
  • increased levels of uric acid in the blood
  • cardiac complications such as disturbances in the heart rhythm ( ECG effect), inflammation of the heart muscle or heart sac, heart failure. Cardiac effects may be delayed for several weeks, months, or years after stopping treatment
  • inflammation of the mucous membranes of the mouth, esophagus, and rectum
  • diarrhea, nausea, or vomiting
  • temporary hair loss
  • skin changes
  • pigmentation of nail beds, loosening of nails

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

  • elevated liver values
  • when administered directly to the bladder, localized side effects have been reported that are usually transient, such as irritation, blood in the urine, abnormally abundant urinary excretion, painful urination with dropwise urine
  • when administered directly to the bladder, bleeding catarrh has also been reported which may lead to decreased bladder capacity
  • abdominal pain, constipation, indigestion, cold sores

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

  • increased risk of children later developing cancer

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

  • blood cancer ( leukemia )
  • inflammation of the eye ( conjunctivitis )
  • increased tear flow
  • redness of the face (may occur if infusion one occurs too quickly)
  • damage to the gastrointestinal tract that can lead to wounds and bleeding with bloody or black stools

Very rare (may affect up to 1 in 10,000 people) :

  • lung effects may manifest as abnormally rapid breathing, shortness of breath, water in the alveoli, pneumonia, and blood clots in the lungs
  • concomitant inflammation and a blood clot in blood vessels
  • oral cancer may occur when Doxorubicin Ebewe is taken for a long time (more than one year)

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

  • deterioration of children’s growth just before puberty as well as hormonal disorders
  • redness and pain on hands and feet

Concomitant radiotherapy of the liver can lead to liver damage.

Hypersensitivity reactions such as fever, allergic reaction affecting the whole body, swelling of the face, tongue, or throat, and skin reactions in the form of redness, itching, hives have been reported.

Doxorubicin is very irritating. If an infusion is injected outside a vessel, it can cause pain, irritation, inflammation, concomitant inflammation and blood clots in blood vessels, severe wounds, and skin death at the injection site.

Doxorubicin may aggravate radiation damage to the skin. If doxorubicin is given after radiation, it can cause radiation damage to the skin.

Doxorubicin Ebewe redens the urine. There is nothing to worry about. Your urine will soon return to normal color.

5. How to store Doxorubicin Ebewe

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

Store in a refrigerator (2ºC-8ºC).

Store in the original package. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the label and carton after 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 doxorubicin hydrochloride 2 mg/ml.
  • The other ingredients are sodium chloride 9 mg/ml, hydrochloric acid, and water for injections.

What the medicine looks like and the contents of the pack

Doxorubicin Ebewe solution for injection is a clear, blood-red particle-free liquid.

Pack size: 5 ml, 5 x 5 ml, 10 ml, 5 x 10 ml, 25 ml and 100 ml vials.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

EBEWE Pharma Ges.mbH Nfg. KG

Mondseestrasse 11

4866 Unterach

Austria

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Local representative

Sandoz A / S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Muhammad Nadeem

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