2 mg / ml injection 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 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 Epirubicin Rivopharm is and what it is used for 
2. What you need to know before you use Epirubicin Rivopharm 
3. How to use Epirubicin Rivopharm 
4. Possible side effects 
5. How to store Epirubicin Rivopharm 6. Contents of the pack 
and other information 

What Epirubicin Rivopharm is and what it is used for

Epirubicin Rivopharm is a medicine used to treat cancer. Drugs used to treat cancer are often called chemotherapy drugs. Epirubicin Rivopharm belongs to a group of medicines called anthracyclines. These work by slowing down or stopping the growth of fast-growing cells and thus increasing the likelihood of the cells dying.

Epirubicin Rivopharm is used for different types of cancer. How it is used depends on the type of cancer being treated.

Epirubicin Actavis is injected into the bloodstream to treat breast and stomach cancer.

In the treatment of bladder cancer, Epirubicin Actavis is injected into the bladder via a catheter  It can also be used after other treatments to prevent relapse.

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

2. What you need to know before you use Epirubicin Rivopharm

Do not use Epirubicin Rivopharm

  • if you are allergic to epirubicin hydrochloride or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic to other similar medicines belonging to a group of medicines called anthracyclines, which include doxorubicin or daunorubicin)
  • if you are allergic to medicines belonging to the anthracenedione group (including medicines used to treat cancer)
  • if you are breast-feeding.

Epirubicin should not be injected into a vein ( intravenous use):

  • if you know that you have l question are blood counts caused by previous treatment with other anticancer drugs or radiation therapy
  • have been treated with maximum dose at other chemotherapy such as epirubicin and/or other anthracycline s (e.g., doxorubicin or daunorubicin) and anthracenediones, which can increase the risk of adverse s
  • if you have or have had heart disease
  • if you have an acute severe infection
  • if you have severe liver disease.

Epirubicin Rivopharm should not be injected into the bladder:

  • if you have a urinary tract infection (including kidneys, bladder, and urethra)
  • if you have a tumor that penetrates the bladder
  • if there are difficulties in placing a urinary catheter
  • if you have an inflammation of the bladder
  • if you have blood in your urine ( hematuria ).

Warnings and cautions

Talk to your doctor before using Epirubicin Rivopharm

  • if you have kidney or liver disease. Inform the doctor before treatment so that he/she can take this into account.
  • if you have received or will receive any vaccine

Your doctor will also do regular check-ups:

  • so that the blood values ​​do not become too low
  • of the levels of uric acid and other factors in the blood
  • so that your heart and liver function normally
  • if you have received or will receive radiation treatment of the area around the heart.

Tell your doctor if you experience swelling and pain in your mouth or mucous membranes.

The urine may turn red for 1-2 days after treatment.

Children

There are no data regarding safety and efficacy in children.

Other medicines and Epirubicin Rivopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is especially true for:

  • cimetidine (used to reduce stomach acid)
  • trastuzumab (used to treat cancer)
  • paclitaxel and docetaxel (used against cancer)
  • interferon alfa-2b (used to treat cancer and lymphoma and certain variants of hepatitis)
  • quinine (used to treat malaria and leg cramps)
  • dexverapamil (used to treat certain heart conditions)
  • drugs that can affect your heart, such as 5-fluorouracil, cyclophosphamide, cisplatin, taxanes (used to treat cancer), or calcium channel blockers (used to treat high blood pressure or certain heart diseases
  • drugs that can affect the liver
  • live vaccine
  • other drugs that can affect the bone marrow (such as other medicines for cancer, sulfonamide and chloramphenicol (medicines for bacterial infection), diphenylhydantoin (used for epilepsy ), amidopyrine derivatives (used to treat pain and fever), and some medicines for viruses ).
  • Dexrazoxane (used to treat heart problems caused by epirubicin)

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 for advice before using this medicine.

Pregnancy

Epirubicin Rivopharm may cause birth defects if used during pregnancy. You must tell your doctor if you are pregnant or become pregnant during treatment. You must not use Epirubicin Rivopharm during pregnancy unless your doctor tells you to.

If you or your partner are being treated with Epirubicin Rivopharm, effective contraception is recommended. If you become pregnant during treatment or if you wish to have children after treatment, consultation with a genetics expert should be done.

Breast-feeding

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

Fertility

There is a risk of sterility caused by treatment with epirubicin. Male patients should consider freezing sperm before starting treatment.

Epirubicin may cause missed menstruation or premature menopause in premenopausal women.

Driving and using machines

Epirubicin Rivopharm may cause episodes of nausea and vomiting that may temporarily impair the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

Epirubicin Rivopharm contains excipients

This medicine contains 3.54 mg of sodium per ml. This should be considered for patients on a controlled sodium diet.

3. How to use Epirubicin Rivopharm

Epirubicin Rivopharm 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. Factors that affect are the type of cancer you have, your health, height, weight, liver function, and any other treatment you receive.

Via injection or infusion into a friend

Epirubicin Rivopharm can be given as an injection into a vein for 3-5 minutes. It can also be diluted and then given slowly, usually as a drip into a vein, for 30 minutes.

Via the bladder

If the medicine is given directly into the bladder, you must not drink any liquid for 12 hours before the treatment so that the urine does not dilute the medicine too much. The solution should be retained in the bladder for 1-2 hours after injection. 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.

Care must be taken to prevent urine from coming into contact with the skin when emptying the bladder. In case of skin contact, wash with soap and water without scrubbing.

Doctors will regularly check with blood tests to detect any side effects. To detect possible heart effects, doctors will also perform heart tests for several weeks after treatment.

If you use more Epirubicin Rivopharm then you should 

It can affect your heart, lower your blood cells, and cause severe gastrointestinal problems (mainly severe inflammation of the mucous membranes, ( mucositis )). You may experience soreness in your mouth. Because this medicine will be given to you while you are in the hospital, it is unlikely that you will receive too little or too much medicine. Contact a doctor if you are worried about anything.

4. Possible side effects

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

Tell your doctor immediately if any of the following side effects occur when epirubicin is given as a drip directly into the bloodstream, as these are serious side effects. You may need emergency medical treatment:

  • redness, pain, or swelling at the injection site; Tissue damage can occur if the injection is inadvertently injected outside the vein
  • symptoms of the heart or blood clots in the lungs, such as chest pain, shortness of breath, swollen ankles (these symptoms may appear up to several weeks after stopping treatment with epirubicin)
  • severe allergic reaction, symptoms include fainting, rash, swelling of the face and difficulty breathing, wheezing. In some cases, collapse may occur.
  • fever with an extreme increase in body temperature above 41 ° C ( hyperpyrexia )

Tell your doctor as soon as possible if you experience any of the following:

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

Bone marrow dysfunction (leading to anemia ), hair loss (usually reversible ), decreased beard growth, red urine for 1 to 2 days after receiving the medicine.

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

Severe loss of appetite leading to weight loss ( anorexia ), loss of fluid from the body (dehydration), nausea or vomiting, diarrhea (which can cause dehydration), loss of appetite, abdominal pain, inflammation of the esophagus ( esophagitis ), increased pigmentation in the mouth, swelling and pain in the mouth, sores on the lips and/or tongue and/or under the tongue, hot flashes, changes in blood cells, leading to bleeding, fever or infection, redness, pain or swelling at the injection site: tissue damage may occur after accidental injection outside a vein, allergic reactions or inflammation in the bladder (sometimes with bleeding) after injection of the drug into the bladder.

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

Decreased levels of blood clots ( thrombocytopenia ) often cause unusual bruising or bleeding, headaches, increased pigmentation of the skin and nails, reddening of the skin, the sensitivity of the skin to light (with radiation therapy), venous inflammation along with blood clots.

Rare side effects (may affect up to 1 in 1000 people):

Leukemia (blood cancer), severe allergic reaction throughout the body ( anaphylaxis ), hives ( urticaria ), elevated levels of uric acid in the blood (hyperuricemia) which may lead to gout, fever and/or chills, dizziness, missed periods ( amenorrhea ), decreased sperm production, gout, changes in heart or liver function, general malaise, feeling of weakness.

No known frequency (cannot be calculated from the available data):

Pneumonia ( CAP ), blood poisoning ( sepsis ), septicemia with severe complications ( septic shock ), bleeding and lack of oxygen in body tissues s, redness and eye swelling, shock, occlusion of a blood vessel caused by a blood clot (e.g., the lungs), rash, itching, skin changes, skin redness, a severe bacterial infection in the skin, pain in the mouth, burning sensation inside the mouth.

If epirubicin hydrochloride is injected directly into the bladder, you may experience pain or difficulty urinating, or frequent urination. Blood can also be seen in the urine.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

5. How to store Epirubicin Rivopharm

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

Store in a refrigerator (2ºC-8ºC).

Keep the vial in the outer carton. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the label and carton after “EXP.” Or EXP. The expiration date is the last day of the specified month.

Do not use this medicine if there are visible deteriorations.

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. One milliliter solution for injection contains 2 mg epirubicin hydrochloride.
  • Other excipients are sodium chloride, hydrochloric acid (for pH adjustment), and water for injections.

What the medicine looks like and the contents of the pack

Epirubicin Rivopharm 2 mg/ml solution for injection is a clear, red solution.

Pack sizes

1 x 5 ml vial (10 mg in 5 ml)

1 x 10 ml vial (20 mg in 10 ml)

1 x 25 ml vial (50 mg in 25 ml)

1 x 50 ml vial (100 mg in 50 ml)

1 x 100 ml vial (200 mg in 100 ml)

One 5 ml bottle of Epirubicin Rivopharm 2 mgmt/pollution for injection contains 10 mg epirubicin hydrochloride equivalent to 9.35 mg epirubicin.

One 10 ml bottle of Epirubicin Rivopharm 2 mg/ml solution for injection contains 20 mg epirubicin hydrochloride equivalent to 18.7 mg epirubicin.

One 25 ml vial of Epirubicin Rivopharm 2 mg/ml solution for injection contains 50 mg epirubicin hydrochloride equivalent to 46.75 mg epirubicin.

One 50 ml vial of Epirubicin Rivopharm 2 mg/ml solution for injection contains 100 mg epirubicin hydrochloride equivalent to 93.5 mg epirubicin.

One 100 ml bottle of Epirubicin Rivopharm 2 mg/ml solution for injection contains 200 mg epirubicin hydrochloride equivalent to 187 mg epirubicin.

Marketing Authorization Holder and Manufacturer

Rivopharm Ltd.

17 Corrig Road

Sandyford, Dublin 18, Ireland

Agent

SanoSwiss UAB

Aukstaiciu str. 26A

LT-44169 Kaunas

Lithuania

+370 700 01320

info@sanoswiss.com

Muhammad Nadeem

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