Epirubicin Aurovitas 2 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Epirubicin Aurovitas 2 mg/ml injection solution EFG

Epirubicin hydrochloride

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Epirubicin Aurovitas is and what it is used for
2. What you need to know before using Epirubicin Aurovitas
3. How to use Epirubicin Aurovitas
4. Possible adverse effects
5. How to store Epirubicin Aurovitas
6. Contents of the pack and other information

1. What Epirubicin Aurovitas is and what it is used for

Epirubicin is an anticancer medication. Sometimes, treatment with an anticancer drug is called chemotherapy. Epirubicin belongs to a group of medicines known as anthracyclines. These medicines act on actively growing cells, slowing down or stopping their growth, and increasing the likelihood of cell death.

Epirubicin is used to treat several types of cancer. The way it is used depends on the type of cancer 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 catheter, epirubicin is used to treat cancer of the bladder wall. It may also be used after other treatments to prevent these cells from growing again.

2. What you need to know before using Epirubicina Aurovitas

Do not use Epirubicina Aurovitas

• If you are allergic to epirubicin hydrochloride or to 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 drugs called anthracyclines, such as doxorubicin or daunorubicin).
• If you are allergic to medicines belonging to the anthracenedione group (including medicines used to treat cancer).
• If you are breastfeeding.

Epirubicin must not be injected into a vein (intravenous route) if:

• You know that your blood cell count is low due to previous treatment with other anticancer drugs or radiotherapy.
• You are being treated with other chemotherapeutic agents at maximum doses such as epirubicin and/or other anthracyclines (such as doxorubicin or daunorubicin) and anthracenediones, which may increase the risk of adverse effects.
• You have or have had heart problems.
• You have a serious acute infection.
• You have severe liver problems.

Epirubicin must not be injected into the bladder if:

• You have a urinary tract infection (including kidneys, bladder, or urethra).
• There are tumours invading the bladder.
• There are difficulties placing the catheter into the bladder.
• You have inflammation of the bladder.
• You have blood in the urine (haematuria).

Warnings and precautions

Talk to your doctor before starting Epirubicina Aurovitas:

• If you have liver or kidney problems.
• If you have been given or are due to receive any vaccine.

You must inform your doctor before starting treatment, as extra caution is required.

Your doctor will also carry out regular blood tests:

• To ensure that your blood cell count does not become too low.
• To monitor levels of uric acid and other factors in the blood.
• To check that your heart and liver are functioning normally.
• If you have received or are due to receive radiotherapy to the area near the heart.

You should inform your doctor if you experience swelling and pain in the mouth or mucosa.

It is possible for your urine to appear red for one or two days after administration.

Children

There is no data available on safety and efficacy in children.

Other medicines and Epirubicina Aurovitas

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines. In particular:

• Cimetidine (used to reduce stomach acidity).
• Trastuzumab (used in the treatment of cancer), which may take up to 7 months to be eliminated from the body. Since trastuzumab can affect the heart, epirubicin must not be used until 7 months after completing trastuzumab treatment. If epirubicin is used before this time, cardiac function must be closely monitored.
• Paclitaxel and docetaxel (used in certain types of cancer).
• Interferon alfa-2b (used in certain types of cancer and lymphoma, and in certain types of yellow fever).
• Quinine (used to treat malaria and leg cramps).
• Dexverapamil (used to treat certain heart conditions).
• Medicines that may 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).
• Medicines that may affect the liver.
• Live vaccines.
• Other medicines that may affect the bone marrow (such as other cancer treatments), sulfonamides and chloramphenicol (antibacterial medicines), phenytoin (antiepileptic), amidopyrine derivatives (some medicines used, for example, to treat pain and fever), and certain antiviral medicines.
• Dexrazoxane (a medicine used to prevent chronic cardiac toxic effects caused by epirubicin).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

Epirubicin may cause birth defects when used during pregnancy. It is important that you inform your doctor if you are pregnant or become pregnant during treatment. You must not use epirubicin during pregnancy unless clearly instructed by your doctor.

If you or your partner are being treated with epirubicin, you are advised to use an effective method of contraception to prevent pregnancy. If you become pregnant during treatment or wish to have children after treatment ends, genetic counselling is recommended.

Breastfeeding

Epirubicin may be harmful to breastfed infants. Therefore, women must stop breastfeeding before starting treatment with epirubicin and for at least 7 days after the last dose.

Fertility

There is a risk of infertility due to treatment with epirubicin. Male patients should consider the possibility of sperm preservation before treatment.

Epirubicin may cause absence of menstruation or premature menopause in premenopausal women.

Both men and women should seek advice on fertility preservation before treatment. Women of childbearing age must use effective contraceptive methods during treatment with epirubicin and for at least 6.5 months after the last dose. Men must use effective contraceptive methods during treatment and for at least 3.5 months after the last dose.

Driving and use of machines

Epirubicin may cause episodes of nausea and vomiting, which may temporarily reduce your ability to drive or operate machinery.

Epirubicina Aurovitas contains sodium

This medicine contains 0.154 mmol of sodium (3.54 mg) per ml of injectable solution. The different pack sizes of Epirubicina Aurovitas contain the following amounts of sodium:

25 ml vial: this medicine contains 88.55 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 4.43% of the maximum daily recommended sodium intake for an adult.

50 ml vial: this medicine contains 177.1 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 8.86% of the maximum daily recommended sodium intake for an adult.

100 ml vial: this medicine contains 354.21 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 17.71% of the maximum daily recommended sodium intake for an adult.

This medicine may be prepared for administration with solutions containing sodium. Inform your doctor if you are on a low-salt (sodium) diet.

3. How to use Epirubicina Aurovitas

Epirubicin will be administered to you by a doctor or nurse, either into a vein or directly into the bladder. Your doctor will decide the correct dose and the number of days you will receive treatment, depending on the type of cancer you have, your general health, height, weight, liver function, and any other treatments you may be receiving.

By injection or intravenous infusion

Epirubicin may be given by injection into a vein over 3–5 minutes. It may also be diluted and then slowly infused, usually by intravenous drip over 30 minutes.

Administration into the bladder

If the injection is administered into the bladder, you must not drink any liquids during the 12 hours before treatment, so that urine does not excessively dilute the medicine. After administration, the solution should remain in the bladder for 1–2 hours. You may sometimes need to change position to ensure the medicine reaches all parts of the bladder.

You must take care to avoid contact between the bladder contents and your skin when urinating. If skin contact occurs, wash the affected area thoroughly with soap and water, without rubbing.

Your doctor will perform regular blood tests to detect any unwanted effects. To monitor for possible heart damage, your doctor will also check your heart function for several weeks after treatment has ended.

If you are given more Epirubicina Aurovitas than you should

It may affect the heart, reduce the number of blood cells, and cause gastrointestinal problems (mainly mucositis). You may notice the development of mouth sores. However, since this medicine will be administered while you are in the hospital, it is unlikely that you will receive too little or too much.

If you are given more epirubicin than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount administered.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If any of the following adverse effects occur when epirubicin is administered by intravenous infusion, inform your doctor immediately, as these are very serious adverse effects. You may require urgent medical attention:

• If you develop redness, pain, or swelling at the injection site; tissue damage may occur if the drug is accidentally injected outside the vein.
• If you experience symptoms of heart problems or blood clots in the lungs, such as chest pain, shortness of breath, or ankle swelling (these effects may occur up to several weeks after completing epirubicin treatment).
• If you have a severe allergic reaction, with symptoms including fainting, skin rash, facial swelling, difficulty breathing or wheezing. In some cases, you may collapse.
• Fever, with body temperature rising above 41°C (hyperpyrexia).

If you experience any of the following adverse effects, inform your doctor as soon as possible:

Very common: may affect more than 1 in 10 people

• Infection.
• Suppression of blood cell production in the bone marrow (myelosuppression), decreased number of white blood cells (leukopenia), decreased number of a specific type of white blood cells (granulocytopenia and neutropenia), decreased number of red blood cells (anemia), low levels of certain white blood cells accompanied by fever (febrile neutropenia), decreased number of platelets (thrombocytopenia).
• Inflammation of a mucous membrane (mucositis), inflammation inside the mouth (stomatitis), malaise (vomiting), watery or frequent bowel movements (diarrhea), feeling unwell (nausea), which may lead to loss of appetite and abdominal pain.
• Hair loss, usually reversible, reduced beard growth.
• Red discoloration of the urine for 1 or 2 days after administration.
• Absence of menstruation.
• Red eyes (conjunctivitis), inflammation of the cornea of the eye (keratitis).
• Hot flushes.
• Skin damage.
• Inflammation of a vein (phlebitis).
• Feeling unwell, fever.
• Changes in levels of certain liver enzymes (called transaminases).
• Bladder infection (chemical cystitis) has been observed after administration into the bladder, sometimes with blood in the urine.

Common: may affect up to 1 in 10 people

• Loss of water (dehydration).
• Impaired heart function (congestive heart failure). Symptoms may include:
  • Difficulty breathing (dyspnea).
  • Fluid accumulation in the legs (edema).
  • Enlargement of the liver.
  • Fluid accumulation in the abdominal cavity (ascites).
  • Fluid accumulation in the lungs (pulmonary edema).
  • Fluid accumulation between the chest and lungs (pleural effusions).
  • Third heart sound (gallop rhythm).
• Local skin toxicity, skin rash, itching, increased pigmentation of the skin and nails, skin changes.
• Redness along the vein (erythema at the infusion site).
• Bleeding.
• Redness of the skin.
• Chills.
• Reduced/loss of appetite.
• Asymptomatic changes in heart function (asymptomatic decreases in left ventricular ejection fraction).
• Potentially life-threatening irregular heartbeats (ventricular tachycardia), decreased heart rate, disturbances in the conduction of heart impulses (atrioventricular block, bundle branch block).
• After administration into the bladder, bladder infection (bacterial cystitis), pain or burning during urination, frequent need to urinate have been observed.
• Ulcers in the gastrointestinal tract, erosions and gastric lesions, gastrointestinal bleeding, pain behind the breastbone, indigestion and difficulty swallowing due to esophageal inflammation, pain or burning in the gastrointestinal tract, inflammation of the mucous membrane of the gastrointestinal tract and inside the mouth with burning sensation and pain.

Uncommon: may affect up to 1 in 100 people

• Certain types of blood cancer (acute lymphocytic leukemia, acute myeloid leukemia).
• Blood poisoning (sepsis), lung infection (pneumonia).
• Feeling of weakness (asthenia).
• Redness of the skin (erythema), hives.
• Blockage in a blood vessel.
• Inflammation and pain in the arms or legs due to inflammation of a blood vessel possibly caused by a blood clot.
• Formation of blood clots in the lungs causing chest pain and difficulty breathing.

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

• Sudden potentially life-threatening allergic reaction. Symptoms include sudden signs of allergy such as skin rash, itching or hives, swelling of the face, lips, tongue or other parts of the body, dyspnea, wheezing or difficulty breathing, allergic reactions after administration of the medicine into the bladder.
• Increased levels of uric acid in the blood.
• Dizziness.
• Toxic effects on the heart, such as abnormalities in the ECG (electrocardiogram), different types of irregular heartbeats (arrhythmias), or disease of the heart muscle (cardiomyopathy).
• Absence of sperm in semen.

Frequency not known: cannot be estimated from available data

• Potentially life-threatening condition occurring when blood pressure is too low due to blood poisoning (septic shock).
• Potentially life-threatening condition in which blood pressure is too low (shock).
• Rapid decrease in blood pressure, sometimes with skin reactions or rash.
• Inadequate tissue oxygenation may occur as a result of suppression of blood cell production in the bone marrow (myelosuppression).
• Blockage of a blood vessel by a blood clot (thromboembolism).
• Thickening of the walls of veins, local pain, severe cellulitis.
• Increased pigmentation of the oral mucosa.
• Increased sensitivity to light (photosensitivity), hypersensitivity of irradiated skin (radiation recall reaction).
• Severe tissue damage following leakage of the injectable solution into surrounding tissue.
• Headache.
• Pain.

If epirubicin hydrochloride is injected directly into the bladder, you may experience pain or difficulty urinating. You may also notice blood in the urine.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Epirubicin Aurovitas

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

Store in a refrigerator (between 2°C and 8°C).

Keep the vial in the outer packaging to protect it from light.

Do not use this medicine after the expiry date stated on the carton and label, following EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Epirubicin Aurovitas

• The active substance is epirubicin hydrochloride. Each millilitre of injectable solution contains 2 mg of epirubicin hydrochloride.
• The other components are sodium chloride, hydrochloric acid (for pH adjustment) and water for injections.

Appearance of the product and contents of the container

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

Pack sizes:

1 vial of 25 ml (50 mg/25 ml)

1 vial of 50 ml (100 mg/50 ml)

1 vial of 100 ml (200 mg/100 ml)

A 25 ml vial of Epirubicin Aurovitas 2 mg/ml solution for injection EFG contains 50 mg of epirubicin hydrochloride, equivalent to 46.75 mg of epirubicin.

A 50 ml vial of Epirubicin Aurovitas 2 mg/ml solution for injection EFG contains 100 mg of epirubicin hydrochloride, equivalent to 93.5 mg of epirubicin.

A 100 ml vial of Epirubicin Aurovitas 2 mg/ml solution for injection EFG contains 200 mg of epirubicin hydrochloride, equivalent to 187 mg of epirubicin.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium:	Epirubicin Eugia 2 mg/ml solution for injection
Spain:	Epirubicin Aurovitas 2 mg/ml solution for injection
Portugal:	Epirubicin Aurovitas

Date of the most recent review of this leaflet: August 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended solely for healthcare professionals:

Epirubicina Aurovitas 2 mg/ml solution for injection EFG

Instructions for use

ANTINEOPLASTIC MEDICINE

Incompatibilities

Prolonged contact with alkaline pH solutions (including solutions containing bicarbonates) should be avoided, as they cause hydrolysis of the medicine. Only the diluents specified in the section “Instructions for use” should be used.

The injectable solution and any diluted solution must not be mixed with any other medicine. Physical incompatibility has been reported with heparin.

Epirubicin must not be mixed with other medicines.

Instructions for use

Intravenous administration: it is recommended that the medicine be administered through the tubing of an intravenous saline infusion under uniform flow (0.9% sodium chloride). To minimize the risk of thrombosis or perivenous extravasation, typical infusion times range between 3 and 20 minutes, depending on the dose and volume of the infusion solution. Direct injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return when aspirating with a needle.

Intravesical administration: prior to administration, Epirubicina Aurovitas must be diluted in sterile water for injection or in sterile 0.9% saline solution. Epirubicin should be instilled using a catheter and must be retained in the bladder for 1–2 hours. During instillation, the patient should change position to ensure complete contact of the solution with the pelvic bladder mucosa. To avoid excessive dilution of urine, patients should be instructed not to drink any fluids during the 12 hours prior to instillation. Patients should be advised to urinate immediately after the instillation period ends.

The injectable solution does not contain preservatives and any unused portion from the vial must be discarded immediately.

Guidelines for safe handling and disposal of antineoplastic medicines:

1. The preparation of an infusion solution must be carried out by trained personnel under aseptic conditions.

2. The preparation of an infusion solution must be performed in a designated aseptic area.

3. Disposable protective gloves, protective goggles, gown, and appropriate mask must be worn.

4. Care must be taken to avoid accidental contact of the medicine with the eyes. In case of eye contact, rinse thoroughly with water and/or 0.9% sodium chloride solution. Then consult a physician for clinical evaluation.

5. In case of skin contact, wash the affected area thoroughly with water and soap or with sodium bicarbonate solution. However, do not scrub the skin with a brush. Always wash hands after removing gloves.

6. Spills or leaks should be treated with a diluted sodium hypochlorite solution (1% available chlorine), preferably by first soaking and then rinsing with water. All cleaning materials must be discarded as described below.

7. Pregnant female personnel must not handle cytotoxic preparations.

8. Care and appropriate precautions must be taken when disposing of materials (syringes, needles, etc.) used to reconstitute and/or dilute cytotoxic medicines. Disposal of unused medicine or waste material must comply with local requirements.

Storage conditions

Medicinal product in the packaging for supply:

Store in a refrigerator (between 2°C and 8°C). Keep the vial in the outer packaging to protect it from light.

After first opening of the container:

From a microbiological standpoint, the product should be used immediately after the first puncture of the rubber stopper. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user.

After dilution of the injectable solution:

The product should be used immediately after the first puncture of the rubber stopper. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user.

For further information, consult the Summary of Product Characteristics for Epirubicina Aurovitas 2 mg/ml solution for injection EFG.