2 mg / ml solution for injection / infusion 
epirubicin hydrochloride

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

-Save this leaflet, you may need to read it again.

-If you have any further questions, ask your doctor, pharmacist, or nurse.

-If you get any side effects, talk to your doctor, pharmacist, or nurse. 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 Accord is and what it is used for 
2. What you need to know before you are treated with Epirubicin Accord 
3. How to get Epirubicin Accord 
4. Possible side effects 
5. How to store Epirubicin Accord 
6 Contents of the package and other information 

What Epirubicin Accord is and what it is used for

The medicine you have been prescribed is called ‘Epirubicin Accord 2 mg/ml, solution for injection/infusion, but in the continuation of this leaflet it will be called’ Epirubicin Accord ‘.

What is Epirubicin Accord?

Epirubicin Accord is a cancer medicine. Drugs used to treat cancer are often called chemotherapy drugs. Epirubicin Accord 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.

What is Epirubicin Accord used for?

Epirubicin Accord is used for different types of cancer alone or in combination with other medicines. How it is used depends on the type of cancer being treated.

Epirubicin Accord is used to treat breast and stomach cancer.

Epirubicin Accord is used to treat abnormal cells or cancer of the bladder, by injecting it into the bladder via a catheter. It can also be used after other treatments to prevent relapse.

Contact a doctor if you do not feel better or if you feel worse.

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

2. What you need to know before you are treated with Epirubicin Accord

Do not use Epirubicin Accord

-if you are allergic to epirubicin or any of the other ingredients of this medicine (listed in section 6) or similar chemotherapy medicines ( anthracyclines or anthracenediones)

-if you are pregnant or breastfeeding

-if you know you have low blood levels, then Epirubicin Accord may lower these further

-if you have a severe liver disease

-if you have recently had a heart attack, impaired heart muscle function, very irregular heartbeat, sudden chest pain, non-inflammatory heart muscle disease, or have previously had other severe heart problems, or if you are currently receiving treatment for this.

-If you have been treated with epirubicin Accord or similar chemotherapeutic agents, as previous treatment with these drugs may increase the risk of side effect s

-if you have an infection that affects several organs

-if you have a urinary tract infection

-if you have inflammation of the bladder

-if you have invasive tumors that have penetrated the bladder

-if it is difficult to insert a catheter into your bladder

-if you have blood in your urine

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Epirubicin Accord:

• if the liver or kidneys are not working properly

• if you have received or will soon receive a vaccination

• if you currently have acute poisonings such as

  • acute inflammation of the mouth
  • low white blood cell count
  • low platelet count
  • the infection you in general

This will help your doctor decide if this medicine is right for you.

Use of other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, in particular the following.

  • cimetidine (commonly used to treat stomach ulcers and heartburn). Cimetidine may potentiate the effect of Epirubicin Accord.
  • calcium channel blockers
  • interferon α2b (used to treat cancer)
  • quinine (anti-malarial drug )
  • antibiotics, e.g. sulfonamide and chloramphenicol
  • antiretroviral drugs (used to treat HIV infection )
  • diphenylhydantoin (used to treat epilepsy )
  • analgesics , eg amidopyrine derivatives
  • dexverapamil (used to treat certain heart conditions)
  • trastuzumab for cancer treatment Your doctor should, if possible, avoid using Epirubicin Accord for up to 27 weeks after stopping trastuzumab treatment. If Epirubicin Accord is used within this period, close monitoring of cardiac function is recommended
  • dexrazoxane (used to prevent heart problems caused by epirubicin)
  • Vaccination with a live vaccine should not be given to patients receiving epirubicin
  • paclitaxel or docetaxel (medicines used to treat cancer). When paclitaxel is given before epirubicin, it may increase the concentration of epirubicin in the blood. However, when paclitaxel and docetaxel are co-administered with epirubicin, they do not affect the concentration of epirubicin.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. You should avoid getting pregnant while you or your partner are being treated with this medicine. If you are sexually active, you should use an effective contraceptive to prevent pregnancy during treatment, whether you are male or female. This medicine can cause malformations, so you must tell your doctor if you think you may be pregnant.

Breast-feeding

You should stop breast-feeding before starting treatment with this medicine as some of the medicines may reach breast milk and possibly harm the baby.

Fertility

Men: There is a risk of sterility as a result of treatment with epirubicin and male patients should consider saving sperm before treatment.

Women: Epirubicin can lead to missed menstrual cycles or premature menopause(the last period) in women who have not reached menopause.

Driving and using machines

There are no special precautions, so long as you feel fully recovered after the hospital treatment and you have discussed this with your doctor.

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 Accord contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per ml, ie essentially ‘sodium-free’.

3. How to get Epirubicin Accord

If you have been prescribed Epirubicin Accord, you will only be given it by doctors or nurses who have experience in providing chemotherapy 

This medicine is usually given by a doctor or nurse in the form of a drip ( infusion ) into a vein. Based on your condition, your doctor will determine the dose you should receive and the number of treatment days.

Your doctor will determine the dose by taking into account your condition, your height, and weight. With the help of your height and weight, the doctor calculates your body surface area and based on this, dose one is calculated.

Epirubicin Accord can also be given directly into the bladder to treat bladder cancer or to prevent it from recurring. Dose one depends on the type of bladder cancer you have. When the medicine is given directly into the bladder, do not drink any liquid for 12 hours before treatment. This is so that the urine does not dilute the medicine in the bladder.

Although a treatment regimen is sometimes sufficient, the doctor usually recommends additional treatments at three or four-week intervals. Several treatment courses may be required before the disease is under control and you feel better.

Examinations performed regularly during treatment with Epirubicin Accord

During treatment, your doctor will regularly examine:

  • your blood – to check whether you need treatment for low blood cell s
  • your heart function – high doses of Epirubicin Accord can damage the heart. A heart injury can only appear after many weeks of treatment, and therefore heart function should be examined regularly
  • your liver blood test is taken to check that this medicine does not adversely affect liver function
  • uric acid level in the blood – Epirubicin Accord may increase the blood uric acid content and thus cause gout. If the uric acid content is too high, your doctor may prescribe you another medicine instead.

If you take more Epirubicin Accord then you should

High doses can intensify side effects, such as mouth ulcers, or reduce the number of white blood cells (fighting infections ) and platelets (helps with blood clotting). If this happens, you may need antibiotics or blood transfusions. There is a treatment for sores in the mouth, which reduces the discomfort during recovery.

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, Epirubicin Accord can cause side effects, although not everybody gets them.

The most serious side effects are

If you experience any of the following side effects, tell your doctor immediately as you may need urgent medical attention or hospitalization:

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

  • Decreased white blood cell count (which fights infection ), which increases the risk of infection and fever ( leukopenia )
  • Decreased platelet count ( platelets that help the blood to coagulate), which can make it easier for you to get bruises or bleeding if you injure yourself
  • Reduction of certain types of white blood cells – granulocytes and neutrophils ( granulocytopenia and neutropenia )
  • The decrease in certain types of white blood cells accompanied by fever (febrile neutropenia )
  • Inflammation of the transparent part of the eye called the cornea
  • High fever

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

  • Bleeding
  • Redness at the infusion site

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

  • Certain types of blood cancer ( acute lymphocytic leukemia, acute myeloid leukemia )
  • Pneumonia ( CAP )
  • Blockage in a blood vessel
  • Swelling and pain in the arms and legs due to inflammation in a blood vessel, possibly including a blood clot
  • Blood clots in the lungs leading to chest pain and shortness of breath

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

  • Sudden life-threatening allergic reaction. Symptoms include sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing.
  • Heart damage (cardiac toxicity)

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

  • A life-threatening condition that occurs when blood pressure is too low due to blood poisoning ( septic shock )

Other side effects ar

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

  • Infection is
  • Eye inflammation with red and watery eyes
  • The low number of red blood cells ( anemia ) can make you feel tired and lacking energy
  • Hot flashes
  • Inflammation in a friend
  • Nausea
  • Vomiting
  • Inflammation of the oral mucosa
  • Diarrhea
  • Hair loss
  • Skin damage
  • Red urine for 1 to 2 days after administration of epirubicin
  • Absence of menstruation
  • Painful inflammation and ulceration of the lining of the digestive tract
  • General malaise
  • Altered levels of certain liver enzymes
  • After direct administration of epirubicin into the bladder, inflammation ( cystitis ) may occur

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

  • Decreased appetite / no appetite
  • Reduced amount of water or body fluids
  • Severe cardiac arrhythmia ( ventricular arrhythmia )
  • Disorders in the conduction of cardiac impulses
  • Certain types of arrhythmias (AV block, branch block)
  • Slow heartbeat ( bradycardia )
  • The heart pumps insufficient blood which can lead to shortness of breath, fluid retention, and abnormal heart rhythm
  • Reddening of the skin
  • Pain behind the sternum, indigestion, and difficulty swallowing due to inflammation of the esophagus
  • Pain or burning sensation in the gastrointestinal tract
  • Inflammation of the lining of the gastrointestinal tract
  • Ulceration of the gastrointestinal tract
  • Rash, itching
  • Abnormal discoloration of the nails
  • Skin changes
  • Abnormal discoloration of the skin
  • Frequent urination
  • Overindulge
  • Local reactions such as burning
  • Impaired heart function

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

  • High fever, chills, general malaise, possibly cold arms or legs due to blood poisoning
  • Bleeding in the gastrointestinal tract
  • Hives
  • Reddening of the skin
  • Feeling weak

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

  • The increased amount of uric acid in the blood
  • Absence of sperm cells in the semen
  • Feeling unsteady

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

  • The emergence of dark spots in the mouth
  • Discomfort in the abdomen
  • Reddening of the skin or other reactions similar to scalding on exposure to sunlight or ultraviolet rays
  • Changes in the skin where you have previously received radiation treatment

5. How to store Epirubicin Accord

Store in a refrigerator (2 ºC-8 ºC). Do not freeze.

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

Always keep Epirubicin Accord in a safe place out of the reach and sight of children.

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.

Do not use Epirubicin Accord if there are visible deteriorations.

The medicine 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 in Epirubicin Accord is epirubicin hydrochloride.

One ml contains 2 mg of epirubicin hydrochloride.

The other ingredients are sodium chloride, hydrochloric acid, and water for injections.

What the medicine looks like and the contents of the pack

Epirubicin Accord is a clear, red solution.

Pack sizes :

1 x 5 ml vial (10 mg / 5 ml)

1 x 10 ml vial (20 mg / 10 ml)

1 x 25 ml vial (50 mg / 25 ml)

1 x 50 ml vial (100 mg / 50 ml)

1 x 100 ml vial (200 mg / 100 ml)

5 and 10 ml vials: type I cylinder glass vial with a 20 mm (RTS) chlorobutyl rubber stopper and a white aluminum cap.

25 ml vial: type I cylinder glass vial with a 20 mm (RTS) chlorobutyl rubber stopper and a white/clear blue aluminum cap.

50 ml vial: clear type I glass vial with a 20 mm (RTS) chlorobutyl rubber stopper and a clear blue aluminum cap.

100 ml vial: type I clear glass vial with a 20 mm (RTS) chlorobutyl rubber stopper and a white/clear blue aluminum cap.

Pack size: 1 vial

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited

Sage House,

319, Pinner Road,

North Harrow,

Middlesex,

HA1 4HF,

UK 

or

Laboratories FUNDACIO DAU,

C / From letter C, 12-14,

Poligono Industrial de la Zona Franca,

08040 Barcelona,

Spain

or

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

or

Accord Healthcare BV 
Winthontlaan 200 
3526 KV Utrecht The 
Netherlands

Muhammad Nadeem

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