• Farmarubicin is an injection that contains epirubicin hydrochloride. It belongs to a group of medicines called cytotoxics used for chemotherapy. Farmarubicincauses cells that are actively growing, such as cancer cells, to slow or stop their growth and increases the likelihood that they die. This medicine helps to selectively kill the cancer tissue rather than normal, healthy tissue.

• Farmarubicin is used to treat a variety of cancers, either alone or in combination with other drugs. The way in which it is used depends upon the type of cancer that is being treated.

• It has been found to be particularly useful in the treatment of cancers of the breast, ovaries, stomach, bowel and lung. In addition, this medicine can be given to treat cancers of the blood forming tissues such as malignant lymphomas, leukaemias and multiple myeloma.

• Farmarubicin can also be put directly into the bladder through a tube. This is sometimes used to treat abnormal cells or cancers of the bladder wall. It can be used after other treatments to try and prevent such cells from growing again.

You must talk to a doctor if you do not feel better or if you feel worse.

Do not use Farmarubicin:

• if you are allergic to epirubicin or any of the other ingredients of this medicine (listed in section 6) or similar chemotherapy drugs (anthracyclines or anthracenediones)
• if you have infections affecting multiple organs
• If you have urine infection
• if you have inflammation of the bladder
• if you have invasive tumours penetrating the bladder
• if you have catheterisation problems (your doctor has problems inserting a catheter (tube) into your bladder)
• if you have presence of  blood in urine
• if you have decreased ability to produce blood cells leading to low blood cell counts, as it can lower them further
• if you have previously been treated with Farmarubicinor similar chemotherapy drugs, as previous treatment with these medicines can increase the risk of side effects
• if you have suffered from recent heart attack, poor functioning of the heart muscle, severe irregular heartbeat pattern, sudden pain in the chest, non-inflammatory disease of the heart muscle or any other severe heart trouble in the past, or are presently receiving treatment for this
• if you have severe liver disease
• if you are pregnant or breast-feeding

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Farmarubicin:

• if your liver or kidneys are not working properly
• if you have had or you are due to have any vaccination
• if you are currently suffering from acute toxicities such as
  • acute inflammation of the mouth
  • low white blood cell count
  • low platelet count or
  • infections in general

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

Other medicines and Farmarubicin:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those obtained without a prescription, particularly the following:

• Cimetidine (a drug usually used to treat stomach ulcers and heartburn). Cimetidine can make the effects of Farmarubicin stronger
• Calcium channel blockers (medicines for the heart)
• Quinine (antimalaria drug)
• Antibiotics such as sulphonamide and chloramphenicol
• Antiretroviral (drugs used to treat infection by HIV)
• Diphenylhydantoin (a drug used to treat epilepsy)
• Painkillers such as amidopyrine derivate
• Trastuzumab therapy for treatment of cancer Your doctor should avoid using Farmarubicin for up to 27 weeks after stopping trastuzumab when possible. If Farmarubicin is  used before this time, careful monitoring of cardiac function is recommended
• Vaccination with a live vaccine should be avoided in patients receiving epirubicin
• Paclitaxel or docetaxel (drugs used to treat cancer).  When paclitaxel is given prior to epirubicin, it may increase concentration of epirubicin in blood. However when paclitaxel and docetaxel are given together and given after epirubicin, they did not affect concentration of epirubicin
• Dexverapamil (used to treat some heart conditions)
• Dexrazoxane (used to prevent chronic cumulative cardiotoxicity caused by epirubicin)
• Interferon α2b (used to treat cancers)

Pregnancy, breast-feeding 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 being given this medicine. Avoid becoming pregnant while you or your partner is being treated with this medicine. If you are sexually active, you are advised to use effective birth control to prevent pregnancy during treatment, whether you are male or female. It may cause birth defects, so it is important to tell your doctor if you think you are pregnant.

Breast feeding

You should stop breast feeding before starting treatment with this medicine as some of the drug may get into your milk and possibly harm your child.

Fertility

Men: There is a risk of sterility due to therapy with epirubicin and male patients should consider storage of sperm before treatment.

Women: Epirubicin may cause lack of menstrual cycles or premature menopause in premenopausal women.

Driving and using machines

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

Farmarubicin contains sodium

This medicinal product contains less than 1mmol sodium (23 mg) per dose, i.e. essentially sodium free.

If you are prescribed Farmarubicin it will only be given to you by doctors or nurses experienced in giving chemotherapy.

This medicine will normally be given to you by a doctor or a nurse through a drip (infusion) into a vein.  Your doctor will decide what dose to give and the number of days’ treatment you will receive depending on your condition.

The dose is decided by taking into account the condition you have, your height and weight.  From your height and weight the doctor will work out your body surface area, and it is this that your dose is calculated from.

Farmarubicin can also be put directly into the bladder to treat bladder cancer, or to help prevent it returning.  The dose depends on the type of bladder cancer you have. When this medicine is injected directly into the bladder, you will be instructed not to drink any fluid for 12 hours before treatment to avoid dilution of the medicine with urine in your bladder.

While one course of treatment may sometimes be enough, more often your doctor will advise further courses in three or four weeks’ time.  It may take several courses before your illness is under control and you feel better.

Regular checks by your doctor during Farmarubicin treatment

During treatment your doctor will be making regular checks of your:

• Blood - to check for low blood cell counts that may need treatment
• Heart function - heart damage can occur when high doses of Farmarubicin are given. This may not be detected for several weeks, so regular tests may be required during this period
• Liver – using blood tests to check that this medicine is not affecting the way it functions in a harmful way
• Blood uric acid levels – Farmarubicin may increase uric acid levels in the blood, which might cause gout.  Another medicine may be given if your uric acid levels are too high

If you receive high doses of Farmarubicin

High doses can worsen side effects like sores in the mouth or may decrease the number of white blood cells (which fight infection) and platelets (these help the blood to clot) in the blood. Should this happen, you may need antibiotics or blood transfusions. Mouth ulcers can be treated to make them less uncomfortable as they heal.

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

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

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

•                  Infections

•                  Eye inflammation with red eyes and watery eyes

•                  A low red blood cell count (anaemia) that can leave you feeling tired and lethargic

•                  White blood cell counts (which fight infection) can drop, which increases the chance of infections and fever; (leukopenia)

•                  Decreased thrombocytes (platelets in the blood that help the blood to clot) may occur, which could make you bruise or bleed when injured more easily

•                  Reduction in the number of certain types of white blood cells – granulocytes and neutrophiles (granulocytopenia and neutropenia)

•                  A reduction in certain types of white blood cells accompanied by fever (febrile neutropenia)

•                  Inflammation of the transparent part of the eye called cornea

•                  Hot flushes

•                  Inflammation of a vein

•                  Nausea

•                  Vomiting

•                  Inflammation of the mucous lining in the mouth

•                  Diarrhoea

•                  Hair loss

•                  Skin lesion

•                  Red coloured urine for 1 to 2 days after administration of epirubicin

•                  Absence of menstruation

•                  Painful inflammation and ulceration of the mucous membranes lining the digestive tract

•                  Feeling generally unwell

•                  Fever

•                  Changes in levels of some liver enzymes

•                  After direct administration of epirubicicn into the bladder, inflammation (cystitis) is possible

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

•           Reduced appetite/loss of appetite

•           Lose water or body fluids

•           Severe cardiac rhythm disorder (ventricular arrhythmia)

•           Cardiac impulse conduction disorders

•           Certain forms of heart rhythm disorders (AV block, bundle branch block)

•           Slow heartbeat (bradycardia)

•           Insufficient pumping of blood by the heart which can cause shortness of breath, accumulation of fluid, and abnormal heart rhythm.

•           Bleeding

•           Redness of the skin

•           Pain behind the breastbone, indigestion, and difficulty in swallowing due to inflammation in the oesophagus

•           Pain or burning in the gastrointestinal tract

•           Inflammation of the mucous membrane of the gastrointestinal tract

•           Ulcers in the gastrointestinal tract

•           Rash, itching

•           Abnormal discolouration of nails

•           Skin changes

•           Abnormal discolouration of skin

•           Frequent urination

•           Redness at the infusion site

•           Chills

•           Local reactions such as burning sensation

•           Reduced heart function

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

•           High fevers, chills, general malaise, possible cold arms or legs due to blood poisoning

•           Lung infection (pneumonia)

•           Certain types of cancer of the blood (acute lymphatic leukaemia, acute myeloid leukaemia)

•           Certain types of cancer of the blood (acute lymphatic leukaemia, acute myeloid leukaemia)

•           Blockage in a blood vessel

•           Swelling and pain in the legs or arms due to inflammation of a blood vessel, possibly including blood clotting

•           Blood clots in the lungs which causes chest pain and breathlessness

•           Gastrointestinal tract bleeding

•           Hives

•           Skin redness

•           Feeling of weakness

Please contact your doctor or nurse immediately if you notice any of the following side effects.

Although they are rare these symptoms can be serious:

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 trouble breathing

•           Increased level of uric acid in the blood.

•           Heart damage (cardiotoxicity)

•           Absence of sperm cells in the sperm

•           Light headedness

Not known: (frequency cannot be estimated from the available data)

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

•           Life-threatening condition where the blood pressure is too low

•           Insufficient oxygen supply to the tissue due to inhibited blood cell production in the bone marrow

•           Appearance of dark spots inside the mouth

•           Abdominal discomfort

•           Skin redness or other reactions similar to scalding when exposed to sunlight or ultraviolet rays

•           Changes in the skin where you previously received radiation treatment

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side affects you can help provide more information on the safety of this medicine.

To report any side effects:

·        The unopened vials should be stored in the original container until ready for use. Store at 2° to 8°C (in a refrigerator). Do not freeze.

• Keep out of the sight and reach of children.

·        Farmarubicin should not be used after the expiry date printed on the box and on the vial label after EXP. The expiry date refers to the last day of that month. The pharmacist will check this when your medicine is prepared for you. If the solution is cloudy after preparation, the pharmacist will dispose of it safely.

·        Shelf life: 36 months.

Shelf life after first opening the container:

FarmarubicinSolution for Injection does not contain a preservative or bacteriostatic agent. Vials are, therefore for single use only and any unused portion must be discarded after use.