LV

•    If you suffer from severe heart muscle disease (cardiomyopathy)

•    if you have an irregular heart beat (arrythmia)

•    if you have had previous treatment at maximum doses with idarubicin and/or any other similar medicines such as daunorubicin ordoxorubidn

•    if you are breast feeding (see 'Pregnancy and breast-feeding')

•    if you have taken the yellow fever vacdne.

Idarubicin Hydrochloride 1 mg/ml Solution for Injection is given to you with special care in case of one of the following conditions:

•    Your doctor may wish to delay your next course of treatment until your blood has recovered. You will have regular blood tests to check this.

•    Idarubidn Hydrochloride 1 mg/ml solution for injection may cause harm to your heart, if you have suffered from heart trouble in the past, or are presently receiving treatment, please make sure your doctor knows. You may have regular tests to check the functions of the heart, priorto and during treatment with Idarubidn.

•    infants and children seem to be more sensitive to heart damage caused by antracyciins

•    idarubidn may harm an unborn baby. You are advised to use effective birth control whether male or female, to prevent pregnancy during treatment with Idarubicin (see 'Pregnancy and breast-feeding').

•    Problems with kidneys or liver.

Your doctor will be making regular checks as follows:

•    Blood tests to make sure there are enough blood ceils for your blood to function

•    Blood tests to check for uric acid levels

•    Heart tests since idarubidn can affect your heart

•    Blood tests to check your liver is working properly; Idarubicin can affect the liver.

Your urine may have a red colour for 1 to 2 days after treatment with idarubicin. Please check with your doctor or pharmacist in case you have any questions or are worried about the colour of your urine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, induding medicines obtained without a prescription.

in particular, you should tell your doctor if you are taking or have recently taken any of the following medicines:

•    other medicines against cancer affecting the bone marrow function

•    immunosuppressant medicines (such as cydosporine)

•    live vaccines like yellow fever vaccine

•    medicines for heart diseases (e.g. calcium channel blockers)

•    potentially cardiotoxic (harmful to the heart) medicines (e.g. cydophosphamide)

•    medicines affecting your liver or kidney function

•    medicines used to prevent blood clotting (e.g. acenocoumarol)

•    medicines used to treat convulsions (e.g. phenytoin and fosphenytoin).

The following information is intended for healthcare professionals only:

The following protective recommendations are given due to the ■ toxic nature of this substance:    ¹

*    This product should be handled only by personnel who have been trained in the safe handling of such preparations

*    Pregnant staff should be excluded from working with this drug

*    Personnel handling Idarubicin Hydrochloride 1 mg/ml Solution for Injection should wear protective clothing: goggles, gowns and disposable gloves and masks

*    All items used for administration or cleaning, including gloves, should be placed in high risk, waste-disposal bags for high temperature incineration

*    The solution is hypotonic and the recommended administration procedure described below must be followed.

Intravenous administration:

Idarubicin Hydrochloride 1 mg/ml Solution for Injection must be administered only by the intravenous route. A slow administration over 5 to 10 minutes via the tubing of a freely running intravenous infusion of sodium chloride 9 mg/ml (0.9 %) solution for infusion must be followed. A direct push injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return upon needle aspiration.

Spillage or leakage should be treated with dilute sodium hypochlorite (1 % available chlorine) solution, preferably by soaking, and then with water.

All cleaning materials should be disposed of as indicated previously. Accidental contact with the skin and eyes should be treated immediately by copious lavage with water, or sodium bicarbonate solution, medical attention should be sought.

Discard any unused solution.

Q POSSIBLE SIDE EFFECTS

Like all medicines, Idarubicin Hydrochloride 1 mg/ml Solution for injection can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare the symptoms can be severe.

•    You may have allergic reactions such as feel dizzy, feverish, short of breath with a tight chest, with or without an itchy rash

•    You have an inflammation of the pericardium (the fibrous sac surrounding the heart), inflammation of the heart muscle, a disease of the electrical system of the heart

•    A condition in which a blood clot that has formed inside a blood vessel or inside the heart, redness of the skin, typically over the cheeks or neck

•    Stomach ulcer (abdominal pain or burning sensation).

•    Hand foot syndrome (tingling, redness, flaking, swelling or small sores on the palms of the hands or soles of the feet)

•    Anaemia (low red cells) that can leave you feeling tired and lethargic

•    Leukopenia (low white cells) leading to increased chance of infections with symptoms of raised temperature or fever and chills (like flu)

•    Thrombocytopenia (low platelets, these help the blood to clot). You may bruise more easily or bleed more than usual if you hurt yourself.

•    Tumour lysis syndrome (severe infections can occur after treatment with idarubidn alone or in combination with other medicines, and may be fatal).

The following side effects have been reported at the approximate frequencies shown: Very common: may affect more than 1 in 10 people

•    Infections

•    Decrease in number of red blood cells, reduced numbers of white blood cells, abnormally low amount of platelets

•    A lack or loss of appetite for food

•    Feeling sick or being sick, the painful inflammation and ulceration of the mucous membranes lining the digestive tract, diarrhoea, stomach ache

•    Hair loss

•    Red colouration of urine

•    Fever (rise in temperature)

•    Headache

•    Chills.

Common: may affect up to 1 in 10 people

•    Increase or decrease in heart rate, irregular heart beat/pulse, heart failure, heart attack

•    Inflammation of the vein, swelling (inflammation) of a vein caused by a blood clot

•    Bleeding from the intestines, bellyache

•    Liver enzyme elevation

•    Rash, itch

•    Haemorrhages

•    Increased sensitivity of irradiated skin 'radiation recall reaction'.

Uncommon: may affect up to 1 in 100 people

•    Blood infection, bacteria in the blood

•    Cancers of blood such as secondary leukaemia or unfavourable leukaemia (acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS))

•    Painful joints due to increased uric acid levels in your blood (gouty arthritis)

•    ECG changes

•    Shock

•    inflammation of the oesophagus, inflammation of the colon

•    Darkening of the skin and nails

•    Excessive loss of body fluid

•    Spreading of bacterial infection below the skin surface and tissue damage

•    Heart attack

•    Hives.

Rare: may affect up to 1 in 1000 people

•    Stroke.

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

•    Serious allergic reaction

•    inflammation of the pericardium (the fibrous sac surrounding the heart), defect in the heart's electrical system

•    Minor ulceration of the gastric mucosa

•    Hand foot syndrome

•    inflammation of covering of the heart and heart muscle

•    Thromboembolism

•    Flush.

Unknown frequency:

•    Change in certain chemicals in the blood

•    Abnormally low levels of all blood cells produced by the bone marrow

•    Local skin reaction.

if any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

©HOW TO STORE IDARUBICIN HYDROCHLORIDE 1 mg/ml SOLUTION FOR INJECTION

Keep out of the sight and reach of children.

This medicine should not be used after the expiry date which is stated on the carton.

The expiry date refers to the last day of that month.

Store in a refrigerator (2°C to 8°C) and in the original packaging in order to protect from light.

When the vials are opened, the product should be used immediately. Any unused product should be discarded.

Do not use Idarubicin Hydrochloride 1 mg/ml Solution for injection if you notice any visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Q FURTHER INFORMATION

What Idarubicin Hydrochloride 1 mg/ml Solution for Injection contains

•    The active substance is idarubicin hydrochloride. Each ml of solution for injection contains 1 mg idarubicin hydrochloride.

Each vial of 5 ml solution for injection contains 5 mg idarubicin hydrochloride.

Each vial of 10 ml solution for injection contains 10 mg idarubicin hydrochloride.

•    The other ingredients are glycerol, hydrochloric add and water for injections

What Idarubicin Hydrochloride 1 mg/ml Solution for Injection looks like and contents of the pack

Idarubicin Hydrochloride 1 mg/ml injection is a clear, orange-reddish solution, free from visible particles.

This medicine is supplied to the hospital as glass vials containing 1 mg/ml idarubicin hydrochloride in carton boxes. It is available as a ready to use injectable solution and comes in two sizes:

•    5 mg of idarubicin hydrochloride in 5 ml solution

•    10 mg of idarubicin hydrochloride in 10 ml solution Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

TEVA UK Limited,

Eastbou rne,

BN229AG Manufacturer

Teva Pharmaceutical Works Private Limited Company Tancsics Mihaly ut 82.

H-2100 Godollo,

Hungary

This leaflet was last revised in 04/2014.

PL 00289/1080