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IDARUBICIN HYDROCHLORIDE 1 mg/ml SOLUTION FOR INJECTION

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

-    Keep this leaflet. You may need to read it again.

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

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Idarubicin Hydrochloride 1 mg/ml Solution for injection will be referred to as Idarubicin Injection throughout the remainder of the leaflet

What is in this leaflet:

1.    What Idarubicin Injection is and what it is used for

2.    What you need to know before you are given Idarubicin Injection

3.    How Idarubicin Injection will be given to you

4.    Possible side effects

5.    How to store Idarubicin Injection

6.    Contents of the pack and other information

1. What Idarubicin injection is and what is it used for

The name of your medicine is Idarubicin Injection. It contains an active ingredient called idarubicin hydrochloride, which belongs to a group of drugs called anthracyclines. It is used for the treatment of certain types of leukaemia (cancer of the white blood cells). It may also be used in combination with other cancer medicines.

2. What you need to know before you take Idarubicin injection

Do not take Idarubicin Injection:

-    If you are allergic to idarubicin or any of the other ingredients in this medicine (listed in section 6).

-    If you have had an allergic (hypersensitive) reaction to any other anti cancer medicines such as daunorubicin or doxorubicin.

-    If you suffer from severe liver or kidney problems.

-    If your bone marrow function is decreased, i.e your bone marrow is producing fewer blood cells. This may be due to previous treatment with medicines containing the same active substance, similar drugs, or recent radiotherapy.

-    If you have an infection which is not under control.

-    If you suffer from severe cardiac or heart problems or if you have recently had a heart attack.

-    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 or doxorubicin

-    If you are breast feeding (see ‘Pregnancy and breast-feeding’)

-    If you have taken the yellow fever vaccine.

Warnings and precautions

Idarubicin 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

-    Idarubicin 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, prior to and during treatment with Idarubicin

-    Infants and children seem to be more sensitive to heart damage caused by antracyclins.

-    Idarubicin 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 cells for your blood to function

-    Blood tests to check for uric acid levels

-    Heart tests since Idarubicin 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.

Other medicines and Idarubicin injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

-    Cyclosporine A (immunosupressant medicine)

-    live vaccines like yellow fever vaccine

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

-    potentially cardiotoxic (harmful to the heart) medicines (e.g. cyclophosphamide)

-    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)

Also tell your doctor if you are receving ratiotherapy.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.

You should not be treated with Idarubicin unless clearly indicated by your doctor. Your doctor will need to consider any possible risks to you or your child.

If you are a woman of childbearing potential you should avoid becoming pregnant during treatment with Idarubicin.

If you are a man you should avoid fathering a child during treatment with Idarubicin and for 3 months thereafter. There is a risk that treatment with Idarubicin will lead to male infertility and you may wish to seek advice about sperm storage before the treatment starts.

You should not breast-feed whilst receiving Idarubicin, as some of the drug may get into your milk and possibly harm your child.

Ask your doctor for advice before taking any medicine.

Driving and using machines

The effects of Idarubicin injection on the ability to drive and use machines has not been fully evaluated.

Please check with your doctor before you drive or operate machinery.

3. How Idarubicin injection will be given to you

Idarubicin injection will be given to you by injection into your veins as a drip only. Your doctor or specialist will prescribe the required amount (the dose). The dose is decided by taking into account your condition being treated, your height and weight. From your height and weight the doctor will work out your body surface area; this is necessary because the dose is usually calculated as "... milligrams per square metre" (mg/m²), given by injection, on 3-5 consecutive days.

However, your doctor may alter the dose and number of days depending on your condition and any other treatment you may receive.

If you are given more Idarubicin Injection than you should have received

It is most unlikely that you will be given too much medicine by your nurse or doctor. Your doctor and nurse will be monitoring your progress, and checking the medicine that you are given. Always ask if you are not sure why you are getting a dose of medicine.

4. Possible side effects

Like all medicines, this medicine 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 idarubicin alone or in combination with other medicines, and may be fatal).

The following side effects have been reported at the approximate frequencies shown:

(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

(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’.

(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.

(may affect up to 1 in 1000 people)

•    Stroke.

(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

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

•    Change in certain chemicals in the blood.

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

•    Local skin reaction.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Idarubicin 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 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.

6. Contents of the pack and further information

What Idarubicin Injection contains

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

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

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

-    The other ingredients are glycerol, hydrochloric acid and water for injections

What Idarubicin Injection looks like and contents of the pack

Idarubicin 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,

Eastbourne,

BN22 9AG

Manufacturer

Teva Pharmaceutical Works Private Limited Company Tancsics Mihaly ut 82.

H-2100 Godollo,

Hungary

OR*

Pharmachemie B.V.

P.O. Box 552; 2003 RN Haarlem The Netherlands

OR*

TEVA Sante SA Rue Bellocier 89107 Sens France

OR*

TEVA UK Ltd Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG

OR*

Teva Operations Poland Sp. Z.o.o., Mogliska 80 Str.

31-546 Krakow Poland

This leaflet was last revised in June 2015.

PL 00289/1080

The following information is intended for healthcare professionals only:

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

•    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 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 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.