Package leaflet: Information for the user

Imatinib Helm AG 100 mg film-coated tablets Imatinib Helm AG 400 mg film-coated tablets Imatinib

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

-    Keep this leaflet. Y ou may need to read it again.

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

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

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

What is in this leaflet:

1.    What Imatinib Helm AG is and what it is used for

2.    What you need to know before you take Imatinib Helm AG

3.    How to take Imatinib Helm AG

4.    Possible side effects

5.    How to store Imatinib Helm AG

6.    Contents of the pack and other information

1. What Imatinib Helm AG is and what it is used for

Imatinib Helm AG is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer.

Imatinib Helm AG is a treatment for children for:

-    Chronic myeloid leukaemia (CML):

-    and where bone marrow transplantation is not considered as the first line of treatment. Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named “myeloid” cells) start growing out of control.

-    Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.

-    newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL) integrated with chemotherapy.

Imatinib Helm AG is a treatment for adults for:

Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) in blast crisis

-    Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).

Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named “lymphoblasts”) start growing out of control. Imatinib Helm AG inhibits the growth of these cells.

-    Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. Imatinib Helm AG inhibits the growth of these cells in a certain subtype of these diseases.

-    Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells (named eosinophils) start growing out of control. Imatinib Helm AG inhibits the growth of these cells in a certain subtype of these diseases.

-    Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. Imatinib Helm AG inhibits the growth of these cells.

In the rest of this leaflet, we will use the abbreviations when talking about these diseases.

Imatinib, which is contained in Imatinib Helm AG, may also be authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.

If you have any questions about how Imatinib Helm AG works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take IMATINIB HELM AG

Imatinib Helm AG will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.

Follow all your doctor’s instructions carefully, even if they differ from the general information contained in this leaflet.

Do not take Imatinib Helm AG

- if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6). If this applies to you, tell your doctor without taking Imatinib Helm AG

If you think you may be allergic but are not sure, ask your doctor for advice.

Warnings and Precautions

Talk to your doctor before taking Imatinib Helm AG:

-    if you have or have ever had a liver, kidney or heart problem.

-    if you are taking the medicine levothyroxine because your thyroid has been removed.

If any of these apply to you, tell your doctor before taking Imatinib Helm AG.

During treatment with Imatinib Helm AG, tell your doctor straight away if you put on weight very quickly. Imatinib Helm AG may cause your body to retain water (severe fluid retention).

While you are taking Imatinib Helm AG, your doctor will regularly check whether the medicine is working. You will also have blood tests and be weighed regularly.

Children and adolescents

Imatinib Helm AG is a treatment for children with CML. There is no experience in children with CML below 2 years of age and with Ph-positive ALL below 1 year of age.

There is very limited experience in children with MDS/MPD, DFSP and HES/CEL.

Some children and adolescents taking Imatinib Helm AG, may have slower than normal growth. The doctor will monitor the growth at regular visits.

Other medicines and Imatinib Helm AG

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John’s Wort). Some medicines can interfere with the effect of Imatinib Helm AG when taken together. They may increase or decrease the effect of Imatinib Helm AG either leading to increased side effects or making Imatinib Helm AG less effective. Imatinib Helm AG may do the same to some other medicines.

Tell your doctor if you are using medicines that prevent the formation of blood clots.

Pregnancy, breast-feeding and fertility

-    If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine

-    Imatinib Helm AG is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss with you the possible risks of taking Imatinib Helm AG during pregnancy.

-    Women who might become pregnant are advised to use effective contraception during treatment.

-    Do not breast-feed during the treatment with Imatinib Helm AG.

-    Patients who are concerned about their fertility while taking Imatinib Helm AG are advised to consult with their doctor.

Driving and using machines

You may feel dizzy or drowsy or get blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until you are feeling well again.

3. How to take IMATINIB HELM AG

Your doctor has prescribed Imatinib Helm AG because you suffer from a serious condition. Imatinib Helm AG can help you to fight this condition.

However, always take this medicine exactly as your doctor or pharmacist has told you. It is important that you do this as long as your doctor or pharmacist tells you to do. Check with your doctor or pharmacist if you are not sure.

Do not stop taking Imatinib Helm AG unless your doctor tells you to. If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight away.

Imatinib Helm AG packed in HDPE bottles contains purified rayon. After each opening of the HDPE bottle, the rayon should be removed and kept in a clean and dry place. Following removal of the tablet(s), the rayon should be carefully re-inserted into the bottle.

If you are a woman who is pregnant or might become pregnant and is trying to open the HDPE bottle, you should handle the rayon and the tablets with caution in order to avoid skin-eye contact or inhalation. You should wash your hands immediately after handling the rayon and the tablets.

How much Imatinib Helm AG to take

Use in adults:

Your doctor will tell you exactly how many tablets of Imatinib Helm AG to take.

- If you are being treated for CML in blast crisis:

The starting dose is 600 mg to be taken as 6 tablets of 100 mg once a day

The starting dose is 600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg once a

day.

For CML in blast crisis, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning 4 tablets in the evening. If your daily dose is 800 mg, you should take 1 tablet of 400 mg in the morning and a second tablet of 400 mg in the evening.

- If you are being treated for Ph-positive ALL:

The starting dose is 600 mg to be taken as 6 tablets once a day.

The starting dose is 600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg once a day.

-    If you are being treated for MDS/MPD:

The starting dose is 400 mg, to be taken as 4 tablets once a day.

The starting dose is 400 mg, to be taken as 1 tablet of 400 mg once a day.

-    If you are being treated for HES/CEL:

-    The starting dose is 100 mg, to be taken as 1 tablet of once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 4 tablets once a day, depending on how you respond to the treatment.

The starting dose is 100 mg, to be taken as 1 tablet of 100 mg once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 1 tablet of 400 mg once a day, depending on how you respond to the treatment.

If you are being treated for DFSP:

The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.

The dose is 800 mg per day, to be taken as 1 tablet of 400 mg in the morning and a second tablet of 400 mg in the evening.

Use in children and adolescents

The doctor will tell you how many tablets of Imatinib Helm AG to give to your child. The amount of Imatinib Helm AG given will depend on your child’s condition, body weight and height. The total daily dose in children must not exceed 800 mg, to be taken as 8 tablets of 100mg. to be taken as 2 tablets of 400 mg. The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).

When and how to take Imatinib Helm AG

-    Take Imatinib Helm AG with a meal. This will help protect you from stomach problems when taking Imatinib Helm AG.

-    Swallow the tablets whole with a large glass of water.

-    Swallow the tablet whole with a large glass of water.

If you are unable to swallow the tablets, you can dissolve them in a glass of still water or apple juice:

-    Use about 50 ml for each 100 mg tablet

-    Use about 200 ml for each 400 mg tablet

-    Stir with a spoon until the tablets have completely dissolved

-    Once the tablet has dissolved, drink everything in the glass straight away. Traces of the dissolved tablets may be left behind in the glass.

How long to take Imatinib Helm AG

Keep taking Imatinib Helm AG every day for as long as your doctor tells you.

If you take more Imatinib Helm AG than you should

If you have accidentally taken too many tablets, talk to your doctor straight away. You may require medical attention. Take the medicine pack with you.

If you forget to take Imatinib Helm AG

-    If you forget a dose, take it as soon as you remember. However if it is nearly time for the next dose, skip the missed dose.

-    Then continue with your normal schedule.

-    Do not take a double dose to make up a forgotten dose.

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

4. Possible side effects

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

usually mild to moderate.

Some side effects may be serious. Tell your doctor straight away if you get any of the following:

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

•    Rapid weight gain.Imatinib Helm AG may cause your body to retain water (severe fluid retention).

•    Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Helm AG can reduce the number of white blood cells, so you might get infections more easily.

•    Unexpected bleeding or bruising (when you have not hurt yourself).

Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):

•    Chest pain, irregular heart rhythm (signs of heart problems).

•    Cough, having difficulty breathing or painful breathing (signs of lung problems).

•    Feeling light-headed, dizzy or fainting (signs of low blood pressure).

•    Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).

•    Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).

•    Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).

•    Severely decreased urine output, feeling thirsty (signs of kidney problems).

•    Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).

• Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).

•    Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).

•    Eye pain or deterioration in vision,bleeding in the eyes.

•    Pain in your hips or difficulty walking.

•    Numb or cold toes and fingers (signs of Raynaud’s syndrome).

•    Sudden swelling and redness of the skin (signs of a skin infection called cellulites).

•    Difficulty hearing.

•    Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).

•    Bruising.

•    Stomach pain with feeling sick (nausea).

•    Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).

•    Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).

•    Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).

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

•    Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).

If you get any of the above, tell your doctor straight away.

Other side effects may include:

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

•    Headache or feeling tired.

•    Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.

•    Rash.

•    Muscle cramps or joint, muscle or bone pain.

•    Swelling such as round your ankles or puffy eyes.

•    Weight gain.

If any of these affects you severely, tell your doctor.

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

•    Anorexia, weight loss or a disturbed sense of taste.

•    Feeling dizzy or weak.

•    Difficulty in sleeping (insomnia).

•    Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.

•    Nose bleeds.

•    Pain or swelling in your abdomen, flatulence, heartburn or constipation.

•    Itching.

•    Unusual hair loss or thinning.

•    Numbness of the hands or feet.

•    Mouth ulcers.

•    Joint pain with swelling.

•    Dry mouth, dry skin or dry eye.

•    Decreased or increased skin sensitivity.

•    Hot flushes, chills or night sweats.

If any of these affects you severely, tell your doctor.

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

•    Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.

•    Slowing of growth in children and adolescents.

If any of these affects you severely, tell your doctor.

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

Yellow Card Scheme

Website: 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 IMATINIB HELM AG

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

•    Do not use this medicine after the expiry date which is stated on the carton.

•    Do not store above 25°C.

•    Do not use any pack that is damaged or shows signs of tampering.

•    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 other information

What Imatinib Helm AG contains

The active substance is imatinib mesilate.

Each film-coated tablet contains 100 mg imatinib (as mesilate).

Each film-coated tablet contains 400 mg imatinib (as mesilate).

The other ingredients are: sodium stearyl fumarate The tablet coating is made of:

Opadry Brown consisting of hydroxypropylmethyl cellulose, red iron oxide (E172), yellow iron oxide (E172), talc

What Imatinib Helm AG looks like and contents of the pack

Imatinib Helm AG 100 mg film-coated tablets are brownish , round, biconvex, film-coated tablets debossed with "100" on one side and a score line on the other side, with "N" on one side of the score line and "I" on the other side of the score line. The tablet can be divided into equal halves.

Imatinib Helm AG 400 mg film-coated tablets are brownish , oval, biconvex, film-coated tablets debossed with "400" on one side and "NI" on the other side.

Imatinib Helm AG film-coated tablets are supplied in alu/alu blister or HDPE bottles. Pack sizes alu/alu blister

20, 60, 90, 120 and 180 film-coated tablets (for 100 mg).

10, 30 and 90 film-coated tablets (for 400 mg).

Pack sizes HDPE bottles:

60, 90, 120 and 180 film-coated tablets (for 100 mg). 30 and 90 film-coated tablets (for 400 mg).

Not all pack sizes may be available in your country.

Marketing Authorisation Holder and Manufacturer

Helm AG Nordkanalstr. 28 20097 Hamburg Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany	Imatinib Helm AG 100 mg Filmtabletten Imatinib Helm AG 400 mg Filmtabletten
Italy	Imatinib Helm AG 100 mg compresse rivestite con film Imatinib Helm AG 400 mg compresse rivestite con film

This leaflet was last revised in 04/2015