Imatinib Koanaa - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Imatinib Koanaa 80 mg/mL oral solution

imatinib

Read all of this leaflet carefully before you start taking 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, 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 Koanaa is and what it is used for

• 2. What you need to know before you take Imatinib Koanaa

• 3. How to take Imatinib Koanaa

• 4. Possible side effects

• 5. How to store Imatinib Koanaa

• 6. Contents of the pack and other information

1. What Imatinib Koanaa is and what it is used for

Imatinib Koanaa 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 Koanaa is a treatment for adults and children for:

• - Chronic myeloid leukaemia (CML). 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 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 inhibits the growth of these cells.

Imatinib Koanaa is also a treatment for adults for:

• - Myelodysplastic/my­eloproliferati­ve diseases (MDS/MPD). These are a group of blood

diseases in which some blood cells start growing out of control. Imatinib 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 inhibits the growth of these cells in a certain subtype of these diseases.

• - Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. It

arises from uncontrolled cell growth of the supporting tissues of these organs.

• - Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin

in which some cells start growing out of control. Imatinib inhibits the growth of these cells.

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

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

2. What you need to know before you take Imatinib Koanaa

Imatinib Koanaa 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 Koanaa:

• – 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 Koanaa.

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 Koanaa:

• – 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 you have ever had or might now have a hepatitis B infection. This is because Imatinib Koanaa

could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started.

• – if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Koanaa,

contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopat­hy (TMA).

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

You may become more sensitive to the sun while taking Imatinib Koanaa. It is important to cover sun-exposed areas of skin and use sunscreen with high sun protection factor (SPF). These precautions are also applicable to children.

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

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

Children and adolescents

Imatinib Koanaa is also a treatment for children with CML. There is no experience in children with CML below 2 years of age. There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.

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

Other medicines and Imatinib Koanaa

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 Koanaa when taken together. They may increase or decrease the effect of Imatinib Koanaa, either leading to increased side effects or making Imatinib Koanaa less effective. Imatinib Koanaa 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 Koanaa 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 Koanaa during pregnancy.

• – Women who might become pregnant are advised to use effective contraception during treatment

and for 15 days after ending treatment.

• – Do not breast-feed during the treatment with Imatinib Koanaa and for 15 days after ending

treatment, as it may harm your baby.

• – Patients who are concerned about their fertility while taking Imatinib Koanaa 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.

Imatinib Koanaa contains maltitol and sodium benzoate

Imatinib Koanaa contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per ml of oral solution, that is to say essentially ‘sodium-free’.

This medicinal product contains 0.2 mg of sodium benzoate (E211) in each ml.

3. How to take Imatinib Koanaa

Your doctor has prescribed Imatinib Koanaa because you suffer from a serious condition. Imatinib Koanaa 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. Check with your doctor or pharmacist if you are not sure.

Do not stop taking Imatinib Koanaa 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.

How much Imatinib Koanaa to take

Use in adults

Your doctor will tell you exactly how much Imatinib Koanaa to take.

• – If you are being treated for CML:

The usual starting dose is either 400 mg or 600 mg:

• – 400 mg to be taken as 5 mL once a day.

• – 600 mg to be taken as 7.5 mL once a day.

• - If you are being treated for GIST:

The starting dose is 400 mg to be taken as 5 mL once a day.

For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (10 mL), you should take 5 mL in the morning and 5 mL in the evening.

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

The starting dose is 600 mg to be taken as 7.5 mL once a day.

• - If you are being treated for MDS/MPD:

The starting dose is 400 mg to be taken as 5 mL once a day.

• - If you are being treated for HES/CEL:

The starting dose is 100 mg, to be taken as 1.25 mL once a day. Depending on how you respond to treatment, your doctor may decide to increase the dose to 400 mg, to be taken as 5 mL once a day.

• - If you are being treated for DFSP:

The dose is 800 mg per day (10 mL), to be taken as 5 mL in the morning and 5 mL in the evening.

Use in children and adolescents

The doctor will tell you how much Imatinib Koanaa to give to your child. The amount of Imatinib Koanaa given will depend on your child’s condition, body weight and height. The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL. 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).

Method and route of administration Imatinib is for oral use.

Take imatinib with a meal and a large glass of water. This will help protect you from stomach problems when taking Imatinib Koanaa.

Measuring your dose using the oral syringe provided

Your pack contains a bottle of solution and a plastic oral syringe to measure the right amount of liquid prescribed for you. The numbers up the side show how many millilitres (mls) of liquid you have inside the syringe.

Dose equivalence for the syringe

Each 20 mg = 0.25 ml

Amount of	Measured	Amount of	Measured	Amount of	Measured	Amount of	Measured
imatinib	Amount	imatinib	Amount	imatinib	Amount	imatinib	Amount
(mg)	(mL)	(mg)	(mL)	(mg)	(mL)	(mg)	(mL)
100mg	1.25ml	280mg	3.5ml	460mg	5.75ml	640mg	8ml
120mg	1.5ml	300mg	3.75ml	480mg	6ml	660mg	8.25ml
140mg	1.75ml	320mg	4ml	500mg	6.25ml	680mg	8.5ml
160mg	2ml	340mg	4.25ml	520mg	6.5ml	700mg	8.75ml
180mg	2.25ml	360mg	4.5ml	540mg	6.75ml	720mg	9ml
200mg	2.5ml	380mg	4.75ml	560mg	7ml	740mg	9.25ml
220mg	2.75ml	400mg	5ml	580mg	7.25ml	760mg	9.5ml
240mg	3ml	420mg	5.25ml	600mg	7.5ml	780mg	9.75ml
260mg	3.25ml	440mg	5.5ml	620mg	7.75ml	800mg	10ml

Dosing should be to the nearest measured amount in mL for paediatrics patients.

Instructions for use:

Open the bottle: press the cap and turn it anticlockwise (figure 1)

• Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure3). Ensure it is well fixed.
• Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5).
• Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).
• Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).
• Put the end of the syringe into-your mouth and push the piston slowly back in to take the medicine.
• Drink the whole contents of the syringe.
• Close the bottle with the plastic screw cap.
• Wash the syringe with water only.

How long to take Imatinib Koanaa

Keep taking imatinib every day for as long as your doctor tells you.

If you take more Imatinib Koanaa than you should

If you have accidentally taken too much solution, talk to your doctor straight away. You may require medical attention. Take the medicine pack and this leaflet with you.

If you forget to take Imatinib Koanaa

• – 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 Koanaamay cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Koanaacan 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 cellulitis).

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 (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).

Blood clots in small blood vessels (thrombotic microangiopathy).

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).

• Chronic renal failure.
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a

liver infection).

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, during Imatinib Koanaa treatment or after you

have stopped taking Imatinib Koanaa.

• 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.

• Painful and/or blistering skin lesions.
• 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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Imatinib Koanaa

• 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 and bottle after EXP.
• Store below 300 C. Store in the original package in order to protect from light.
• After opening the bottle, do not store above 25°C. The content of the bottle should be discarded

after 30 days of opening.

• 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 Koanaa contains

• – The active substance is imatinib (as mesylate). One mL of oral solution contains 80 mg imatinib

(as mesylate)

• – The other ingredients are maltitol, liquid (E965), glycerol (E422), sodium benzoate (E211),

What Imatinib Koanaa looks like and contents of the pack

Imatinib Koanaa is a clear yellow to brownish yellow coloured solution.

Imatinib Koanaa is packaged in a 150 ml amber plastic bottle with a child resistant tamper-evident closure containing 150mL of oral solution. Each carton contains 1 bottle and one 10 ml oral syringe with adaptor (graduated in 0.25ml increments, equivalent to 20 mg imatinib).

Marketing Authorisation Holder

Koanaa Healthcare GmbH

Fehrgasse 7,

2401 Fischamend, Austria

Manufacturer

Drehm Pharma GmbH

Hietzinger, Hauptstraße 37/2

A-1130 Wien, Austria

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

This leaflet was last revised in

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