Imatinib 80mg/ml Oral Solution

Patient Leaflet Updated 12-Mar-2021 | Rosemont Pharmaceuticals Limited

Imatinib 80mg/ml Oral Solution

Package leaflet: Information for the user

Imatinib 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 Oral Solution is and what it is used for
2. What you need to know before you take Imatinib Oral Solution
3. How to take Imatinib Oral Solution
4. Possible side effects
5. How to store Imatinib Oral Solution
6. Contents of the pack and other information

1. What Imatinib Oral Solution is and what it is used for

Imatinib Oral Solution 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 Oral Solution 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 Oral Solution inhibits the growth of these cells.

Imatinib Oral Solution 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 Oral Solution 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.
  • Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. Imatinib Oral Solution 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 Oral Solution works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Imatinib Oral Solution

Imatinib Oral Solution 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:

  • 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 Oral Solution.

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 Oral Solution:

  • 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 Oral Solution 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, 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 Oral Solution.

You may become more sensitive to the sun while taking Imatinib Oral Solution. 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 Oral Solution, tell your doctor straight away if you put on weight very quickly. Imatinib Oral Solution may cause your body to retain water (severe fluid retention).

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

Children and adolescents

Imatinib Oral Solution 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, and HES/CEL.

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

Other medicines and Imatinib Oral Solution

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 Oral Solution when taken together. They may increase or decrease the effect of Imatinib Oral Solution, either leading to increased side effects or making Imatinib Oral Solution less effective. Imatinib Oral Solution 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 Oral Solution 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 Oral Solution during pregnancy.
  • Women who might become pregnant are advised to use effective contraception during treatment.
  • Do not breast-feed during the treatment with Imatinib Oral Solution
  • Patients who are concerned about their fertility while taking Imatinib Oral Solution 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 Oral Solution contains

Imatinib oral solution also contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains 0.2 mg sodium benzoate salt in each unit volume which is equivalent to 0.2 mg/mL.

3. How to take Imatinib Oral solution

Your doctor has prescribed Imatinib Oral Solution because you suffer from a serious condition. Imatinib Oral Solution 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 Oral Solution 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 Oral Solution to take

Use in adults

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

  • If you are being treated for CML:
    Depending on your condition 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.

For CML, 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. Your doctor may decide to increase the dose to 400 mg, to be taken as 5 mL once a day, depending on how you respond to treatment.
  • 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 Oral Solution to give to your child. The amount of Imatinib Oral Solution given will depend on your child’s condition, body weight and height. The total daily dose in children 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 Oral Solution with a meal. This will help protect you from stomach problems when taking Imatinib Oral Solution.

Measuring your dose using the oral syringe provided

Your pack contains 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.

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 (figure 3). 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).

  • Remove the syringe from the adaptor. 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 Oral Solution

Keep taking Imatinib Oral Solution every day for as long as your doctor tells you

If you take more Imatinib Oral Solution 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 with you.

If you forget to take Imatinib Oral Solution

  • 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 Oral Solution may cause your body to retain water (severe fluid retention).
  • Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Oral Solution 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 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):

  • Feeling tired.
  • Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
  • Rash
  • Muscle cramps or joint, muscle or bone pain, during Imatinib Oral Solution treatment or after you have stopped taking Imatinib Oral Solution.
  • 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.or by searching for MHRA yellow card in the google play or Apple app store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imatinib Oral Solution

  • 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.
  • Store below 30°C. Store in the original package in order to protect from light.
  • 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.
  • After opening the bottle, do not store above 25°C. The content of the bottle should be discarded after 30 days of opening.

6. Contents of the pack and other information

What Imatinib Oral Solution contains

  • The active substance is imatinib mesilate. Each 1 mL of Imatinib Oral Solution contains 80 mg imatinib (as mesilate)
  • The other ingredients are maltitol, liquid (E965), glycerol (E422), sodium benzoate (E211), acesulfame potassium (E950), citric acid monohydrate, strawberry flavour (flavouring components, glyceryl triacetate, water, triethyl citrate), purified water.

What Imatinib Oral Solution looks like and contents of the pack

Imatinib Oral Solution is a clear yellow to brownish yellow coloured solution with characteristic odour.

Imatinib Oral Solution is packaged in 150 ml Amber PET bottle with a child resistant tamper-evident closure. Each carton contains 1 bottle and a 5 ml oral syringe with adaptor (graduated at every 1.25ml equivalent to 100 mg).

Marketing Authorisation Holder

Rosemont Pharmaceuticals Ltd
Yorkdale Industrial Park
Braithwaite Street
Leeds
LS11 9XE
UK
Tel: + 44 (0) 113 244 1400

Manufacturer:

LM Manufacturing Limited
Sandretto Building
Cavalry Hill Industrial Park
Weedon
Northampton
NN7 4PP
United Kingdom

If you would like this leaflet in different format information or want to report any side effects, please contact marketing authorisation holder listed above.

This leaflet was last revised in January 2021.

PMLF0132 J1ZD1RBJ1

Company Contact Details
Rosemont Pharmaceuticals Limited
Address

Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE

Telephone

+44 (0)113 244 1400

Customer Care direct line

+44 (0)800 919 312

Out of Hours contact

[email protected]semontpharma.com

WWW

http://www.rosemontpharma.com

Fax

+44 (0)113 245 3567

Out of Hours Telephone

+44 (0)7836 557 879