Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using IMANIB?
IMANIB contains the active ingredient imatinib. IMANIB is used to treat children and
adults who have certain types of cancer and leukemia.
2. What should I know before I use IMANIB?
Do not use if you have ever had an allergic reaction to IMANIB or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with IMANIB and affect how it works.
4. How do I use IMANIB?
Your doctor will tell you exactly how many tablets of IMANIB to take
Follow the instructions provided and use IMANIB until your doctor tells you to stop
5. What should I know while using IMANIB?
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using IMANIB.
Have regular check-ups to make sure the treatment is working
|
Things you should not do
|
Do not stop using this medicine suddenly (unless your doctor tells you to)
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how IMANIB
affects you
|
Drinking alcohol
|
There are no known interactions between IMANIB and alcohol
|
Looking after your medicine
|
Store it in a cool dry place away from moisture, heat or sunlight
Keep out of reach of children
|
6. Are there any side effects?
Common side effects include headache, dizziness, light-headedness or vertigo, upset
stomach, nausea (feeling sick), vomiting, diarrhoea, constipation, rash, eczema, itchy
or dry skin, skin darkening or lightening, symptoms of sunburn which happens more
quickly than normal, noticeable swelling, stiffness in joints or muscles, pain in
bones or along veins, weakness, feeling generally unwell, numbness, tingling in fingers
and toes, change in sense of taste, irritated eyes, blurred vision, ringing in the
ears, changes in appetite and weight, hair loss, throat pain, cough or cold symptoms,
loss of interest in sex, problems with sexual function, breast enlargement, nipple
pain, painful periods, slowing of growth in children and adolescents
Active ingredient(s):
imatinib mesilate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using IMANIB. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using IMANIB.
Where to find information in this leaflet:
1. Why am I using IMANIB?
IMANIB contains the active ingredient imatinib. IMANIB belongs to a group of anti-cancer medicines known as tyrosine kinase inhibitors.
IMANIB is used to treat children and adults who have certain types of cancer and leukemia,
including chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia with Philadelphia
chromosome positive (Ph- positive ALL).
IMANIB is also used to treat adults for:
Myelodysplastic / myeloproliferative diseases (MDS/ MPD).
These are a group of blood diseases in which some blood cells start growing out of
control.
Aggressive systemic mastocytosis (ASM).
It is a cancer in which certain blood cells, called "mast" cells, grow out of control.
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.
Gastro-intestinal stromal tumours (GIST).
This is a type of cancer of the stomach and bowels. This cancer affects the tissue
that surrounds the stomach and bowels and the cells grow uncontrollably.
Dermatofibrosarcoma protuberans (DFSP).
DFSP is a cancer of the tissue beneath the skin in which some cells start growing
out of control.
IMANIB works by slowing the growth of and killing cancer cells while leaving normal
cells alone.
2. What should I know before I use IMANIB?
Warnings
Do not use IMANIB if:
you are allergic to imatinib, or any of the ingredients listed at the end of this
leaflet.
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
If you experience an allergic reaction, stop using the medicine and inform your doctor
or pharmacist immediately.
Some of the symptoms of an allergic reaction may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
This medicine may be harmful to your unborn baby. If it is necessary for you to take
it during pregnancy, your doctor will let you know.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known if the active ingredient, imatinib, passes into the breast milk. Breastfeeding
is not recommended because this medicine could affect your baby.
Tell your doctor if you have ever had any of the following medical problems or procedures:
kidney or liver problems
problems with your heart
you have had your thyroid gland removed
hepatitis B infection. During treatment with IMANIB, hepatitis B may become active
again.
Your doctor may want to take special precautions in this case.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with IMANIB and affect how it works.
St. John's wort, a herbal medicine found in many products that you can buy without
a prescription
paracetamol, a medicine found in many common pain relievers and cold remedies (e.g.
Panadol®, Panadeine®, Codral®, Tylenol®) which are known to be associated with liver toxicity.
antibiotic medicines such as rifampicin, ketoconazole, erythromycin, clarithromycin,
itraconazole
antiviral medicines used to treat HIV/AIDS
dexamethasone, a steroid medicine
medicines for high cholesterol, such as simvastatin
medicines used to treat epilepsy, such as phenytoin, carbamazepine, phenobarbitone
warfarin, a medicine used to prevent blood clots
some medicines used to treat mental disorders and depression
some medicines used to treat high blood pressure and heart problems
cyclosporin
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect IMANIB.
4. How do I use IMANIB?
How much to take
Your doctor will tell you exactly how many tablets of IMANIB to take
Do not exceed the recommended dose prescribed by your doctor
Follow the instructions provided and use IMANIB until your doctor tells you to stop
Your doctor may direct you to take a higher or lower dose or stop treatment depending
on how your body responds to IMANIB.
IMANIB is usually taken as a single dose each day. However, your doctor may want you
to take them in two doses, one in the morning and one in the evening
When to take IMANIB
Take IMANIB every day; at the same time, with water and food for as long as your doctor
recommends
How to take IMANIB
Take IMANIB with a large glass of water and food. This will help avoid stomach irritation
If you are unable to swallow the tablets:
Put the required tablets in a glass of water or apple juice (approximately 50 mL for
a 100 mg tablet or 200 mL for a 400 mg tablet)
Stir with a spoon to completely dissolve the tablets
Drink immediately
If you forget to use IMANIB
IMANIB should be taken regularly at the same time each day. If you miss your dose
at the usual time, take the missed dose as soon as you remember, then continue with
your normal schedule.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you take too much IMANIB
If you think that you have used too much IMANIB, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using IMANIB?
Things you should do
Make sure you follow your doctor's instructions carefully and keep all appointments.
You will need regular check-ups to make sure the treatment is working. Regular blood
tests, weight checks and urine tests can also find side effects before they become
serious.
Use a method of contraception to prevent pregnancy during treatment and for 15 days
after ending treatment.
Some children taking IMANIB may have slower than normal growth. Growth will be monitored
at regular visits by your doctor.
Call your doctor straight away if you
Become pregnant or think you might be pregnant
Think you might be having an allergic reaction to IMANIB treatment
Remind any doctor, dentist or pharmacist you visit that you are using IMANIB.
Things you should not do
Do not stop using this medicine suddenly unless your doctor tells you to
Do not give this medicine to anyone else even if they have the same condition as you
Drinking grapefruit juice
Avoid drinking grapefruit juice while you are being treated with IMANIB. Grapefruit
juice may interact with IMANIB and affect how your body uses this medicine.
Treating a headache, cold or other minor aches and pains
Try to avoid taking medicines containing paracetamol (e.g. Panadol®, Panadeine®, Codral®, Tylenol®) to treat minor aches and pains. Ask your pharmacist to suggest an alternative medicine.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how IMANIB
affects you.
IMANIB may cause dizziness, light-headedness or drowsiness in some people.
Wear sun protection when outdoors
When you are outdoors, wear protective clothing and use at least a 15+ sunscreen.
Do not use sunlamps or tanning beds.
This medicine may cause your skin to be much more sensitive to sunlight than it normally
is.
Exposure to sunlight may cause a skin rash, itching, redness or severe sunburn. If
your skin does appear to be burning, tell your doctor.
Drinking alcohol
Tell your doctor if you drink alcohol.
There are no known interactions of IMANIB with alcohol.
Looking after your medicine
Keep your medicine in the original container until it is time to take it
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on windowsills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What IMANIB contains
Active ingredient
(main ingredient)
|
Imatinib (as mesilate)
|
Other ingredients
(inactive ingredients)
|
Magnesium stearate
OPADRY complete film coating system 03F565018 BROWN (proprietary ingredient number
108518)
|
Potential allergens
|
IMANIB tablets are free from lactose and gluten.
|
Do not take this medicine if you are allergic to any of these ingredients.
What IMANIB looks like
IMANIB 100 mg tablet is a dark yellow to brownish orange, film-coated, round tablet
debossed with 'I' and '1' on either side of the break line on one side and plain on
the other side of the tablet. Packed in a blister packs of 60, 180 tablets and a HDPE
bottle of 100 tablets.
IMANIB 400 mg tablet is a dark yellow to brownish orange, film-coated, oval tablet
debossed with 'I' and '2' on either side of the break line on one side and plain on
the other side of the tablet. Packed in a blister pack of 30 tablets and a HDPE bottle
of 100 tablets.
Australian Register Numbers
IMANIB 100 mg tablets – AUST R 225494 (blister pack)
IMANIB 400 mg tablets – AUST R 225488 (blister pack)
IMANIB 100 mg tablets – AUST R 225492 (bottle pack)
IMANIB 400 mg tablets – AUST R 225497 (bottle pack)
Not all pack sizes and presentations are marketed in Australia.
Sponsor
Sun Pharma ANZ Pty Ltd
12 Waterloo Road Macquarie Park NSW 2113
Australia
Tel: 1800 726 229
Distributor
IMANIB is distributed in Australia by:
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in July 2024.