Active ingredient
- imatinib mesilate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL17780/0678, PL17780/0679.
Imatinib Zentiva 100 mg & 400mg film-coated tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Imatinib 100 mg Film-coated Tablets
Imatinib 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.
What is in this leaflet:
1. What imatinib is and what it is used for
2. What you need to know before you take imatinib
3. How to take imatinib
4. Possible side effects
5. How to store imatinib
6. Contents of the pack and other information
1. WHAT IMATINIB IS AND WHAT IT IS USED FOR
Imatinib 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 is a treatment for adults and children for:
Imatinib is also a treatment for adults for:
In the rest of this leaflet, we will use the abbreviations when talking about these diseases.
If you have any questions about how imatinib works or why this medicine has been prescribed for you, ask your doctor
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMATINIB
Imatinib 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 this applies to you, tell your doctor without taking imatinib.
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 if you:
If any of these apply to you, tell your doctor before taking imatinib.
During treatment with imatinib, tell your doctor straight away if you put on weight very quickly. Imatinib may cause your body to retain water (severe fluid retention).
While you are taking imatinib, your doctor will regularly check whether the medicine is working. You will also have blood tests and be weighed regularly.
Children and adolescents
Imatinib 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 may have slower than normal growth. The doctor will monitor the growth at regular visits.
Other medicines and imatinib
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 when taken together. They may increase or decrease the effect of imatinib, either leading to increased side effects or making imatinib less effective. Imatinib 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
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
Your doctor has prescribed imatinib because you suffer from a serious condition. Imatinib can help you to fight this condition.
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 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 to take
Use in adults
Your doctor will tell you exactly how many tablets of imatinib to take.
If you are being treated for CML:
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 (eight 100 mg or two 400 mg tablets), you should take four 100 mg tablets or one 400 mg tablet in the morning and four 100 mg tablets or one 400 mg tablet in the evening.
If you are being treated for Ph-positive ALL:
The starting dose is 600 mg to be taken as six 100 mg tablets or one 400 mg tablet plus two 100 mg tablets once a day.
If you are being treated for MDS/MPD:
The starting dose is 400 mg to be taken as four 100 mg tablets or one 400 mg tablet once a day.
If you are being treated for HES/CEL:
The starting dose is 100 mg, to be taken as one 100 mg tablet once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as four 100 mg tablets or one 400 mg tablet once a day, depending on how you respond to treatment.
If you are being treated for DFSP:
The dose is 800 mg per day (eight 100 mg or two 400 mg tablets), to be taken as four 100 mg tablets or one 400 mg tablet in the morning and four 100 mg tablets and one 400 mg tablet in the evening.
Use in children and adolescents
The doctor will tell you how many tablets of imatinib to give to your child. The amount of imatinib 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).
When and how to take imatinib
If you are unable to swallow the tablets, you can dissolve them in a glass of still water or apple juice.
How long to take imatinib
Keep taking imatinib every day for as long as your doctor tells you.
If you take more imatinib than you should
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
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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):
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from the available data):
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):
If any of these affect you severely, tell your doctor.
Common (may affect up to 1 in 10 people):
If any of these affect you severely, tell your doctor.
Not known (frequency cannot be estimated from the available data):
If any of these affect you severely, tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 search 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
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 blister. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 contains:
The active substance is imatinib mesilate. Each tablet of Imatinib contains imatinib mesilate equivalent to either 100 mg or 400 mg imatinib.
The other ingredients are:
Tablet core: Microcrystalline cellulose, low substituted hydroxypropyl cellulose, povidone, crospovidone (Type A), silica colloidal anhydrous, magnesium stearate.
Tablet coating: Hypromellose, macrogol 400, talc, red iron oxide (E172), yellow iron oxide (E172).
What imatinib looks like and contents of the pack
Imatinib 100 mg film-coated tablets are dark yellow to brownish-orange, round shaped, film-coated tablets of 10.1 mm (± 5%) diameter with a break-line on one side and “100” on the other side. The tablet can be divided into equal doses.
Imatinib 400 mg film-coated tablets are dark yellow to brownish-orange, oval-shaped, film-coated tablets, 21.6 mm long and 10.6 mm wide (± 5%) wide with a break-line on one side and “400” on the other side. The tablet can be divided into equal doses.
They are supplied in packs of 10, 20, 30, 60, 90, 120, 180 film-coated tablets.
Not all pack sizes may be marketed.
The Marketing Authorisation Holder is
The manufacturer is
or
This leaflet was last updated in May 2020
‘Zentiva’ is a registered trademark. © 2020 Zentiva.
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