Imatinib Teva Pharma 400 mg Film-coated Tablets

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

IMATINIB

Fáanlegur frá:

Teva Pharma B.V. (utrecht) Swensweg 5, 2031 GA Haarlem, Netherlands

ATC númer:

L01XE01

INN (Alþjóðlegt nafn):

IMATINIB 400 mg

Lyfjaform:

FILM-COATED TABLET

Samsetning:

IMATINIB 400 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

ANTINEOPLASTIC AGENTS

Leyfisstaða:

Withdrawn

Leyfisdagur:

2014-10-08

Upplýsingar fylgiseðill

1

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

IMATINIB TEVA PHARMA 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. 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 

WHAT IS IN THIS LEAFLET:  
1. What Imatinib Teva Pharma is and what it is used for  
2. What you need to know before you take Imatinib Teva Pharma  
3. How to take Imatinib Teva Pharma  
4. Possible side effects  
5. How to store Imatinib Teva Pharma  
6. Contents of the pack and other information 

1. 
WHAT IMATINIB TEVA PHARMA IS AND WHAT IT IS USED FOR 

Imatinib Teva Pharma  is a medicine containing an active substance
called imatinib. This medicine works by 
inhibiting the growth of abnormal cells in 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.  

In adult patients Imatinib Teva Pharma is used to treat a late stage
of Chronic Myeloid Leukaemia called 
“blast crisis.” In children however it may be used to treat all
stages of the illness. 

In the rest of this leaflet, we will use the abbreviation, CML, when
talking about this disease. 

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

2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMATINIB TEVA PHARMA  
 

Vara einkenni

Page 
1
 of 
19

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Imatinib Teva Pharma 400 mg Film-coated Tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

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

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Film-coated tablet. 

_(400 mg)_ 
Imatinib Teva Pharma 400 mg Film-coated Tablets are orange-brown,
oblong, film-coated tablets debossed 
with 7630 on one side and a score line on the other side. The
tablet is debossed with 9 and 3 at each side of 
the score line.  

The film-coated tablets have dimensions of 20.5 mm x 10 mm. 

The tablet can be divided into equal doses.  

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Imatinib Teva Pharma is indicated for the treatment of: 


Paediatric patients with newly diagnosed Philadelphia chromosome
(bcr-abl) positive (Ph+) chronic 
myeloid leukaemia (CML)  for whom bone marrow transplantation is
not considered as the first line 
of treatment. 


Paediatric patients with Ph+ CML in chronic phase after failure
of interferon-alpha therapy or in 
accelerated phase._ _


Adult and paediatric patients with Ph+ CML in blast crisis._ _

The effect of imatinib on the outcome of bone
marrow transplantation has not been determined._ _

In adult and paediatric patients, the effectiveness of imatinb is
based on overall haematological and 
cytogenetic response rates and progression-free survival in
CML. There are no controlled trials 
demonstrating a clinical benefit or increased
survival for this disease. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Therapy should be initiated by a physician experienced in the
treatment of patients with haematological 
malignancies. 

2

The prescribed dose should be administered orally with a