Imatinib Rowex 400mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Imatinib mesilate

Available from:

Rowex Ltd

ATC code:

L01XE; L01XE01

INN (International Name):

Imatinib mesilate

Dosage:

400 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

oral use

Units in package:

Pack size: 10, 30 and 90 tablets

Prescription type:

Product subject to prescription which may not be renewed (A)

Manufactured by:

Lek Pharmaceuticals d.d

Therapeutic group:

protein-tyrosine kinase inhibitor

Therapeutic area:

Protein kinase inhibitors; imatinib

Therapeutic indications:

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 or blast crisis. adult patients with Ph+ CML in blast crisis. adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. adult patients with relapsed or refractory Ph+ ALL as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR
rearrangement. adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurre

Authorization status:

Marketed

Authorization date:

2015-12-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMATINIB ROWEX 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Imatinib Rowex is and what it is used for
2.
What you need to know before you take Imatinib Rowex
3.
How to take Imatinib Rowex
4.
Possible side effects
5.
How to store Imatinib Rowex
6.
Contents of the pack and other information
1. WHAT IMATINIB ROWEX IS AND WHAT IT IS USED FOR
Imatinib Rowex 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 ROWEX 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
Rowex
inhibits the growth of
these cells.
IMATINIB ROWEX IS ALSO A TREATMENT FOR ADULTS FOR:
•
MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD)
. These are a group of blood diseases
in

Summary of Product characteristics

HealthProductsRegulatoryAuthority
10February2023
CRN00D9R5
Page1of29
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ImatinibRowex400mg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.
Verydarkyellowtobrownishorange,ovaloid,biconvexwithbevellededges,debossedwith“400”ononesideandscoreonthe
othersideandSLoneachsideofthescore.Approximatelength19.2mmandwidth7.7mm.
Thefilm-coated tabletcanbedividedintoequaldoses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ImatinibRowexisindicatedforthetreatmentof

adultand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.

adultandpaediatricpatientswithPh+CMLinchronicphaseafterfailureofinterferon-alphatherapy,orin
acceleratedphaseorblastcrisis.

adultandpaediatricpatientswithnewlydiagnosedPhiladelphiachromosomepositiveacutelymphoblastic
leukaemia(Ph+ALL)integratedwithchemotherapy.

adultpatientswithrelapsedorrefractoryPh+ALLasmonotherapy.

adultpatientswithmyelodysplastic/myeloproliferativediseases(MDS/MPD)associatedwithplatelet-derived
growthfactorreceptor(PDGFR)genere-arrangements.

adultpatientswithadvancedhypereosinophilicsyndrome(HES)and/orchroniceosinophilicleukaemia(CEL)with
FIP1L1-PDGFRαrearrangement.