IMATINIB 100 Milligram Capsules Hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-07-2017
Summary of Product characteristics
(SPC)
19-07-2017
Active ingredient:
IMATINIB MESILATE
Available from:
Cipla (EU) Limited
ATC code:
L01X
INN (International Name):
IMATINIB MESILATE
Dosage:
100 Milligram
Pharmaceutical form:
Capsules Hard
Administration route:
Oral use
Units in package:
20, 60, 120 and 180 capsules
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
S&D Pharma CZ, Cipla (EU) Limited
Therapeutic group:
antineoplastic agents; protein kinase inhibitor
Therapeutic area:
OTHER CYTOSTATICS
Therapeutic indications:
It s 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 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
Authorization status:
Authorised
Authorization date:
2015-08-07
Patient Information leaflet
Package Leaflet – Information for the patient
Imatinib 100mg capsules, hard
imatinib This medicin e is subject to additional monitoring. This will allow quick ide ntification of new
safety information. You can help by reporting any side effects you may get. See section 4 for how
to report adverse reactions
Read all of this leaflet carefully before you start taking this medicine because it contains
important informa tion 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 i llness 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 capsules is and what it is used f or
2. What you need to know before you take imatinib capsules
3. How to take imatinib capsules
4. Possible side effects
5. How to store imatinib capsules
6. Contents of the pack and other information
1. What imatinib capsules is and what it is used for
Imatinib capsule 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:
- Chronic myel oid 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 is used to treat a late stage of Chronic Myeloid Leukaemia called
“blast crisis”. In children and adolescents however it may be used to treat all stages of the
illness.
- Philadelphia chromosome positive acute lymphoblast ic leukaemia (Ph -positive ALL) .
Leukaemia is a cancer o
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imatinib 100mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains 100mg imatinib (as mesilate)
EXCIPIENT WITH KNOWN EFFECTS:
Each 100mg capsules contains 40 mg of lactose anhydrous.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Hard capsule are light yellow granules filled in size “3” hard
gelatin capsule with brown cap and white body.
Capsule length: 15.8 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imatinib 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 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 recurrent
and/or metastatic DFSP who are not eligible for surgery
The effect of imatinib on the outcome of bone marrow transplantation
has not been determined.
In adult and paediatric patients, the effectiveness of imatinib is
based on overall haematological and cytogenetic
response rates and progression-free survival in CML, on haematological
and cytogenetic response rates in Ph+ ALL,
MDS/MPD, on haematological response rates in H
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