REDISTRA CAPSULE 100MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

IMATINIB MESILATE EQUIV TO IMATINIB

Available from:

ZYFAS PHARMA PTE LTD

ATC code:

L01XE01

Pharmaceutical form:

CAPSULE

Composition:

IMATINIB MESILATE EQUIV TO IMATINIB 100 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Dr Reddy’s Laboratories Ltd

Authorization status:

ACTIVE

Authorization date:

2021-11-15

Patient Information leaflet

MARCH 02, 2021
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB 100 MG & 400 MG CAPSULES
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 or 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 or 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 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
Redistra 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 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 inhibits the
growth of these cells.
REDISTRA IS ALSO A TREATMENT FOR ADULTS FOR:
Gastrointestinal stromal tumours (GIST). GIST is a cancer of the
stomach and bowels. It arises from
uncontrolled cell growth of the supporting tissues of

Summary of Product characteristics

For the use of a Physician or a Hospital only
March 2, 2021
1
REDISTRA
IMATINIB 100 MG & 400 MG CAPSULE
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
CAPSULE
Each capsule contains 100 or 400 mg Imatinib (as Mesilate)
IMATINIB CAPSULES 100 MG:
Off-white to brownish yellow colour granular powder filled in Orange
to grayish-orange opaque Size ‘1’ Hard Gelatin capsule imprinted
with ‘RDY’ on cap and ‘100’ on
body with red ink.
IMATINIB CAPSULES 400 MG:
Off-white to brownish yellow color granular powder filled in Very
dark yellow to brownish-orange opaque Size '00' Hard Gelatin capsule
imprinted with 'RDY' on cap
and '400' on body with red ink.
EXCIPIENTS
IMATINIB 100 MG & 400 MG CAPSULE CONTAINS:
Crospovidone, Sodium Stearyl Fumarate
CAPSULE SHELL - IMATINIB 100 MG CAPSULE:
Gelatin, Sodium laurilsulfate, Water, Titanium
dioxide (E171), Iron Oxide red (E172), Iron Oxide yellow (E172),
CAPSULE SHELL - IMATINIB 400 MG CAPSULE:
Gelatin, Sodium laurilsulfate, Water, Titanium
dioxide (E171), Iron Oxide black (E172), Iron oxide red (E172), Iron
Oxide yellow (E172),
CLINICAL INFORMATION
INDICATIONS
Imatinib is indicated for the
•
treatment of adult and paediatric patients with newly diagnosed
Philadelphia
chromosome positive chronic myeloid leukaemia (Ph+ CML).
•
treatment of adult and paediatric patients with Ph+ CML in blast
crisis, accelerated phase,
or in chronic phase after failure of interferon-alpha therapy.
•
treatment of paediatric patients with newly diagnosed Philadelphia
chromosome positive
acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy.
•
treatment of adult patients with relapsed or refractory Ph+ ALL as
monotherapy.
•
treatment of adult patients with Kit+ (CD117) unresectable and/or
metastatic malignant
gastrointestinal stromal tumours (GIST).
•
adjuvant treatment of adult patients following complete gross
resection of Kit+ GIST
The effectiveness of Imatinib is based on overall haematological and
cytogenetic response rates
and progression-free survival in CML, on