Sunitinib Dr. Reddy’s 12.5 mg hard capsules

Land: Malta

Taal: Engels

Bron: Medicines Authority

Beschikbaar vanaf:

Reddy Pharma Iberia S.A. Avinguda De Josep Tarradellas 38 Barcelona, 08029, Spain

ATC-code:

L01EX01

INN (Algemene Internationale Benaming):

SUNITINIB 12.5 mg

farmaceutische vorm:

HARD CAPSULE

Samenstelling:

SUNITINIB 12.5 mg

Prescription-type:

POM

Therapeutisch gebied:

ANTINEOPLASTIC AGENTS

Product samenvatting:

Licence number in the source country: NOT APPLICAPABLE

Autorisatie-status:

Authorised

Autorisatie datum:

2022-09-05

Bijsluiter

Page
1
of
9
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUNITINIB DR. REDDY’S 12.5 MG HARD CAPSULES
SUNITINIB DR. REDDY’S 25 MG HARD CAPSULES SUNITINIB DR. REDDY’S 50 MG HARD CAPSULES
Sunitinib
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.
-
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. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sunitinib Dr. Reddy’s is and what it is used for
2.
What you need to know before you take Sunitinib Dr. Reddy’s
3.
How to take Sunitinib Dr. Reddy’s
4.
Possible side effects
5.
How to store Sunitinib Dr. Reddy’s
6.
Contents of the pack and other information
1
WHAT SUNITINIB DR. REDDY’S IS AND WHAT IT IS USED FOR
Sunitinib Dr. Reddy’s contains the active substance sunitinib, which
is a protein kinase inhibitor. It is used to
treat cancer by preventing the activity of a special group of proteins
which are known to be involved in the
growth and spread of cancer cells.
Sunitinib Dr. Reddy’s is used to treat adults with the following
types of cancer:
-
Gastrointestinal stromal tumour (GIST), a type of cancer of the
stomach and bowel, where imatinib (another
anticancer medicine) no longer works or you cannot take imatinib.
-
Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that
has spread to other parts of the body.
-
Pancreatic neuroendocrine tumours (pNET) (tumours of the
hormone-producing cells in the pancreas) that
have progressed or cannot be removed with surgery.
If you have any questions about how Sunitinib Dr. Reddy’s works or
why this medicine has been prescribed for
you, ask your doctor.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUNITI

Productkenmerken

Common Technical Document
Sunitinib Dr. Reddy’s 12.5, 25 and 50 mg
Capsules
Page 1 of 2
Summary of Product Characteristics
1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib Dr. Reddy’s 12.5 mg hard capsules
Sunitinib Dr. Reddy’s 25 mg hard capsules
Sunitinib Dr. Reddy’s 50 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains sunitinib malate, equivalent to 12.5 mg of
sunitinib.
Each capsule contains sunitinib malate, equivalent to 25 mg of
sunitinib.
Each capsule contains sunitinib malate, equivalent to 50 mg of
sunitinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Sunitinib 12.5 mg capsule
Hard gelatine capsule with orange cap and orange body, printed with
white imprint “SNB” and “12.5” on the
body. The capsule is filled with orange powder. Capsule size: 4
(length of approximately 14 mm).
Sunitinib 25 mg capsule
Hard gelatine capsule with caramel (light brown) cap and orange body,
printed with white imprint “SNB” and
“25” on the body. The capsule is filled with orange powder.
Capsule size: 3 (length of approximately 16 mm).
Sunitinib 50 mg capsule
Hard gelatine capsule with caramel cap and caramel body (light brown),
printed with black imprint “SNB” and
“50” on the body. The capsule is filled with orange powder.
Capsule size: 1EL (elongated; length of approximately
20 mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)
Sunitinib Dr. Reddy’s is indicated for the treatment of unresectable
and/or metastatic malignant gastrointestinal
stromal tumour (GIST) in adults after failure of imatinib treatment
due to resistance or intolerance.
Metastatic renal cell carcinoma (MRCC)
Sunitinib Dr. Reddy’s is indicated for the treatment of
advanced/metastatic renal cell carcinoma (MRCC) in
adults.
Pancreatic neuroendocrine tumours (pNET)
Common Technical Document
Sunitinib Dr. Reddy’s 12.5, 25 and 50 mg
Capsules
Page 2 of 3
Sunitinib Dr. Reddy’s is indicated for the tre