Sunitinib Medichem 37.5mg Hard Capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SUNITINIB

Available from:

Medichem, S.A. Fructuós Gelabert 6-8, 08970, Sant Joan Despí, (Barcellona), Spain

ATC code:

L01XE01

INN (International Name):

SUNITINIB 37.5 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

SUNITINIB 37.5 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2017-12-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUNITINIB MEDICHEM 12.5 MG HARD CAPSULES
SUNITINIB MEDICHEM 25 MG HARD CAPSULES
SUNITINIB MEDICHEM 37.5 MG HARD CAPSULES
SUNITINIB MEDICHEM 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 Medichem is and what it is used for
2.
What you need to know before you take Sunitinib Medichem
3.
How to take Sunitinib Medichem
4.
Possible side effects
5.
How to store Sunitinib Medichem
6.
Contents of the pack and other information
1.
WHAT SUNITINIB MEDICHEM IS AND WHAT IT IS USED FOR
Sunitinib Medichem 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 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 works or why this
medicine has been prescribed for you,
ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUNITINIB MEDICHEM
DO NOT TAKE SUNITINIB MEDICHE

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib Medichem 12.5 mg hard capsules
Sunitinib Medichem 25 mg hard capsules
Sunitinib Medichem 37.5 mg hard capsules
Sunitinib Medichem 50 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
12.5 mg hard capsules
Each capsule contains sunitinib malate, equivalent to 12.5 mg of
sunitinib.
25 mg hard capsules
Each capsule contains sunitinib malate, equivalent to 25 mg of
sunitinib.
37.5 mg hard capsules
Each capsule contains sunitinib malate, equivalent to 37.5 mg of
sunitinib.
50 mg hard capsules
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.
Sunitinib Medichem 12.5 mg hard capsules
Gelatine capsules with orange cap and orange body and containing
yellow to orange granules.
Sunitinib Medichem 25 mg hard capsules
Gelatine capsules with caramel cap and orange body and containing
yellow to orange granules.
Sunitinib Medichem 37.5 mg hard capsules
Gelatine capsules with yellow cap and yellow body and containing
yellow to orange granules.
Sunitinib Medichem 50 mg hard capsules
Gelatine capsules with caramel cap and caramel body and containing
yellow to orange granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal Stromal Tumour (GIST)
Sunitinib 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 is indicated for the treatment of advanced/metastatic renal
cell carcinoma (MRCC) in
2
adults.
Pancreatic Neuroendocrine Tumours (pNET)
Sunitinib
is
indicated
for
the
treatment
of
unresectable
or
metastatic,
well-differentiated
pancreatic neuroendocrine tumours (pNET) with disease progression in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy with sunitinib should be initiated by a physician experienced
in the admi