Sunitinib Sandoz 25 mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SUNITINIB

Available from:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC code:

L01EX01

INN (International Name):

SUNITINIB 25 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

SUNITINIB 25 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2019-05-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUNITINIB SANDOZ 12.5 MG HARD CAPSULES
SUNITINIB SANDOZ 25 MG HARD CAPSULES
SUNITINIB SANDOZ 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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sunitinib Sandoz is and what it is used for
2.
What you need to know before you take Sunitinib Sandoz
3.
How to take Sunitinib Sandoz
4.
Possible side effects
5.
How to store Sunitinib Sandoz
6.
Contents of the pack and other information
1.
WHAT SUNITINIB SANDOZ IS AND WHAT IT IS USED FOR
Sunitinib Sandoz 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 Sandoz 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 Sandoz works or why this
medicine has been
prescribed for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUNITINIB SANDOZ
DO NOT TAKE SUNITINIB SANDOZ:
-
if you are allergic to sunitin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib Sandoz 12.5 mg hard capsules
Sunitinib Sandoz 25 mg hard capsules
Sunitinib Sandoz 50 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Sunitinib Sandoz 12.5 mg hard capsules
Each capsule contains 12.5 mg of sunitinib.
Excipient with known effect:
Each capsule contains 0.42 mg of sodium.
Sunitinib Sandoz 25 mg hard capsules
Each capsule contains 25 mg of sunitinib.
Excipient with known effect:
Each capsule contains 0.84 mg of sodium.
Sunitinib Sandoz 50 mg hard capsules
Each capsule contains 50 mg of sunitinib.
Excipient with known effect:
Each capsule contains 1.68 mg of sodium.
Sunitinib Sandoz 12.5 mg hard capsules (capsules)
Gelatin capsules of size 4 with orange cap and orange body, printed
with white ink “12.5 mg”
on the body and containing yellow to orange granules.
Sunitinib Sandoz 25 mg hard capsules (capsules)
Gelatin capsules of size 3 with caramel cap and orange body, printed
with white ink “25 mg”
on the body and containing yellow to orange granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)
Sunitinib Sandoz 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 Sandoz is indicated for the treatment of advanced/metastatic
renal cell carcinoma
(MRCC) in adults.
Pancreatic neuroendocrine tumours (pNET)
Sunitinib Sandoz 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 administration of
anticancer agents.
Posology
For GIST and MRCC, the recommended dose of