Sunitinib Pharmacare 25 mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Pharmacare Premium Limited HHF 003 Halfar Industrial Estate Birzebbugia BBG 3000, Malta

ATC code:

L01EX01

INN (International Name):

SUNITINIB 25 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

SUNITINIB 25 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-06-20

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
SUNITINIB PHARMACARE 12.5 MG HARD CAPSULES
SUNITINIB PHARMACARE 25 MG HARD CAPSULES
SUNITINIB PHARMACARE 37.5 MG HARD CAPSULES
SUNITINIB PHARMACARE 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 Pharmacare is and what it is used for
2.
What you need to know before you take Sunitinib Pharmacare
3.
How to take Sunitinib Pharmacare
4.
Possible side effects
5.
How to store Sunitinib Pharmacare
6.
Contents of the pack and other information
1.
WHAT SUNITINIB PHARMACARE IS AND WHAT IT IS USED FOR
Sunitinib Pharmacare 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 Pharmacare 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 others 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 Pharmacare works or why
this medicine has been
prescribed for you, ask you

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib Pharmacare 12.5 mg hard capsules
Sunitinib Pharmacare 25 mg hard capsules
Sunitinib Pharmacare 37.5 mg hard capsules
Sunitinib Pharmacare 50 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
12.5 mg hard capsules
Each capsule contains 12.5 mg of sunitinib
25 mg hard capsules
Each capsule contains 25 mg of sunitinib
37.5 mg hard capsules
Each capsule contains 37.5 mg of sunitinib
50 mg hard capsules
Each capsule contains 50 mg of sunitinib
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Sunitinib Pharmacare 12.5 mg hard capsules
Hard gelatin capsule size ‘4’ with orange cap and orange body,
printed with white ink ‘SB 12.5’ and
white line on the body and containing yellow to orange granules.
Sunitinib Pharmacare 25 mg hard capsules
Hard gelatin capsule size ‘3’ with caramel cap and orange body,
printed with white ink ‘SB 25’ and
white line on the body and containing yellow to orange granules.
Sunitinib Pharmacare 37.5 mg hard capsules
Hard gelatin capsule size ‘2’ with yellow cap and yellow body,
printed with black ink ‘SB 37.5’ and
black line on the body and containing yellow to orange granules.
Sunitinib Pharmacare 50 mg hard capsules
Hard gelatin capsule size ‘1’ with caramel cap and caramel body,
printed with white ink ‘SB 50’ and
white line on the body and containing yellow to orange granules.
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4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)
Sunitinib Pharmacare 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 Pharmacare is indicated for the treatment of
advanced/metastatic renal cell carcinoma
(MRCC) in adults.
Pancreatic neuroendocrine tumours (pNET)
Sunitinib Pharmacare is indicat