Sunitinib Remedica 12.5mg Hard Capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SUNITINIB

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

L01EX01

INN (International Name):

SUNITINIB 12.5 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

SUNITINIB 12.5 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2019-03-06

Patient Information leaflet

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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib Remedica 12.5 mg hard capsules
Sunitinib Remedica 25 mg hard capsules
Sunitinib Remedica 37.5 mg hard capsules
Sunitinib Remedica 50 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sunitinib Remedica 12.5 mg hard capsules
Each hard capsule contains 12.5 mg of sunitinib.
Excipient with known effect:
Each hard capsule contains 0.42 mg of sodium.
Sunitinib Remedica 25 mg hard capsules
Each hard capsule contains 25 mg of sunitinib.
Excipient with known effect:
Each hard capsule contains 0.84 mg of sodium.
Sunitinib Remedica 37.5 mg hard capsules
Each hard capsule contains 37.5 mg of sunitinib.
Excipient with known effect:
Each hard capsule contains 1.26 mg of sodium.
Sunitinib Remedica 50 mg hard capsules
Each hard capsule contains 50 mg of sunitinib.
Excipient with known effect:
Each hard capsule contains 1.68 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules.
Sunitinib Remedica 12.5 mg hard 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 Remedica 25 mg hard 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.
Sunitinib Remedica 37.5 mg hard capsules
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Gelatin capsules of size 2 with yellow cap and yellow body, printed
with black ink “37.5 mg” on the
body and containing yellow to orange granules.
Sunitinib Remedica 50 mg hard capsules
Gelatin capsules of size 1 with caramel cap and caramel body, printed
with white ink “50 mg” on the
body and containing yellow to orange granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)
Sunitinib
Remedica
is
indicated
for
the
treatment
of
unresectable and/or