Sunitinib Mylan 37.5mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SUNITINIB

Available from:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

L01EX01

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:

2019-06-18

Patient Information leaflet

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

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib Mylan 12.5 mg hard capsules
Sunitinib Mylan 25 mg hard capsules
Sunitinib Mylan 37.5 mg hard capsules
Sunitinib Mylan 50 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sunitinib Mylan 12.5 mg hard capsules
Each capsule contains 12.5 mg of sunitinib.
Excipient with known effect:
Each capsule contains 0.4 mg of sodium.
Sunitinib Mylan 25 mg hard capsules
Each capsule contains 25 mg of sunitinib.
Excipient with known effect:
Each capsule contains 0.8 mg of sodium.
Sunitinib Mylan 37.5 mg hard capsules
Each capsule contains 37.5 mg of sunitinib.
Excipient with known effect:
Each capsule contains 1.3 mg of sodium.
Sunitinib Mylan 50 mg hard capsules
Each capsule contains 50 mg of sunitinib.
Excipient with known effect:
Each capsule contains 1.7 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Sunitinib Mylan 12.5 mg hard capsules (capsules)
Gelatin capsules of of 14.2 mm ± 0.5 mm size with orange cap and
orange body, printed with white
ink “12.5 mg” on the body and containing yellow to orange
granules.
Sunitinib Mylan 25 mg hard capsules (capsules)
Gelatin capsules of of 15.9 mm ± 0.5 mm size with caramel cap and
orange body, printed with white
ink “25 mg” on the body and containing yellow to orange granules.
Sunitinib Mylan 37.5 mg hard capsules (capsules)
Gelatin capsules of of 17.9 mm ± 0.5 mm size with yellow cap and
yellow body, printed with black
ink “37.5 mg” on the body and containing yellow to orange
granules.
2
Sunitinib Mylan 50 mg hard capsules (capsules)
Gelatin capsules of 19.3 mm ± 0.5 mm size 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
Mylan
is
indicated
for
the
treatment
of
unresectable
and/or
metastatic
malignant
gastrointestinal stromal tumour (GIST) in