Sunitinib Rowex 50 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sunitinib

Available from:

Rowex Ltd

ATC code:

L01XE; L01XE04

INN (International Name):

Sunitinib

Dosage:

50 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

Protein kinase inhibitors; sunitinib

Authorization status:

Marketed

Authorization date:

2019-05-03

Patient Information leaflet

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

Summary of Product characteristics

HealthProductsRegulatoryAuthority
19January2024
CRN00DKXT
Page1of23
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SunitinibRowex50mghardcapsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachcapsulecontains50mgofsunitinib.
Excipient with known effect:
Eachcapsulecontains1.68mgofsodium.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Hardcapsule(capsule).
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 Rowex 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Rowexisindicatedforthetreatmentofadvanced/metastaticrenalcellcarcinoma(MRCC)inadults.
Pancreatic neuroendocrine tumours (pNET)
Sunitinib Rowex 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
Sunitinib Rowex is 50 mg taken orally once
daily, for 4 consecutive weeks,
followedbya2-weekrestperiod(Schedule4/2)tocompriseacompletecycleof6weeks.
ForpNET,the�