Gefimira 250 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

GEFITINIB

Beschikbaar vanaf:

Helm AG

ATC-code:

L01XE02

INN (Algemene Internationale Benaming):

GEFITINIB

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Gefitinib

Autorisatie datum:

2018-09-11

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GEFIMIRA 250 MG FILMOMHULDE TABLETTEN
gefitinib
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, pharmacist or
nurse.

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, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Gefimira is and what it is used for
2.
What you need to know before you take Gefimira
3.
How to take Gefimira
4.
Possible side effects
5.
How to store Gefimira
6.
Contents of the pack and other information
1.
WHAT GEFIMIRA IS AND WHAT IT IS USED FOR
Gefimira contains the active substance gefitinib which blocks a
protein called ‘epidermal
growth factor receptor’ (EGFR). This protein is involved in the
growth and spread of cancer
cells.
Gefimira is used to treat adults with non-small cell lung cancer. This
cancer is a disease in
which malignant (cancer) cells form in the tissues of the lung.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GEFIMIRA
DO NOT TAKE GEFIMIRA

if you are allergic to gefitinib or any of the other ingredients of
this medicine (listed in
section 6, ‘What Gefimira contains’).

if you are breast-feeding.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Gefimira

if you have ever had any other lung problems. Some lung problems may
get worse
during treatment with Gefimira.

if you have ever had problems with your liver.
CHILDREN AND ADOLESCENTS
Gefimira is not indicated in children and adolescents under 18 years.
OTHER MEDICINES AND GEFIMIRA
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines.
In particular, tell your doctor or ph

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
Gefimira 250 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg of gefitinib.
Excipient with known effect:
Each film-coated tablet contains 161 mg of lactose (as monohydrate)
Each tablet contains 0.1 mg sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
The film-coated tablets are brown, round and biconvex, marked with
“250” on one side and plain on the other.
The film-coated tablets have a diameter of approx. 11.1 mm and a
thickness of approx. 5.6 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gefimira is indicated as monotherapy for the treatment of adult
patients with locally advanced or metastatic
non-small cell lung cancer (NSCLC) with activating mutations of
EGFR-TK (see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Gefimira should be initiated and supervised by a
physician experienced in the use of
anticancer therapies.
Posology
The recommended posology of Gefimira is one 250 mg tablet once a day.
If a dose is missed, it should be
taken as soon as the patient remembers. If it is less than 12 hours to
the next dose, the patient should not take
the missed dose. Patients should not take a double dose (two doses at
the same time) to make
up for a
forgotten dose.
_Paediatric population_
The safety and efficacy of Gefimira in children and adolescents aged
less than 18 years have not been
established. There is no relevant use of gefitinib in the paediatric
population in the indication of NSCLC.
_Hepatic impairment_
Patients with moderate to severe hepatic impairment (Child-Pugh B or
C) due to cirrhosis have
increased
plasma concentrations of gefitinib. These patients should be closely
monitored for adverse events. Plasma
concentrations
were
not
increased
in
patients
with
elevated
aspartate
transaminase
(AST),
alkaline
phosphatase or bilirubin due to liver metastases (see section 5.2).
_Renal impairment_
No dose adjustment is requ