Gefitinib Sandoz 250 mg, filmomhulde tabletten

País: Holanda

Língua: holandês

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

Ingredientes ativos:

GEFITINIB

Disponível em:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Código ATC:

L01XE02

DCI (Denominação Comum Internacional):

GEFITINIB

Forma farmacêutica:

Filmomhulde tablet

Composição:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYVINYLALCOHOL (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Via de administração:

Oraal gebruik

Área terapêutica:

Gefitinib

Data de autorização:

2018-10-27

Folheto informativo - Bula

Sandoz B.V.
Gefitinib Sandoz 250 mg, filmomhulde tabletten
RVG 121544
v2
1.3.1.3 Bijsluiter
Juni 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GEFITINIB SANDOZ 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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] 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.
[Nationally completed name] 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 [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
−
if you are allergic to gefitinib or any of the other ingredients of
this medicine (listed in section 6).
−
if you are breast-feeding.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking [Nationally completed
name]
−
if you have ever had any other lung problems. Some lung problems may
get worse during
treatment with [Nationally completed name].
−
if you have ever had pro

Características técnicas

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Gefitinib Sandoz 250 mg, filmomhulde tabletten
RVG 121544
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Juni 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gefitinib Sandoz 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 155.3 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Brown, round, biconvex, impressed with “250” on one side and plain
on the other side. The diameter of
the film-coated tablet is 11.1 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] 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 [Nationally completed name] should be initiated and
supervised by a physician
experienced in the use of anticancer therapies.
Posology
The recommended posology of [Nationally completed name] 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 gefitinib 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
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Gefitinib Sandoz 250 mg, filmomhulde tabletten
RVG 121544
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plasma concentrations of gefitinib. These patients should be closely
monitored for adverse events.
P