Gefitinib Helm AG 250 mg filmomhulde tabletten

País: Holanda

Língua: holandês

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

Ingredientes ativos:

GEFITINIB

Disponível em:

Helm AG

Código ATC:

L01XE02

DCI (Denominação Comum Internacional):

GEFITINIB

Forma farmacêutica:

Filmomhulde tablet

Composição:

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)

Via de administração:

Oraal gebruik

Área terapêutica:

Gefitinib

Data de autorização:

2018-09-11

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GEFITINIB HELM AG 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 Gefitinib Helm AG is and what it is used for
2.
What you need to know before you take Gefitinib Helm AG
3.
How to take Gefitinib Helm AG
4.
Possible side effects
5.
How to store Gefitinib Helm AG
6.
Contents of the pack and other information
1.
WHAT GEFITINIB HELM AG IS AND WHAT IT IS USED FOR
Gefitinib Helm AG 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.
Gefitinib Helm AG 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 GEFITINIB HELM AG
DO NOT TAKE GEFITINIB HELM AG

if you are allergic to gefitinib or any of the other ingredients of
this medicine (listed in
section 6, ‘What Gefitinib Helm AG contains’).

if you are breast-feeding.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Gefitinib Helm AG

if you have ever had any other lung problems. Some lung problems may
get worse
during treatment with Gefitinib Helm AG.

if you have ever had problems with your liver.
CHILDREN AND ADOLESCENTS
Gefitinib Helm AG is not indicated in children and adolescents under
18 years.
OTHER MEDICINES AND GEFITINIB HELM AG
Tell yo

Características técnicas

1.
NAME OF THE MEDICINAL PRODUCT
Gefitinib Helm AG 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
Gefitinib Helm AG 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 Gefitinib Helm AG should be initiated and supervised by
a physician experienced in the use of
anticancer therapies.
Posology
The recommended posology of Gefitinib Helm AG 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 Helm AG 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).