Gefinor Tablet, film coated 250mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GEFITINIB

Available from:

Ethypharm 194 Bureaux de la Colline, Bâtiment D, 92213 Saint-Cloud cedex, France

ATC code:

L01XE02

INN (International Name):

GEFITINIB 250 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

GEFITINIB 250 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2018-12-04

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEFINOR 250 MG FILM-COATED TABLETS
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 Gefinor is and what it is used for
2.
What you need to know before you take Gefinor
3.
How to take Gefinor
4.
Possible side effects
5.
How to store Gefinor
6.
Content of the pack and other information
1.
WHAT GEFINOR IS AND WHAT IT IS USED FOR
Gefinor 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.
Gefinor 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 GEFINOR
DO NOT TAKE GEFINOR
-
if you are allergic to gefitinib or to 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 Gefinor
-
if you have ever had any other lung problems. Some lung problems may
get worse during
treatment with Gefinor.
-
if you have ever had problems with your liver.
CHILDREN AND ADOLESCENTS
Gefinor is not indicated in children and adolescents under 18 years.
OTHER MEDICINES AND GEFINOR
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines.
In particular, tell your doctor or pharmacist if you are taking any of
the following medici

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gefinor 250 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of gefitinib.
Excipient with known effect:
Each tablet contains 141.41 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets (tablet).
Tablets are brown, round, 11 mm of diameter engraved with “250” on
one side and plain on the
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gefinor 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 Gefinor should be initiated and supervised by a
physician experienced in the use of
anticancer therapies.
POSOLOGY
The recommended posology of Gefinor 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 Gefinor 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 required in patients with impaired renal
function at creatinine clearance
> 20 ml/min. Only limited data are available in pat