Iressa

Țară: Uniunea Europeană

Limbă: engleză

Sursă: EMA (European Medicines Agency)

Ingredient activ:

gefitinib

Disponibil de la:

AstraZeneca AB

Codul ATC:

L01XE02

INN (nume internaţional):

gefitinib

Grupul Terapeutică:

Antineoplastic agents

Zonă Terapeutică:

Carcinoma, Non-Small-Cell Lung

Indicații terapeutice:

Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase.

Rezumat produs:

Revision: 16

Statutul autorizaţiei:

Authorised

Data de autorizare:

2009-06-24

Prospect

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IRESSA 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 IRESSA is and what it is used for
2.
What you need to know before you take IRESSA
3.
How to take IRESSA
4.
Possible side effects
5.
How to store IRESSA
6.
Contents of the pack and other information
1.
WHAT IRESSA IS AND WHAT IT IS USED FOR
IRESSA 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.
IRESSA 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 IRESSA
DO NOT TAKE IRESSA

if you are allergic to gefitinib or any of the other ingredients of
this medicine (listed in
section 6, ‘What IRESSA contains’).

if you are breast-feeding.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking IRESSA

if you have ever had any other lung problems. Some lung problems may
get worse during
treatment with IRESSA.

if you have ever had problems with your liver.
32
CHILDREN AND ADOLESCENTS
IRESSA is not indicated in children and adolescents under 18 years.
OTHER MEDICINES AND IRESSA
Tell your doctor or pharmacist if you are taking, have recently taken,
or might take any other
medicines.
In particular, tell your doctor or pharm

Caracteristicilor produsului

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
IRESSA 250 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of gefitinib.
Excipients with known effect:
Each tablet contains 163.5 mg of lactose (as monohydrate).
Each tablet contains 3.86 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets (tablet).
Tablets are brown, round, biconvex, impressed with “IRESSA 250” on
one side and plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IRESSA 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 IRESSA should be initiated and supervised by a
physician experienced in the use of
anti-cancer therapies.
Posology
The recommended posology of IRESSA 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 IRESSA in children and adolescents aged
less than 18 years has 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. Onl