IRESSA 250 mg TABLET

País: Sudáfrica

Idioma: inglés

Fuente: South African Health Products Regulatory Authority (SAHPRA)

Disponible desde:

AstraZeneca Pharmaceuticals (Pty) Ltd

Dosis:

250,0 mg

formulario farmacéutico:

TABLET

Composición:

EACH TABLET CONTAINS GEFITINIB 250,0 mg

Estado de Autorización:

Registered

Información para el usuario

AstraZeneca Pharmaceuticals (Pty) Ltd
Approval date: 24 March 2022
Iressa 250 mg (Film-coated Tablet)
Page 1 of 9
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
IRESSA ® 250 MG FILM COATED TABLETS
(gefitinib)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING IRESSA.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other
health care provider.
•
IRESSA has been prescribed for you personally and you should not share
your
medicine with other people. It may harm them, even if their symptoms
are the same
as yours.
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.
AstraZeneca Pharmaceuticals (Pty) Ltd
Approval date: 24 March 2022
Iressa 250 mg (Film-coated Tablet)
Page 2 of 9
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 hypersensitive (allergic) to gefitinib or any of the other
ingredients of
IRESSA (listed in section 6)
•
if you are breast feeding
•
if you are pregnant
WARNINGS AND PRECAUTIONS
Take special care with 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
CHILDREN AND ADOLESCENTS
IRESSA is not indicated in children and adolescents under 18 years.
OTHER MEDICINES AND IRESSA
Always tell your health care provider if you are taking any other
medicine. (This includes
all complementary or traditiona

Ficha técnica

AstraZeneca Pharmaceuticals (Pty) Ltd
Approval date: 24 March 2022
Iressa 250 mg (Film-coated tablet)
PROFESSIONAL INFORMATION
SCHEDULING STATUS: S4
1. NAME OF THE MEDICINE
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).
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 epidermal
growth factor receptor (EGFR)-tyrosine kinase (TK) domain (see section
4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with IRESSA should be initiated and supervised by a doctor
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
AstraZeneca Pharmaceuticals (Pty) Ltd
Approval date: 24 March 2022
Iressa 250 mg (Film-coated tablet)
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 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 Class
B or Class 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 serum asp