Gefitinib Mylan

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

gefitinib

Saatavilla:

Mylan Pharmaceuticals Limited

ATC-koodi:

L01XE02

INN (Kansainvälinen yleisnimi):

gefitinib

Terapeuttinen ryhmä:

Antineoplastic agents, Protein kinase inhibitors

Terapeuttinen alue:

Carcinoma, Non-Small-Cell Lung

Käyttöaiheet:

Gefitinib Mylan 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.

Tuoteyhteenveto:

Revision: 6

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-09-27

Pakkausseloste

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GEFITINIB MYLAN 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 Gefitinib Mylan is and what it is used for
2.
What you need to know before you take Gefitinib Mylan
3.
How to take Gefitinib Mylan
4.
Possible side effects
5.
How to store Gefitinib Mylan
6.
Contents of the pack and other information
1.
WHAT GEFITINIB MYLAN IS AND WHAT IT IS USED FOR
Gefitinib Mylan 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 Mylan 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 MYLAN
_ _
DO NOT TAKE GEFITINIB MYLAN:
-
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 Gefitinib Mylan
-
if you have ever had any other lung problems. Some lung problems may
get worse during
treatment with Gefitinib Mylan.
-
if you have ever had problems with your liver.
-
if you have ever had stomach problems (gastrointestinal perforation)
Tell your doctor immediately if you experience dehydration or eye
problems whilst taking this
medicine (see section 4).
CHILDREN A

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Gefitinib Mylan 250 mg film-coated tablets
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).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Brown, round, biconvex film-coated tablets with approximately 11.1 mm
x 5.6 mm of dimension and
marked with “250” on one side and plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gefitinib Mylan 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 Mylan should be initiated and supervised by a
physician experienced in the
use of anticancer therapies.
Posology
The recommended posology of Gefitinib Mylan 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.
_ _
_CYP2D6 poor metabolisers _
No specific dose adjustment is recommended in patients with known
CYP2D6 poor metaboliser
genotype, but these patients should be closely monitored for adverse
events (see section 5.2).
_Dose adjustment due to toxicity _
Patients with poorly tolerated diarrhoea or skin adverse reactions may
be successfully managed by
providing a brief (up to 14 days) therapy interruption followed by
reinstatement of the 250 mg dose
(see section 4.8). For patients unable to tolerate treatment after a
therapy interruption, gefitinib should
be discontinued and an alternative treatment should be considered.
_Special populations _
_Paediatric population _
3
The safety and ef