Veiasu Film-Coated Tablets 250mg

País: Malasia

Idioma: inglés

Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes activos:

Gefitinib

Disponible desde:

LOTUS HEALTHCARE MALAYSIA SDN. BHD.

Designación común internacional (DCI):

Gefitinib

Unidades en paquete:

3 x 10 Tablets

Fabricado por:

Lotus Pharmaceutical Co., Ltd. Nantou Plant

Información para el usuario

Consumer Medication Information Leaflet (RiMUP)
_____________________________________________________________________________
1
VEIASU FILM-COATED TABLETS
Gefitinib (250mg)
What is in this leaflet
1.
What Veiasu is used for
2.
How Veiasu works
3.
Before you use Veiasu
4.
How to use Veiasu
5.
While you are using
Veiasu
6.
Side effects
7.
Storage & disposal of
Veiasu
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
What Veiasu is used for
Veiasu is used to treat advanced
non-small cell lung cancer
(NSCLC), which is a type of
lung cancer.
How Veiasu works
Veiasu contains the active
substance gefitinib. Gefitinib
works by blocking a protein
called ‘epidermal growth factor
receptor’ (EGFR). This protein
is involved in the growth and
spread of cancer cells.
Before you use Veiasu
When you must not use it
Do not take Veiasu tablets if you
are allergic (hypersensitive) to
gefitinib or any of the other
ingredients of Veiasu tablets
(see ingredient list).
Veiasu is not recommended for
use in children or adolescents.
Before you start to use it
If you have the following:

Having or had any other
lung diseases (other than
your lung cancer). Some of
these diseases may worsen
during treatment with
Veiasu

Pregnant or trying to be
pregnant. You should avoid
becoming pregnant during
treatment with Veiasu

Breastfeeding. For the safety
of your baby, you should
discontinue breastfeeding
during treatment with Veiasu
Taking other medicines
Please tell your doctor or
pharmacist if you are taking or
have recently taken any other
medicines, including medicines
obtained without a prescription.
Please inform your doctor if you
are taking any of the following
medicines:

Warfarin (to prevent blood
clots). Veiasu may affect it.
Your doctor may need to
check your blood more often.

Phenytoin, carbamazepine,
rifampicin, barbiturates, St
John’s Wort or itraconazole
or any other medicines that
reduce the acidity on your
stomach, such as ranitidine.
These medicines may affect
the way

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PRINT COLOURS
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GEFITINIB MALAYSIA 250MG 3X10S
FCT PIL
Die Cut size
Created
Modified
Proof round
ART Code
2 Pages - 293x700mm
RM 26/04/2023
RM 03/05/2023
02
ARTDB025177P
MINIMUM FONT SIZE = 9PT
IF THE ABOVE MINIMUM FONT SIZE IS NOT
ACCEPTABLE FOR THIS ARTWORK (EXCLUDING
CODES) PLEASE DO NOT APPROVE.
REGULATORY APPROVAL
Veiasu tablets 250 mg
GEFITINIB
PRODUCT PARTICULARS
1.
NAME OF PRODUCT
Veiasu film-coated tablets 250mg
2.
NAME AND STRENGTH OF ACTIVE INGREDIENT(S)
Each Veiasu film-coated tablet contains 250mg of gefitinib.
3.
DOSAGE FORM
Film-coated tablets.
4.
PRODUCT DESCRIPTION
Brown, round, biconvex tablets film-coated debossed with “LP100”
on one side and plain on the other side.
5.1
PHARMACODYNAMICS
Gefitinib is a selective inhibitor of the epidermal growth factor
receptor (EGFR) tyrosine kinase, commonly ex-
pressed in solid human tumours of epithelial origin. Inhibition of
EGFR tyrosine kinase activity inhibits tumour
growth, metastasis and angiogenesis and increases tumour cell
apoptosis.
Patients that have never smoked, have adenocarcinoma histology, are
female gender or are of Asian ethnic-
ity, are more like to benefit from treatment with gefitinib. These
clinical characteristics are also associated
with a higher rate of EGFR mutation positive tumours.
_Resistance:_ Most NSCLC (non-small cell lung cancer) tumors with
sensitizing EGFR kinase mutations eventu-
ally develop resistance to gefitinib treatment with a median time to
disease progression of 1 year. In about
60% of cases, resistance is associated with a secondary T790M mutation
for which T790M targeted EGFR
TKIs may be considered as