Erlotinib Zentiva 150 mg, filmomhulde tabletten

País: Países Bajos

Idioma: neerlandés

Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredientes activos:

ERLOTINIBHYDROCHLORIDE 163,9 mg/stuk SAMENSTELLING overeenkomend met ; ERLOTINIB 150 mg/stuk

Disponible desde:

Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)

Código ATC:

L01XE03

Designación común internacional (DCI):

ERLOTINIBHYDROCHLORIDE 163,9 mg/stuk SAMENSTELLING overeenkomend met ; ERLOTINIB 150 mg/stuk

formulario farmacéutico:

Filmomhulde tablet

Composición:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Vía de administración:

Oraal gebruik

Área terapéutica:

Erlotinib

Resumen del producto:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); NATRIUMZETMEELGLYCOLAAT (E468); POLYETHYLEENGLYCOL (E 1521); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Fecha de autorización:

1900-01-01

Información para el usuario

ERLOTINIB HYDROCHLORIDE_25 mg_100 mg_150 mg_film-coated
tablet_NL_en_NL-H-4011-001-003_
EPAR 05/2023 + DL 10/2023
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ERLOTINIB ZENTIVA 25 MG FILMOMHULDE TABLETTEN
ERLOTINIB ZENTIVA 100 MG FILMOMHULDE TABLETTEN
ERLOTINIB ZENTIVA 150
MG FILMOMHULDE TABLETTEN
erlotinib
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 further questions, ask your doctor or pharmacist.
−
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 or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Erlotinib Zentiva is and what it is used for
2. What you need to know before you take Erlotinib Zentiva
3. How to take Erlotinib Zentiva
4. Possible side effects
5. How to store Erlotinib Zentiva
6. Contents of the pack and other information
1.
WHAT ERLOTINIB ZENTIVA IS AND WHAT IT IS USED FOR
Erlotinib Zentiva contains the active substance erlotinib. Erlotinib
Zentiva is a medicine used to treat cancer by
preventing the activity of a protein called epidermal growth factor
receptor (EGFR). This protein is known to be
involved in the growth and spread of cancer cells.
Erlotinib Zentiva is indicated for adults. This medicine can be
prescribed to you if you have non-small cell lung
cancer at an advanced stage. It can be prescribed as initial therapy
or as therapy if your disease remains largely
unchanged after initial chemotherapy, provided your cancer cells have
specific EGFR mutations. It can also be
prescribed if previous chemotherapy has not helped to stop your
disease.
This medicine can also be prescribed to you in combination with
another treatment called gemcitabine if you
have cancer of the pancreas at a metastatic stage.
2.
WHAT YOU NEE

Ficha técnica

ERLOTINIB HYDROCHLORIDE_25 mg_100 mg_150 mg_film-coated
tablet_NL_en_NL-H-4011-001-003_
EPAR 05/2023 + DL 10/2023
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
ERLOTINIB ZENTIVA 25 MG FILMOMHULDE TABLETTEN
ERLOTINIB ZENTIVA 100 MG FILMOMHULDE TABLETTEN
ERLOTINIB ZENTIVA 150 MG FILMOMHULDE TABLETTEN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Erlotinib Zentiva 25 mg film-coated tablets: Each film-coated tablet
contains 25 mg erlotinib (as erlotinib
hydrochloride).
Excipients with known effect: Each film-coated tablet contains 17.7 mg
lactose monohydrate, 0.29 mg sodium.
Erlotinib Zentiva 100 mg film-coated tablets: Each film-coated tablet
contains 100 mg erlotinib (as erlotinib
hydrochloride).
Excipients with known effect: Each film-coated tablet contains 70.7 mg
lactose monohydrate, 1.17 mg sodium.
Erlotinib Zentiva 150 mg film-coated tablets: Each film-coated tablet
contains 150 mg erlotinib (as erlotinib
hydrochloride).
Excipients with known effect: Each film-coated tablet contains 106 mg
lactose monohydrate, 1.75 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Erlotinib Zentiva 25 mg film-coated tablets: White, round, biconvex
tablets with “E9OB” embossed in one side
and “25” in the other, with a diameter of approximately 6 mm.
Erlotinib Zentiva 100 mg film-coated tablets: White, round, biconvex
tablets with a score line on both sides, on
one side the tablet is embossed with “E9OB” above the score line
and “100” below the score line, with
a diameter of approximately 10 mm. The tablet can be divided into
equal doses.
Erlotinib Zentiva 150 mg film-coated tablets: White, round, biconvex
tablets with “E9OB” embossed in one
side and “150” in the other, with a diameter of approximately 10.4
mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-small cell lung cancer (NSCLC)
Erlotinib Zentiva is indicated for the first-line treatment of
patients with locally advanced or metastatic non-
small cell lung cancer (NSC