Erlotinib Actavis 150mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ERLOTINIB HYDROCHLORIDE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

L01XE03

INN (International Name):

ERLOTINIB HYDROCHLORIDE 150 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ERLOTINIB HYDROCHLORIDE 150 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2017-05-31

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
ERLOTINIB ACTAVIS 25 MG FILM-COATED TABLETS
ERLOTINIB ACTAVIS 100 MG FILM-COATED TABLETS
ERLOTINIB ACTAVIS 150 MG FILM-COATED TABLETS
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 Actavis is and what it is used for
2.
What you need to know before you take Erlotinib Actavis
3.
How to take Erlotinib Actavis
4.
Possible side effects
5.
How to store Erlotinib Actavis
6.
Contents of the pack and other information
1.
WHAT ERLOTINIB ACTAVIS IS AND WHAT IT IS USED FOR
Erlotinib Actavis contains the active substance erlotinib. Erlotinib
Actavis 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 Actavis 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 NEED TO KNOW BEFORE YOU TAKE ERLOTINIB ACTAVIS
DO NOT TAKE ERLOTINIB ACTAVIS:
-
if you are allergic to erlotinib or any o

Summary of Product characteristics

Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Erlotinib Actavis 25 mg film-coated tablets
Erlotinib Actavis 100 mg film-coated tablets
Erlotinib Actavis 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 25 mg erlotinib (as erlotinib
hydrochloride).
One film-coated tablet contains 100 mg erlotinib (as erlotinib
hydrochloride).
One film-coated tablet contains 150 mg erlotinib (as erlotinib
hydrochloride).
Excipients with known effect:
Each 25 mg film-coated tablet contains 20.94 mg lactose anhydrous.
Each 100 mg film-coated tablet contains 83.77 mg lactose anhydrous.
Each 150 mg film-coated tablet contains 125.65 mg lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Erlotinib Actavis 25 mg film-coated tablets: White, round, biconvex
film-coated tablets of 6 mm with
uniform appearance and intact edges, engraved with A105 on one side.
Erlotinib Actavis 100 mg film-coated tablets: White, round, biconvex
film-coated tablets of 10 mm
with uniform appearance and intact edges, engraved with A116 on one
side.
Erlotinib Actavis 150 mg film-coated tablets: White, round, biconvex
film-coated tablets of 11 mm
with uniform appearance and intact edges, engraved with A127 on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-Small Cell Lung Cancer (NSCLC)
Erlotinib Actavis is indicated for the first-line treatment of
patients with locally advanced or
metastatic non- small cell lung cancer (NSCLC) with EGFR activating
mutations.
Erlotinib Actavis is is also indicated for switch maintenance
treatment in patients with locally
advanced or metastatic NSCLC with EGFR activating mutations and stable
disease after first-line
chemotherapy.
Erlotinib Actavis is is also indicated for the treatment of patients
with locally advanced or metastatic
NSCLC after failure of at least one prior chemotherapy regimen.
When prescribing Erlotinib Actavis, factors associated with prolonged
sur