Erlotinib 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Erlotinib hydrochloride

Available from:

Viatris UK Healthcare Ltd

ATC code:

L01EB02

INN (International Name):

Erlotinib hydrochloride

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 5016695925363

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ERLOTINIB 25 MG
FILM-COATED TABLETS
ERLOTINIB 100 MG
FILM-COATED TABLETS
ERLOTINIB 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 is and what it is used for
2. What you need to know before you take
Erlotinib
3. How to take Erlotinib
4. Possible side effects
5
How to store Erlotinib
6. Contents of the pack and other
information
1. WHAT ERLOTINIB IS AND WHAT IT IS
USED FOR
Erlotinib contains the active substance
erlotinib. Erlotinib 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 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
DO NOT TAKE ERLOTINIB:
•
if you are allergic to erlotinib or any of
the ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS:
•
if you are taking o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Erlotinib 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg erlotinib (as erlotinib
hydrochloride).
Excipient(s) with known effect:
Each film-coated tablet contains 95.93 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to yellowish, round biconvex, film-coated tablet, engraved with
‘100’ on one
side and approximately 8.9 mm in diameter.
4.1
THERAPEUTIC INDICATIONS
Non-Small Cell Lung Cancer (NSCLC)
Erlotinib is indicated for the first-line treatment of patients with
locally advanced or
metastatic non- small cell lung cancer (NSCLC) with Epidermal Growth
Factor
Receptor (EGFR) activating mutations.
Erlotinib 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 is also indicated for the treatment of patients with locally
advanced or
metastatic NSCLC after failure of at least one prior chemotherapy
regimen. In
patients with tumours without EGFR activating mutations, Erlotinib is
indicated when
other treatment options are not considered suitable.
When prescribing Erlotinib, factors associated with prolonged survival
should be
taken into account.
No survival benefit or other clinically relevant effects of the
treatment have been
demonstrated in patients with EGFR-IHC negative tumours (see section
5.1).
Pancreatic cancer
Erlotinib in combination with gemcitabine is indicated for the
treatment of patients
with metastatic pancreatic cancer.
When prescribing Erlotinib, factors associated with prolonged survival
should be
taken into account (see sections 4.2 and 5.1).
No survival advantage could be shown for patients with locally
advanced disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Erlotinib treatment should be supervised by a physician experienced in
the use of
anti-cance