Erlotinib 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Erlotinib hydrochloride

Available from:

Sandoz Ltd

ATC code:

L01EB02

INN (International Name):

Erlotinib hydrochloride

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 07613421037437

Patient Information leaflet

21075491
ERLOTINIB TABLETS
21075491
ERLOTINIB TABLETS
21075491
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ERLOTINIB 25 MG FILM-COATED TABLETS
ERLOTINIB 100 MG FILM-COATED TABLETS
ERLOTINIB150 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 any 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 tablets is and what it is used for
2. What you need to know before you take Erlotinib tablets
3. How to take Erlotinib tablets
4. Possible side effects
5. How to store Erlotinib tablets
6. Contents of the pack and other information 1.
WHAT ERLOTINIB TABLETS IS AND WHAT IT IS USED FOR
Erlotinib tablets contains the active substance erlotinib. Erlotinib
tabletsis 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 tablets 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 TABLETS
DO NOT TAKE
Erlotinib tablets
•
i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Erlotinib 25 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg of erlotinib (as
hydrochloride).
_Excipient(s) with known effect _
_ _
Each film-coated tablet contains 17.33 mg of lactose monohydrate
Each film-coated tablet contains 0.312 mg of sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White round biconvex film coated tablet debossed with ‘C1’ on one
side and
plain on the other. Diameter: 5.50 mm ± 0.20 mm (5.30 mm-5.70 mm).
4
CLINICAL PARTICULARS
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 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 Epidermal Growth Factor Receptor
(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
Erlot