Tarceva 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Erlotinib hydrochloride

Available from:

Roche Products Ltd

ATC code:

L01XE03

INN (International Name):

Erlotinib hydrochloride

Dosage:

100mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 5000471006551

Patient Information leaflet

1
uk-ie-mt-pil-Tarceva-clean-180406-25-100-150-tabs
PACKAGE LEAFLET: INFORMATION FOR THE USER
TARCEVA 25 MG FILM-COATED TABLETS
TARCEVA 100 MG FILM-COATED TABLETS
TARCEVA 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 Tarceva is and what it is used for
2.
What you need to know before you take Tarceva
3.
How to take Tarceva
4.
Possible side effects
5.
How to store Tarceva
6.
Contents of the pack and other information
1.
WHAT TARCEVA IS AND WHAT IT IS USED FOR
Tarceva contains the active substance erlotinib. Tarceva 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.
Tarceva 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 TARCEVA
DO NOT TAKE TARCEVA:
•
if you are allergic to erlotinib or any of the ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIO

Summary of Product characteristics

OBJECT 1
TARCEVA 25 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 18-Apr-2018 | Roche
Products Limited
1. Name of the medicinal product
Tarceva 25 mg film-coated tablets
Tarceva 100 mg film-coated tablets
Tarceva 150 mg film-coated tablets
2. Qualitative and quantitative composition
Tarceva 25 mg film coated tablets
Each film-coated tablet contains 25 mg erlotinib (as erlotinib
hydrochloride).
Tarceva 100 mg film-coated tablets
Each film-coated tablet contains 100 mg erlotinib (as erlotinib
hydrochloride).
Tarceva 150 mg film-coated tablets
Each film-coated tablet contains 150 mg erlotinib (as erlotinib
hydrochloride).
Excipients with known effect
_Tarceva 25 mg film coated tablets _
Each 25 mg film-coated tablet contains 27.43 mg Lactose monohydrate.
_Tarceva 100 mg film-coated tablets _
Each 100 mg film-coated tablet contains 69.21 mg Lactose monohydrate.
_Tarceva 150 mg film-coated tablets _
Each 150 mg film-coated tablet contains 103.82 mg Lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Tarceva 25 mg film coated tablets
White to yellowish, round, biconvex tablets with 'T 25' engraved on
one side.
Tarceva 100 mg film-coated tablets
White to yellowish, round, biconvex tablets with 'T 100' engraved on
one side.
Tarceva 150 mg film-coated tablets
White to yellowish, round, biconvex tablets with 'T 150' engraved on
one side.
4. Clinical particulars
4.1 Therapeutic indications
Non-Small Cell Lung Cancer (NSCLC)
Tarceva is indicated for the first-line treatment of patients with
locally advanced or metastatic non-small
cell lung cancer (NSCLC) with EGFR activating mutations.
Tarceva 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.
Tarceva 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 wi