Erlotinib 100mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Erlotinib hydrochloride

Mevcut itibaren:

Sandoz Ltd

ATC kodu:

L01EB02

INN (International Adı):

Erlotinib hydrochloride

Doz:

100mg

Farmasötik formu:

Oral tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 08010500; GTIN: 07613421037451

Bilgilendirme broşürü

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.
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 other medicines that may
increase or decrease the amount of erlotinib
in your blood or influence its effect (for
example antifungals like ketoconazole,
protease inhibitors, erythromycin,
clarithromycin, phenytoin, carbamazepine,
barbiturates, rifampicin, ciprofloxacin,
omeprazole, ranitidine, St. John’s Wort or
proteasome inhibitors), talk to your doctor.
In some cases these medicines may reduce
the efficacy or increase the side effects
of Erlotinib and your doctor may need to
adjust your treatment. Your doctor might
avoid treating you with these medicines
while you are receiving Erlotinib.
• if you are taking anticoagulants (a medicine
which helps to prevent thrombosis or blood
clotting e.g. warfarin), Erlotinib may
increase your tendency to bleed. Talk to
your doctor, he will need to regularly
monitor you with some blood tests.
• if you are taking statins (medicines to lower
your blood cholesterol), Erlotinib may
increase the risk of statin related muscle
problems, which on rare occasions can
lead to serious muscle breakdown
(

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Erlotinib Sandoz 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. The diameter of the tablet is 8.9 mm ± 5 %.
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.
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
Erlotinib treatment should be supervised by a physician experienced in
the use of
anti-cancer therapies.
Posology
Patients with Non-Small Cell Lung Cancer:
EGFR mutation testing should be perform