ERLOTINIB TARO 150 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ERLOTINIB AS HYDROCHLORIDE

Available from:

TARO INTERNATIONAL LTD, ISRAEL

ATC code:

L01XE03

Pharmaceutical form:

FILM COATED TABLETS

Composition:

ERLOTINIB AS HYDROCHLORIDE 150 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SYNTHON CHILE LTDA, CHILE

Therapeutic area:

ERLOTINIB

Therapeutic indications:

Non-Small Cell Lung Cancer (NSCLC): Erlotinib Taro 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 Taro is indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations and stable disease after first-line chemotherapy. Erlotinib Taro is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.Pancreatic cancer: Erlotinib Taro is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Authorization date:

2021-12-30

Patient Information leaflet

Page 1 of 7
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
ERLOTINIB TARO 25 MG
ERLOTINIB TARO 100 MG
ERLOTINIB TARO 150 MG
FILM-COATED TABLETS
NAME AND QUANTITY OF ACTIVE INGREDIENT:
Each film-coated tablet contains:
erlotinib 25 mg (as erlotinib hydrochloride)
erlotinib 100 mg (as erlotinib hydrochloride)
erlotinib 150 mg (as erlotinib hydrochloride)
Inactive ingredients and allergens: see section 2 under “Important
information regarding
some of the ingredients of the medicine” and section 6, “Further
Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have further questions,
consult your doctor or
pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others; it may
harm them even if it seems to you that their ailment is similar to
yours.
Erlotinib Taro is not intended for use in children and adolescents
below the age of 18.
IMPORTANT INFORMATION FOR YOUR REVIEW
•
Avoid pregnancy during the course of treatment with Erlotinib Taro,
and do not breastfeed
during the course of treatment with the medicine.
•
It is advisable to stop smoking during the course of treatment with
Erlotinib Taro.
•
Take the medicine on an empty stomach - at least one hour before or
two hours after the
end of a meal. Do not take the medicine with grapefruit or with
grapefruit juice.
•
Erlotinib Taro contains a type of sugar called lactose.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Erlotinib Taro is intended for treatment of adults and can be
prescribed for you in the following
situations:
•
Treatment of patients with advanced non-small cell lung cancer (NSCLC)
if previous
chemotherapy treatment was unsuccessful in stopping your disease.
•
First line treatment in patients with advanced non-small cell lung
cancer (NSCLC) if the
cancer cells express mutations in EGFR.
•
Maintenance treatm

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
ERLOTINIB TARO 25 mg, 100 mg, and 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ERLOTINIB TARO 25 mg: One film-coated tablet contains 25 mg erlotinib
(as erlotinib
hydrochloride). Excipients with known effect: Each film-coated tablet
contains 17.66 mg Lactose
monohydrate.
ERLOTINIB TARO 100 mg: One film-coated tablet contains 100 mg
erlotinib (as erlotinib
hydrochloride). Excipients with known effect: Each film-coated tablet
contains 70.65 mg Lactose
monohydrate.
ERLOTINIB TARO 150 mg: One film-coated tablet contains 150 mg
erlotinib (as erlotinib
hydrochloride). Excipients with known effect: Each film-coated tablet
contains 105.98 mg Lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film Coated Tablets.
ERLOTINIB TARO 25 mg: White, round, biconvex tablets with “E9OB”
debossed on one side and “25” on the
other. The tablets have a diameter of approximately 6 mm.
ERLOTINIB TARO 100
mg: White, round, biconvex with a score line on both sides, on one
side the tablet is
debossed with “E9OB” above the score line and “100” below the
score line. The tablets have a diameter of
approximately 10 mm.
E
RLOTINIB TARO 150 mg: White, round, biconvex tablets with “E9OB”
debossed in one side and “150” on the
other”. The tablets have a diameter of approximately 10.4 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-Small Cell Lung Cancer (NSCLC)
ERLOTINIB TARO 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 TARO is indicated for switch maintenance treatment in
patients with locally advanced or
metastatic non- small cell lung cancer (NSCLC) with EGFR activating
mutations and stable disease after
first-line chemotherapy.
ERLOTINIB TARO is indicated for the treatment of patients with locally
advanced or metastatic non-
small cell lung cancer after failure of at least one prior
che