ERLOTINIB S.K. 25 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ERLOTINIB HYDROCHLORIDE

Available from:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

ATC code:

L01XE03

Pharmaceutical form:

FILM COATED TABLETS

Composition:

ERLOTINIB HYDROCHLORIDE 25 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

REMEDICA LTD., CYPRUS

Therapeutic area:

ERLOTINIB

Therapeutic indications:

Non-Small Cell Lung Cancer (NSCLC): Erlotinib S.K. 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 S.K. 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 S.K. 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 S.K. is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Authorization date:

2022-06-26

Patient Information leaflet

Patient leaflet in accordance with the Pharmacists’ Regulations
(Medicinal Products) -
1986
The medicine is dispensed with a doctor’s prescription only
Erlotinib S.K. 25 mg film-coated tablets
Erlotinib (erlotinib as hydrochloride) 25 mg
Erlotinib S.K.100 mg film-coated tablets
Erlotinib (erlotinib as hydrochloride) 100 mg
Erlotinib S.K.150 mg film-coated tablets
Erlotinib (erlotinib as hydrochloride) 150 mg
For excipients and allergens, please see Section 2, subsection
“Important information about some
of the ingredients of this medicine”, and Section 6 – Further
Information.
Read the entire leaflet carefully before using the medicine. This
leaflet contains concise
information about the medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed to treat your illness.
Do not pass it on to others.
It may
harm them, even if it appears to you that they have a similar illness.
1.
What
Erlotinib S.K.
is and what it is used for
Erlotinib S.K.
contains the active substance erlotinib.
Erlotinib S.K.
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 S.K.
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.
Therapeutic group:
antineoplastic agent protein kinase inhibitor
2.
What you need to know before you take
Erlotinib
S.K.
Do not take
Erlotinib S.K.
:

if you are allergic to erlotinib or any of the ingredien

Summary of Product characteristics

https://www.medicines.org.uk/emc/product/8846/smpc/print
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ERLOTINIB S.K. 25 MG
film-coated tablets
ERLOTINIB S.K. 100 MG
film-coated tablets
ERLOTINIB S.K. 150 MG
film-coated tablets
Summary of Product Characteristics Updated 24-Nov-2022 | Roche
Products Limited
1.
Name of the medicinal product
ERLOTINIB S.K. 25 MG
film-coated tablets
ERLOTINIB S.K.
100 MG
film-coated tablets
ERLOTINIB S.K. 150 MG
film-
coated tablets
2.
Qualitative and quantitative composition
ERLOTINIB S.K.
25 mg film-coated tablets
Each film-coated tablet contains 25 mg erlotinib (as erlotinib
hydrochloride).
ERLOTINIB S.K
100 mg film-coated tablets
Each film-coated tablet contains 100 mg erlotinib (as erlotinib
hydrochloride).
ERLOTINIB S.K
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 23.98 mg Lactose monohydrate.
_Tarceva 100 mg_
_film-coated tablets _
Each 100 mg film-coated tablet contains 95.93 mg Lactose monohydrate.
_Tarceva 150 mg_
_film-coated tablets _
Each 150 mg film-coated tablet contains 143.90 mg Lactose monohydrate.
For the
full list of excipients, see section 6.1.
3.
Pharmaceutical form
Film-coated tablet.
ERLOTINIB S.K
25 mg film coated tablets
White to yellowish, round, biconvex tablets with '25' engraved on one
side.
ERLOTINIB S.K
100 mg
film-coated tablets
White to yellowish, round, biconvex tablets with '100' engraved on one
side.
ERLOTINIB S.K
150 mg
film-coated tablets
White to yellowish, round, biconvex tablets with ' 150' engraved on
one side.
4.
Clinical particulars
4.1
Therapeutic indications
Non-Small Cell Lung
Cancer (NSCLC)
ERLOTINIB S.K
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 S.K
is also indicated for switch maintenance treatment in patients with
locally advanced or metastatic
NSCLC with EGFR activating mutations and