Letrozol Orion 2,5 mg Filmdragerad tablett

País: Suécia

Língua: sueco

Origem: Läkemedelsverket (Medical Products Agency)

Ingredientes ativos:

letrozol

Disponível em:

Orion Corporation

Código ATC:

L02BG04

DCI (Denominação Comum Internacional):

letrozole

Dosagem:

2,5 mg

Forma farmacêutica:

Filmdragerad tablett

Composição:

laktosmonohydrat Hjälpämne; tartrazin aluminiumlack Hjälpämne; letrozol 2,5 mg Aktiv substans

Tipo de prescrição:

Receptbelagt

Resumo do produto:

Förpacknings: Blister, 30 tabletter; Blister, 100 tabletter

Status de autorização:

Avregistrerad

Data de autorização:

2016-06-09

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LETROZOL ORION 2.5 MG FILM-COATED TABLETS
letrozole
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 Letrozol Orion is and what it is used for
2.
What you need to know before you take Letrozol Orion
3.
How to take Letrozol Orion
4.
Possible side effects
5.
How to store Letrozol Orion
6.
Contents of the pack and other information
1.
WHAT LETROZOL ORION IS AND WHAT IT IS USED FOR
WHAT LETROZOL ORION IS AND HOW IT WORKS
Letrozol Orion contains an active substance called letrozole. It
belongs to a group of medicines called
aromatase inhibitors. It is a hormonal (or “endocrine”) breast
cancer treatment. Growth of breast
cancer is frequently stimulated by oestrogens which are female sex
hormones. Letrozol Orion reduces
the amount of oestrogen by blocking an enzyme (“aromatase”)
involved in the production of
oestrogens and therefore may block the growth of breast cancer that
needs oestrogens to grow. As a
consequence tumour cells slow or stop growing and/or spreading to
other parts of the body.
WHAT LETROZOL ORION IS USED FOR
Letrozol Orion is used to treat breast cancer in women who have gone
through menopause i.e.
cessation of periods.
It is used to prevent cancer from happening again. It can be used as
first treatment before breast
cancer surgery in case immediate surgery is not suitable or it can be
used as first treatment after breast
cancer surgery or following five years treatment with tamixofen.
Letrozol Orion is also used to
prevent breast t

Características técnicas

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Letrozol Orion 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg letrozole.
Excipients with known effect:
Each film-coated tablet contains 42.8 mg lactose (as monohydrate) and
0.0024 mg tartrazine
aluminium lake.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, circular, biconvex film-coated tablets plain on both sides.
Diameter of the tablet is
6.1 ± 0.20 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Adjuvant treatment of postmenopausal women with hormone receptor
positive invasive early
breast cancer.

Extended adjuvant treatment of hormone-dependent-invasive breast
cancer in postmenopausal
women who have received prior standard adjuvant tamoxifen therapy for
5 years.

First-line treatment in postmenopausal women with hormone-dependent
advanced breast
cancer.

Advanced breast cancer after relapse or disease progression, in women
with natural or
artificially induced postmenopausal endocrine status, who have
previously been treated with
anti-oestrogens.

Neo-adjuvant treatment of postmenopausal women with hormone receptor
positive, HER-2
negative breast cancer where chemotherapy is not suitable and
immediate surgery not indicated.
Efficacy has not been demonstrated in patients with hormone receptor
negative breast cancer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult and elderly patients_
The recommended dose of Letrozol Orion is 2.5 mg once daily. No dose
adjustment is required for
elderly patients.
In patients with advanced or metastatic breast cancer, treatment with
letrozole should continue until
tumour progression is evident.
In the adjuvant and extended adjuvant setting, treatment with
letrozole should continue for 5 years or
until tumour relapse occurs, whichever is first.
3
In the adjuvant setting a sequential treatment schedule (letrozole 2
years followed by tamoxifen
3 years) could a