Femara

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Letrozole 2.5mg;  

Beschikbaar vanaf:

Novartis New Zealand Ltd

INN (Algemene Internationale Benaming):

Letrozole 2.5 mg

Dosering:

2.5 mg

farmaceutische vorm:

Film coated tablet

Samenstelling:

Active: Letrozole 2.5mg   Excipient: Colloidal silicon dioxide Hypromellose As 0.087 mg Pigment suspension white + 0.087 mg Pigment suspension yellow + 1.663 mg additional Iron oxide yellow Lactose monohydrate Macrogols Magnesium stearate Maize starch Microcrystalline cellulose Purified talc Sodium starch glycolate Titanium dioxide

Eenheden in pakket:

Blister pack, physicians sample, 15 tablets

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Novartis Pharma Schweizerhalle AG

therapeutische indicaties:

Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer Extended adjuvant treatment of invasive early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy for five years. First-line treatment in postmenopausal women with 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.

Product samenvatting:

Package - Contents - Shelf Life: Blister pack, physicians sample - 15 tablets - 60 months from date of manufacture stored at or below 30°C - Blister pack, - 30 tablets - 60 months from date of manufacture stored at or below 30°C

Autorisatie datum:

1996-05-14

Bijsluiter

FEMARA
® 
2.5MG TABLETS 
LETROZOLE 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about Femara. 
It does not contain all the available
information. It does not take the place of talking
to your doctor or pharmacist. 
All medicines have risks and benefits. Your doctor has weighed
the risks of you taking Femara against the benefits they 
expect it will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST. 
KEEP THIS LEAFLET WITH THE MEDICINE. 
You may need to read it again. 
WHAT FEMARA IS USED FOR 
Femara is used to treat breast cancer in women who
are post-menopausal - that is, women who no longer have
periods, 
either naturally due to their age or after surgery or
chemotherapy. 
Femara is available in tablets containing 2.5 mg of the active
ingredient, letrozole. 
Letrozole belongs to a family of medicines called aromatase
inhibitors. They are also called "antioestrogens" because they 
act by reducing the production of oestrogen in your body. 
Oestrogen stimulates the growth of certain types of breast
cancer. These cancers are called "oestrogen-dependent." 
Reducing the production of oestrogen may help to keep the cancer
from growing. 
This may be the first time you are taking an "antioestrogen" such
as Femara or you may have taken another 
"antioestrogen" such as tamoxifen in the past. 
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY FEMARA HAS
BEEN PRESCRIBED FOR YOU. 
Your doctor may have prescribed Femara for another reason. 
Femara is only available with a doctor's prescription. It is
not addictive. 
BEFORE YOU TAKE FEMARA 
_WHEN YOU MUST NOT USE IT _
DO NOT TAKE FEMARA IF YOU HAVE AN ALLERGY TO: 
• letrozole, the active ingredient in Femara 
• any other ingredients of Femara listed at the end of this
leaflet 
Some of the symptoms of an allergic reaction may include
rash, itching or hives on the

Productkenmerken

NEW ZEALAND DATA SHEET 
FEMARA
®

LETROZOLE  
2.5 MG FILM-COATED TABLETS. 

DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM 
Film-coated tablets. 
Coated tablet, dark yellow, round, slightly biconvex with bevelled
edges. One side bears the 
imprint “FV”, the other “CG”. 
Active substance:
4,4'-[(1H-1,2,4-triazol-1-yl)-methylene]bis-benzonitrile (INN/USAN= 
letrozole). 
Each film-coated tablet contains 2.5 mg letrozole. 
For a full list of excipients, see List of excipients. 
LIST OF EXCIPIENTS 
Colloidal anhydrous silica, microcrystalline cellulose, lactose
monohydrate, magnesium 
stearate, maize starch, sodium starch glycollate, hydroxypropyl
methylcellulose, polyethylene 
glycol 8000, talc, titanium dioxide (E 171), iron oxide yellow (E
172). 
INDICATIONS
Letrozole is not indicated in hormone receptor negative disease. 
Letrozole is indicated in: 
  Adjuvant treatment of postmenopausal women with hormone
receptor positive invasive 
early breast cancer. 
  Extended adjuvant treatment of invasive early breast cancer in
post menopausal women 
who have received prior standard adjuvant tamoxifen therapy for five
years.  
  First-line treatment in postmenopausal women with 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. 
DOSAGE AND ADMINISTRATION
DOSAGE 
GENERAL TARGET POPULATION 
ADULTS 
The recommended dose of Femara
®
 is 2.5 mg once daily. In the adjuvant and extended 
adjuvant setting, treatment with Femara should continue for 5 years or
until disease 
relapse/recurrence occurs, whichever comes first. In the large
pivotal study of letrozole versus 
tamoxifen in the adjuvant setting, no benefit in efficacy or safety
was obtained by sequential 
administration of these treatments compared with letrozole
administered continuously for 5 
years. In patients with me