Femara 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Letrozole

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

L02BG04

INN (International Name):

Letrozole

Dosage:

2.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030401; GTIN: 5010678553703 5010678553604 5010678906097

Patient Information leaflet

Telephone [phone]
[e-mail]
www.freyrsolutions.com
FREYR Software Services Pvt. Ltd.,
Level 4, Building No. H-08,
Phoenix SEZ, Hitech City,
Hyderabad, India - 500081
GLOBAL REGULATORY
SOLUTIONS & SERVICES
Live Text:
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Production Site:
Torre
WO:
1962779
CTM:
Uniyal, Neelima
Comp. Description:
LFT_FEMARA_FCT_2,5 MG_GB
Printing Colours:
Black
Comp. No. New:
1962779 GB TA
Comp. No. Old:
N/A
Format/Dimension:
148 x 314.96 mm
Tech. Drawing No.:
5666/O
Technical Colours:
Cutting
Min. Font Size Text:
8 pt
Font Type:
News Gothic
Proof No.:
2
Date:
26-Apr-2021
Harischandra
Braille:
N/A
1 of 2
! PLEASE TURN OVERPRINTING ON !
PACKAGE LEAFLET: INFORMATION FOR
THE USER 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 or nurse.
-
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 or nurse.
This includes any possible side
effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. What Femara is and what it is
used for
2. What you need to know before you
take Femara
3. How to take Femara
4. Possible side effects
5. How to store Femara
6. Contents of the pack and other
information
1. WHAT FEMARA IS AND WHAT IT IS
USED FOR
WHAT FEMARA IS AND HOW IT WORKS
Femara 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. Femara reduces the amount
of oestrogen by blocking an enzyme
(“aromatase”) involved in the production
of oestrogens and therefore may block
the

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Femara
®
2.5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: letrozole.
Each film-coated tablet contains 2.5 mg letrozole.
Excipient with known effect: each tablet contains 61.5 mg of lactose
(monohydrate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
Film-coated tablet, dark yellow, round, slightly biconvex with
bevelled edges. One
side bears the imprint “FV”, the other “CG”.
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 Femara is 2.5 mg once daily. No dose
adjustment is
required for elderly patients.
In patients with advanced or metastatic breast cancer, treatment with
Femara should
continue until tumour progression is evident.
In the adjuvant and extended adjuvant setting, treatment with Femara
should continue
for 5 years or until tumour relapse occurs, whichever is first.
In the adjuvant setting a sequential treatment schedule (letrozole 2
years followed by
tamoxifen 3 years) could also be considered (see sections 4.4 and