Femara 2.5 mg film-coated tablets

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Letrozole

Sẵn có từ:

Originalis B.V.

Mã ATC:

L02BG04

INN (Tên quốc tế):

Letrozole

Liều dùng:

2.5 milligram(s)

Dạng dược phẩm:

Film-coated tablet

Loại thuốc theo toa:

Product subject to prescription which may not be renewed (A)

Khu trị liệu:

letrozole

Ngày ủy quyền:

2018-09-14

Tờ rơi thông tin

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 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 FEMARA IS USED FOR
Femara 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 tamoxifen. Femara is also used
to
prevent breast tumour spreading to other parts of the body in patients
with advanced breast cancer.
If you have any questions about how Femara works or why this medicine
has been prescribed for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMARA
Follow all the doctor’s instructions carefully. They may differ from
the
general information in this leaflet.
DO NOT TAKE FEMARA
–
if you are allergic to letrozole or to any of the other ingredients of
this
medicine (listed in section 6),
–
if you still have periods, i.e. if you have not yet gone through the
menopause,
–
if you are pregnant,
–
if you are breast-feeding.
If any of these conditions apply to you, DO NOT TAKE THIS MEDICINE AND
TALK TO YOUR DOCTOR.
WARNINGS

Đặc tính sản phẩm

Health Products Regulatory Authority
18 October 2019
CRN009C9H
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Femara 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg letrozole.
Excipient(s) with known effect: lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
_Product imported from Czech Republic_
Film-coated tablet, dark yellow, round, slightly biconvex. One side
bears the imprint “FV”, the other “CG”
4 CLINICAL PARTICULARS
As per PA0896/012/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0896/012/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Cellulose microcrystalline
Maize starch
Sodium starch glycolate
Magnesium stearate
Silica colloidal anhydrous
Hypromellose
Talc
Macrogol 8000
Titanium dioxide E171
Iron oxide yellow E172
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product is the date shown on the
blister and outer package of the product as marketed in the
country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Health Products Regulatory Authority
18 October 2019
CRN009C9H
Page 2 of 2
Blisters packs: 30 tablets per pack, 10 tablets per blister strip.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Originalis B.V.
Joop Geesinkweg 901
1114 AB Amsterdam-Duivendrecht
Netherlands
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA2306/001/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14th September 2018
10 DATE OF REVISION OF THE TEXT
October 2019