Evifyne

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

Raloxifene hydrochloride

Dostupné s:

Eli Lilly Australia Pty Ltd

Třída:

Medicine Registered

Informace pro uživatele

EVIFYNE
®

_Raloxifene hydrochloride_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
you with answers to some common
questions about this medicine. It does
not contain all the available
information and does not take the
place of talking with your doctor.
All medicines have risks and
benefits. Your doctor has more
information about this medicine than
is contained in this leaflet. Also, your
doctor has had the benefit of taking a
full and detailed history from you
and is in the best position to make an
expert judgement to meet your
individual needs.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT EVIFYNE IS USED
FOR
EVIFYNE belongs to a group of non-
hormonal medicines called Selective
Estrogen Receptor Modulators
(SERMs). When a woman reaches
menopause, the level of the female
sex hormone, oestrogen, goes down.
EVIFYNE mimics some of the
beneficial effects of oestrogen after
menopause.
EVIFYNE is used to prevent and
treat osteoporosis in women after
menopause.
Osteoporosis causes your bones to
become thin and fragile - it is
especially common in women after
menopause. While osteoporosis may
have no symptoms at first, it makes
your bones more likely to break,
especially in your spine, hips and
wrists. Osteoporosis may also cause
back pain, loss of height and a curved
back.
Fractures may occur during normal,
everyday activity, such as lifting, or
from minor injury that would not
ordinarily fracture normal bone.
EVIFYNE is also used to reduce the
risk of invasive breast cancer in
women with osteoporosis after
menopause and reduce the risk of
invasive breast cancer in women at
high risk of invasive breast cancer
after menopause.
Breast cancer is invasive when it has
spread outside the milk duct or milk-
making glands and has grown into
normal tissue inside the breast.
Invasive cancers can spread cancer to
other parts of the body through the
bloodst

Charakteristika produktu

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EVIFYNE 
Raloxifene Hydrochloride 

NAME OF THE MEDICINE 

EVIFYNE (raloxifene hydrochloride) 

The active ingredient in EVIFYNE tablets is raloxifene
hydrochloride.  Chemically, raloxifene 
hydrochloride is methanone,
[6-hydroxy-2-(4-hydroxyphenyl)benzo[_b_]thien-3-yl]-[4-[2-(1-
piperidinyl)ethoxy]phenyl]-, hydrochloride and its empirical formula
is C
28
H
27
NO
4
S

HCl 
which corresponds to a molecular weight of 510.05.  

S
HO
O
O
OH
HN
+
CL
-
4'
6

The CAS number for raloxifene HCl is 82640-04-8.  The CAS number for
raloxifene free base 
is 84449-90-1. 

DESCRIPTION 

Raloxifene hydrochloride is an off-white
to pale-yellow solid that is very slightly soluble in 
water.  Each film coated tablet contains 60 mg raloxifene
hydrochloride, which is equivalent 
to 56 mg raloxifene free base.  The tablets
also contain povidone, polysorbate 80, lactose 
anhydrous, lactose, crospovidone, magnesium stearate, Color Mixture
White YS-1-18027-A, 
Carnauba Wax, OPACODE BLUE 2-1-10537G and OPACODE
S-1-10537G BLUE. 

PHARMACOLOGY 

LONGTERM POST-MENOPAUSAL HEALTH AND THE ROLE OF OESTROGEN 

Oestrogen exerts agonistic effects on a number of bodily tissues.
 For example, oestrogen 
affects the structure and integrity of bone.  
Decreases in oestrogen levels after oophorectomy or menopause lead
to increases in bone 
resorption, accelerated bone loss and increased risk of fracture.
 Bone is initially lost rapidly 
because the compensatory increase in bone formation is inadequate
to offset resorptive 
losses.  This imbalance between resorption and formation is
related to loss of oestrogen, and 
may also involve age-related impairment of osteoblasts
or their precursors.  Vertebral 
fractures are the most common type of osteoporotic fracture
in post-menopausal