Evista Tablet 60 mg

Land: Malaysia

Språk: engelska

Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiva substanser:

RALOXIFENE HYDROCHLORIDE

Tillgänglig från:

Lotus Pharmaceutical Co Ltd

INN (International namn):

RALOXIFENE HYDROCHLORIDE

Enheter i paketet:

28Tablet Tablets

Tillverkad av:

LILLY S.A.

Bipacksedel

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
EVISTA
® TABLET
Raloxifene hydrochloride (60mg)
1
WHAT IS IN THIS LEAFLET
1.
What Evista is used for
2.
How Evista works
3.
Before you use Evista
4.
How to use Evista
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Evista
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial number
WHAT EVISTA IS USED FOR
Evista is a prescription
medicine for women after
menopause to treat or prevent
osteoporosis. You should take
calcium and vitamin D along
with Evista if you do not get
enough calcium and vitamin D
in your diet. Evista is not for
use in premenopausal women.
Evista is also use for the
reduction of the risk of
invasive breast cancer in
postmenopausal women.
HOW EVISTA WORKS
Evista contains the active
ingredient raloxifene
hydrochloride. Evista belongs
to a group of non-hormonal
medicines called selective
oestrogen receptor modulators
(SERMs). Evista treats
osteoporosis by helping make
bones stronger and less likely
to break. It helps prevent
osteoporosis by building bone
and stopping the thinning of
bone that occurs after
menopause. It also works to
decrease the risk of invasive
breast cancer by blocking
estrogen in breast and uterine
tissue.
BEFORE YOU USE EVISTA
-
_When you must not use it _
You should not take Evista if
you:
•
Are allergic to raloxifene
or any of the other
ingredients of this
medicine. (see sectopn
PRODUCT DESCRIPTION).
•
Are pregnant or could
become pregnant. Evista
could harm your unborn
child.
•
Are breast-feeding. Ask
your doctor or pharmacist
for advice before taking
any medicine.
•
Have or have had blood
clots that required a
doctor’s treatment. This
may include clots in the
legs, lungs, or eyes.
Taking Evista may
increase the risk of
getting these blood clots.
While infrequent, these
clots can cause serious
medical problems,
disability, or death.
Have liver disease
(including cholestasis
[any condition in which
the flow of bile

Produktens egenskaper

EVISTA ®
60 mg flm coated tabletsraloxifene hydrochloride
1.  NAME OF THE MEDICINAL PR ODUCTEVISTA 60 mg flm coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITIONEach flm coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base. 
3.  PHARMACEUTICAL FORMFilm coated tablets. Elliptically shaped, white tablets imprinted with the code 4165.
4.  CLINICAL PAR TICULARS
4.1. Therapeutic indications
EVISTA is indicated f or the treatment and prevention of osteoporosis in postmenopausal women. A signifcant 
reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
When determining the choice of EVISTA or other therapies, including oestrogens, for an individual 
postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and 
breast tissues, and cardiovascular risks and benefts.
Evista is indicated for the reduction in risk of invasive breast cancer \
in postmenopausal women with
osteoporosis.
4.2.   Posology and method of administration
The recommended posology is one tablet daily by oral administration, which may be taken at any time of 
the day without regard to meals. No dose adjustment is necessary for the elderly. Due to the nature of this 
disease process, EVISTA is intended for long term use.
Generally calcium and vitamin D supplements are advised in women with a low dietary intake.
4.3.   Contraindications
Must not be used in women with child bearing potential.
Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary 
embolism and retinal vein thrombosis.
Hypersensitivity to raloxifene or to any of the excipients in the tablet.
Hepatic impairment including cholestasis.
Severe renal impairment.
Unexplained uterine bleeding.
EVISTA should not