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:

2 x 14 Tablets

Tillverkad av:

Bushu Pharmaceuticals Ltd

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 FILM COATED TABLETS
RALOXIFENE HYDROCHLORIDE
1. NAME OF THE MEDICINAL PRODUCT
EVISTA 60 mg film coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 60 mg raloxifene hydrochloride,
equivalent to 56 mg raloxifene free
base.
3. PHARMACEUTICAL FORM
Tablets are elliptical, white film coated with "ALV" debossed on one
side.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
EVISTA is indicated for the treatment and prevention of osteoporosis
in postmenopausal women. A significant
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 benefits.
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 be used in patients with signs or symptoms of
endometrial cancer as safety in this
patient group has not been adequately studied.
4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Raloxifene is associated with an increased risk for venous
thro