EVISTA TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Eli Lilly (S.A.) (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS RALOXIFENE HYDROCHLORIDE 60,0 mg

Authorization status:

Registered

Authorization date:

2001-01-01

Patient Information leaflet

PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S3
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
EVISTA 60 mg tablets
READ THIS INFORMATION BEFORE YOU START TAKING EVISTA.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

EVISTA has been prescribed for you personally and you should not share
your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT EVISTA CONTAINS:

The active substance is raloxifene hydrochloride. Each tablet contains
60 mg of raloxifene hydrochloride, which is equivalent to 56 mg
raloxifene.

The other ingredients are povidone, polysorbate 80, anhydrous lactose,
lactose monohydrate,
crospovidone, magnesium stearate, titanium dioxide (E 171),
hypromellose, macrogol 400,
carnauba wax, shellac, propylene glycol, indigo carmine (E 132).
WHAT EVISTA IS USED FOR:

EVISTA 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. EVISTA mimics some of the helpful effects
of oestrogen after
menopause.

EVISTA is used to reduce the risk of development of invasive breast
cancer in postmenopausal
women with osteoporosis. The risk reduction is not applicable to
oestrogen receptor negative
(ER-) cancers or cancers of unknown oestrogen receptor status.

EVISTA is indicated for the prevention and treatment of osteoporosis
in postmenopausal
women. EVISTA reduces the risk of vertebral fractures in women with
postmenopausal
osteoporosis. A reduction in the risk of hip fractures has not been
shown.
BEFORE YOU TAKE EVISTA:
DO NOT TAKE EVISTA IF YOU:

Could still have a baby.

Are being treated or have been treated for blood clots (deep vein
thrombosis, pulmonary
embolism or retinal (in the eye) vein thrombosis).

Have had an allergic reaction in the past to EVISTA or to any of the
other ingredients listed at
the beginning of this

Summary of Product characteristics

SCHEDULING STATUS:
Schedule 3
PROPRIETARY NAME AND DOSAGE FORM:
EVISTA Tablets
COMPOSITION:
Each film-coated tablet contains raloxifene hydrochloride 60 mg.
It also contains povidone, polysorbate 80, anhydrous lactose, lactose
monohydrate, crospovidone,
magnesium stearate, titanium dioxide (E 171), hypromellose, macrogol
400, carnauba wax, shellac,
propylene glycol and indigo carmine (E 132).
PHARMACOLOGICAL CLASSIFICATION:
A 34 Other
PHARMACOLOGICAL ACTION:
PHARMACODYNAMIC PROPERTIES:
Raloxifene is a non-steroidal benzothiophene derivative which acts as
a Selective Oestrogen Receptor
Modulator (SERM). The selective profile of raloxifene includes
oestrogen agonist effects on bone and
lipids and oestrogen antagonist effects in breast and uterine tissues.
_SKELETAL EFFECTS:_ Raloxifene reduces the resorption of bone and
decreases overall bone turnover. In
clinical trials in women who were 2 to 8 years postmenopausal,
raloxifene 60 mg per day produced
significant increases in bone mineral density (BMD) of hip and spine
as well as total body mineral mass
compared to placebo. Bone quality was maintained during these trials.
Treatment with raloxifene for
three years in postmenopausal women with a mean age of 66 years and
with osteoporosis reduced the
incidence of vertebral fractures.
_EFFECTS ON LIPID METABOLISM:_ In clinical trials, raloxifene
decreased serum total cholesterol and LDL
cholesterol without significant effects on serum total HDL cholesterol
or triglycerides. Raloxifene
increased serum HDL-2 cholesterol and apolipoprotein A
1
, while serum fibrinogen, apolipoprotein B and
lipoprotein(a) were decreased.
_EFFECTS ON THE ENDOMETRIUM:_ Raloxifene was not associated with
endometrial thickening (see ‘Special
Precautions’).
_EFFECTS ON BREAST TISSUE:_ Raloxifene has no stimulatory effect on
breast tissue. Across all placebo-
controlled trials, raloxifene was indistinguishable from placebo with
regard to frequency and severity of
breast symptoms.
A reduction in the risk to develop invasive breast cancer has b