EVISTA TABLET 60 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

RALOXIFENE HCl

Available from:

LOTUS INTERNATIONAL PTE. LTD.

ATC code:

G03XC01

Dosage:

60 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

RALOXIFENE HCl 60 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

LILLY SA

Authorization status:

ACTIVE

Authorization date:

1999-04-09

Patient Information leaflet

BONE LOSS
I.
NAME OF PRODUCT
EVISTA® tablets 60mg
II.
DESCRIPTION OF PRODUCT
EVISTA® tablets are white, oval shaped and film coated. Each
EVISTA® tablet has the identicode ‘ALV’ debossed on one
side. Each tablet of EVISTA® contains 60mg of the
active
ingredient called Raloxifene.
The tablet also contains:
Tablet Core: Povidone, polysorbate 80, anhydrous lactose,
lactose monohydrate, crospovidone, magnesium stearate.
Tablet Coating: Titanium dioxide (E 171), hydroxypropyl
methylcellulose 2910,
3 cps, hydroxypropyl
methylcellulose 2910, 6 cps,
macrogol 400,
polysorbate 80, carnauba wax.
Ill.
WHAT IS THE MEDICINE?
EVISTA® belongs to a group of non-hormonal medicines called
Selective Estrogen Receptor Modulators. When a woman
reaches menopause, the level of the female sex hormone,
oestrogen, goes down. EVISTA® mimics some of the beneficial
effects of oestrogen after menopause.
Estrogen is a female hormone that affects your bones as well
as other parts of the body.
With the onset of menopause, a woman's body produces up
to 80% less
1
estrogen. A reduction in estrogen has a high
impact on bones. It causes bones to become thinner and
weaker and may result in a condition called osteoporosis.
Osteoporosis 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.
EVISTA
Ra
l oxi f ene
HCI
YOUR DOCTOR HAS RECOMMENDED EVISTA®
(RALOXIFENE HCI) FOR YOU. THIS LEAFLET WILL
PROVIDE ANSWERS TO SOME COMMON QUESTIONS
ABOUT THIS MEDICINE, TO BETTER UNDERSTAND
HOW EVISTA® CAN HELP YOU COPE WITH THE
EFFECTS OF MENOPAUSE. 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 INFORMAT

Summary of Product characteristics

EVISTA
®
60MG 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.
Excipients with known effect:
Each tablet contains lactose (149.40 mg).
For excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablets for oral use. Elliptically shaped, white tablets
imprinted with the code 4165.
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. For
those postmenopausal women taking EVISTA for osteoporosis treatment,
EVISTA has been to shown to
reduce the risk of invasive breast cancer.
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 (see Section
5.1).
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. 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.
Elderly
No dose adjustment is necessary for the elderly.
Renal impairment
EVISTA should not be used in patients with severe renal impairment
(see section 4.3). In patients with
moderate and mild renal impairment, EVISTA should be used with
caution.
Hepatic impairment
EVISTA should not be used in patients with hepatic impairment (see
section 4.3 and 4.4).
Paediatric population
EVISTA should not be used in children of any age. There is no relevant
use of EVISTA in the paediatric
population.
4.3. CONTRAINDICATIONS
Hypersensitivi