RALOVISTA Raloxifene hydrochloride 60 mg tablets, blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
16-09-2022
Summary of Product characteristics
(SPC)
16-09-2022
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
raloxifene hydrochloride, Quantity: 60 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Raloxifene hydrochloride
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: colloidal anhydrous silica; crospovidone; polysorbate 80; povidone; microcrystalline cellulose; magnesium stearate; glycine; titanium dioxide; hypromellose; Carnauba Wax; macrogol 400
Administration route:
Oral
Units in package:
28 tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Raloxifene is indicated for the prevention and treatment of osteoporosis in post-menopausal women.,Raloxifene is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis.Raloxifene is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer.
Product summary:
Visual Identification: White to off-white, oval, biconvex, film coated tablets with 'C' on one side and '12' on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-01-14
Patient Information leaflet
RALOVISTA
1
RALOVISTA
_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 RALOVISTA IS
USED FOR
RALOVISTA 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. RALOVISTA
mimics some of the beneficial effects
of oestrogen after menopause.
RALOVISTA 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.
RALOVISTA 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
bloo
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION – RALOVISTA (RALOXIFENE
HYDROCHLORIDE) TABLET
1
NAME OF THE MEDICINE
Raloxifene hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 60 mg raloxifene hydrochloride, which
is equivalent to 56 mg raloxifene
free base.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
_RALOVISTA_
Raloxifene hydrochloride 60 mg tablets; White to off-white, oval,
biconvex, film
coated tablets with ‘C’ on one side and ‘12’ on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
RALOVISTA is indicated for the prevention and treatment of
osteoporosis in post-menopausal women.
RALOVISTA is indicated for the reduction in the risk of invasive
breast cancer in postmenopausal
women with osteoporosis.
RALOVISTA is indicated for the reduction in the risk of invasive
breast cancer in postmenopausal
women at high risk of invasive breast cancer.
High risk of breast cancer is defined as at least one breast biopsy
showing lobular carcinoma in situ
(LCIS) or atypical hyperplasia, one or more first-degree relatives
with breast cancer, or a 5-year
predicted risk of breast cancer >1.66% (based on the modified Gail
model). Among the factors included
in the modified Gail model are the following: current age, number of
first-degree relatives with breast
cancer, number of breast biopsies, age at menarche, nulliparity or age
of first live birth. Currently, no
single clinical finding or test result can quantify risk of breast
cancer with certainty.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dosage is one 60 mg raloxifene hydrochloride tablet
per day orally, which may be
taken at any time of day without regard to meals. No dose adjustment
is necessary for the elderly.
Supplemental calcium should be added to the diet if daily intake is
inadequate.
There are no data on the discontinuation effects of raloxifene.
Raloxifene exerts its effect through the
oestrogen receptor and does not accumulate in any target tissue.
Ther
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