Raloxifene GH Raloxifene hydrochloride 60 mg tablets blister

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

raloxifene hydrochloride, Quantity: 60 mg

Saatavilla:

Generic Health Pty Ltd

INN (Kansainvälinen yleisnimi):

Raloxifene hydrochloride

Lääkemuoto:

Tablet, film coated

Koostumus:

Excipient Ingredients: microcrystalline cellulose; poloxamer; calcium hydrogen phosphate dihydrate; citric acid monohydrate; sodium starch glycollate; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000

Antoreitti:

Oral

Kpl paketissa:

7 (sample pack), 28

luokka:

Medicine Registered

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

Raloxifene GH is proposed to be used for:,1. the prevention and treatment of osteoprosis in post-menopausal women,2. the reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis,3. 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.

Tuoteyhteenveto:

Visual Identification: White, elliptical, film-coated tablets; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2013-06-07

Pakkausseloste

CONSUMER MEDICINE INFORMATION
RALOXIFENE GH
(RALOXIFENE HYDROCHLORIDE) FILM-COATED TABLETS
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 RALOXIFENE GH IS
USED FOR
Raloxifene GH belongs to a
group of non-hormonal
medicines called Selective
Oestrogen (Estrogen) Receptor
Modulators (SERMs). When a
woman reaches menopause, the
level of the female sex hormone,
oestrogen, goes down.
Raloxifene GH mimics some of
the beneficial effects of
oestrogen after menopause.
Raloxifene GH 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.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
RALOXIFENE GH HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription.
BEFORE YOU TAKE
RALOXIFENE GH
TELL YOUR DOCTOR IF YOU HAVE
ANY OF THE FOLLOWING
CONDITIONS OR IF YOU HAVE EVER
EXPERIENCED ANY OF THESE
CONDITIONS.
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE RALOXIFENE GH:
•
if you have not been through
menopau

Valmisteyhteenveto

AUSTRALIAN PRODUCT INFORMATION – RALOXIFENE GH
(RALOXIFENE HYDROCHLORIDE) TABLETS
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.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Raloxifene GH tablets are white, elliptical film-coated tablets.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Raloxifene GH is indicated for the prevention and treatment of
osteoporosis in post-menopausal
women.
Raloxifene GH is indicated for the reduction in the risk of invasive
breast cancer in postmenopausal
women with osteoporosis.
Raloxifene GH 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 DOSE AND METHOD OF ADMINISTRATION
The recommended dosage is one 60 mg Raloxifene GH 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.
Raloxifene GH v4.0
Page 2 of 21
There are no data on the discontinuation effects of Raloxifene GH.
Raloxifene exerts its effect through
the oestrogen receptor and does not accumulate in any target tissue.
Therefore, co