Raloxifene Aurobindo 60mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RALOXIFENE HYDROCHLORIDE

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

G03XC01

INN (International Name):

RALOXIFENE HYDROCHLORIDE 60 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

RALOXIFENE HYDROCHLORIDE 60 mg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Withdrawn

Authorization date:

2013-08-07

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RALOXIFENE AUROBINDO 60 MG FILM COATED TABLETS
raloxifene hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist.. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
What Raloxifene Aurobindo is and what it is used for
2
What you need to know before you take Raloxifene Aurobindo
3
How to take Raloxifene Aurobindo
4
Possible side effects
5
How to store Raloxifene Aurobindo
6
Contents of the pack and other information
1.
WHAT RALOXIFENE AUROBINDO IS AND WHAT IT IS USED FOR
Raloxifene Aurobindo contains the active substance raloxifene
hydrochloride.
Raloxifene Aurobindo is used to treat and prevent osteoporosis in
postmenopausal women. Raloxifene
Aurobindo reduces the risk of vertebral fractures in women with
postmenopausal osteoporosis. A reduction
in the risk of hip fractures has not been shown.
How Raloxifene Aurobindo works
Raloxifene belongs to a group of non-hormonal medicines called
Selective Oestrogen Receptor Modulators
(SERMs). When a woman reaches the menopause, the level of the female
sex hormone oestrogen goes
down. Raloxifene mimics some of the helpful effects of oestrogen after
the menopause.
Osteoporosis is a disease that causes your bones to become thin and
fragile - this disease is especially
common in women after the menopause. Although it may have no symptoms
at first, osteoporosis makes you
more likely to break bones, especially in your spine, hips and wrists
and may cause back pain, loss of height
and a curved back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RALOXIFENE AUROBINDO
DO NOT

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Raloxifene Aurobindo 60 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60 mg of raloxifene hydrochloride,
equivalent to 56 mg raloxifene
free base.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, elliptical, film-coated tablets debossed with 'X'
on one side and '57' on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Raloxifene Aurobindo 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 Raloxifene Aurobindo 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
Posology
The recommended dose 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, Raloxifene 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: _
Raloxifene should not be used in patients with severe renal impairment
(see section 4.3). In patients
with moderate and mild renal impairment, Raloxifene should be used
with caution.
_Hepatic impairment: _
Raloxifene should not be used in patients with hepatic impairment (see
section 4.3).
_Paediatric Population _
Raloxifene should not be used in children of any age. There is no
relevant use of Raloxifene in the
paediatric population.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Must not be used in women with child b