Raloxifene Hydrochloride 60mg film-coated Tablets

Land: Malta

Taal: Engels

Bron: Malta Medicines Authority

Werkstoffen:

RALOXIFENE HYDROCHLORIDE

Beschikbaar vanaf:

Brillpharma (Ireland) Limited Inniscarra, Main Street, Rathcoole, Co. Dublin, Ireland

ATC-code:

G03XC01

INN (Algemene Internationale Benaming):

RALOXIFENE HYDROCHLORIDE 60 mg

farmaceutische vorm:

FILM-COATED TABLET

Samenstelling:

RALOXIFENE HYDROCHLORIDE 60 mg

Prescription-type:

POM

Therapeutisch gebied:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Autorisatie-status:

Withdrawn

Autorisatie datum:

2014-11-11

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Raloxifene hydrochloride 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 this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE
IS AND WHAT IT IS USED FOR
The name of your medicine is
Raloxifene hydrochloride 60 mg film-coated tablets and
contains the active ingredient raloxifene hydrochloride. Raloxifene
hydrochloride a 60 mg
film-coated tablet 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 hydrochloride 60 mg
film-coated
tablets mimics some of the helpful effects of oestrogen after the
menopause.
This medicine is used to treat and prevent osteoporosis in
postmenopausal women. It reduces
the risk of vertebral fractures in women with postmenopausal
osteoporosis. A reduction in the
risk of hip fractures has not been shown.
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 cur

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Raloxifene hydrochloride 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.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White to off-white, oval biconvex film-coated tablets plain on one
side and ‘60’ on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Raloxifene hydrochloride 60 mg film-coated tablets 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 hydrochloride 60 mg
film-coated tablets 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 _
Adults and the elderly:
The recommended dose is one tablet daily by oral administration, which
may be taken at any
time of the day without regard to meals. No dose adjustment is
necessary for the elderly.
Due to the nature of this disease process, Raloxifene hydrochloride 60
mg film-coated
tablets is intended for long term use.
Generally calcium and vitamin D supplements are advised in women with
a low dietary
intake.
Use in renal impairment:
Raloxifene hydrochloride 60 mg film-coated tablets should not be used
in patients with
severe
renal
impairment
(see
section
4.3).
In
patients
with
moderate
and
mild
renal
impairment, Raloxifene hydrochloride 60 mg film-coated tablets should
be used with
caution.
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Use in hepatic impairment:
Raloxifene hydrochloride 60 mg film-coated tablets should not be used
in patients with
hepatic impairment (see section 4.3 and section 4.4).
Paediatric population: