Raloxifene Hydrochloride 60mg Film-coated Tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Raloxifene

Tilgængelig fra:

Accord Healthcare Ireland Ltd.

ATC-kode:

G03XC; G03XC01

INN (International Name):

Raloxifene

Dosering:

60 milligram(s)

Lægemiddelform:

Film-coated tablet

Terapeutisk område:

Selective estrogen receptor modulators; raloxifene

Autorisation status:

Not marketed

Autorisation dato:

2015-01-30

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Raloxifene Hydrochloride is and what it is used for
2.
What you need to know before you take Raloxifene Hydrochloride
3.
How to take Raloxifene Hydrochloride
4.
Possible side effects
5.
How to store Raloxifene Hydrochloride
6.
Contents of the pack and other information
1.
WHAT RALOXIFENE HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Raloxifene Hydrochloride contains the active substance raloxifene
hydrochloride.
Raloxifene Hydrochloride is used to treat and prevent osteoporosis in
postmenopausal women.
Raloxifene Hydrochloride 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 Hydrochloride works
Raloxifene Hydrochloride 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 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 b

Produktets egenskaber

Health Products Regulatory Authority
11 December 2019
CRN009HMY
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Raloxifene Hydrochloride 60mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 60 mg raloxifene hydrochloride,
equivalent to 56 mg raloxifene free base.
Excipient(s) with known effect:
Each tablet contains lactose monohydrate (1.5 mg).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Elliptically shaped (12.6 mm x 6.6 mm), white film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Raloxifene Hydrochloride 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 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
Hydrochloride 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 Hydrochloride should not be used in patients with severe
renal impairment (see section 4.3). In patients with
moderate and mild renal impairment, Raloxifene Hydrochloride should be
used with caution.
_Hepatic impairment:_
Raloxifene Hydrochloride should not be used in patients with hepatic
impairment (see section 4.3 and 4.4).
_Paediatric population_
Raloxifene Hydrochloride should not be used in children of any age.
There is no relevant use