RALOXIFENE HYDROCHLORIDE ACTAVIS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RALOXIFENE HYDROCHLORIDE

Available from:

Actavis Group PTC ehf

ATC code:

G03XC01

INN (International Name):

RALOXIFENE HYDROCHLORIDE

Dosage:

60 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

raloxifene

Authorization status:

Marketed

Authorization date:

2015-01-30

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Raloxifene Hydrochloride Actavis 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 Actavis 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 Actavis 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 Actavis 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 Actavis should not be used in patients with
severe renal impairment (see section 4.3). In
patients with moderate and mild renal impairment, Raloxifene
Hydrochloride Actavis should be used with caution.
_Hepatic impairment:_
Raloxifene Hydrochloride Actavis should not be used in patients with
hepatic impairment (see section 4.3 and 4.4).
_Paediatric population_
Raloxifene Hydrochloride Actavis should not be used in children of any
age. There is no relevant use of Raloxifene