Raloxifene Hydrochloride Film Coated Tablets 60mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RALOXIFENE HYDROCHLORIDE

Available from:

Bristol Laboratories Limited

ATC code:

G03XC01

INN (International Name):

RALOXIFENE HYDROCHLORIDE

Pharmaceutical form:

FILM-COATED TABLET

Composition:

RALOXIFENE HYDROCHLORIDE 60 milligram(s)

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Authorised

Authorization date:

2014-11-11

Patient Information leaflet

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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  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.  

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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 

Summary of Product characteristics

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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 embossed with
'C' on one side
and '12'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 _
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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.
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 populatio