Raloxifene Hydrochloride Actavis 60mg Film-coated Tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Raloxifene hydrochloride

Available from:

Actavis Group PTC ehf

ATC code:

G03XC01

INN (International Name):

Raloxifene hydrochloride

Dosage:

60 mg

Pharmaceutical form:

Film-coated Tablet

Administration route:

Oral use

Units in package:

14, 28, 30, or 84 tablets

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Pharmathen S.A., Pharmathen International S.A.

Therapeutic group:

Selective Oestrogen Receptor Modulator

Therapeutic indications:

It is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Authorization status:

Authorised

Authorization date:

2015-01-19

Patient Information leaflet

Raloxifene 60mg tablet leaflet - UK
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TECHNICAL APPROVAL
AAAH5476
5
31.12.14
jh
08.01.15
jh
Pharmathen
200 x 400
11.5
31.12.14
07.01.15
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.
•   The full name of this medicine is Raloxifene 
Hydrochloride 60mg Film-coated Tablets 
but within the leaflet it will be referred to as 
Raloxifene Tablets.
WHAT IS IN THIS LEAFLET
1.  What Raloxifene Tablets are and what they are 
used for
2.  What you need to know before you take 
Raloxifene Tablets
3. How to take Raloxifene Tablets
4. Possible side effects
5. How to store Raloxifene Tablets
6. Contents of the pack and other information
1.  WHAT RALOXIFENE TABLETS ARE AND WHAT THEY ARE 
USED FOR
Raloxifene Tablets contains the active substance 
raloxifene hydrochloride.
Raloxifene Tablets are used to treat and prevent 
osteoporosis in postmenopausal women. Raloxifene 
Tablets reduce the risk of vertebral fractures in 
women with postmenopausal osteoporosis. A 
reduction in the risk of hip fractures has not been 
shown.
How Raloxifene Tablets work.
Raloxifene Tablets belong to a group of non-
hormonal medicines called Selective Oestrogen 
Receptor Modulators (SERMs). When a woman 
reaches t

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 monohydarate (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 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