Raloxifene 60mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Raloxifene hydrochloride

Available from:

Actavis UK Ltd

ATC code:

G03XC01

INN (International Name):

Raloxifene hydrochloride

Dosage:

60mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040101; GTIN: 5012617024275

Patient Information leaflet

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Details
RALOXIFENE 60MG FILM-COATED TABLET LEAFLET - UK
Black
BBBA1707
C.Grant
23/01/18
30/01/18
C.Grant
170x480
11.5pt
IL/Pharmathen
23/01/18
24/01/18
04
Version 2
01.11.2017
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 h

Summary of Product characteristics

OBJECT 1
RALOXIFENE HYDROCHLORIDE 60MG FILM-COATED
TABLETS
Summary of Product Characteristics Updated 19-Jun-2015 | Accord-UK Ltd
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 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