Evirex 60mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Raloxifene hydrochloride

Հասանելի է:

Somex Pharma

ATC կոդը:

G03XC01

INN (Միջազգային անվանումը):

Raloxifene hydrochloride

Դոզան:

60mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 06040101

Տեղեկատվական թերթիկ

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU
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Կարդացեք ամբողջական փաստաթուղթը

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Evirex 60 mg film coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 60 mg raloxifene hydrochloride,
equivalent to 56 mg
raloxifene free base.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film coated tablet.
White to off-white, oval biconvex film-coated tablets with 'C' on one
side and '12' on
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Evirex 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 Evirex 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. No dose adjustment is
necessary for
the elderly. Due to the nature of this disease process, Evirex is
intended for long term
use.
Generally calcium and vitamin D supplements are advised in women with
a low
dietary intake.
_Paediatric population: _
Evirex should not be used in children of any age. There is no relevant
use of
Evirex in the paediatric population.
Elderly:
No dose adjustment is necessary for the elderly
Use in renal impairment:
Evirex should not be used in patients with severe renal impairment
(see section 4.3).
In patients with moderate and mild renal impairment, Evirex should be
used with
caution.
Use in hepatic impairment:
Evirex should not be used in patients with hepatic impairment (see
section 4.3 and
4.4)
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in 6.1
Must not be used in women with child bearing potential (see section
4.6