Evista
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
07-06-2022
Charakterystyka produktu
(SPC)
07-06-2022
Sprawozdanie z oceny publicznego
(PAR)
31-03-2009
Składnik aktywny:
raloxifene hydrochloride
Dostępny od:
Substipharm
Kod ATC:
G03XC01
INN (International Nazwa):
raloxifene
Grupa terapeutyczna:
Sex hormones and modulators of the genital system,
Dziedzina terapeutyczna:
Osteoporosis, Postmenopausal
Wskazania:
Evista is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Evista 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.
Podsumowanie produktu:
Revision: 30
Status autoryzacji:
Authorised
Data autoryzacji:
1998-08-05
Ulotka dla pacjenta
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
Evista 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 Evista is and what it is used for
2.
What you need to know before you take Evista
3.
How to take Evista
4.
Possible side effects
5.
How to store Evista
6.
Contents of the pack and other information
1.
WHAT EVISTA IS AND WHAT IT IS USED FOR
Evista contains the active substance raloxifene hydrochloride.
Evista is used to treat and prevent osteoporosis in postmenopausal
women. Evista reduces the risk of
vertebral fractures in women with postmenopausal osteoporosis. A
reduction in the risk of hip
fractures has not been shown.
How Evista works:
Evista 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. Evista 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, especially in your spine, hips
and wrists and may cause back
pain, loss of height and a curved back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EVISTA
DO NOT TAKE EVISTA:
•
If you are being treated or have been treated for blood clots in the
legs (deep vein thrombosis),
in the lun
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Evista 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.
Excipient with known effect:
Each tablet contains lactose (149.40 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
Elliptically shaped, white tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Evista 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 Evista 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, Evista 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: _
Evista should not be used in patients with severe renal impairment
(see section 4.3). In patients with
moderate and mild renal impairment, Evista should be used with
caution.
_ _
_Hepatic impairment: _
Evista should not be used in patients with hepatic impairment (see
section 4.3 and 4.4).
3
_Paediatric population: _
Evista should not be used in children of any age. There is no relevant
use of Evista in the paediatric
population.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Must not be used in women with child bearing potential (see section
4.6).
Active o
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