Fablyn
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
21-06-2012
Charakterystyka produktu
(SPC)
21-06-2012
Sprawozdanie z oceny publicznego
(PAR)
22-06-2012
Składnik aktywny:
Lasofoxifene tartrate
Dostępny od:
Dr. Friedrich Eberth Arzneimittel GmbH
Kod ATC:
G03
INN (International Nazwa):
lasofoxifene
Grupa terapeutyczna:
Sex hormones and modulators of the genital system,
Dziedzina terapeutyczna:
Osteoporosis, Postmenopausal
Wskazania:
Fablyn is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1).When determining the choice of Fablyn or other therapies, including oestrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Podsumowanie produktu:
Revision: 2
Status autoryzacji:
Withdrawn
Data autoryzacji:
2009-02-24
Ulotka dla pacjenta
34
B. PACKAGE LEAFLET
Medicinal product no longer authorised
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
FABLYN 500 MICROGRAM FILM-COATED TABLETS
lasofoxifene
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1.
What FABLYN is and what it is used for
2.
Before you take FABLYN
3.
How to FABLYN
4.
Possible side effects
5.
How to store FABLYN
6.
Further information
1.
WHAT FABLYN IS AND WHAT IT IS USED FOR
FABLYN is used to treat osteoporosis in women after the menopause
(postmenopausal osteoporosis)
who are likely to break bones, especially in the spine, hips and
wrists. It belongs to a group of
medicines called Selective Estrogen Receptor Modulators (SERM).
In women with postmenopausal osteoporosis, FABLYN reduces the risk of
both fractures of the spine
(vertebral fractures) and non-spine fractures (non-vertebral
fractures), but not hip fractures.
2.
BEFORE YOU TAKE FABLYN
_ _
DO NOT TAKE FABLYN
if you are allergic (hypersensitive) to lasofoxifene or any of the
other ingredients of FABLYN.
if you currently have or previously had blood clots, for example in
your veins, lungs or eyes
(deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
if you have any vaginal bleeding. This must be investigated by your
doctor BEFORE STARTING
TREATMENT.
if you could still become pregnant.
if you are pregnant or breast-feeding.
Medicinal product no longer authorised
36
TAKE SPECIAL CARE WITH FABLYN
IF YOU ARE IMMOBILE FOR SOME TIME
, such as, needing to be admitted to a hospital or having to
stay in bed while recovering from an operation or an
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Charakterystyka produktu
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
FABLYN 500 microgram film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains lasofoxifene tartrate, equivalent to
500 micrograms lasofoxifene.
Excipient: Each film-coated tablet contains 71.34 mg lactose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Triangular, peach-coloured, film-coated tablets debossed with
“Pfizer” on one side and “OPR 05” on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FABLYN is indicated for the treatment of osteoporosis in
postmenopausal women at increased risk of
fracture. A significant reduction in the incidence of vertebral and
non-vertebral fractures but not hip
fractures has been demonstrated (see section 5.1).
When determining the choice of FABLYN or other therapies, including
estrogens, for a
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
_ _
Adult (postmenopausal women):
The recommended dose is one 500 microgram tablet daily.
The tablet may be taken any time of day without regard to food and
beverage intake.
Supplemental calcium and/or vitamin D should be added to the diet if
daily intake is inadequate.
Postmenopausal women require an average of 1,500 mg/day of elemental
calcium. The recommended
intake of vitamin D is 400-800 IU daily.
Children and adolescents below 18 years of age:
There is no indication for FABLYN in children and adolescents below 18
years of age since the medicinal
product is for use in postmenopausal women only. Therefore safety and
efficacy have not been studied (see
section 5.2).
Elderly women (65 years and older):
No dose adjustment is necessary in elderly female patients (see
section 5.2).
Medicinal product no longer authorised
3
Hepatic insufficiency:
No
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