Bondenza (previously Ibandronic Acid Roche)
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
13-05-2013
Charakterystyka produktu
(SPC)
13-05-2013
Sprawozdanie z oceny publicznego
(PAR)
13-05-2013
Składnik aktywny:
ibandronic acid
Dostępny od:
Roche Registration Ltd.
Kod ATC:
M05BA06
INN (International Nazwa):
ibandronic acid
Grupa terapeutyczna:
Drugs for treatment of bone diseases
Dziedzina terapeutyczna:
Osteoporosis, Postmenopausal
Wskazania:
Treatment of osteoporosis in post-menopausal women at increased risk of fracture.A reduction in the risk of vertebral fractures has been demonstrated. Efficacy on femoral-neck fractures has not been established.
Podsumowanie produktu:
Revision: 16
Status autoryzacji:
Withdrawn
Data autoryzacji:
2004-02-23
Ulotka dla pacjenta
B. PACKAGE LEAFLET
38
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
BONDENZA
150 mg film-coated tablets
Ibandronic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAU
SE 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.
WHAT IS IN THIS LEAFLET
:
PLANNING WHEN TO TAKE BONDENZA
WITH PEEL-OFF STICKERS FOR YOUR PERSONAL CALENDAR
1.
What Bondenza is and what it is used for
2.
What you need to know before you take Bondenza
3.
How to take Bondenza
4.
Possible side effects
5.
How to store Bondenza
6.
Content of the pack and other information
1.
WHAT BONDENZA IS AND WHAT IT IS USED FOR
Bondenza belongs to a group of medicines called bisphospho
nates. It contains the active substance
ibandronic acid. Bondenza may reverse bone loss by stopping more loss
of bone and increasing bone
mass in most women who take it, even though they won’t be able to
see or feel a difference. Bondenza
may help lower the chances of breaking bones (fractures). This
reduction in fractures was shown for
the spine but not for the hip.
BONDENZA IS PRESCRIBED TO YOU TO TREAT POSTMENOPAUSAL OSTEOPOROSIS
BECAUSE YOU HAVE AN
INCREASED RISK OF FRACTURES
. Osteoporosis is a thinning and weakening of the bones, which is
common
in women after the menopause. At the menopause, a woman’s ovaries
stop producing the female
hormone, oestrogen, which helps to keep her skeleton healthy.
The earlier a woman reaches the menopause, the greater her risk of
fractures in osteoporosis.
Other things that can increase the risk of fractures include:
-
not enough calcium and vitamin D in the diet
-
smoking, or drinkin
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Charakterystyka produktu
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Bondenza 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg ibandr
onic acid (as sodium monohydrate).
Excipients with known effect:
Contains 162.75 mg lactose monohydrate (equivalent t
o 154.6 mg anhydrous lactose).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off white film-coated tablets, of oblong shape marked
“BNVA” on one side, and “150” on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of osteoporosis in postmenopausal women at increased risk of
fracture (see section 5.1).
A reduction in the risk of vertebral fractures has been
demonstrated, efficacy on femoral neck fractures
has not been established.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one 150 mg film-coated tablet once a month.
The tablet should preferably
be taken on the same date each month.
Bondenza should be taken after an overnight fast (at l
east 6 hours) and 1 hour before the first food or
drink (other than water) of the day (see section 4.5) or any other
oral medicinal products or
supplementation (including calcium).
In case a dose is missed, patients should be instructed to take one
Bondenza 150 mg tablet the morning
after the tablet is remembered, unless the time to the next scheduled
dose is within 7 days. Patients
should then return to taking their dose once a month on their
originally scheduled date.
If the next scheduled dose is within 7 days, patients should wait
until their next
dose and then continue
taking one tablet once a month as originally scheduled.
Patients should not take two tablets within the same week.
Patients should receive supplemental calcium and / or vitam
in D if dietary intake is inadequate (see
section 4.4 and section 4.5).
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established.
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