Bonviva
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
11-08-2023
Valmisteyhteenveto
(SPC)
11-08-2023
Julkisesta arviointikertomuksesta
(PAR)
18-05-2016
Aktiivinen ainesosa:
ibandronic acid
Saatavilla:
Atnahs Pharma Netherlands B.V.
ATC-koodi:
M05BA06
INN (Kansainvälinen yleisnimi):
ibandronic acid
Terapeuttinen ryhmä:
Drugs for treatment of bone diseases
Terapeuttinen alue:
Osteoporosis, Postmenopausal
Käyttöaiheet:
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.
Tuoteyhteenveto:
Revision: 29
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2004-02-23
Pakkausseloste
40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
BONVIVA
150 mg film-coated tablets
Ibandronic acid
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 Bonviva is and what it is used for
2.
What you need to know before you take Bonviva
3.
How to take Bonviva
4.
Possible side effects
5.
How to store Bonviva
6.
Content of the pack and other information
1.
WHAT BONVIVA IS AND WHAT IT IS USED FOR
Bonviva belongs to a group of medicines called bisphosphonates. It
contains the active substance
ibandronic acid. Bonviva 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. Bonviva
may help lower the chances of breaking bones (fractures). This
reduction in fractures was shown for
the spine but not for the hip.
BONVIVA 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 drinking too much alcohol
•
not enough walking or other weight-bearing exercise
•
a family history of ost
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bonviva 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg ibandronic acid (as sodium
monohydrate).
Excipients with known effect:
Contains 154.6 mg anhydrous lactose (equivalent to 162.75 mg lactose
monohydrate).
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.
Bonviva should be taken after an overnight fast (at least 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
Bonviva 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 vitamin 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. The need
for continued treatment should be r
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