Ibandroninezuur ratiopharm 150 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

NATRIUMIBANDRONAAT 1-WATER 168,75 mg/stuk SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR 150 mg/stuk

Beschikbaar vanaf:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

ATC-code:

M05BA06

INN (Algemene Internationale Benaming):

NATRIUMIBANDRONAAT 1-WATER 168,75 mg/stuk SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR 150 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; LACTOSE 1-WATER ; MACROGOL 3350 ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; LACTOSE 1-WATER ; MACROGOL 3350 ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Ibandronic Acid

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); LACTOSE 1-WATER; MACROGOL 3350; NATRIUMSTEARYLFUMARAAT; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2010-12-31

Bijsluiter

Ibandronic acid, NL/1831/002, 05.09.22
1
rvg 106014 EU PIL IA-020 met NL info-tracked
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
_ _
IBANDRONINEZUUR RATIOPHARM 150 MG, FILMOMHULDE TABLETTEN_ _
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
belongs to a group of medicines called
BISPHOSPHONATES
. It contains the active substance
ibandronic acid.
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. may help
lower the chances of breaking bones (fractures). This reduction in
fractures was shown for the spine but not
for the hip.
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:

Productkenmerken

Ibandronic acid, NL/H/1831/002, 05.09.22
rvg 106014 EU SPC IA-020 met NL info-tracked
1.
NAAM VAN HET GENEESMIDDEL
Ibandroninezuur Ratiopharm 150 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg ibandronic acid (as ibandronic
sodium monohydrate).
_Excipients with known effect:_
Contains 163 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, oblong, biconvex film-coated tablets, 14 mm in
length and debossed with “I9BE” on one
side and on the other side with “150”
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.
Ibandronic acid 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
ibandronic acid 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 osteopor