Ibandroninezuur Polpharma 150 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

NATRIUMIBANDRONAAT 1-WATER SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR

Beschikbaar vanaf:

Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)

ATC-code:

M05BA06

INN (Algemene Internationale Benaming):

NATRIUMIBANDRONAAT 1-WATER COMPOSITION corresponding to ; IBANDRONINEZUUR

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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

Common Technical Document
Ibandronate 150 mg (as sodium monohydrate)
Film-coated tablets
Module 1 - Section 3.5 Core SmPC,
Labelling and PIL
page 1/10
1.3.1
Core Patient Information Leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBANDRONINEZUUR POLPHARMA 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. 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 Ibandronic acid 150 mg is and what it is used for
2.
What you need to know before you take Ibandronic acid 150 mg
3.
How to take Ibandronic acid 150 mg
4.
Possible side effects
5.
How to store Ibandronic acid 150 mg
6.
Contents of the pack and other information
1
WHAT IBANDRONIC ACID 150 MG IS AND WHAT IT IS USED FOR
Ibandronic acid 150 mg belongs to a group of medicines called
bisphosphonates.
It contains the active substance ibandronic acid.
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. Ibandronic acid may help lower the
chances
of breaking bones (fractures). This reduction in fractures was shown
for the
spine but not for the hip.
IBANDRONIC ACID IS PRESCRIBED TO YOU TO TREAT POSTMENOPAUSAL
OSTEOPOROSIS BECAUSE YOU HAVE AN INCREASED RISK OF FRACTURES.
Common Technical Document
Ibandronate 150 mg (as sodium monohydrate)
Film-coated tablets
Module 1 - Section 3.5 Core SmPC,
Labelling and PIL
page 2/10
Osteoporosis is a thinning and weakening of the bones, which is common
in
women after the menopause. At the menopa

Productkenmerken

Common Technical Document
Ibandronate 150 mg (as sodium monohydrate)
Film-coated tablets
Module 1 - Section 3.5 Core SmPC,
Labelling and PIL
page 1/21
1.3.5
Core Summary of Product Characteristics
1
NAME OF THE MEDICINAL PRODUCT
Ibandroninezuur Polpharma 150 mg, filmomhulde tabletten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg ibandronic acid (as ibandronic
sodium monohydrate).
_ _
Excipient with known effect
_: _
lactose monohydrate.
Each film-coated tablet contains 163 mg lactose monohydrate.
For a 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
Common Technical Document
Ibandronate 150 mg (as sodium monohydrate)
Film-coated tablets
Module 1 - Section 3.5 Core SmPC,
Labelling and PIL
page 2/21
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