Ibandroninezuur Ratiopharm 50 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

NATRIUMIBANDRONAAT 1-WATER 56,25 mg/stuk SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR 50 mg/stuk

Beschikbaar vanaf:

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

ATC-code:

M05BA06

INN (Algemene Internationale Benaming):

NATRIUMIBANDRONAAT 1-WATER 56,25 mg/stuk SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR 50 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/H/1831/001, 09.01.20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Ibandroninezuur Ratiopharm 50 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
contains the active substance ibandronic acid. This
belongs to a group of medicines called
bisphosphonates.
is used in adults and prescribed to you if you have
breast cancer that has spread to your
bones (called bone “metastases”).
-
It helps to prevent your bones from breaking (fractures).
-
It also helps to prevent other bone problems that may need surgery or
radiotherapy.
works by reducing the amount of calcium that is lost
from your bones. This helps to stop
your bones from getting weaker.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE :
-
if you are allergic to ibandronic acid or any of the other ingredients
of this medicine that are listed in
section 6.
-
if you have problems with your food pipe/gullet (oesophagus) such as
narrowing or difficulty
swallowing.
-
if you cannot stand or sit upright for at least one hour (60 minutes)
at a time.
-
if you have or ever had low calcium in your blood.
Do no

Productkenmerken

Ibandronic acid, NL/H/1831/001, 09.01.20
SUMMARY OF PRODUCT CHARACTERISTICS
Ibandronic acid, NL/H/1831/001, 09.01.20
1.
NAME OF THE MEDICINAL PRODUCT
Ibandroninezuur Ratiopharm 50 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of ibandronic acid (as
ibandronic sodium monohydrate).
_Excipients with known effect:_
Contains 54 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, 9 mm in
length and debossed with “I9BE” on one
side and on the other side with “50”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
<[Ibandronic acid}> is indicated in adults for the prevention of
skeletal events (pathological fractures, bone
complications requiring radiotherapy or surgery) in patients with
breast cancer and bone metastases.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ibandronic acid therapy should only be initiated by physicians
experienced in the treatment of cancer.
_Posology _
The recommended dose is one 50 mg film-coated tablet daily.
_Special populations_
Patients with hepatic impairment
No dose adjustment is required (see section 5.2).
Patients with renal impairment
No dose adjustment is necessary for patients with mild renal
impairment (CLcr ≥50 and <80 mL/min).
For patients with moderate renal impairment (CLcr ≥30 and <50
mL/min) a dosage adjustment to one 50 mg
film-coated tablet every second day is recommended (see section 5.2).
For patients with severe renal impairment (CLcr <30 mL/min) the
recommended dose is one 50 mg film-
coated tablet once weekly. See dosing instructions, above.
Elderly population (> 65 years)
No dose adjustment is necessary (see section 5.2).
_ _
Paediatric population
The safety and efficacy of ibandronic acid in children and adolescents
below the age of 18 years have not
been established. No data are available (see section 5.1 and 5.2).
_ _
_Method of administration _
For oral use.
Ibandronic a