Ibandroninezuur STADA 50 mg, filmomhulde tabletten

País: Holanda

Língua: holandês

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

Ingredientes ativos:

NATRIUMIBANDRONAAT 1-WATER SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR

Disponível em:

Stada Arzneimittel AG

Código ATC:

M05BA06

DCI (Denominação Comum Internacional):

NATRIUMIBANDRONAAT 1-WATER COMPOSITION corresponding to ; IBANDRONINEZUUR

Forma farmacêutica:

Filmomhulde tablet

Composição:

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),

Via de administração:

Oraal gebruik

Área terapêutica:

Ibandronic Acid

Resumo do produto:

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);

Data de autorização:

2010-12-31

Folheto informativo - Bula

1
NL PL Ibandronic acid(Tbl) NL1834 50 mg
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBANDRONINEZUUR STADA 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 Ibandroninezuur STADA 50 mg is and what it is used for.
2. What you need to know before you take Ibandroninezuur STADA 50 mg.
3. How to take Ibandroninezuur STADA 50 mg.
4. Possible side effects.
5. How to store Ibandroninezuur STADA 50 mg
6. Contents of the pack and other information.
1. WHAT IBANDRONINEZUUR STADA 50 MG IS AND WHAT IT IS USED FOR
Ibandroninezuur STADA 50 mg contains the active substance ibandronic
acid. This belongs to
a group of medicines called bisphosphonates.
Ibandroninezuur STADA 50 mg 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.
Ibandroninezuur STADA 50 mg 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 IBANDRONINEZUUR STADA 50 MG
DO NOT TAKE IBANDRONINEZUUR STADA 50 MG:

if you are allergic to ibandronic acid or any of the other ingredients
of this medicine (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

Características técnicas

1
NL SmPC Ibandronic acid(Tbl) NL1834 50 mg
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ibandroninezuur STADA 50 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of ibandronic acid (as
ibandronic acid sodium
monohydrate).
Excipient(s) with known effect
Contains 54 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
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.
_Hepatic impairment _
No dose adjustment is required (see section 5.2).
_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 (> 65 years) _
No dose adjustment is necessary (see section 5.2).
_Paediatric population _
2
NL SmPC Ibandronic acid(Tbl) NL1834 50 mg
The safety and efficacy of ibandronic acid in children and adolescents
below 18 years have
not been established. No data are available (see section 5.1 and 5.2).
Method of administration
For oral use.
Ibandronic acid tablets should be taken after an overnight fast (at
least 6 hours) and b