Bicalutamide Sandoz 50 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

BICALUTAMIDE 50 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

L02BB03

INN (Algemene Internationale Benaming):

BICALUTAMIDE 50 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

GLYCEROLTRIACETAAT (E 1518) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; METHYLCELLULOSE (E 461) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON (E 1201) ; TITAANDIOXIDE (E 171), GLYCEROLTRIACETAAT (E 1518) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; METHYLCELLULOSE (E 461) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON (E 1201) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Bicalutamide

Product samenvatting:

Hulpstoffen: GLYCEROLTRIACETAAT (E 1518); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; METHYLCELLULOSE (E 461); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON (E 1201); TITAANDIOXIDE (E 171);

Autorisatie datum:

2007-12-13

Bijsluiter

Sandoz B.V.
Page 1/6
Bicalutamide Sandoz
®
50 mg, filmomhulde tabletten
RVG 33519
V13
1.3.1-3 Package Leaflet
Mei 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BICALUTAMIDE SANDOZ
® 50 MG, FILMOMHULDE TABLETTEN
bicalutamide
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 [nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[nationally completed name] is one of a group of drugs called
anti-androgens. It interferes with some
of the actions of the male sex hormones.
[nationally completed name] is used to treat prostate cancer.It is
used either as
-
MONOTHERAPY
in tumor stages called ‘locally advanced’ or as
-
COMBINATION THERAPY
in tumor stages called ‘advanced’ together with other treatments
such as
surgical castration or drugs which reduce the levels of androgens in
the body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
-
if you are allergic (hypersensitive) to bicalutamide or any of the
other ingredients of this
medicine (listed in section 6.1).
-
if you are a woman, a child or an adolesent.
-
if you are taking any medications containing terfenadine, astemizole
or cisapride (see ‘Other
medicines and [nationally completed name]’,

Productkenmerken

Sandoz B.V.
Page 1/10
Bicalutamide Sandoz 50 mg, filmomhulde tabletten
RVG 33519
V10
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bicalutamide Sandoz 50 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of bicalutamide.
Excipients with known effect:
Each film-coated tablet contains 57 mg of lactose and 0.0154 mmol
(0.3528 mg) of sodium.
This medicine contains less than 1 mmol sodium (23 mg) per dosage
unit, that is to say essentially
‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White and round film-coated tablet with a diameter of approximately 7
mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Combination therapy with [Nationally completed name] 50 mg: _
Treatment of advanced prostate cancer in combination with luteinizing
hormone-releasing hormone
(LHRH) analogue therapy or surgical castration.
_Monotherapy with 3 tablets of [Nationally completed name] 50 mg (150
mg bicalutamide): _
[Nationally completed name] at a dose of 150 mg is indicated either
alone or as adjuvant to radical
prostatectomy or radiotherapy in patients with locally advanced
prostate cancer at high risk for disease
progression (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Combination therapy with [Nationally completed name] 50 mg: _
Adult males including elderly patients: one tablet (50mg) once daily
with or without food.
Treatment with bicalutamide may be started either 3 days before or at
the same time as commencing
treatment with an LHRH analogue, or at the same time as surgical
castration.
Renal impairment: no dosage adjustment is necessary for patients with
renal impairment.
Sandoz B.V.
Page 2/10
Bicalutamide Sandoz 50 mg, filmomhulde tabletten
RVG 33519
V10
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2020
Hepatic impairment: no dosage adjustment is necessary for patients
with mild hepatic impairment.
Increase