Bilumide 50 mg, filmomhulde tabletten

Valsts: Nīderlande

Valoda: holandiešu

Klimata pārmaiņas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktīvā sastāvdaļa:

BICALUTAMIDE 50 mg/stuk

Pieejams no:

Bennett Pharmaceuticals S.A 20 Agias Kiriakis street 14561 ATHENE (GRIEKENLAND)

ATĶ kods:

L02BB03

SNN (starptautisko nepatentēto nosaukumu):

BICALUTAMIDE 50 mg/stuk

Zāļu forma:

Filmomhulde tablet

Kompozīcija:

HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOLEN ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; NATRIUMZETMEELGLYCOLAAT ; POLYDEXTROSE (E 1200) ; POVIDON (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505), HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOLEN ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT ; POLYDEXTROSE (E 1200) ; POVIDON (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505), HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOLEN ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYDEXTROSE (E 1200) ; POVIDON (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505),

Ievadīšanas:

Oraal gebruik

Ārstniecības joma:

Bicalutamide

Produktu pārskats:

Hulpstoffen: HYPROMELLOSE (E 464); LACTOSE 1-WATER; MACROGOLEN; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); NATRIUMZETMEELGLYCOLAAT (E468); POLYDEXTROSE (E 1200); POVIDON (E 1201); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505);

Autorizācija datums:

1900-01-01

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
BILUMIDE 50 MG, FILMOMHULDE TABLETTEN
Bicalutamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IM-
PORTANT 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 Bilumide 50 mg,
FILMOMHULDE TABLETTEN
is and what it is used for
2.
What you need to know before you take Bilumide 50 mg,
FILMOMHULDE TABLETTEN
3.
How to take Bilumide 50 mg,
FILMOMHULDE TABLETTEN
4.
Possible side effects
5.
How to store Bilumide 50 mg,
FILMOMHULDE TABLETTEN
6.
Contents of the pack and other information
1.
WHAT BILUMIDE 50 MG, FILMOMHULDE TABLETTEN IS AND WHAT IT IS USED FOR
Bilumide 50 mg,
FILMOMHULDE TABLETTEN
is one of a group of drugs called anti-androgens. It interferes
with some of the actions of the male sex hormones.
Bilumide 50 mg used to treat prostate cancer. It is used 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 BILUMIDE 50 MG, FILMOMHULDE
TABLETTEN
DO NOT TAKE BILUMIDE 50 MG, FILMOMHULDE TABLETTEN
-
if you are allergic to bicalutamide or any of the other ingredients of
this medicine (listed in sec-
tion 6).
-
if you are a woman, a child or an adolescent.
-
if you are taking any medications containing terfenadine, astemizole
or cisapride (see ‘Other medi-
cines and Bilumide 50 mg, filmomhulde tabletten’, below.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Bilumide 50 mg:
-
if you have any liver problems. Bicalutamide level

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bilumide 50 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 50 mg bicalutamide.
Excipient with known effect: lactose monohydrate 58.56 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White film coated tablet, debossed with "BIC 50" on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of advanced prostate cancer in combination with LHRH
analogue therapy or surgical
castration.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adult males including the elderly: one tablet (50 mg) daily with or
without food. Treatment
with bicalutamide should be commenced at least 3 days before
commencing treatment with an
LHRH analogue, or at the same time as surgical castration.
_Paediatric population_
Bicalutamide is not indicated in children.
Patients with renal impairment: No dosage adjustment is necessary in
patients with renal im-
pairment.
Patients with hepatic impairment: No dosage adjustment is necessary in
patients with mild he-
patic impairment. Increased accumulation may occur in patients with
moderate to severe hepatic
impairment (see section 4.4 ).
4.3
CONTRAINDICATIONS
Bicalutamide is contra-indicated in females and children (see section
4.6).
Bicalutamide must not be given to any patient who has shown a
hypersensitivity reaction to the
active substance or to any of the excipients listed in section 6.1.
Co-administration of terfenadine, astemizole or cisapride with
bicalutamide is contraindicated
(see section 4.5).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Initiation of treatment should be under the direct supervision of a
specialist.
Bicalutamide is extensively metabolised in the liver. Data suggests
that its elimination may be
slower in subjects with severe hepatic impairment and this could lead
to increased accumulation
of bicalutamide. Therefore, bicalutamide should be used with caution
in patients with moderate
to severe hepatic impairment.
Periodic