Bicalutamide Pharmathen 50 mg, filmomhulde tabletten

País: Holanda

Língua: holandês

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

Ingredientes ativos:

BICALUTAMIDE;

Disponível em:

Pharmathen S.A.

Código ATC:

L02BB03

DCI (Denominação Comum Internacional):

BICALUTAMIDE;

Forma farmacêutica:

Filmomhulde tablet

Via de administração:

Oraal gebruik

Área terapêutica:

Bicalutamide

Resumo do produto:

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);

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
BICALUTAMIDE PHARMATHEN 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 onto
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
sec-
tion 4.
WHAT IS IN THIS LEAFLET
1.
What [nationally completed name] 50 mg is and what it is used for
2.
What you need to know before you take [nationally completed
name] 50 mg
3.
How to take [nationally completed name] 50 mg
4.
Possible side effects
5.
How to store [nationally completed name] 50 mg
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] 50 MG IS AND WHAT IT IS USED
FOR
[nationally completed name] 50 mg 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] 50 mg is 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 [NATIONALLY COMPLETED
NAME] 50
DO NOT TAKE [NATIONALLY COMPLETED NAME] 50 MG
−
if you are allergic to bicalutamide or any of the other ingredients of
this medicine (listed in section 6).
−
if you are a woman, a child or an adolescent.
−
if you are taking any medications containing terfenadine, astemizole
or cisapride (see ‘Other medicines and [nationally completed name]
50 mg’, below).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking [nationally completed
name] 50 mg:
−
if you have any liver problem

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bicalutamide Pharmathen 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 surgi-
cal 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 for patients with renal impairment.
Patients with hepatic impairment:
No dosage adjustment is necessary in patients with mild hepatic
impairment. Increased accu-
mulation 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 to the active
substance or to any of the excipients listed in section 6.1.
Coadministration 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 accumula-
tion of bicalutamide. Therefore, bicalutamide should be used with
caution in patients with
moderate to severe hepatic impairment.
P