Bicalutamide Fair-Med 150mg Film-coated Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Bicalutamide

Verfügbar ab:

Fair-Med Healthcare GmbH

ATC-Code:

L02BB; L02BB03

INN (Internationale Bezeichnung):

Bicalutamide

Dosierung:

150 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Anti-androgens; bicalutamide

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2012-09-14

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
BICALUTAMIDE FAIR-MED 150 MG FILM-COATED TABLETS
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.
_ _
WHAT IS IN THIS LEAFLET
1.
What Bicalutamide Fair-Med is and what it is used for
2.
What you need to know before you take Bicalutamide Fair-Med
3.
How to take Bicalutamide Fair-Med
4.
Possible side effects
5.
How to store Bicalutamide Fair-Med
6.
Contents of the pack and other information
1.
WHAT BICALUTAMIDE FAIR-MED IS AND WHAT IT IS USED FOR
Bicalutamide Fair-Med contains a medicine called bicalutamide. This
belongs to a group of
medicines called non-steroidal anti-androgens. It works by blocking
the effect of the male sex
hormones (androgens) and inhibits cell growth in the prostate in this
way.
Bicalutamide Fair-Med 150 mg is indicated either alone or in
combination with surgical
removal of the prostate gland or radiotherapy in patients with locally
advanced prostate
cancer at high risk of disease progression.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BICALUTAMIDE FAIR-MED
DO NOT TAKE BICALUTAMIDE FAIR-MED:

if you are allergic to bicalutamide or any of the other ingredients of
this medicine
(listed in Section 6).

if you are already taking a medicine called cisapride or certain
anti-histamine
medicines (terfenadine or astemizole).

if you are a woman.
Do not take Bicalutamide Fair-Med if any of the above apply to you. If
you are not sure, talk
to your doctor or pharmacist before taking Bicalutamide Fair-Med.
Bicalutamide Fair-Med must not be given to children and ado

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bicalutamide Fair-Med 150mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg Bicalutamide
Excipient(s) with known effect: Each tablet contains 188.0 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex, scored, film coated tablet.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bicalutamide Fair-Med 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
Adult males including the elderly: The dosage is one 150 mg tablet to
be taken orally once a day.
The tablets should be swallowed whole with liquid.
Bicalutamide Fair-Med 150 mg should be taken continuously for at least
2 years or until disease progression.
Children and adolescents: Bicalutamide Fair-Med is contraindicated in
children and adolescents.
Renal impairment: No dosage adjustment is necessary for patients with
renal impairment. There is no experience with
the use of bicalutamide in patients with severe renal impairment
(creatinine clearance < 30 ml/min) (see Section 4.4).
Hepatic impairment: No dosage adjustment is necessary for patients
with mild hepatic impairment. Increased
accumulation may occur in patients with moderate to severe hepatic
impairment (see section 4.4).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Bicalutamide Fair-Med is contraindicated in females, children and
adolescents (see section 4.6).
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