Flutamin

Ország: Új-Zéland

Nyelv: angol

Forrás: Medsafe (Medicines Safety Authority)

Aktív összetevők:

Flutamide 250mg;  

Beszerezhető a:

Viatris Limited

INN (nemzetközi neve):

Flutamide 250 mg

Adagolás:

250 mg

Gyógyszerészeti forma:

Tablet

Összetétel:

Active: Flutamide 250mg   Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Pregelatinised maize starch Purified water Sodium laurilsulfate

db csomag:

Blister pack, PVC (Translucent Green)/Al, 100 tablets

Osztály:

Prescription

Recept típusa:

Prescription

Gyártó:

Fermion Oy

Terápiás javallatok:

For the palliative treatment of advanced prostatic cancer in previously untreated patients or those who have not responded or who have become refractory to hormonal manipulation. As a component of the treatment used in the management of locally advanced prostatic carcinoma.

Termék összefoglaló:

Package - Contents - Shelf Life: Blister pack, PVC (Translucent Green or Opaque White)/Al - 100 tablets - 24 months from date of manufacture stored at or below 25°C

Engedély dátuma:

1998-04-14

Betegtájékoztató

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
FLUTAMIN
_FLUTAMIDE 250 MG TABLETS_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Flutamin.
This leaflet answers some common
questions about Flutamin.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Flutamin
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT FLUTAMIN IS
USED FOR
Flutamin may be used alone or in
combination with another medicine
(luteinising hormone-releasing
hormone [LHRH] agonists) in the
treatment of prostate cancer.
Flutamin contains the active
ingredient Flutamide. It belongs to a
group of medicines called non-
steroidal anti-androgen medicines.
The causes of prostate cancer are
unknown but the disease is often
responsive to treatment.
Flutamin works by blocking the
effects of androgens, which are
male hormones that prostate cancer
cells need for growth.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
Flutamin is available only with a
doctor's prescription.
There is no evidence that Flutamin
is addictive.
FLUTAMIN IS SUITABLE FOR USE IN
MEN ONLY. FLUTAMIN SHOULD NOT
BE USED IN WOMEN OR CHILDREN.
BEFORE YOU TAKE
FLUTAMIN
WHEN YOU MUST NOT TAKE IT:
Do not take Flutamin if:
•
you have a serious liver
problem
•
you are female
DO NOT TAKE FLUTAMIN IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
Flutamide
•
any of the ingredients listed at
the end of this leaflet
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
DO NOT GI

Termékjellemzők

Page 1 of 10
NEW ZEALAND DATA SHEET
FLUTAMIN
1. PRODUCT NAME
Flutamin, 250 mg, tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of flutamide.
Excipients with known effect: maize starch and lactose.
Allergen Declaration: Contains sulfites and sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
A yellow 0.4921” (12.5 mm) round, biconvex, tablet debossed with FT
above the score and 250
below the score on one side of the tablet and G on the other side.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
For the palliative treatment of advanced prostatic cancer in
previously untreated patients or those
who have not responded or who have become refractory to hormonal
manipulation.
As a component of the treatment used in the management of locally
advanced prostatic carcinoma.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
The recommended dosage is one tablet three times a day at intervals of
eight hours.
Flutamide tablets have been administered as monotherapy with or
without surgical castration and in
combination
with
medical
(luteinising
hormone-releasing
hormone
[LHRH]
agonist)
hormonal
manipulation.
When flutamide is used in combination with an LHRH agonist from the
outset, the flare reaction can
be reduced if flutamide is initiated before the LHRH agonist.
Therefore, it is recommended to start
flutamide either at the same time or at least 24 hours before the LHRH
agonist.
In localised prostatic carcinoma, administration of flutamide and an
LHRH agonist should begin eight
weeks prior to radiation therapy and continue through the course of
radiation therapy. Prior to radical
prostatectomy, flutamide should be administered for 3 months.
Page 2 of 10
_SPECIAL POPULATIONS_
HEPATIC IMPAIRMENT
In patients with impaired liver function, long-term treatment with
flutamide should only be initiated
after careful assessment of the individual benefits and risks.
RENAL IMPAIRMENT
Flutamide should be administered with caution in patients with
impaired renal fu