APO-CYPROTERONE ACETATE cyproterone acetate 100mg tablet blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

cyproterone acetate, Quantity: 100 mg

Dostupno od:

Arrotex Pharmaceuticals Pty Ltd

INN (International ime):

cyproterone acetate

Farmaceutski oblik:

Tablet, uncoated

Sastav:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate

Administracija rute:

Oral

Jedinice u paketu:

50 tablets

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Inoperable prostatic carcinoma. To suppress flare with initial luteinising hormone releasing hormone (LHRH) analogue therapy; in long-term palliative treatment where LHRH analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with LHRH analogues or who have had orchidectomy.

Proizvod sažetak:

Visual Identification: White to off white, capsule shaped tablet with '100' engraved on one face, and a break line on the other face.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status autorizacije:

Licence status A

Datum autorizacije:

2004-06-22

Uputa o lijeku

APO-CYPROTERONE 100 MG TABLETS
1
APO-CYPROTERONE
100 MG TABLETS
_Contains the active ingredient cyproterone (as cyproterone acetate) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about cyproterone. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Cyproterone 100 mg. It is an anti-
androgen medication. It contains the
active ingredient cyproterone (as
cyproterone acetate).
It is used in men to treat cancer of the
prostate gland. It can also be used in
conjunction with other medications
or following surgical removal of the
testes to treat side effects such as
"hot flushes" or "sweats" and to
prevent any initial worsening of the
disease.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS _
Some types of cancer of the prostate
gland require androgenic hormones
to grow. This medicine works in two
ways. Firstly it stops the androge

Svojstava lijeka

1
AUSTRALIAN PRODUCT INFORMATION – APO-CYPROTERONE
ACETATE (CYPROTERONE ACETATE) 100MG TABLETS
1
NAME OF THE MEDICINE
Cyproterone acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg cyproterone acetate as the active
ingredient.
3
PHARMACEUTICAL FORM
Tablets: White to off-white, capsule-shaped tablet with '100' engraved
on one face, and a
break line on the other face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inoperable Prostatic Carcinoma
•
To suppress “flare” with initial luteinising hormone releasing
hormone (LHRH)
analogue therapy.
•
In long-term palliative treatment where LHRH analogues or surgery are
ineffective,
not tolerated, contraindicated or where oral therapy is preferred.
•
In the treatment of hot flushes in patients treated with LHRH
analogues or who have
had orchidectomy.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Cyproterone Acetate 100 mg Tablets are intended for oral
administration.
The maximum daily dose is 300 mg.
The tablets should be taken with some liquid after a meal.
INOPERABLE PROSTATIC CARCINOMA
To Reduce the Initial Increase of Male Sex Hormones (‘flare’) in
Treatment with LHRH
Agonists
Initially 1 tablet APO-Cyproterone Acetate 100 mg twice daily (i.e.
200 mg a day) alone for 5-
7 days, followed by 1 tablet APO-Cyproterone Acetate 100 mg twice
daily (i.e. 200 mg a
day) for 3-4 weeks together with an LHRH agonist in the dosage
recommended by the
manufacturer.
Long-Term Palliative Treatment without Orchidectomy
100 mg (1 tablet APO-Cyproterone Acetate 100 mg) two or three times
daily. Treatment
should not be interrupted, nor the dosage reduced, after improvement
or remissions have
occurred.
Treatment of Hot Flushes (in Patients Treated with LHRH Analogues or
Post-Orchidectomy)
2
50 mg to 150 mg (half to one and a half tablets) per day with upward
titration up to 1 tablet
three times daily (300 mg) if necessary (see SECTION 4.4 SPECIAL
WARNINGS AND
PRECAUTIONS FOR USE, SECTION 4.8 ADVERSE EFFECTS (UNDESIRABLE
EFFECTS) and SECTION 4.9 OVER