Procur

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cyproterone acetate 50mg;  ;  

Available from:

Douglas Pharmaceuticals Limited

INN (International Name):

Cyproterone acetate 50 mg

Dosage:

50 mg

Pharmaceutical form:

Tablet

Composition:

Active: Cyproterone acetate 50mg     Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone

Units in package:

Blister pack, PVC/PVDC/Al, 20 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Hubei Gedian Humanwell Pharmaceuticals Co., Ltd.

Therapeutic indications:

In Men · Antiandrogen treatment in inoperable carcinoma of the prostate

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 20 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 50 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, White HDPE/PP screw cap - 20 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, White HDPE/PP screw cap - 50 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2006-01-24

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
1
PROCUR
_Cyproterone acetate _
50 mg and 100 mg tablets
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING PROCUR
This
leaflet
answers
some
common
questions
about Procur. It does not contain all 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 Procur 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 PROCUR IS USED FOR
Procur
tablets
contain
the
active
ingredient
cyproterone acetate. Cyproterone acetate is an
antiandrogen. It works by blocking the actions of
sex
hormones
(androgens)
that
are
produced
mainly
in
men
but also,
to
a
lesser
extent in
women.
In men, Procur is used:
•
to treat prostate cancer
•
to control sexual desire in men who have an
increased
sex
drive
(hypersexuality)
and/or
sexual abnormalities.
In women, Procur is used:
•
to treat severe signs of androgenisation such
as excessive hair growth.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY PROCUR HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with a doctor's
prescription.
BEFORE YOU TAKE PROCUR
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PROCUR IF YOU HAVE AN ALLERGY TO:
•
any medicine containing cyproterone acetate
•
any of the ingredients listed at the end of this
leaflet
Some of the symptoms of an allergic reaction may
include:
•
difficulty in breathing or wheezing
•
shortness of breath
•
swelling of the face, tongue, lips, or other parts
of the body
•
hives on the skin, rash, or itching
DO NOT TAKE PROCUR IF:
•
you are allergic to cyproterone acetate or any
other ingredient listed at the end of this leaflet
•
you are pregnant
•
you are breastfeeding
•
you
suffer
from
liver
diseases
(including
previous
or
existing
liver
tumours,
Dubin-
Johnson syndrome

Summary of Product characteristics

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
PROCUR® 50 mg and 100 mg tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PROCUR 50 mg tablet contains 50 mg of cyproterone acetate.
Each PROCUR 100 mg tablet contain 100 mg of cyproterone acetate.
EXCIPIENT(S) WITH KNOWN EFFECT
PROCUR tablet contains lactose monohydrate. For the full list of
excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
PROCUR 50 mg Tablets are white to off-white, round, flat, tablets
having a score and embossed
50 on one side and plain on the other.
PROCUR 100 mg Tablets are white to off white, capsule shaped tablets
having a score on one face
and embossed 100 on the other.
PROCUR (Cyproterone acetate) is an antiandrogenic hormone preparation.
Cyproterone acetate
is a white or almost white crystalline powder, practically insoluble
in water, very soluble in
methylene chloride, freely soluble in acetone, soluble in methanol,
sparingly soluble in ethanol.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
MEN
•
Antiandrogen treatment in inoperable carcinoma of the prostate
•
Reduction of drive in sexual deviations
WOMEN
•
Severe
signs
of
androgenization,
e.g.
very
severe
hirsutism
in
the
female,
severe
androgenetic alopecia, often attended by severe forms of acne and/or
seborrhoea.
2 | P a g e
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
_ADULT MEN _
Antiandrogen treatment in inoperable carcinoma of the prostate
To eliminate the effect of adrenocortical androgens after orchiectomy:
two 50 mg tablets once or
twice daily (= 100-200 mg total daily dose). Without orchiectomy: two
50 mg tablets twice to three
times daily (= 200-300 mg total daily dose).
Treatment should not be interrupted, nor the dosage reduced after
improvement or remissions
have occurred.
To reduce the initial increase of male sex hormones in treatment with
LH-RH agonists: Initially two
50 mg tablets PROCUR twice daily (= 200 mg total daily dose) alone for
5 - 7 days followed by two
50 mg tablets PROCUR twice daily (= 200 mg total daily dose) for 3 - 4
weeks tog