CYPRONE 100 cyproterone acetate 100mg tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

cyproterone acetate, Quantity: 100 mg

Inapatikana kutoka:

Alphapharm Pty Ltd

INN (Jina la Kimataifa):

cyproterone acetate

Dawa fomu:

Tablet, uncoated

Tungo:

Excipient Ingredients: colloidal anhydrous silica; maize starch; pregelatinised maize starch; lactose monohydrate; magnesium stearate; povidone

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

50

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

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.

Bidhaa muhtasari:

Visual Identification: White capsule shaped biconvex tablet with "CPA 100" marked on one side and scored on the other; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2016-06-01

Taarifa za kipeperushi

CYPRONE 100
_contains cyproterone acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Cyprone 100.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Cyprone 100
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT CYPRONE 100
IS USED FOR
Cyprone 100 contains cyproterone
acetate as the active ingredient.
Cyproterone acetate belongs to a
group of medicines called anti-
androgens. Androgens such as
testosterone are natural male sex
hormones. In some types of prostate
cancer, androgens may help the
cancer cells to grow. By blocking
these hormones, 100 may slow or
stop the growth of cancer.
Cyprone 100 may be used in
combination with other medications
following surgical removal of the
testes to treat side effects such as
"sweats" or "hot flushes" and to
prevent any initial worsening of the
disease.
Cyprone 100 is for use only in men.
This medicine is available only with
a doctor's prescription.
There is no evidence that Cyprone
100 is addictive.
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.
BEFORE YOU TAKE
CYPRONE 100
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CYPRONE 100 IF YOU
HAVE AN ALLERGY TO:
•
cyproterone acetate
•
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 TAKE CYPRONE 100 IF YOU
SUFFER FROM:
•
liver disease, previous or existing
liver tumours unless they are
caused by metastases from
prostate cancer (your do

Tabia za bidhaa

AUSTRALIAN PRODUCT INFORMATION
CYPRONE 100
_Cyproterone acetate tablets _
1
NAME OF THE MEDICINE
Cyproterone acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Cyprone 100 tablet contains 100 mg of cyproterone acetate as the
active ingredient.
Excipients with known effect: Contains sugars (as lactose).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Cyprone 100
:
capsule shaped, biconvex white tablets with 'CPA 100' marked on one
side and
scored on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inoperable prostatic carcinoma
•
To suppress 'flare' with initial luteinising hormone releasing hormone
(LHRH) analogue therapy;
•
long
‐
term palliative treatment where LHRH analogues or surgery are
ineffective, not tolerated,
contraindicated or where oral therapy is preferred;
•
treatment of hot flushes in patients treated with LHRH analogues or
who have had orchidectomy.
4.2
DOSE AND METHOD OF ADMINISTRATION
The maximum daily dose is 300 mg.
INOPERABLE PROSTATIC CARCINOMA
Cyprone 100 should be taken with some liquid after a meal.
TO REDUCE THE INITIAL INCREASE OF MALE SEX HORMONES ('FLARE') IN
TREATMENT WITH LUTEINISING
HORMONE RELEASING HORMONE (LHRH) AGONISTS
Initially 1 Cyprone 100 tablet twice daily (i.e. 200 mg a day) alone
for five to seven days, followed by 1 tablet
Cyprone 100 twice daily (i.e. 200 mg a day) for three to four weeks
together with an LHRH agonist in the
dosage recommended by the manufacturer.
IN LONG
‐
TERM PALLIATIVE TREATMENT OF ADVANCED PROSTATE CANCER IN PATIENTS WHO
HAVE NOT HAD AN
ORCHIECTOMY
100 mg (1 tablet Cyprone 100) two to three times daily. Treatment
should not be interrupted nor the dosage
reduced after improvement or remissions have occurred.
TO TREAT HOT FLUSHES IN PATIENTS UNDER TREATMENT WITH LUTEINISING
HORMONE RELEASING HORMONE
ANALOGUES OR WHO HAVE HAD ORCHIECTOMY
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.
Cyprone