Anterone 100 cyproterone acetate 100mg tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

cyproterone acetate, Quantity: 100 mg

Beschikbaar vanaf:

Cipla Australia Pty Ltd

INN (Algemene Internationale Benaming):

cyproterone acetate

farmaceutische vorm:

Tablet, uncoated

Samenstelling:

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

Toedieningsweg:

Oral

Eenheden in pakket:

50, 20

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

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.

Product samenvatting:

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

Autorisatie-status:

Licence status A

Autorisatie datum:

2016-10-19

Bijsluiter

Anterone 100
1
ANTERONE 100
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ANTERONE 100?
Anterone 100 contains the active ingredient cyproterone acetate.
Anterone 100 may slow or stop the growth of cancer.
Anterone 100 tablets may be used in combination with other medicines
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.
For more information, see Section 1. Why am I using Anterone 100? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ANTERONE 100?
Do not use if you have ever had an allergic reaction to cyproterone
acetate or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Anterone 100? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Anterone 100 and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ANTERONE 100?
Your doctor will tell you the dose that you should take. The usual
daily dose is 50‐300 mg (one half to three tablets) of
Anterone 100. Your doctor may request you take Anterone 100 with other
medicines and/or change your dose during
treatment. More instructions can be found in Section 4. How do I use
Anterone 100? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ANTERONE 100?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist when you visit that you are
using Anterone 100.
•
Your doctor will check your liver function and red blood cell count
during treatment with Anterone
100 and whenever any symptoms or signs suggesting liver problems are
observed and to ensure you
do not become

Productkenmerken

AUSTRALIAN PRODUCT INFORMATION - ANTERONE 100 (CYPROTERONE ACETATE)
100 MG TABLETS
1
NAME OF THE MEDICINE
Cyproterone acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Anterone 100 tablets
Each tablet contains 100 mg cyproterone acetate
Excipient with known effect
Contains lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
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

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
The maximum daily dose is 300 mg.
INOPERABLE PROSTATIC CARCINOMA
.
Anterone 100 should be taken with some liquid after a meal
TO REDUCE THE INITIAL INCREASE OF MALE SEX HORMONES ('FLARE') IN
TREATMENT WITH LHRH AGONISTS
Initially 1 Anterone 100 tablet twice daily (i.e. 200 mg a day) alone
for 5-7 days, followed by 1
Anterone 100 tablet twice daily (i.e. 200 mg a day) for 3-4 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 Anterone 100 tablet) 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 LHRH ANALOGUES
OR WHO HAVE HAD
ORCHIECTOMY
50 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.
_ _
PAEDIATRIC USE
Anterone 100 tablets is not recommended for use in male children and
adolescents below 18 years of
age due to a lack of