Ginet

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Cyproterone acetate 2mg;  ;  ; Ethinylestradiol 0.035mg;  

Verfügbar ab:

REX Medical Ltd

INN (Internationale Bezeichnung):

Cyproterone acetate 2 mg

Darreichungsform:

Film coated tablet

Zusammensetzung:

Active: Cyproterone acetate 2mg     Ethinylestradiol 0.035mg   Excipient: Hypromellose Lactose monohydrate Magnesium stearate Povidone Propylene glycol Purified talc   Quinoline yellow Starch Titanium dioxide Colloidal silicon dioxide Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Propylene glycol Purified talc   Starch Titanium dioxide

Einheiten im Paket:

Blister pack, uPVC/aluminium with VMCH seal. 3 x 21 active and 3 x 7 placebo (total, 84) tablets per carton, 84 tablets

Klasse:

Prescription

Verschreibungstyp:

Prescription

Hergestellt von:

Cipla Ltd

Anwendungsgebiete:

Androgen-dependent diseases in women are an indication for treatment with GINET. These diseases may include: acne (where local treatment or oral antibiotics alone have not been successful), especially pronounced forms of acne that may be accompanied by inflammation or formation of nodes (acne nodulocystica, acne papulopustulosa), seborrhea, mild forms of hirsutism and/or androgenic alopecia. Oral contraception in women requiring treatment for these androgen-dependent diseases is an indication for treatment with GINET. However GINET is not recommended in women solely for contraception. It should not be used in combination with other hormonal contraceptives. GINET is indicated for the relief of symptoms of polycystic ovary syndrome.

Produktbesonderheiten:

Package - Contents - Shelf Life: Blister pack, uPVC/aluminium with VMCH seal. 3 x 21 active and 3 x 7 placebo tablets per carton - 84 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, uPVC/aluminium with VMCH seal. 6 x 21 active and 6 x 7 placebo tablets per carton - 168 tablets - 36 months from date of manufacture stored at or below 25°C

Berechtigungsdatum:

2002-05-03

Gebrauchsinformation

CONSUMER MEDICINE INFORMATION
GINET
_Cyproterone acetate 2mg and Ethinylestradiol 35mcg tablets _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about GINET. 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 your taking
GINET against the benefits this medicine is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor,
professional
health care provider or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT IS GINET USED FOR
GINET is used to treat women with acne, hair loss or increased growth
of facial and body hair
if these conditions are the result of over-production of male-type
hormones called androgens.
GINET contains two substances that act against the androgens,
cyproterone acetate and
ethinylestradiol.
As well as being an antiandrogen, cyproterone acetate acts like the
female sex-hormone
progestogen, and when combined with an estrogen (as in GINET, with
ethinylestradiol),
is an oral contraceptive for women being treated for androgen-
dependent symptoms;
however, GINET is not recommended in women solely for contraception.
GINET can also be used to treat polycystic ovary syndrome, a hormone
imbalance that can
cause
irregular
or
absent
periods,
acne,
excessive
hair
growth,
infertility,
recurrent
miscarriage and obesity.
Your doctor may have prescribed GINET for another purpose.
Ask your doctor if you have any questions why GINET has been
prescribed for you.
GINET is not addictive.
This medicine is available only with a prescription.
BEFORE YOU USE GINET
_ _
_WHEN YOU MUST NOT TAKE IT _
Do not take GINET if:
1.
you are pregnant or think you might be pregnant, GINET must not be
used by women
who are pregnant or who think they might be pregnant.
2.
you are breast-feeding, GINET must not be used by women who are
breast-feeding.
3.
you have, or have ever had, a condition involvin

Fachinformation

NEW ZEALAND DATASHEET
1 PRODUCT NAME
GINET
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cyproterone Acetate 2.00 mg and Ethinylestradiol
Tablets 35 mcg.
3 PHARMACEUTICAL FORM
Each blister tray contains 21 yellow active tablets and 7 larger white
inactive tablets. Each
active tablet is a yellow, biconvex, film-coated tablet, containing
cyproterone acetate 2 mg
and ethinylestradiol 35 micrograms (0.035 mg) with a diameter of 5.7
mm. Each inactive
tablet is a white, round, biconvex, tablet, plain on both sides with a
diameter of 7.1 mm.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Androgen-dependent diseases in women are an indication for treatment
with GINET. These
diseases may include: acne (where local treatment or oral antibiotics
alone have not been
successful), especially pronounced forms of acne that may be
accompanied by inflammation
or formation of nodes (acne nodulocystica, acne papulopustulosa),
seborrhea, mild forms of
hirsutism and/or androgenic alopecia.
Oral contraception in women requiring treatment for these
androgen-dependent diseases is
an indication for treatment with GINET. However, GINET is not
recommended in women
solely
for
contraception.
It
should
not
be
used
in
combination
with
other
hormonal
contraceptives.
GINET is indicated for the relief of symptoms of polycystic ovary
syndrome.
4.2 Dose and method of administration
Any previously used hormonal contraception should be discontinued. To
achieve therapeutic
efficacy and the required contraceptive protection, GINET needs to be
taken regularly. The
dose
regimen
of
GINET
is
similar
to
the
usual
regimen
for
most
combined
oral
contraceptives. Thus, the same administration rules for most combined
oral contraceptives
(COC’s) must be considered.
Intermenstrual bleeding and eventual deterioration of the therapeutic
and contraceptive
reliability may be caused by not taking GINET regularly at about the
same time each day.
HOW TO TAKE GINET
Tablets must be taken in the order directed on the blister each day at
about the same