Estelle-35 ED

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Cyproterone acetate 2mg;  ; Ethinylestradiol 0.035mg;  

Disponible depuis:

Douglas Pharmaceuticals Limited

DCI (Dénomination commune internationale):

Cyproterone acetate 2 mg

forme pharmaceutique:

Film coated tablet

Composition:

Active: Cyproterone acetate 2mg   Ethinylestradiol 0.035mg   Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry buff OY-3690 Opadry white Y-1R-7000B Opaglos white 6000 Povidone Purified water Quinoline yellow Sucrose Lactose monohydrate Magnesium stearate Microcrystalline cellulose

Unités en paquet:

Blister pack, PVC/PVDC/Al pack, 28 tabs, 28 tablets

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Sicor de Mexico SA de CV

indications thérapeutiques:

ESTELLE-35 and ESTELLE-35 ED are indicated for the treatment of androgen dependent diseases in women, such as acne (where oral antibiotics or local treatment alone has not been successful), especially pronounced forms and those which are accompanied by seborrhoea or by inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica), androgenic alopecia, mild forms of hirsutism. ESTELLE-35 and ESTELLE-35 ED are also indicated for oral contraception in women requiring treatment for these androgen-dependent diseases; it is not recommended in women solely for contraception. ESTELLE-35 and ESTELLE-35 ED are also indicated for treating the symptoms of polycystic ovary syndrome.

Descriptif du produit:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al pack - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al pack,3x28 tabs - 84 tablets - 36 months from date of manufacture stored at or below 30°C

Date de l'autorisation:

2000-11-23

Notice patient

CONSUMER MEDICINE INFORMATION
ESTELLE-35® ED
_cyproterone acetate and ethinylestradiol _
2 mg/0.035 mg
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
USING ESTELLE-35 ED.
This
leaflet
answers
some
common
questions
about Estelle-35 ED. 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 Estelle-35 ED
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 ESTELLE-35 ED IS USED FOR
Estelle-35 ED is used to treat women who suffer
from conditions arising from increased secretion
of
or
increased
response
to
androgen
(male)
hormones. Such conditions include acne, hair loss
(alopecia)
or
moderately
increased
growth
of
facial and body hair (hirsutism).
Estelle-35
ED
may
also
be
used
to
treat
the
symptoms of polycystic ovary syndrome.
Estelle 35-ED should be withdrawn 3 to 4 cycles
after the treated condition has been completely
resolved.
Estelle-35
ED
provides
effective
oral
contraception
in
women
being
treated
for
androgen-dependent diseases. It is not intended
to be used solely for contraceptive purposes.
Your doctor may have prescribed Estelle-35 ED
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY ESTELLE-35 ED HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with a doctor's
prescription.
BEFORE YOU TAKE ESTELLE-35 ED
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ESTELLE-35 ED IF YOU HAVE AN ALLERGY
TO:
•
any medicine containing cyproterone acetate
and/or ethinylestradiol (the active ingredients
in Estelle-35 ED).
•
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

Résumé des caractéristiques du produit

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Estelle-35® 2 mg/35 microgram film coated tablet
Estelle-35® ED 2 mg/35 microgram film coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each active tablet of Estelle-35 and Estelle-35 ED contains:
Cyproterone acetate
2 mg
Ethinylestradiol
35 micrograms
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
Sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
ESTELLE-35
Film coated, yellowish buff, round, biconvex, active tablets that are
plain on both sides, with a
diameter of 5 mm.
ESTELLE-35 ED
Active tablets are film coated, yellowish buff, round, biconvex
tablets that are plain on both sides,
with a diameter of 5 mm.
Placebo tablets are white, round, biconvex tablets that are plain on
both sides, with a diameter of
7.1 mm.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
ESTELLE-35/ESTELLE-35 ED IS NOT RECOMMENDED IN WOMEN SOLELY FOR
CONTRACEPTION.
Estelle-35/Estelle-35 ED is indicated for the treatment of
androgen-dependent diseases in women,
such as acne (where oral antibiotics or local treatment alone has not
been successful), especially
pronounced forms and those which are accompanied by seborrhoea or by
inflammation or
2 | P a g e
formation of nodes (acne papulopustulosa, acne nodulocystica),
androgenic alopecia, mild forms
of hirsutism.
Estelle-35/Estelle-35 ED is also indicated for oral contraception in
women requiring treatment for
these androgen-dependent diseases; it is not recommended in women
solely for contraception.
It should not be used in combination with other hormonal
contraceptives.
Estelle-35/Estelle-35 ED is also indicated for treating the symptoms
of polycystic ovary syndrome.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Estelle-35/Estelle-35 ED is to be taken regularly in order to achieve
the therapeutic efficacy and
the
required
contraceptive
protection.
Previously
used
hormonal
contraception
should
be
discontinued. The dose regimen of Estelle-35/Estelle-35 ED is similar
to the usual regimen of most
combi