Cerazette

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Desogestrel 0.075mg;  

Disponible desde:

Organon (New Zealand) Limited

Designación común internacional (DCI):

Desogestrel 0.075 mg

Dosis:

0.07 mg

formulario farmacéutico:

Film coated tablet

Composición:

Active: Desogestrel 0.075mg   Excipient: Colloidal silicon dioxide dl-Alpha tocopherol Hypromellose Lactose monohydrate Macrogol 400 Maize starch Povidone Purified talc Stearic acid Titanium dioxide

Unidades en paquete:

Calendar pack, 1 strip of 28 tabs, 28 tablets

clase:

Prescription

tipo de receta:

Prescription

Fabricado por:

Aspen Oss B.V

Resumen del producto:

Package - Contents - Shelf Life: Calendar pack, 1 strip of 28 tabs - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Calendar pack, 3 strips of 28 tabs - 84 tablets - 36 months from date of manufacture stored at or below 30°C - Calendar pack, 6 strips of 28 tabs - 168 tablets - 36 months from date of manufacture stored at or below 30°C

Fecha de autorización:

1997-05-13

Información para el usuario

CERAZETTE
®
Tablets for oral use
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
•
Keep this leaflet. You may
need to read it again.
•
This leaflet will provide
information about the benefits
and risks of Cerazette
®
. It will
also advise you about how to
take Cerazette
®
properly and
when to tell your doctor about
health-related conditions. If
you have any further
questions, ask your doctor or
your pharmacist.
•
This medicine has been
prescribed for you. Do not
pass it on to others. It may
harm them, even if their
symptoms are the same as
yours.
•
If any of the side effects
gets serious, or if you notice
any side effects not listed in
this leaflet, please tell your
doctor or your pharmacist.
WHAT IS CERAZETTE
®
AND WHAT IS IT USED
FOR?
_HOW DOES CERAZETTE_
_®_
_ _
_WORK? _
Cerazette
®
contains a small
amount of one type of female
sex hormone, the progestagen
desogestrel. For this reason
Cerazette
®
is called a
progestagen-only-pill (POP), or
a mini-pill. Contrary to combined
pills, mini-pills do not contain an
oestrogen hormone next to the
progestagen. Most mini-pills
work primarily by preventing the
sperm cells from entering the
womb but, unlike combined pills,
they do not always prevent an
egg cell from ripening.
Cerazette
®
is distinct from other
mini-pills because, like
combined pills, in most cases it
does prevent the egg cells from
ripening. As a result, Cerazette
®
provides high contraceptive
efficacy. In contrast to the
combined pill, Cerazette
®
can be
used by women who do not
tolerate oestrogens and by
women who are breast feeding.
A disadvantage is that vaginal
bleeding may occur at irregular
intervals during the use of
Cerazette
®
. You also may not
have any bleeding at all.
_WHY IS CERAZETTE_
_®_
_ USED? _
To prevent pregnancy.
When Cerazette
®
is taken
correctly (without missing
tablets), the chance of becoming
pregnant is very low.
BEFORE YOU START TO
TAKE CERAZETTE
®
Cerazette
®
, like all hormonal
contraceptives, does not
protect against HIV infection
(AIDS) or any o

Ficha técnica

Page 1 of 9
NEW ZEALAND DATA SHEET
1
CERAZETTE 75 MICROGRAM FILM-COATED TABLET
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 microgram desogestrel.
Excipient with known effect:
- lactose monohydrate
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Film coated tablet.
The tablet is white, round, biconvex and 5 mm in diameter. On one side
it is coded KV above
2 and on the reverse side ORGANON.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
4.2 DOSE AND METHOD OF ADMINISTRATION
HOW TO TAKE CERAZETTE
Tablets must be taken in the order directed on the package, every day
at about the same time,
with some liquid as needed. One tablet is to be taken daily for 28
consecutive days. Each
subsequent pack is started immediately after finishing the previous
pack.
HOW TO START CERAZETTE
No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman’s natural cycle
(day 1 is the first day of her
menstrual bleeding). Starting on days 2-5 is allowed, but during the
first cycle a barrier method
is recommended in addition for the first 7 days of tablet-taking.
Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC),
vaginal ring, or transdermal patch)
The woman should start with CERAZETTE preferably on the day after the
last active tablet
(the last tablet containing the active substances), or on the day of
removal of her vaginal ring
or patch. In these cases, the use of an additional contraceptive is
not necessary.
The women may also start at the latest on the day following the usual
tablet-free, patch-free,
ring-free, or placebo tablet interval of her previous combined
hormonal contraceptive, but
during the first 7 days of tablet-taking an additional barrier method
is recommended.
Changing from a progestogen-only-method (minipill, injection, implant
or from a progestogen-
releasing intrauterine system [IUS])
The woman may switch any day from the minipill, (from an implant