CERAZETTE

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

DESOGESTREL

Disponível em:

Imbat Limited

Código ATC:

G03AC09

DCI (Denominação Comum Internacional):

DESOGESTREL

Dosagem:

75 Microgram

Forma farmacêutica:

Film Coated Tablet

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

desogestrel

Status de autorização:

Authorised

Data de autorização:

2014-06-13

Folheto informativo - Bula

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CERAZETTE
® 75 MICROGRAM FILM-COATED TABLETS
(desogestrel)
Your medicine is available using the above name but will be
referred to as Cerazette throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your
doctor or pharmacist.

This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Cerazette is and what it is used for
2.
What you need to know before you take Cerazette
3.
How to take Cerazette
4.
Possible side effects
5.
How to store Cerazette
6.
Contents of the pack and other information
1.
WHAT CERAZETTE IS AND WHAT IT IS USED FOR
Cerazette is used to prevent pregnancy. Cerazette contains a
small amount of one type of female sex hormone, the
progestogen DESOGESTREL. For this reason Cerazette is called
a progestogen-only-pill (POP). Contrary to the combined pill,
the POP does not contain an oestrogen hormone next to the
progestogen.
Most POPs work primarily by preventing the sperm cells from
entering the womb but do not always prevent the egg cell
from ripening, which is the primary action of combined pills.
Cerazette is distinct from most POPs in having a dose that in
most cases is high enough to prevent the egg cell 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CERAZETT

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cerazette 75 microgram film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 micrograms desogestrel.
Excipient of known effect: lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from United Kingdom:_
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
As per PA1286/048/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1286/048/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet Core
Silica, Colloidal anhydrous
All-rac-
-tocopherol
Lactose monhydrate
Maize starch
Povidone
Stearic acid
Film coating
Hypromellose
Macrogol 400
Talc
Titanium dioxide (E 171)
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strips and outer carton of the product as
marked in the country of origin.
Use within 1 month from the date of first opening of the sachet.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original sachet in order to protect from light and
moisture. For storage conditions after first opening the
sachet, see section 6.3.
6.5 NATURE AND CO