CERAZETTE 75 Microgram Film Coated Tablet

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

DESOGESTREL

Доступна с:

PCO Manufacturing

код АТС:

G03AC09

ИНН (Международная Имя):

DESOGESTREL

дозировка:

75 Microgram

Фармацевтическая форма:

Film Coated Tablet

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

Progestogens

Статус Авторизация:

Authorised

Дата Авторизация:

2013-05-17

тонкая брошюра

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
CERAZETTE
® 75 MICROGRAM FILM-COATED TABLETS
desogestrel
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 do 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 DO YOU NEED TO KNOW BEFORE YOU TAKE CERAZETTE
Cerazette, like other hormonal contraceptives, does not protect
against HIV infection
(AIDS) or any other se

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cerazette 75 microgram film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 microgram desogestrel.
Excipient(s) with known effect: lactose monohydrate
For the 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 (E171)
6.2 INCOMPATIBILITIES
Not applicable.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 22/08/2016_
_CRN 2180223_
_page number: 1_
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the
market in the country of origin. Shelf-life after first opening the sachet: 1 month.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special temperature storage conditions. Store the blister pack 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 CONTENTS OF CONTAINER
Each blister contains 28 tablets. Each carton contains 1blister packed separately in a sachet.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
The active substance etonogestrel shows an environmental risk to fish. Any un