CERAZETTE

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

DESOGESTREL

Beszerezhető a:

IMED Healthcare Ltd.

ATC-kód:

G03AC09

INN (nemzetközi neve):

DESOGESTREL

Adagolás:

75 Microgram

Gyógyszerészeti forma:

Film Coated Tablet

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

desogestrel

Engedélyezési státusz:

Authorised

Engedély dátuma:

2013-02-08

Betegtájékoztató

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 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 CERAZETTE
Cerazette, like other hormonal contraceptives, does not protect
against HIV infection (AIDS) or any
other sexually transmitted dise

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cerazette 75 microgram film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 microgram desogestrel.
Excipient(s) with known effect: Each tablet contains Lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the UK:_
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 monohydrate
Maize starch
Povidone
Stearic acid
Film coating
Hypromellose
Macrogol 400
Talc
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf-life expiry date of the product is the date shown on the
container and outer carton of the product on the
market in the country of origin.
Use within 1 month from the date of first opening of the sachet.
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
lig