Cerazette 75 microgram film-coated tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Desogestrel

Saatavilla:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC-koodi:

G03AC; G03AC09

INN (Kansainvälinen yleisnimi):

Desogestrel

Annos:

75 microgram(s)

Lääkemuoto:

Film-coated tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Progestogens; desogestrel

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

1998-08-14

Pakkausseloste

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 transmi

Valmisteyhteenveto

Health Products Regulatory Authority
23 November 2020
CRN009XRJ
Page 1 of 9
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 approximately
55mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
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
Contraception.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To achieve contraceptive effectiveness, Cerazette must be used as
directed (see ‘How to take ‘Cerazette’ and ‘How to start
Cerazette’).
Special populations
_Renal impairment_
No clinical studies have been performed in patients with renal
impairment.
_Hepatic impairment_
No clinical studies have been performed in patients with hepatic
insufficiency. Since the metabolism of steroid hormones might
be impaired in patients with severe hepatic disease, the use of
Cerazette in these women is not indicated as long as liver
function values have not returned to normal (see section 4.3).
_Paediatric population_
The safety and efficacy of Cerazette in adolescents below 18 years has
not been established. No data are available.
Method of administration
Oral use.
HOW TO TAKE CERAZETTE
Tablets must be taken every day at about the same time so that the
interval between two tablets always is 24 hours. The first
tablet should be taken on the first day of menstrual bleeding.
Thereafter one tablet each day is to be taken continuously,
without taking any notice on possible bleeding. A new blister is
started directly the day after the previous one.
HOW TO START CERAZETTE
Health Products Regulatory Authority
23 November 2020
CRN009XRJ
Page 2 of 9
_No preceding hormonal contraceptive use [in the past month]_
Tablet-taking has to star