CERAZETTE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DESOGESTREL

Available from:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC code:

G03AC09

Pharmaceutical form:

FILM COATED TABLETS

Composition:

DESOGESTREL 0.075 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ORGANON LLC, USA

Therapeutic group:

DESOGESTREL

Therapeutic area:

DESOGESTREL

Therapeutic indications:

Contraceptive.

Authorization date:

2014-06-30

Patient Information leaflet

[Organon] Proprietary
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
CERAZETTE
®
Film coated Tablets
Each film coated tablet contains:
Desogestrel 0.075 mg
For a list of inactive ingredients see section 6.1 "What CERAZETTE
contains". See also section 2.8
“IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF
CERAZETTE”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains concise information about CERAZETTE. If you have
any further questions, ask
your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
medical condition seems similar to yours.
1. WHAT CERAZETTE IS AND WHAT IT IS USED FOR?
CERAZETTE is used to prevent pregnancy.
THERAPEUTIC GROUP: Progestogens, hormonal contraceptives.
•
There are 2 main kinds of hormone contraceptive.
−
The combined pill, "THE PILL", which contains 2 types of female sex
hormone an oestrogen and a
progestogen,
−
The progestogen-only pill, POP, which doesn't contain an oestrogen.
•
CERAZETTE is a progestogen-only-pill (POP
or a mini-pil).
•
CERAZETTE contains a small amount of one type of female sex hormone,
the progestogen
DESOGESTREL.
•
Most POPs work primarily by preventing the sperm cells from entering
the womb but they do not always
prevent the egg cell from ripening, which is the main way that
combined pills work.
•
CERAZETTE is different from most POPs in having a dose that in most
cases prevents the egg cell from
ripening. As a result, CERAZETTE is a highly effective contraceptive.
•
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.
On the other hand, you may not have any bleeding at all.
2. BEFORE YOU USE CERAZETTE
CERAZETTE, like other hormona

Summary of Product characteristics

1
[Organon] Proprietary
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cerazette
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 microgram desogestrel.
Excipient (s) with known effect: Each tablet contains approximately 55
mg 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
Contraceptive.
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.
2
[Organon] Proprietary
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
_ _
_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-