Cerazette 75microgram tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Desogestrel

Fáanlegur frá:

Organon Pharma (UK) Ltd

ATC númer:

G03AC09

INN (Alþjóðlegt nafn):

Desogestrel

Skammtar:

75microgram

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 07030201; GTIN: 5013257001718

Upplýsingar fylgiseðill

UNITED KINGDOM USER PACKAGE LEAFLET OF CERAZETTE
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, pharmacist
or Family Planning
Nurse.

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, pharmacist or Family
Planning Nurse.
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
Do not take…
Warnings and precautions
Pregnancy and breast-feeding
3.
How to take Cerazette
Starting your first pack
Changing from other methods
After a baby
If you forget 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.

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).

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

Vara einkenni

OBJECT 1
CERAZETTE 75 MICROGRAM FILM-COATED TABLET
Summary of Product Characteristics Updated 27-Jan-2017 | Merck Sharp &
Dohme Limited
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 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
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
_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 th