New Zealand - English - Medsafe (Medicines Safety Authority)
Tablets for oral use
What is in this leaflet
Keep this leaflet. You may
need to read it again.
This leaflet will provide
information about the benefits
and risks of Cerazette
. It will
also advise you about how to
when to tell your doctor about
health-related conditions. If
you have any further
questions, ask your doctor or
This medicine has been
prescribed for you. Do not
pass it on to others. It may
harm them, even if their
symptoms are the same as
If any of the side effects
gets serious, or if you notice
any side effects not listed in
this leaflet, please tell your
doctor or your pharmacist.
What is CERAZETTE
and what is it used
How does Cerazette
contains a small
amount of one type of female
sex hormone, the progestagen
desogestrel. For this reason
is called a
progestagen-only-pill (POP), or
a mini-pill. Contrary to combined
pills, mini-pills do not contain an
oestrogen hormone next to the
progestagen. Most mini-pills
work primarily by preventing the
sperm cells from entering the
womb but, unlike combined pills,
they do not always prevent an
egg cell from ripening.
is distinct from other
mini-pills because, like
combined pills, in most cases it
does prevent the egg cells from
ripening. As a result, Cerazette
provides high contraceptive
efficacy. In contrast to the
combined pill, Cerazette
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
. You also may not
have any bleeding at all.
Why is Cerazette
To prevent pregnancy.
correctly (without missing
tablets), the chance of becoming
pregnant is very low.
Before you start to
, like all hormonal
contraceptives, does not
protect against HIV infection
(AIDS) or any other sexually
When should you not take
Do not use Cerazette
have any of the conditions
listed below. If any of these
apply to you, tell your doctor
before starting to use
. Your doctor may
advise you to use a non-
hormonal method of birth
If you have a thrombosis.
Thrombosis is the formation
of a blood clot in a blood
vessel [e.g. of the legs (deep
venous thrombosis) or the
If you have jaundice
(yellowing of the skin) or
severe liver disease.
If you have a cancer that
grows under the influence of
sex steroid hormones.
If you have any unexplained
If you are pregnant or think
you might be pregnant.
If you are allergic to any of
the ingredients of
If any of these conditions
appear for the first time while
consult your doctor promptly.
When do you have to take
special care with
is used in the
presence of any of the conditions
listed below, you may need to be
kept under close observation.
Your doctor can explain to you
what to do. Therefore, if any of
these apply to you, tell your
doctor before starting to use
You have or have had breast
You have liver cancer;
You have ever had a
You have diabetes;
You suffer from epilepsy;
You suffer from tuberculosis;
You have high blood
You have or have had
pigmentation patches on the
skin, particularly of the face);
if so avoid too much exposure
to the sun or ultraviolet
Decreased Bone Mass
Oestrogens are important to
maintain the strength of your
bones. During the use of
, the concentration
in your blood of the natural
oestrogen estradiol is
comparable to the
concentration seen in the first
half of your natural cycle but is
decreased in comparison with
the second half of the natural
cycle. It is not known whether
this has an effect on the
strength of your bones.
Every woman is at risk of breast
cancer whether or not she takes
oral contraceptives (‘the Pill’).
Breast cancer has been found
slightly more often in women
who take the Pill than in women
of the same age who do not
take the Pill. When women stop
taking the Pill, the risk gradually
decreases, so that 10 years
after stopping the risk is the
same as for women who have
never taken the Pill. Breast
cancer is rare under 40 years of
age but the risk increases as
the woman gets older.
Therefore, the extra number of
breast cancers diagnosed is
higher among women who use
the Pill at a higher age. How
long a woman takes the Pill is
In every 10,000 women who
take the Pill for up to 5 years but
stop taking it by the age of 20,
there would be less than 1 extra
case of breast cancer found up
to 10 years after stopping, in
addition to the 4 cases normally
diagnosed in this age group.
Likewise, in 10,000 women who
take the Pill for up to 5 years but
stop taking it by the age of 30,
there would be 5 extra cases in
addition to the 44 cases
normally diagnosed. In 10,000
women who take the Pill for up
to 5 years but stop taking it by
the age of 40, there would be 20
extra cases in addition to the
160 cases normally diagnosed.
Breast cancers found in women
who take the Pill, seem less
likely to have spread than breast
cancers found in women who do
not take the Pill. It is not known
whether the difference in breast
cancer risk is caused by the Pill.
It may be that the women were
examined more often, so that the
breast cancer is noticed earlier.
Thrombosis is the formation of a
blood clot, which may block a
blood vessel. A thrombosis
sometimes occurs in the deep
veins of the legs (deep venous
thrombosis). If this clot breaks
away from the veins where it is
formed, it may reach and block
the arteries of the lungs, causing
a so-called “pulmonary
embolism”. As a result, fatal
situations may occur. Deep
venous thrombosis is a rare
occurrence. It can develop
whether or not you are taking
the Pill. It can also happen if you
become pregnant. The risk is
higher in Pill-users than in non-
users, but it is not as high as the
risk during pregnancy. The risk
with progestagen-only pills like
is believed to be
lower than in users of Pills that
also contain oestrogens
(combined Pills). If you notice
possible signs of a thrombosis,
you should see your doctor
immediately. (See also section
‘When should you contact
Using Other Medicines
Please tell your doctor or
pharmacist if you are taking or
have recently taken any other
medicines or herbal products,
including medicines obtained
without a prescription. Also tell
any other doctor or dentist who
prescribes another medicine (or
your pharmacist) that you use
Some medicines may stop
properly. These include
medicines used for the treatment
topiramate and phenobarbital),
tuberculosis (e.g., rifampicin,
HIV infection (e.g., ritonavir,
Hepatitis C virus infection (e.g.,
other infectious diseases (e.g.,
high blood pressure in the
blood vessels of the lungs
stomach upset (medical
depressive moods (the herbal
remedy St. John’s wort)
If you are taking medicines or
herbal products that might make
less effective, a
barrier contraceptive method
should also be used. Since the
effect of another medicine on
Cerazette may last up to 28 days
after stopping the medicine, it is
necessary to use the additional
barrier contraceptive for that
long. Cerazette may also
interfere with how other
medicines work, causing either
an increase in effect (e.g.,
ciclosporine) or a decrease in
effect (e.g., lamotrigine).
Vaginal bleeding may occur at
irregular intervals during the use
. This may be just
slight staining which may not
even require a pad, or heavier
bleeding, which looks rather like
a scanty period and requires
sanitary protection. You may
also not have any bleeding at all.
The irregular bleedings are not a
sign that the contraceptive
protection of Cerazette
decreased. In general, you need
not take any action; just continue
to take Cerazette
. If, however,
bleeding is heavy or prolonged
consult your doctor.
During the use of all low-dose
hormonal contraceptives, small
fluid-filled sacs may develop in
the ovaries. These are called
ovarian cysts. They usually
disappear on their own.
Sometimes they cause mild
abdominal pain. Only rarely,
they may lead to more serious
must not be used by
women who are pregnant, or
who think they may be
may be used while
you are breastfeeding.
does not influence
the production or the quality of
breast milk. However, a small
amount of the active substance
passes over into
The health of breast-fed
children whose mothers were
studied up to 2.5 years of
age. No effects on the growth
and development of the
children were observed.
If you are breastfeeding and
want to use Cerazette
contact your doctor.
Driving and using
There are no indications of any
effect of the use of Cerazette
on alertness and concentration.
about some of the
ingredients of Cerazette
If you have been told by your
doctor that you have
intolerance to some sugars,
contact your doctor before
When should you contact
How do you take
When and how to take the
28 tablets. Arrows are printed
on the front side of the pack,
between the tablets. If you turn
over your pack, and look at the
back side, you will see the days
of the week printed on the foil.
Each day corresponds to one
tablet. Every time you start a
new pack of Cerazette
, take a
tablet from the top row. Don’t
start with just any tablet. For
example if you start on a
Wednesday, you must take the
tablet from the top row marked
(at the back) with WED.
Continue to take one tablet a
day until the pack is empty,
always following the direction
indicated by the arrows. By
looking at the back of your
pack you can easily check if
you have already taken your
tablet on a particular day. Take
your tablet each day at about
the same time. Swallow the
tablet whole, with water. You
may have some bleeding
during the use of Cerazette
but you must continue to take
your tablets as normal. When
a pack is empty, you must
start with a new pack of
on the next day –
thus without interruption and
without waiting for a bleed.
You can stop taking Cerazette
whenever you want. From the
day you stop you are no longer
protected against pregnancy.
Starting your first pack of
If you are not taking the pill
Wait for your period to
begin. On the first day of
your period take the first
When you are using
Cerazette®, your doctor will tell
you to return for regular check-
ups. In general, the frequency
and nature of these check-ups
will depend on your personal
Contact your doctor as soon as
you notice possible signs of a
thrombosis (e.g. severe pain
or swelling in either of your
legs, unexplained pains in the
chest, breathlessness, an
unusual cough, especially if
you cough up blood);
you have a sudden, severe
stomach ache or look
jaundiced (indicating possible
you feel a lump in your breast;
you have a sudden or severe
pain in the lower part of your
belly or the stomach area
(possibly indicating an ectopic
pregnancy, this is a pregnancy
outside the womb);
you are to be immobilised (for
example being confined to
bed) or are to have surgery;
consult your doctor at least
four weeks in advance;
you have unusual, heavy
you suspect that you are
need not take extra
You may also start on
days 2-5 of your cycle, but
in that case make sure you
also use an additional
(barrier method) for the
first 7 days of tablet-taking
in the first cycle.
When you change from a
combined pill, vaginal
ring, or transdermal patch.
You can start taking
on the day after
you take the last tablet from
your present Pill pack, or on
the day of removal of your
vaginal ring or patch (this
means no tablet-, ring-, or
patch-free break). If your
present Pill pack also
contains inactive tablets you
can start Cerazette
day after taking the last
active tablet (if you are not
sure which this is, ask your
doctor or pharmacist). If you
follow these instructions, it is
not necessary to use an
You can also start at the
latest the day following the
tablet-, ring-, patch-free
break, or placebo tablet
interval, of your present
contraceptive. If you follow
these instructions, make
sure you use during the
first cycle an additional
(barrier method) for the
first 7 days of tablet-taking.
When you change from
You may stop taking it any
day and start taking
right away. You
need not take extra
When you change from an
injectable or implant or a
intrauterine device (IUD).
Start using Cerazette
when your next injection is
due or on the day that your
implant or your IUD is
removed. You need not
take extra contraceptive
If you have just had a baby.
You can start Cerazette
between 21 and 28 days
after the birth of your baby.
If you start later, make sure
you use during the first
cycle an additional
(barrier method) for the first
7 days of tablet-taking.
However, if intercourse has
pregnancy should be
excluded before starting
information for breast
feeding women can be
found in the paragraph
“Breastfeeding” in the
section “When do you have
to take special care with
”. Your doctor
can also advise you.
After miscarriage or an
Your doctor will advise you.
If you forget to take one or
If you are
less than 12 hours
late in taking a tablet, the
reliability of Cerazette
maintained. Take the missed
tablet as soon as you
remember and take the next
tablet at the usual time.
If you are
more than 12 hours
late in taking any tablet, the
reliability of Cerazette
reduced. The more
consecutive tablets you have
missed the higher the risk that
the contraceptive efficacy is
decreased. Take the last
missed tablet as soon as you
remember and take the next
tablet at the usual time. Use a
condom too for the next 7 days
of tablet-taking. If you missed
one or more tablets in the first
week of tablet-intake and had
intercourse in the week before
missing the tablets, there is a
possibility of becoming
pregnant. Ask your doctor for
If you suffer from
If you vomit within 3-4 hours
after taking your Cerazette
tablet or have severe
diarrhoea, the active ingredient
may not have been completely
absorbed. Follow the advice for
missed tablets in the section “If
you forget to take one or more
tablets”. If you have severe
diarrhoea, please contact your
If too many Cerazette
tablets are taken
There have been no reports of
serious harmful effects from
taking too many Cerazette
tablets at one time. Symptoms
that may occur are nausea,
vomiting and, in women or girls,
slight vaginal bleeding. For
more information ask your
doctor for advice.
If you want to stop taking
You can stop taking Cerazette
at any time you want. If you do
not want to become pregnant,
ask your doctor about other
methods of birth control.
If you stop using Cerazette
because you want to get
pregnant, it is generally
recommended that you wait
until you have had a natural
period before trying to
conceive. This helps you to
work out when the baby will be
Possible Side Effects
Like all medicines, Cerazette
can cause side effects, although
not everybody gets them. Tell
your doctor if you notice any
unwanted effect, especially if
severe or persistent, or if there
is a change in your health that
you think might be caused by
Serious side effects
Serious undesirable effects
associated with the use of
contraceptive Pills are
described in the section “When
do you have to take special
care with Cerazette
read this section for additional
information and consult your
doctor at once where
Other possible side effects
Common (occurring in more than
one per 100 users) are:
Mood altered, decreased
sexual drive (libido)
Breast pain, irregular or no
Increased body weight
Uncommon (occurring in more
than one per 1000 users but
not more than one per 100
Infection of the vagina
Difficulties in wearing contact
Painful menstruation, ovarian
Rare (occurring in less than
one per 1000 users) are:
Rash, hives, painful blue-
red skin lumps (erythema
nodosum) (these are skin
Apart from these side effects,
breast secretion may occur.
In addition, allergic reactions
swelling of the face, lips,
tongue, and/or throat causing
difficulty in breathing or
and/or anaphylaxis) have been
If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
How to store
Store between 2°C to 30°C,
protected from light and
moisture. Do not use after the
expiry date stated on the
Keep your tablets out of the
reach and sight of children.
The active substance is:
desogestrel (75 micrograms).
The other ingredients are:
silica; colloidal anhydrous; all-
monohydrate; maize starch;
povidone; stearic acid;
hypromellose; macrogol 400;
talc and titanium dioxide (E
and the content of the
One blister pack of Cerazette
contains 28 white round tablets.
The tablets are coded KV above
2 on one side and ORGANON*
on the reverse side. Each carton
contains 1 or 3 blister packs,
each separately packed in a
sachet. Not all pack sizes may
Merck Sharp & Dohme (NZ) Ltd
P O Box 99 851
Telephone: 0800 500 673
This leaflet was updated in
Page 1 of 9
NEW ZEALAND DATA SHEET
CERAZETTE 75 microgram Film-coated tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 microgram desogestrel.
Excipient with known effect:
- lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
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.
4.1 Therapeutic indications
4.2 Dose and method of administration
How To Take CERAZETTE
Tablets must be taken in the order directed on the package, every day at about the same time,
with some liquid as needed. One tablet is to be taken daily for 28 consecutive days. Each
subsequent pack is started immediately after finishing the previous pack.
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 2-5 is allowed, but during the first cycle a barrier method
is recommended in addition for the first 7 days of tablet-taking.
Changing from a combined hormonal contraceptive (combined oral contraceptive (COC),
vaginal ring, or transdermal patch)
The woman should start with CERAZETTE preferably on the day after the last active tablet
(the last tablet containing the active substances), or on the day of removal of her vaginal ring
or patch. In these cases, the use of an additional contraceptive is not necessary.
The women may also start at the latest on the day following the usual tablet-free, patch-free,
ring-free, or placebo tablet interval of her previous combined hormonal contraceptive, but
during the first 7 days of tablet-taking an additional barrier method is recommended.
Changing from a progestogen-only-method (minipill, injection, implant or from a progestogen-
releasing intrauterine system [IUS])
The woman may switch any day from the minipill, (from an implant or the IUS on the day of its
removal, from an injectable when the next injection would be due). An additional contraceptive
method is not necessary.
Following first-trimester abortion
contraceptive method is not necessary.
Page 2 of 9
Following delivery or second-trimester abortion
For breastfeeding women see Section 4.6 Fertility, pregnancy and lactation.
The woman should be advised to start at day 21-28 after delivery or second trimester abortion.
When starting later, she should be advised to use a barrier method in addition for the first 7
days of tablet-taking. However, if intercourse has already occurred, pregnancy should be
excluded before the actual start of CERAZETTE use or the woman has to wait for her first
Management of Missed Tablets
Contraceptive protection may be reduced if more than 36 hours have elapsed between two
tablets. If the user is less than 12 hours late in taking any tablet, the missed tablet should be
taken as soon as it is remembered and the next tablet should be taken at the usual time. If
she is more than 12 hours late, she should follow the same advice but also use an additional
method of contraception for the next 7 days. If tablets were missed in the very first week and
intercourse took place in the week before the tablets were missed, the possibility of a
pregnancy should be considered.
Advice in case of gastrointestinal disturbances
In case of severe gastrointestinal disturbance, absorption may not be complete and additional
contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet-
taking, absorption may not be complete. In such an event, the advice concerning missed
tablets, as given under Management of missed tablets is applicable.
No data available.
Progestogen-only contraceptives should not be used in the presence of any of the conditions
listed below. Should any of the conditions appear for the first time during the use of
CERAZETTE, the product should be stopped immediately.
Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1
List of excipients
Known or suspected pregnancy
Active venous thromboembolic disorder
Presence or history of severe hepatic disease as long as liver function values have not
returned to normal
Known or suspected sex steroid sensitive malignancies
Undiagnosed vaginal bleeding
4.4 Special warnings and precautions for use
If any of the conditions mentioned below is present, the benefits of progestogen use should
be weighed against the possible risks for each individual woman and discussed with the
woman before she decides to start using CERAZETTE. In the event of aggravation,
exacerbation or first appearance of any of these conditions, the woman should contact her
physician. The physician should then decide on whether the use of CERAZETTE should be
The risk for breast cancer increases in general with increasing age. During the use of
combined oral contraceptives (COCs) the risk of having breast cancer diagnosed is slightly
increased. This increased risk disappears gradually within 10 years after discontinuation
of OC use and is not related to the duration of use, but to the age of the woman when
using the COC. The expected number of cases diagnosed per 10,000 women who use
Page 3 of 9
combined OCs (up to 10 years after stopping) relative to never users over the same period
has been calculated for the respective age groups and is presented in the table below:
Expected cases non-
The risk in POP users is possibly of similar magnitude as that associated with combined
OCs. However, for POPs the evidence is less conclusive. Compared to the risk of getting
breast cancer ever in life, the increased risk associated with COCs is low. The cases of
breast cancer diagnosed in COC users tend to be less advanced than in those who have
not used COCs. The increased risk in COC users may be due to an earlier diagnosis,
biological effects of the pill or a combination of both.
Since a biological effect of progestogens on liver cancer cannot be excluded an individual
benefit/risk assessment should be made in women with liver cancer.
When acute or chronic disturbances of liver function occur the woman should be referred
to a specialist for examination and advice.
If a sustained hypertension develops during the use of CERAZETTE, or if a significant
increase in blood pressure does not adequately respond to antihypertensive therapy,
discontinuation with the use of CERAZETTE should be considered.
investigations have associated
increased incidence of venous thromboembolism (VTE, deep venous thrombosis and
pulmonary embolism). Although the clinical relevance of this finding for desogestrel used
as a contraceptive in the absence of an oestrogenic component is unknown, CERAZETTE
should be discontinued in the event of a thrombosis. Discontinuation of CERAZETTE
should also be considered in case of long-term immobilisation due to surgery or illness.
Women with a history of thromboembolic disorders should be made aware of the possibility
of a recurrence.
Although progestogens may have an effect on peripheral insulin resistance and glucose
tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics
using progestogen-only pills. However, diabetic patients should be carefully observed
during the first months of use.
Treatment with CERAZETTE leads to decreased oestradiol serum levels, to a level
corresponding with the early follicular phase. It is as yet unknown whether the decrease
has any clinically relevant effect on bone mineral density.
The protection with traditional progestogen-only pills against ectopic pregnancies is not as
good as with combined oral contraceptives, which has been associated with the frequent
occurrence of ovulations during the use of progestogen-only pills. Despite the fact that
CERAZETTE consistently inhibits ovulation, ectopic pregnancy should be taken into
account in the differential diagnosis if the woman gets amenorrhoea or abdominal pain.
Chloasma may occasionally occur, especially in women with a history of chloasma
gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or
ultraviolet radiation whilst taking CERAZETTE.
The following conditions have been reported both during pregnancy and during sex steroid
use, but an association with the use of progestogens has not been established: jaundice
and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus
Page 4 of 9
erythematosus; haemolytic uraemic syndrome; Sydenham’s chorea; herpes gestationis;
otosclerosis-related hearing loss; (hereditary) angioedema.
CERAZETTE contains less than 65mg lactose and therefore should not be administered
to patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency, or glucose-galactose malabsorption.
Before prescription, a thorough case history should be taken and a thorough gynaecological
oligomenorrhoea and amenorrhoea should be investigated before prescription. The interval
between check-ups depends on the circumstances in each individual case. If the prescribed
product may conceivably influence latent or manifest disease (see Section 4.4 Special
warnings and precautions for use), the control examinations should be timed accordingly.
Despite the fact that CERAZETTE is taken regularly, bleeding disturbances may occur. If
bleeding is very frequent and irregular, another contraceptive method should be considered.
If the symptoms persist, an organic cause should be ruled out. Management of amenorrhoea
during treatment depends on whether or not the tablets have been taken in accordance with
the instructions and may include a pregnancy test. The treatment should be stopped if a
Women should be advised that CERAZETTE does not protect against HIV (AIDS) and other
sexually transmitted diseases.
The efficacy of CERAZETTE may be reduced in the event of missed tablets (see Section 4.2
Dose and method of administration, Management of missed tablets), gastrointestinal
medications that decrease the plasma concentration of etonogestrel, the active metabolite of
desogestrel (see Section 4.5 Interactions with other medicines and other forms of
Changes in Vaginal Bleeding Pattern
During the use of a progestogen-only contraceptive, vaginal bleeding may become more
frequent or of longer duration in some women, whereas in others bleeding may become
incidental or be totally absent. These changes are often a reason for women to reject the
method or to be non-compliant. Acceptance of bleeding pattern can be improved by offering
women who have chosen to use CERAZETTE careful counselling on this point. Evaluation of
vaginal bleeding should be done on an ad hoc basis and may include examination to exclude
malignancy or pregnancy.
With all low-dose hormonal contraceptives, follicular development occurs and occasionally the
follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these
enlarged follicles disappear spontaneously. Often, they are asymptomatic; in some cases they
are associated with mild abdominal pain. They rarely require surgical intervention.
4.5 Interactions with other medicines and other forms of interactions
Note: The prescribing information of concomitant medications should be consulted to identify
breakthrough bleeding and/or contraceptive failure. No specific interaction studies have been
performed with CERAZETTE. The following interactions have been reported in the literature
Page 5 of 9
Hepatic metabolism: Interactions can occur with medicinal or herbal products that induce
microsomal enzymes, specifically cytochrome P450 enzymes (CYP), which can result in
increased clearance reducing plasma concentrations of sex hormones and may decrease the
phenytoin, phenobarbital, primidone, bosentan, carbamazepine, rifampicin; and possibly also
oxcarbazepine, rifabutin, topiramate, felbamate, griseofulvin, some HIV protease inhibitors
(e.g., ritonavir, nelfinavir) and non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz),
and the herbal remedy St John’s wort.
Enzyme induction can occur after a few days of treatment. Maximum enzyme induction is
generally observed within a few weeks. After drug therapy is discontinued, enzyme induction
can last for about 28 days.
When co-administered with hormonal contraceptives, many combinations of HIV protease
nevirapine), and/or combinations with Hepatitis C virus (HCV) medicinal products (e.g.,
boceprevir, telaprevir), can increase or decrease plasma concentrations of progestins,
including etonogestrel, the active metabolite of desogestrel. The net effect of these changes
may be clinically relevant in some cases.
Women receiving any of the above mentioned hepatic enzyme-inducing medicinal or herbal
products should be advised that the efficacy of CERAZETTE may be reduced. A barrier
contraceptive method should be used in addition to CERAZETTE during administration of the
hepatic enzyme-inducing medicinal product, and for 28 days after discontinuation of the
hepatic enzyme-inducing medicinal product.
For women on long-term therapy with enzyme-inducing medicinal products an alternative
method of contraception unaffected by enzyme-inducing medicinal products should be
Concomitant administration of strong (e.g., ketoconazole, itraconazole, clarithromycin) or
moderate (e.g., fluconazole, diltiazem, erythromycin) CYP3A4 inhibitors may increase the
During treatment with medical charcoal, the absorption of the steroid in the tablet may be
reduced and thereby the contraceptive efficacy. In such an event, the advice concerning
missed tablets, as given under Management of missed tablets is applicable.
Hormonal contraceptives may interfere with the metabolism of other medicines. Accordingly,
plasma and tissue concentrations may either increase (e.g. ciclosporine) or decrease (e.g.,
Interference with serological testing
Data obtained with combined oral contraceptives have shown that contraceptive steroids may
influence the results of certain laboratory tests, including biochemical parameters of liver,
thyroid, adrenal and renal function, serum levels of (carrier) proteins, e.g. corticosteroid
binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and
parameters of coagulation and fibrinolysis. The changes generally remain within the normal
range. To what extent this also relates to progestogen-only contraceptives is not known.
4.6 Fertility, pregnancy and lactation
Animal studies have shown that very high doses of progestogenic substances may cause
masculinisation of female foetuses.
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Extensive epidemiological studies have revealed neither an increased risk of birth defects in
children born to women who used OCs prior to pregnancy, nor a teratogenic effect when OCs
were taken inadvertently during early pregnancy.
Pharmacovigilance data collected with various desogestrel-containing combined OCs also do
not indicate an increased risk.
CERAZETTE does not influence the production or the quality (protein, lactose, or fat
concentrations) of breast milk. However small amounts of etonogestrel are excreted in the
breast milk. As a result, 0.01-0.05 microgram etonogestrel per kg body weight per day may be
ingested by the child (based on an estimated milk ingestion of 150 mL/kg/day).
Limited long-term follow-up data are available on children, whose mothers started using
CERAZETTE during the 4
week post-partum. They were breast-fed for 7 months and
followed up to 2.5 years of age. Evaluation of growth and physical and psychomotor
development did not indicate any differences in comparison to nursing infants, whose mother
used a copper IUD. Based on the available data CERAZETTE may be used during lactation.
The development and growth of a nursing infant, whose mother uses CERAZETTE, should be
See Section 5.1 Pharmacodynamic Properties, Mechanism of Action.
4.7 Effects on ability to drive and use machines
On the basis of the pharmacodynamic profile, CERAZETTE is expected to have no or
negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
The most commonly reported undesirable effects in the clinical trials with CERAZETTE
(>2.5%) were bleeding irregularities, acne, mood alterations, breast pain, nausea and weight
increase. The undesirable effects mentioned in the table below have been judged, by the
investigators, as having an established, probable or possible link to the treatment.
Frequency of adverse reactions
< 1/100, ≥ 1/1000
and breast disorders
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*MedDRA version 9.0
Breast discharge and, on rare occasions, ectopic pregnancies have been reported with the
use of CERAZETTE during post-marketing surveillance (see Section 4.4 Special warnings
and precautions for use). In addition, hypersensitivity reactions (including angioedema and
anaphylaxis) have been reported during post-marketing surveillance.
In women using (combined) oral contraceptives a number of (serious) undesirable effects have
been reported, some of which are discussed in more detail under Section 4.4 Special
warnings and precautions for use. These include venous thromboembolic disorders, arterial
thromboembolic disorders, hormone-dependent tumours (e.g. liver tumours, breast cancer)
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It
There have been no reports of serious deleterious effects from overdose. Symptoms that may
occur in this case are: nausea, vomiting and, in young girls, slight vaginal bleeding. There are
no antidotes and further treatment should be symptomatic.
For advice on the management of overdose please contact the National Poisons Centre on
0800 POISON (0800 764766).
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Hormonal contraceptives for systemic use, ATC code: G03AC09
Mechanism of action
CERAZETTE is a progestogen-only pill, which contains the progestogen desogestrel. Like
other progestogen-only pills, CERAZETTE is best suited for use during breast feeding and for
women who may not or do not want to use oestrogens. In contrast to traditional progestogen-
only pills, the contraceptive effect of CERAZETTE is achieved primarily by inhibition of
ovulation. Other effects include increased viscosity of the cervical mucus.
Clinical efficacy and safety
When studied for 2 cycles, using a definition of ovulation as a progesterone level greater than
16 nmol/L for 5 consecutive days, the ovulation incidence was found to be 1% (1/103) with a
95% confidence interval of 0.02%-5.29% in the ITT group (user and method failures).
Ovulation inhibition was achieved from the first cycle of use. In this study, when CERAZETTE
was discontinued after 2 cycles (56 continuous days), ovulation occurred on average after 17
days (range 7-30 days).
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In a comparative efficacy trial (which allowed a maximum time of 3 hours for missed pills) the
overall ITT Pearl-Index found for CERAZETTE was 0.4 (95% confidence interval 0.09-1.20),
compared to 1.6 (95% confidence interval 0.42-3.96) for 30 µg levonorgestrel.
The Pearl-Index for CERAZETTE is comparable to the one historically found for combined
OCs in the general OC-using population. Treatment with CERAZETTE leads to decreased
oestradiol levels, to a level corresponding to the early follicular phase. No clinically relevant
effects on carbohydrate metabolism, lipid metabolism and haemostasis have been observed.
5.2 Pharmacokinetic properties
After oral dosing of CERAZETTE, desogestrel is rapidly absorbed and converted into its
biologically active metabolite etonogestrel (ENG). Under steady-state conditions, peak serum
levels are reached 1.8 hours after tablet intake and the absolute bioavailability of etonogestrel
is approximately 70%.
Etonogestrel is 95.5-99% bound to serum proteins, predominantly to albumin and to a lesser
extent to SHBG.
Desogestrel is metabolised via hydroxylation and dehydrogenation to the active metabolite
etonogestrel. Etonogestrel is metabolised via sulphate and glucuronide conjugation.
Etonogestrel is eliminated with a mean half-life of approximately 30 hours, with no difference
between single and multiple dosing. Steady state levels in plasma are reached after 4-5 days.
The serum clearance after i.v. administration of etonogestrel is approximately 10 litres per
hour. Excretion of etonogestrel and its metabolites either as free steroid or as conjugates, is
with urine and faeces (ratio 1.5:1). In lactating women, etonogestrel is excreted in breast milk
with a milk/serum ratio of 0.37-0.55. Based on these data and on an estimated milk intake of
150 mL/kg/day, 0.01-0.05 microgram etonogestrel per kg bodyweight per day may be ingested
by the infant.
5.3 Preclinical safety data
Toxicological studies did not reveal any effects other than those which can be explained from
the hormonal properties of desogestrel.
6.1 List of excipients
Silica, colloidal anhydrous; dl-α-tocopherol, lactose monohydrate, maize starch, povidone,
Hypromellose, macrogol 400, purified talc, titanium dioxide (E 171).
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6.3 Shelf life
The shelf-life of CERAZETTE is 36 months.
6.4 Special precautions for storage
Store at 2°C-30°C, protected from light and moisture.
6.5 Nature and contents of container
Each strip contains 28 tablets.
Cartons contain 1, 3 or 6 strips.
6.6 Special precautions for disposal and other handling
Any unused material should be disposed of in accordance with local requirements.
Merck Sharp & Dohme (New Zealand) Limited
P O Box 99851
Tel: 0800 500 673
DATE OF FIRST APPROVAL
13 May 1997
DATE OF REVISION OF THE TEXT
26 February 2019
SUMMARY TABLE OF CHANGES
Summary of new information
Data sheet reformat.
Updated Undesirable effects with text regarding hypersensitivity reactions