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CERAZETTE 75 MICROGRAM FILM-COATED TABLETS

Active substance(s): DESOGESTREL

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United Kingdom USER PACKAge
leaflet OF CERAZETTE

75 microgram film-coated tablet
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
Contents of the pack and other information
6.
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
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. 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
disease.
2.1 Do not take Cerazette
• if you are allergic to desogestrel, or any of the other
ingredients of Cerazette (listed in section 6).
• 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 lungs (pulmonary embolism)].
• if you have or have had jaundice (yellowing of the skin) or
severe liver disease and your liver is still not working normally.
• if you have or if you are suspected of having a cancer that
grows under the influence of sex-steroids, such as certain
types of breast cancer.
• if you have any unexplained vaginal bleeding.
If any of these conditions apply to you, tell your doctor before
you start to use Cerazette. Your doctor may advise you to use
a non-hormonal method of birth control.
If any of these conditions appear for the first time while using
Cerazette, consult your doctor immediately.
2.2 Warnings and precautions
Before you start Cerazette tell your doctor or Family Planning
Nurse, if
• you have ever had breast cancer.
• you have liver cancer, since a possible effect of Cerazette
cannot be excluded.
• you have ever had a thrombosis.
• you have diabetes.
• you suffer from epilepsy (see section ‘Other medicines and
Cerazette’).
• you have tuberculosis (see section ‘Other medicines and
Cerazette’).
• you have high blood pressure.
• you have or have had chloasma (yellowish-brown
pigmentation patches on the skin, particularly of the face);
if so, avoid too much exposure to the sun or ultraviolet
radiation.
When Cerazette is used in the presence of any of these
conditions, you may need to be kept under close observation.
Your doctor can explain what to do.

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• 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.
• 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.

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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 if a woman continues to take the Pill
when she is older. How long she takes the Pill is less important.

The risk of breast cancer in users of progestogen-only pills like
Cerazette is believed to be similar to that in women who use the
Pill, but the evidence is less conclusive.
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 certain whether the Pill causes the increased risk of
breast cancer. It may be that the women were examined more
often, so that the breast cancer is noticed earlier.
2.2.2 Thrombosis
See your doctor immediately if you notice possible signs of
a thrombosis (see also ‘Regular check-ups’).
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”. A pulmonary embolism can cause chest pain,
breathlessness, collapse or even death.
• 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. The risk with
progestogen-only pills like Cerazette is believed to be lower than
in users of Pills that also contain oestrogens (combined Pills).
2.3 Children and adolescents
No clinical data on efficacy and safety are available in
adolescents below 18 years.
2.4 Other medicines and Cerazette
Please tell your doctor, pharmacist, or Family Planning Nurse
if you are taking, have recently taken or might take any other
medicines or herbal products, including medicines obtained
without a prescription.
Some medicines may stop Cerazette from working properly.
These include medicines used for the treatment of
• epilepsy (e.g. primidone, phenytoin, carbamazepine,
oxcarbazepine, felbamate and phenobarbital)
• tuberculosis (e.g. rifampicin)
• HIV infections (e.g. ritonavir), or other infectious diseases
(e.g. griseofulvin)
• stomach upset (medical charcoal)
• depressive moods (the herbal remedy St. John’s Wort).
Your doctor can tell you if you need to take additional
contraceptive precautions and if so, for how long.
Cerazette may also interfere with how certain medicines work,
causing either an increase in effect (e.g. medicines containing
cyclosporine) or a decrease in effect.
2.5 Pregnancy and breast-feeding
Pregnancy
Do not use Cerazette if you are pregnant, or think you may be
pregnant.
Breast-feeding
Cerazette may be used while you are breast-feeding. Cerazette
does not influence the production or the quality of breast milk.
However, a small amount of the active substance of Cerazette
passes over into the milk.
The health of children who were breast-fed for 7 months while
their mothers were using Cerazette has been studied up until they
were 2½ years of age. No effects on the growth and development
of the children were observed.
If you are breast feeding and want to use Cerazette, please
contact your doctor.
2.6 Driving and using machines
Cerazette has no known effect on the ability to drive or use
machines

2.7 Cerazette contains lactose
Cerazette contains lactose (milk sugar). Please contact your
doctor before taking Cerazette if you have been told by your
doctor that you are intolerant to some sugars.
2.8 Regular check-ups
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 situation.
Contact your doctor as soon as possible if:
• you notice possible signs of a blood clot e.g. severe pain
or swelling in either of your legs; unexplained pains in the
chest, breathlessness, an unusual cough, especially when
you cough up blood (possibly a sign of a thrombosis);
• you have a sudden, severe stomach ache or jaundice
(you may notice yellowing of the skin, the whites of the
eyes, or dark urine, possibly a sign of liver problems);
• you feel a lump in your breast (possibly a sign of breast
cancer);
• you have a sudden or severe pain in the lower abdomen or
stomach area (possibly a sign of an ectopic pregnancy - a
pregnancy outside the womb);
• you are to be immobilised or are to have surgery (consult
your doctor at least four weeks in advance);
• you have unusual, heavy vaginal bleeding;
• you suspect that you are pregnant.
3. How to take Cerazette
3.1 When and how to take the tablets?
Each strip of Cerazette contains 28 tablets – 4 weeks supply.
• Take your tablet each day at about the same time.
Swallow the tablet whole, with water.
• Arrows are printed on the front of the strip, between the
tablets. The days of the week are printed on the back of
the strip. Each day corresponds with one tablet.
• Every time you start a new strip 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 (on the back) with WED.
• Continue to take one tablet every 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.
• You may have some vaginal bleeding during the use of
Cerazette, (See Section 4 Side Effects) but you must
continue to take your tablets as normal.
• When a strip is empty, you must start with a new strip
of Cerazette on the next day - without interruption and
without waiting for a bleed.
3.2 Starting your first pack of Cerazette
• If you are not using hormonal contraception at present
(or in the past month)
Wait for your period to begin. On the first day of your period take
the first Cerazette tablet. Additional contraceptive precautions
are not necessary. If you take your first tablet on days 2-5 of your
period use an additional barrier method of contraception for the
first 7 days of tablet-taking.
• When you change from a combined pill (COC), vaginal
ring, or transdermal patch
If you don’t have a tablet-, ring- or patch-free break
- Start taking Cerazette on the day after you take the
last tablet from the 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
(placebo) tablets you can start Cerazette on the day
after taking the last active tablet (if you are not sure
which this is, ask your doctor or pharmacist).
Please turn over

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2.2.1 Breast cancer
• It is important to regularly check your breasts and you
should contact your doctor as soon as possible if you feel
any lump in your breasts.
• 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. If women stop taking the Pill, this reduces
the risk, so that 10 years after stopping the Pill, the risk is
the same as for women who have never taken the Pill.

• 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.

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- If you follow these instructions, additional
contraceptive precautions are not necessary.
If you have a tablet-, ring- or patch-free break
- You can also start on the day following the tablet-,
ring- or patch-free break, or when you have taken
all the inactive (placebo) tablets, of your present
contraceptive.
- If you follow these instructions, make sure you
use an additional barrier method of contraception
for the first 7 days of tablet-taking.
For Position Only

• When changing from another progestogen-only pill:
Switch on any day from another mini-pill. Additional contraceptive
precautions are not necessary.
• When changing from an injection or implant
or a hormonal IUS:
Start using Cerazette when your next injection is due or on
the day that your implant or your IUS is removed. Additional
contraceptive precautions are not necessary.
• After you have a baby:
You can start Cerazette between 21 to 28 days after the birth of
your baby.
If you start later, make sure that you use an additional barrier
method of contraception until you have completed the first 7 days
of tablet-taking. However, if you have already had sex, check that
you are not pregnant before starting Cerazette. Information for
breast-feeding women can be found in section 2 ‘Before you take
Cerazette’ in the paragraph ‘Pregnancy and breast-feeding’. Your
doctor can also advise you.
• After a miscarriage or an abortion:
Your doctor will advise you.
3.3 If you forget to take Cerazette
• If you are less than 12 hours late:
- Take the missed tablet as soon as you remember and
take the next one at the usual time. Cerazette will still
protect you from pregnancy.
• If you are more than 12 hours late:
- If you are more than 12 hours late in taking any
tablet, you may not be completely protected
against pregnancy. The more consecutive tablets
you have missed, the higher the risk that you might
fall pregnant.
- Take a tablet as soon as you remember and take
the next one at the usual time. This may mean
taking two in one day. This is not harmful. (If you
have forgotten more than one tablet you don’t need
to take the earlier missed ones). Continue to take
your tablets as usual but you must also use an extra
method, such as a condom, for the next 7 days.
- If you are more than 12 hours late taking your tablet
and have had sex it is safe to use emergency
contraception; please consult your pharmacist or
doctor.
- If you missed one or more tablets in the very first
week of tablet-intake and had intercourse in the
week before missing the tablets, you may fall
pregnant. Ask your doctor for advice.
3.4 If you vomit or use medical charcoal
If you vomit, or use medical charcoal 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 forgotten tablets in the section above.
3.5 If too many Cerazette tablets are taken (overdose)
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 young girls, slight vaginal
bleeding. For more information ask your doctor for advice.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

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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.
Serious side effects associated with the use of Cerazette are
described in section 2 ‘What you need to know before you take
Cerazette’. Please read this section for additional information on
‘Breast cancer’ and ‘Thrombosis’ and consult your doctor at once
where appropriate.
Vaginal bleeding may occur at irregular intervals while using
Cerazette. This may be just slight staining which may not even
require a pad, or heavier bleeding, which looks rather like a scanty
period. You may need to use tampons or sanitary towels. You may
also not have any bleeding at all. Irregular bleeding is not a sign
that Cerazette is not working. In general, you need not take any
action; just continue to take Cerazette. If bleeding is heavy or
prolonged you should consult your doctor.
How often are other possible side effects seen?
Common (affecting less than 1 in 10 women): mood changes,
depressed mood, decreased sexual drive (libido), headache,
nausea, acne, breast pain, irregular or no periods, weight
increase.

Marketing Authorisation Holder
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon,
Hertfordshire, EN11 9BU, UK.
Manufacturer
N.V. Organon, P.O. Box 20, 5340 BH Oss, The Netherlands
This medicinal product is authorised in the Member States
of the EEA under the following names:
Austria, Belgium, Croatia, Denmark, Finland, Germany, Greece,
Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal,
Sweden, United Kingdom: Cerazette.
Spain: Cerazet.
This leaflet was revised in March 2016.
In correspondence please quote packing number.
To listen to or request a copy of this leaflet in Braille, large print
or audio
please call, free of charge: 0800 198 5000 (UK Only).
Please be ready to give the following information:
Reference Number: PL 00025/0562
Product name: Cerazette
This is a service provided by the Royal National Institute of Blind
people.
© Merck Sharp & Dohme Limited, 2016. All rights reserved.
PIL.CER.16.UK.4786-WS104

Uncommon (affecting less than 1 in 100 women) infection of the
vagina, difficulties in wearing contact lenses, vomiting, hair loss,
painful periods, ovarian cysts, tiredness.
Rare (affecting less than 1 in 1000 women) skin conditions such
as: rash, hives, painful blue-red skin lumps (erythema nodosum)
Apart from these side effects, breast secretion or leakage may
occur.
You should see your doctor immediately if you experience
symptoms of angioedema, such as (i) swollen face, tongue or
pharynx; (ii) difficulty to swallow; or (iii) hives and difficulties to
breathe.
Reporting of side effects
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. You can also report side effects via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Cerazette
Keep this medicine out of the sight and reach of children.
Do not use after the expiry date which is stated on the package.
The expiry date is the last day of the month stated.
This medicine does not require any special temperature storage
conditions. Store the blister pack in the original sachet in order to
protect from light and moisture. Use within 1 month from the date
of first opening of the sachet.
The active substance etonogestrel shows an environmental risk
to fish.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Cerazette contains
- The active substance is: desogestrel (75 microgram)
- The other ingredients are: colloidal anhydrous silica;
all-rac-α-tocopherol; maize starch; povidone; stearic acid;
hypromellose; macrogol 400; talc; titanium dioxide (E171);
lactose monohydrate (see also ‘Cerazette contains lactose’
in section 2).
What Cerazette looks like and contents of the pack
Each strip of Cerazette contains 28 white round tablets. The
tablets are marked KV above 2 on one side and ORGANON* on
the other. Cerazette comes in a pack of 1, 3, 6 or 13 strips. Each
strip is sealed in a foil sachet. Not all pack sizes may be available.

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3.6 If you stop taking Cerazette
You can stop taking Cerazette whenever you want. From the day
you stop you are no longer protected against pregnancy.

4. Possible side effects

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Technical Info

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56510211

United Kingdom USER PACKAge
leaflet OF CERAZETTE

75 microgram film-coated tablet
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…
Take special care…
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
who are breast feeding.

LF OMD-00021843
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• 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. 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 disease.
2.1 Do not take Cerazette
• if you are allergic to desogestrel, or any of the other
ingredients of Cerazette (listed in section 6).
• 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 lungs (pulmonary embolism)].
• if you have or have had jaundice (yellowing of the skin)
or severe liver disease and your liver is still not working
normally.
• if you have or if you are suspected of having a cancer
that grows under the influence of sex-steroids, such as
certain types of breast cancer.
• if you have any unexplained vaginal bleeding.
If any of these conditions apply to you, tell your doctor before
you start to use Cerazette. Your doctor may advise you to
use a non-hormonal method of birth control.
If any of these conditions appear for the first time while using
Cerazette, consult your doctor immediately.
2.2 Warnings and precautions
Before you start Cerazette tell your doctor or Family Planning
Nurse, if
• you have ever had breast cancer.
• you have liver cancer, since a possible effect of Cerazette
cannot be excluded.
• you have ever had a thrombosis.
• you have diabetes.
• you suffer from epilepsy (see section ‘Other medicines
and Cerazette’).
• you have tuberculosis (see section ‘Other medicines and
Cerazette’).
• you have high blood pressure.
• you have or have had chloasma (yellowish-brown
pigmentation patches on the skin, particularly of the face); if
so, avoid too much exposure to the sun or ultraviolet radiation.
When Cerazette is used in the presence of any of these
conditions, you may need to be kept under close observation.
Your doctor can explain what to do.
2.3 Breast cancer
• It is important to regularly check your breasts and you
should contact your doctor as soon as possible if you feel
any lump in your breasts.
• 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. If women stop taking the Pill, this reduces
the risk, so that 10 years after stopping the Pill, 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 if a woman
continues to take the Pill when she is older. How long she
takes the Pill is less important.
• 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.
• 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.
The risk of breast cancer in users of progestogen-only pills
like Cerazette is believed to be similar to that in women who
use the Pill, but the evidence is less conclusive.
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 certain whether the Pill causes the increased risk
of breast cancer. It may be that the women were examined
more often, so that the breast cancer is noticed earlier.
2.4 Thrombosis
See your doctor immediately if you notice possible signs of a
thrombosis (see also ‘Regular check-ups’).
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”. A pulmonary embolism can cause
chest pain, breathlessness, collapse or even death.
• 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. The risk
with progestogen-only pills like Cerazette is believed to be
lower than in users of Pills that also contain oestrogens
(combined Pills).
Children and adolescents
No clinical data on efficacy and safety are available in
adolescents below 18 years.
2.5 Other medicines and Cerazette
Please tell your doctor, pharmacist, or Family Planning Nurse
if you are taking, have recently taken or might take any other
medicines or herbal products, including medicines obtained
without a prescription.
Some medicines may stop Cerazette from working properly.
These include medicines used for the treatment of

• epilepsy (e.g. primidone, phenytoin, carbamazepine,
oxcarbazepine, felbamate and phenobarbital)
• tuberculosis (e.g. rifampicin)
• HIV infections (e.g. ritonavir), or other infectious diseases
(e.g. griseofulvin)
• stomach upset (medical charcoal)
• depressive moods (the herbal remedy St. John’s Wort).
Your doctor can tell you if you need to take additional
contraceptive precautions and if so, for how long.
Cerazette may also interfere with how certain medicines
work, causing either an increase in effect (e.g. medicines
containing cyclosporine) or a decrease in effect.
2.6 Pregnancy and breast-feeding
Pregnancy
Do not use Cerazette if you are pregnant, or think you may
be pregnant.
Breast-feeding
Cerazette may be used while you are breast-feeding.
Cerazette does not influence the production or the quality of
breast milk. However, a small amount of the active substance
of Cerazette passes over into the milk.
The health of children who were breast-fed for 7 months
while their mothers were using Cerazette has been studied
up until they were 2½ years of age. No effects on the growth
and development of the children were observed.
If you are breast feeding and want to use Cerazette, please
contact your doctor.
2.7 Driving and using machines
Cerazette has no known effect on the ability to drive or use
machines
2.8 Cerazette contains lactose
Cerazette contains lactose (milk sugar). Please contact your
doctor before taking Cerazette if you have been told by your
doctor that you are intolerant to some sugars.
2.9 Regular check-ups
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 situation.
Contact your doctor as soon as possible if:
• you notice possible signs of a blood clot e.g. severe pain
or swelling in either of your legs; unexplained pains in the
chest, breathlessness, an unusual cough, especially when
you cough up blood (possibly a sign of a thrombosis);
• you have a sudden, severe stomach ache or jaundice
(you may notice yellowing of the skin, the whites of the
eyes, or dark urine, possibly a sign of liver problems);
• you feel a lump in your breast (possibly a sign of breast
cancer);

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• you have a sudden or severe pain in the lower abdomen or
stomach area (possibly a sign of an ectopic pregnancy a pregnancy outside the womb);
• you are to be immobilised or are to have surgery (consult
your doctor at least four weeks in advance);
• you have unusual, heavy vaginal bleeding;
• you suspect that you are pregnant.
3. How to take Cerazette
3.1 When and how to take the tablets?
Each strip of Cerazette contains 28 tablets – 4 weeks supply.
• Take your tablet each day at about the same time.
Swallow the tablet whole, with water.
• Arrows are printed on the front of the strip, between the
tablets. The days of the week are printed on the back of
the strip. Each day corresponds with one tablet.
• Every time you start a new strip 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 (on the back) with WED.
• Continue to take one tablet every 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.
• You may have some vaginal bleeding during the use of
Cerazette, (See Section 4 Side Effects) but you must
continue to take your tablets as normal.
• When a strip is empty, you must start with a new strip
of Cerazette on the next day - without interruption and
without waiting for a bleed.
3.2 Starting your first pack of Cerazette
• If you are not using hormonal contraception at present
(or in the past month)
Wait for your period to begin. On the first day of your period
take the first Cerazette tablet. Additional contraceptive
precautions are not necessary. If you take your first tablet on
days 2-5 of your period use an additional barrier method of
contraception for the first 7 days of tablet-taking.
• When you change from a combined pill (COC), vaginal
ring, or transdermal patch
If you don’t have a tablet-, ring- or patch-free break
- Start taking Cerazette on the day after you take the
last tablet from the 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
(placebo) tablets you can start Cerazette on the 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, additional
contraceptive precautions are not necessary.
If you have a tablet-, ring- or patch-free break
- You can also start on the day following the tablet-,
ring- or patch-free break, or when you have taken all the
inactive (placebo) tablets, of your present contraceptive.

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- If you follow these instructions, make sure you use
an additional barrier method of contraception for
the first 7 days of tablet-taking.
• When changing from another progestogen-only pill:
Switch on any day from another mini-pill. Additional
contraceptive precautions are not necessary.
• When changing from an injection or implant or a
hormonal IUS:
Start using Cerazette when your next injection is due or on
the day that your implant or your IUS is removed. Additional
contraceptive precautions are not necessary.
• After you have a baby:
You can start Cerazette between 21 to 28 days after the birth
of your baby.
If you start later, make sure that you use an additional barrier
method of contraception until you have completed the first
7 days of tablet-taking. However, if you have already had sex,
check that you are not pregnant before starting Cerazette.
Information for breast-feeding women can be found in section 2
‘Before you take Cerazette’ in the paragraph ‘Pregnancy and
breast-feeding’. Your doctor can also advise you.
• After a miscarriage or an abortion:
Your doctor will advise you.
3.3 If you forget to take Cerazette
• If you are less than 12 hours late:
- Take the missed tablet as soon as you remember and
take the next one at the usual time. Cerazette will still
protect you from pregnancy.
• If you are more than 12 hours late:
- If you are more than 12 hours late in taking any tablet,
you may not be completely protected against
pregnancy. The more consecutive tablets you have
missed, the higher the risk that you might fall pregnant.
- Take a tablet as soon as you remember and take the
next one at the usual time. This may mean taking two
in one day. This is not harmful. (If you have forgotten
more than one tablet you don’t need to take the earlier
missed ones). Continue to take your tablets as usual
but you must also use an extra method, such as a
condom, for the next 7 days.
- If you are more than 12 hours late taking your tablet and
have had sex it is safe to use emergency contraception;
please consult your pharmacist or doctor.
- If you missed one or more tablets in the very first week
of tablet-intake and had intercourse in the week before
missing the tablets, you may fall pregnant. Ask your
doctor for advice.
3.4 If you vomit or use medical charcoal
If you vomit, or use medical charcoal 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 forgotten tablets in the section above.
3.5 If too many Cerazette tablets are taken (overdose)
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 young girls, slight vaginal
bleeding. For more information ask your doctor for advice.
3.6 If you stop taking Cerazette
You can stop taking Cerazette whenever you want. From the
day you stop you are no longer protected against pregnancy.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. 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.
Serious side effects associated with the use of Cerazette
are described in section 2 ‘What you need to know before
you take Cerazette’. Please read this section for additional
information on ‘Breast cancer’ and ‘Thrombosis’ and consult
your doctor at once where appropriate.
Vaginal bleeding may occur at irregular intervals while
using Cerazette. This may be just slight staining which may
not even require a pad, or heavier bleeding, which looks
rather like a scanty period. You may need to use tampons or
sanitary towels. You may also not have any bleeding at all.
Irregular bleeding is not a sign that Cerazette is not working.
In general, you need not take any action; just continue to
take Cerazette. If bleeding is heavy or prolonged you
should consult your doctor.
How often are other possible side effects seen?
Common (affecting less than 1 in 10 women): mood
changes, depressed mood, decreased sexual drive (libido),
headache, nausea, acne, breast pain, irregular or no periods,
weight increase.
Uncommon (affecting less than 1 in 100 women) infection
of the vagina, difficulties in wearing contact lenses, vomiting,
hair loss, painful periods, ovarian cysts, tiredness.
Rare (affecting less than 1 in 1000 women) skin conditions
such as: rash, hives, painful blue-red skin lumps (erythema
nodosum)
Apart from these side effects, breast secretion or leakage
may occur.
You should see your doctor immediately if you experience
symptoms of angioedema, such as (i) swollen face, tongue or
pharynx; (ii) difficulty to swallow; or (iii) hives and difficulties
to breathe.
Reporting of side effects
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. You can also report side
effects via the national Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of this
medicine.

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5. HOW TO STORE CERAZETTE
Keep this medicine out of the sight and reach of children.
Do not use after the expiry date which is stated on the
package. The expiry date is the last day of the month stated.
This medicine does not require any special temperature
storage conditions. Store the blister pack in the original
sachet in order to protect from light and moisture. Use within
1 month from the date of first opening of the sachet.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Cerazette contains
- The active substance is: desogestrel (75 microgram)
- The other ingredients are: colloidal anhydrous silica;
all-rac-α-tocopherol; maize starch; povidone; stearic
acid; hypromellose; macrogol 400; talc; titanium dioxide
(E171); lactose monohydrate (see also ‘Cerazette contains
lactose’ in section 2).
What Cerazette looks like and contents of the pack
Each strip of Cerazette contains 28 white round tablets. The
tablets are marked KV above 2 on one side and ORGANON*
on the other. Cerazette comes in a pack of 1, 3, 6 or 13 strips.
Each strip is sealed in a foil sachet. Not all pack sizes may be
available.
Marketing Authorisation Holder
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon,
Hertfordshire, EN11 9BU, UK.
Manufacturer:
N.V. Organon, P.O. Box 20, 5340 BH Oss, The Netherlands, or
Organon (Ireland) Ltd., Drynam Road, P.O. Box 2857,
Swords, Co. Dublin, Ireland
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria, Belgium, Denmark, Finland, Germany, Greece,
Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal,
Sweden, United Kingdom: Cerazette.
Spain: Cerazet.
This leaflet was revised in November 2013
In correspondence please quote packing number.
To listen to or request a copy of this leaflet in Braille,
large print or audio
please call, free of charge: 0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name: Cerazette Reference Number: PL 00025/0562
This is a service provided by the Royal National Institute of
Blind people.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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