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CERAZETTE 75 MICROGRAMS FILM COATED TABLETS

Active substance(s): DESOGESTREL / DESOGESTREL

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Patient Information Leaflet

2. What you need to know before you take Cerazette

®

Cerazette 75 micrograms
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.
The name of your medicine is Cerazette 75 micrograms
film-coated tablets but it will be referred to as Cerazette
throughout 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
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.

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.
2.2.1
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.
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.
2.2.2
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
Tell your doctor, pharmacist, or Family Planning Nurse if you are
taking, have recently taken or might take any other medicines or
herbal products. Also tell any other doctor or dentist who
prescribes another medicine (or your pharmacist) that you take
Cerazette. They can tell you if you need to take additional
contraceptive precautions (for example condoms) and if so, for
how long or whether the use of another medicine you need must
be changed.
Some medicines:
- can have an influence on the blood levels of Cerazette.
- can make it less effective in preventing pregnancy.
- can cause unexpected bleeding.
These include medicines used for the treatment of:
• epilepsy (e.g. primidone, phenytoin, carbamazepine,
oxcarbazepine, felbamate, topiramate and
phenobarbital);
• tuberculosis (e.g. rifampicin, rifabutin);
• HIV infections (e.g. ritonavir, nelfinavir, nevirapine,
efavirenz);
• Hepatitis C virus infection (e.g. boceprevir, telaprevir);
• or other infectious diseases (e.g. griseofulvin);
• high blood pressure in the blood vessels of the lungs
(bosentan);
• depressive moods (the herbal remedy St. John’s Wort);
• certain bacterial infections (e.g. clarithromycin,
erythromycin);
• fungal infections (e.g. ketoconazole, itraconazole,
fluconazole);
• high blood pressure (hypertension), angina or certain
heart rhythm disorders (e.g. diltiazem).
If you are taking medicines or herbal products that might make
Cerazette 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 method for
that long. 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 other medicines work,
causing either an increase in effect (e.g. medicines containing
ciclosporine) or a decrease in effect (e.g. lamotrigine).
Ask your doctor or pharmacist for advice before taking any
medicine.
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-, ringor 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-, ringor 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.
• 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 starting the tablet 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
nurse. This includes any possible side effects not listed in this
leaflet. You can also report any side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting any side effects, you can help provide more
information on the safety of this medicine.

5. How to store Cerazette
Keep out of the sight and reach of children
Store the blister pack in the original pouch in order to protect
from light and moisture. Use within 1 month from the date of first
opening of the pouch. Please open the protective cover right
before use.
Do not take the tablets after the expiry date which is stated on
the carton and pouch label after ‘Exp’. The expiry date refers to
the last day of that month.
If the tablets becomes discoloured or shows any sign of
deterioration, seek the advice of your pharmacist.
If your doctor tells you to stop taking this medicine, take any
used tablets back to your pharmacist for safe disposal. Only
keep them if your doctor tells you to.
The active substance etonogestrel shows an environmental risk
to fish.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Cerazette contains
Each film-coated tablet contains 75 micrograms of desogestrel
as the active ingredient. Other ingredients: silica, colloidal
anhydrous; alpha·- tocopherol; lactose monohydrate; maize
starch; povidone; stearic acid. Each film-coated tablet is covered
with a thin coating of hypromellose; macrogol 400; talc and
titanium dioxide (E 171).
What Cerazette looks like and contents of the pack
Each strip of Cerazette contains 28 white round tablets marked
with the letters 'KV' above 2 on one side and Organon * reverse.
Cerazette comes in packs of 3 foil pouches.
Each pouch contains 28 tablets.
Manufactured by: Organon (Ireland) Ltd., PO Box 2857,
Drynam Road, Swords, County Dublin, Ireland.
Produced from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip Middlesex, HA4 0NU, UK.
Cerazette® 75 micrograms film-coated tablets
PL 18799/1532

POM

Leaflet date: 06.02.2017
Cerazette is a registered trademark of Organon Laboratories
Ltd.

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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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