CERAZETTE 75MCG FILM COATED TABLETSView full screen / Print PDF » Download PDF ⇩
Read all of this leaflet carefully before you start using
this medicine because it contains important information
• 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 75micrograms filmcoated tablets but it will be referred to as Cerazette throughout
the remainder of this leaflet.
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
• 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
• 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, like other hormonal contraceptives, does not protect
against HIV infection (AIDS) or any other sexually transmitted
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
• 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.
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.
See your doctor immediately if you notice possible signs of a
thrombosis (see also ‘Regular check-ups’).
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.
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.
2.2 Warnings and precautions
Before you start Cerazette tell your doctor or Family Planning
• 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
• you have tuberculosis (see section ‘Other medicines and
• 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
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
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.
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
• 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
Do not use Cerazette if you are pregnant, or think you may be
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
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
• 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-, 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.
• 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
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
If you start later, make sure that during the first cycle 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
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.
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.
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.
Do not use after the expiry date stated on the package.
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.
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
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
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
Apart from these side effects, breast secretion or leakage may
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
HOW TO STORE CERAZETTE
Do not store above 30°C. Store in the original pouch.
Keep your tablets out of the sight and reach of children.
If your tablets becomes discoloured or shows any sign of
deterioration, you should 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.
CONTENTS OF THE PACK AND OTHER INFORMATION
What Cerazette contains
Each film-coated tablet contains 75 microgram 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).
Warning: This product contains lactose. If you have been told by
your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
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.
NV Organon, PO Box 20, 5340 BH Oss, The Netherlands.
Produced from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip Middlesex, HA4 0NU
CERAZETTE 75micrograms FILM-COATED TABLETS
PL. No: 18799/1532
Leaflet date: 23.06.2014
Cerazette is a registered trademark of Organaon Laboratories
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.