CERELLE 75 MICROGRAM FILM-COATED TABLETS

Active substance: DESOGESTREL

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

CERELLE®

75 microgram film-coated tablets
Desogestrel
Read all of this leaflet carefully before you start taking 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.

What is in this leaflet
1. What Cerelle 75 microgram film-coated tablets
(hereafter: Cerelle) is and what it is used for
2. What you need to know before you take Cerelle
3. How to take Cerelle
4. Possible side effects
5. How to store Cerelle
6. Contents of the pack and other information

1. WHAT CERELLE IS AND WHAT IT IS USED FOR
This medicine is for the prevention of pregnancy.
How does it work?
Cerelle contains a small amount of one type of female sex
hormone, the progestogen, desogestrel. For this reason Cerelle
is called a progestogen-only pill (POP) or mini-pill. Unlike the
combined pill, the POP or mini-pill does not contain an
oestrogen hormone, but only a progestogen. Most POPs or
mini-pills work primarily by preventing the sperm cells from
entering the womb but do not always prevent the egg cell from
ripening which is the primarily action of combined pills.
Cerelle is distinct from other mini-pills in having a dose that in
most cases is high enough to prevent the egg cell from
ripening. As a result, Cerelle provides high contraceptive
efficacy.
In contrast to the combined pill, Cerelle 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 Cerelle. You also may not
have any bleeding at all.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CERELLE
Cerelle will not protect you against HIV infection (AIDS) and
any other sexually transmitted diseases.
Do not take Cerelle
Do not use Cerelle if you have any of the conditions listed
below. If any of these apply to you, tell your doctor before
starting to use Cerelle. Your doctor may advise you to use a
non-hormonal method of birth control.
• If you are allergic to desogestrel or any of the other
ingredients of this medicine (listed in section 6.).
• If you have thrombosis. Thrombosis is the formation of a
blood clot in a blood vessel, which may lead to obstruction
of this blood vessel {e.g. of the legs (deep venous
thrombosis), the lungs (pulmonary embolism), the heart
(heart attack) or brain (stroke)}.
• If you have or have had a severe liver disease and the
function of your liver (as determined by laboratory
investigation of the blood) has not returned to normal.
• If you have cancer that grows under the influence of certain
hormones (progestagens), such as certain types of breast
cancer.
• If you have any unexplained vaginal bleeding.
If any of these conditions appears for the first time while using
Cerelle you should consult your doctor promptly.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cerelle.
If Cerelle is used in the presence of any of the conditions listed
below, you may need to be kept under close observation.
You doctor can explain to you what to do. Therefore if any of
these apply to you, tell your doctor before starting to use
Cerelle:
• you have or have ever had breast cancer;
• you have cancer of the liver;
• you have or ever had venous thromboembolism (occlusion
of a blood vessel due to a blood clot);
• you have diabetes;
• you suffer from epilepsy (see section “Other medicines and
Cerelle”);
• you suffer from tuberculosis (see section “Other medicines
and Cerelle”);
• 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.
Breast cancer
Check your breasts regularly and 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, the risk gradually
decreases, 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 the age until which the woman
continues to take the Pill is higher. 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.
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.
The risk of breast cancer in users of progestogen-only pills like
Cerelle 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 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
See your doctor immediately, if you notice possible signs of
a thrombosis (see also ‘Contact your doctor as soon as
possible if’).
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. The risk with
progestogen-only pills like Cerelle is believed to be lower than
in users of Pills that also contain oestrogens (combined Pills).
Children and adolescents
The safety and efficacy of desogestrel in adolescents below
18 years has not yet been established. No data are available.
Other medicines and Cerelle
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines may stop the pill 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, rifabutin),
• HIV infection (e.g. ritonavir, nelfinavir),
• fungal infections (e.g. griseofulvin),
• medical charcoal used for stomach upset,
• products containing St. John’s Wort (Hypericum
perforatum).
Your doctor can tell you if you need to take additional
contraceptive precautions and if so, for how long.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor for
advice before taking this medicine.
Do not use Cerelle if you are pregnant, or think you may be
pregnant.
Cerelle may be used while you are breast-feeding. Cerelle does
not influence the production or the quality of breast milk.
However, a small amount of the active substance of Cerelle
passes over into the milk. The health of children breast-fed for
7 months whose mothers were using desogestrel has been
studied up to 2.5 years of age. No effects on the growth and
development of the children were observed.
If you are breast feeding and want to use Cerelle, please
contact your doctor.
Driving and using machines
Cerelle has no influence on the ability to drive and use
machines.
Cerelle contains lactose
Patients with lactose intolerance should be aware that Cerelle
tablet also contains 52.34 mg lactose (as lactose monohydrate).
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicinal product.
Regular check-ups
When you are using Cerelle, 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 have 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 indicating 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 indicating liver problems);
• you feel a lump in your breast (possibly indicating
breast cancer);
• you have a sudden or severe pain in the lower
abdomen or stomach area (possibly indicating an
ectopic pregnancy, this is 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 CERELLE
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Each strip of Cerelle contains 28 tablets. Arrows and the days of
the week are printed on the front side of the strip, which help
you take your pill correctly. Take your daily tablet at about the
same time each day. Swallow each tablet whole with water.
Each time you start a new strip of Cerelle take a tablet from
the top row. For example, if you start on a Wednesday, you
should take the tablet from the top row marked “We”. You
should continue to take one tablet a day, until the strip is
empty, always following the direction indicated by the arrows.
Remember to use any remaining tablets from the first row, in
sequence, before starting a new strip. In this way you can easily
check whether you have taken your daily tablet. You may
have some bleeding during the use of Cerelle (see section 4.
”Possible side effects”), but you must continue to take your
tablet as normal.
When a strip is empty, you must start with a new pack of
Cerelle on the next day – without interruption and without
waiting for a bleeding.
Starting your first pack of Cerelle
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 Cerelle tablet. You need not take extra
contraceptive precautions.
You may also start on days 2-5 of your cycle, but in that case
make sure you also use an additional contraceptive method
(barrier method) for the first 7 days of tablet-taking.
When changing from a combined pill, vaginal ring, or
transdermal patch.
You can start taking Cerelle 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 tablets you can start Cerelle 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, you
need not take extra contraceptive precautions.
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 an additional contraceptive method (barrier
method) for the first 7 days of tablet-taking.
When changing from another progestogen-only pill
(mini-pill).
You may stop taking it any day and start taking Cerelle right
away. You need not take extra contraceptive precautions.
When changing from an injectable or implant or a
progestogen-releasing intrauterine device (IUD).
Start using Cerelle when your next injection is due or on the
day that your implant or your IUD is removed. You need not
take extra contraceptive precautions.
After having a baby.
You can start Cerelle between 21 to 28 days after the birth of
your baby. If you start later, make sure that during the first
cycle you use an additional contraceptive method (barrier
method) for the first 7 days of tablet-taking. However, if
intercourse has already occurred, pregnancy should be
excluded before starting Cerelle use. Additional information
for breast-feeding women can be found in ‘Pregnancy and
breast-feeding’ in section 2. Your doctor can also advise you.
After a miscarriage or an abortion.
Your doctor will advise you.
If you forget to take one or more tablets
If you are less than 12 hours late
Take the tablet as soon as you remember, and take the next
one at the usual time. The contraceptive action of Cerelle is
maintained.
If you are more than 12 hours late
Take a tablet as soon as you remember, and take the next one
at the usual time. This may mean taking two tablets on the
same day. This is not harmful. (If you have forgotten more than
one tablet you don’t need to take the earlier missed ones). You
are not protected against pregnancy. Continue to take your
tablets as usual, but you must also use an extra method, such
as a condom for the next 7 days.
The more consecutive tablets you have missed, the higher the
risk that the contraceptive efficacy is decreased.
If you missed one or more tablets in the first week of tabletintake and had sex in the week before missing the tablets, there
is a possibility of becoming pregnant. Ask your doctor for
advice.
If you vomit, have diarrhoea or use medical charcoal
If you vomit or use medical charcoal within 3 - 4 hours after
taking the pill or have severe diarrhoea, the active substance
may not have been completely absorbed. Follow the advice for
missed tablets above.
If you take more Cerelle than you should
There have been no reports on serious harmful effects from
taking too many Cerelle 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 stop taking Cerelle
You can stop taking Cerelle 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 medicine,
ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
You should see your doctor immediately if you experience
symptoms of angioedema, such as swollen face, tongue or
pharynx; difficulty to swallow; or hives and difficulties to
breathe.

On rare occasions, ectopic pregnancy (where the baby
develops somewhere outside the womb) have been reported.
If you have a sudden or severe pain in the lower abdomen or
stomach area (possibly indicating an ectopic pregnancy) you
should contact your doctor as soon as possible.
Serious undesirable effects associated with the use of Cerelle
are described in section 2. “What you need to know before you
take Cerelle”. Please read this section for additional information
and consult your doctor at once where appropriate.
Vaginal bleeding may occur at irregular intervals during the use
of Cerelle. 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 Cerelle is decreased.
In general, you need not take any action; just continue to take
Cerelle. If, however, bleeding is heavy or prolonged you should
consult your doctor.
Users of desogestrel have reported the following side effects:
Common (may affect up to 1 in 10 people):
• mood altered,
• decreased sexual drive (libido),
• depression,
• headache,
• nausea,
• acne,
• breast pain,
• irregular or no menstruation,
• increased body weight.
Uncommon (may affect up to 1 in 100 people):
• infection of the vagina,
• difficulties in wearing contact lenses,
• vomiting,
• hair loss,
• painful menstruation,
• ovarian cyst,
• tiredness.
Rare (may affect up to 1 in 1,000 people):
• rash,
• hives,
• painful blue-red skin lumps (erythema nodosum) (these are
skin conditions).
Apart from these side effects, breast secretion may occur.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via “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 CERELLE
Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from light and
moisture.
This medicinal product does not require any special
temperature storage conditions.
Do not use this medicine after the expiry date which is stated
on the carton. The expiry date refers to the last day of that
month.
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 protect the
environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Cerelle contains
• The active substance is desogestrel. One film-coated tablet
contains 75 microgram desogestrel.
• The other ingredients are:
Tablet core:
Lactose monohydrate,
Potato starch,
Povidone K-30,
Silica, colloidal anhydrous,
Stearic acid,
all-rac-α-tocopherol
Tablet coat:
Poly[vinyl alcohol],
Titanium dioxide (E171),
Macrogol 3000,
Talc
What Cerelle looks like and contents of the pack
Cerelle is white or almost white, round, biconvex film-coated
tablet of about 5.5 mm in diameter, with a sign “D” on one side
and “75” on the other side.
Cerelle film-coated tablets are packed in PVC/PVDCAluminium blister, in a laminated aluminium sachet and
cardboard cartons with a leaflet and etui storing bag enclosed.
Pack sizes:1x28, 3x28 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Gedeon Richter Plc.
Gyömrői út 19-21
1103, Budapest Hungary
Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21
1103, Budapest Hungary
Distributor
Consilient Health (UK) Ltd.
No.1 Church Road,
Richmond upon Thames,
Surrey. TW9 2QE.
This leaflet was last revised in October 2014.

P0223

Expand view ⇕

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.

Hide
(web1)