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Active substance(s): DESOGESTREL

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Debunica 75 microgram film-coated tablets
Read this entire leaflet carefully before you start taking the medicine.

Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you personally. It is not suitable for all women, so
you should not give it to anyone else as it may harm them.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or your pharmacist.

In this leaflet:


1. What Debunica is and what it is used
2. Before you take Debunica
3. How to take Debunica
4. Possible side effects
5. How to store Debunica
6. Further information

contraceptives, does not protect against
HIV infection (AIDS) or any other
sexually transmitted disease.
Do not take Debunica
• If you are allergic to any of the
ingredients of Debunica.
• 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 function is still
not normal.
• If you have or are suspected to have a
cancer that is sensitive to progestogens,
such as certain types of breast cancer.
• If you have any unexplained vaginal
• If you are allergic to peanut or soya.

Debunica is used to prevent pregnancy.
Debunica contains a small amount of one
type of female sex hormone, the
progestogen desogestrel. For this reason
Debunica is called a progestogen-only-pill
(POP), or a mini-pill.
Contrary to the combined pill, the POP or
mini-pill does not contain an oestrogen
hormone next to the progestogen.
Most POPs or minipills work primarily by
preventing the sperm cells from entering
the womb but do not always prevent the
egg cell from ripening, which is the primary
action of combined pills. Debunica 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
contraceptive efficacy. In contrast to the
combined pill, Debunica can be used by
women who do not tolerate oestrogens and
by women who are breastfeeding.
A disadvantage is that vaginal bleeding
may occur at irregular intervals during the
use of Debunica. You also may not have
any bleeding at all.

Desogestrel 75 mcg
UK/H/3416-8, 4784/001/DC

Tell you doctor before you start to use
Debunica if any of these conditions apply to
you. Your doctor may advise you to use a
non-hormonal method of birth control.
Consult your doctor immediately if any of
these conditions appear for the first time
while using Debunica.
Take special care with Debunica
Tell your doctor before you start to use
Debunica, if

in addition to the 160 cases normally

you have ever had cancer of the breast.
you have liver cancer, since a possible
effect of Debunica cannot be excluded.
you have ever had a thrombosis.
you have diabetes.
you suffer from epilepsy (see section
‘Taking other medicines’).
you suffer from tuberculosis (see
section ‘Taking other medicines’).
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.

The risk of breast cancer in users
progestogen-only pills like Debunica is
believed to be similar to that in women who
use the Pill, but the evidence is less
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.

When Debunica 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.

Debunica and 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”.
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 Debunica, is
believed to be lower than in users of Pills
that also contain oestrogens (combined

Debunica and breast cancer
Regularly check your breasts 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 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

Taking other medicines

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

Desogestrel 75 mcg
UK/H/3416-8, 4784/001/DC

Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines or herbal products, including
medicines obtained without a prescription.
Some medicines may stop Debunica from
working properly.
These include medicines used for the
treatment of epilepsy (e.g. primidone,
phenytoin, carbamazepine, oxcarbazepine,
infections (e.g. ritonavir) or other infectious

diseases (e.g. griseofulvin), stomach upset
(medical charcoal), depressive moods (the
herbal remedy St John's wort).

If you are allergic to peanut or soya, do
not use this medicinal product.
Use in adolescents
No clinical data on efficacy and safety are
available in adolescents below 18 years.

Your doctor can tell you if you need to take
additional contraceptive precautions and if
so, for how long.

Regular check-ups

Debunica may also interfere with how
certain medicines work, causing either an
increase in effect (e.g. medicines containing
cyclosporine) or a decrease in effect.

While you are using Debunica you should
see your doctor regularly at least twice a

Pregnancy and breast-feeding

Contact your doctor as soon as possible

Do not use Debunica if you are pregnant, or
think you may be pregnant.

Debunica may be used while you are
breast-feeding. Debunica does not influence
the production or the quality of breast milk.
However, a small amount of the active
substance of Debunica passes over into the

The health of children breast-fed for 7
months whose mothers were using
Debunica 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
Debunica, please contact your doctor.

Driving and using machines

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
you have a sudden, severe stomach
ache or look jaundiced (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
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
you suspect that you are pregnant.

There are no indications of any effect of the
use of Debunica on alertness and


Important information about some of the
ingredients of Debunica

When and how you should take

Debunica contains lactose (milk sugar)
and soy bean oil.

The Debunica pack contains 28 tablets. The
days of the week are printed in the blister
and also arrows are printed indicating the
order to take the pills. Each day correspond
with one tablet. Every time you start a new
pack of Debunica, 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

If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.

Desogestrel 75 mcg
UK/H/3416-8, 4784/001/DC


additional contraceptive method (barrier
method) for the first 7 days of tablet-taking.

marked with ‘WED’ (Wednesday).
Continue to take one tablet a day until the
pack is empty, always following the
direction indicated by the arrows. By
looking at the pill pack you can easily
check if you have already taken a tablet on
a particular day. Take your tablet each day
at about the same time.
Swallow the tablet whole, with water. You
may have some bleeding during the use of
Debunica, but you must continue to take
your tablets as normal. When a pack is
empty, you must start with a new pack of
Debunica on the next day – thus without
interruption and without waiting for a

When changing from another progestogenonly (mini-pill)
You may stop taking it any day and start
taking Debunica 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 Debunica 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.

When to start with the first strip

After having a baby
When no hormonal contraceptive has been
used in the past month

You can start Debunica between 21 and 28
days after the birth of your baby. If you
start later, make sure you use during the
first cycle an additional contraceptive
method (barrier method) for the first 7 days
of tablet-taking.
However, if intercourse has already
occurred, pregnancy should be excluded
before starting Debunica use. Additional
information for breast-feeding women can
be found in 'Pregnancy and Breast-feeding'
in section 2. Your doctor can also advise

Wait for your period to begin. On the first
day of your period take the first Debunica
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
When you change from a combined pill,
vaginal ring, or transdermal patch

After a miscarriage or a premature
termination of pregnancy

You can start taking Debunica on the day
after you take the last tablet from the
present Pill pack, or on the last 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 Debunica 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.

Your doctor will advise you.
If you forget to take Debunica
If you are less than 12 hours late in taking
a tablet, the reliability of Debunica is
maintained. Take the missed tablet as soon
as you remember and take the next tablets
at the usual times.
If you are more than 12 hours late in
taking any tablet, the reliability of Debunica
may be reduced. The more consecutive
tablets you have missed, the higher the risk
that the contraceptive efficacy is decreased.
Take the last missed tablet as soon as you
remember and take the next tablets at the

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
Desogestrel 75 mcg
UK/H/3416-8, 4784/001/DC


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 Debunica is
decreased. In general, you need not take
any action; just continue to take Debunica.
If, however, bleeding is heavy or prolonged
consult your doctor.

usual times. Use an additional contraceptive
method (barrier method) too for the next 7
days of tablet-taking. If you missed one or
more tablets in the first week of tabletintake and had intercourse in the week
before missing the tablets, there is a
possibility of becoming pregnant. Ask your
doctor for advice.
If you suffer from gastro-intestinal
disturbances (e.g. vomiting, severe

Follow the advice for missed tablets in the
section above. If you vomit or use medical
charcoal within 3 - 4 hours after taking your
Debunica tablet or have severe diarrhoea,
the active ingredient may not have been
completely absorbed.

If you take more Debunica than you

There are no mentions of seriously
damaging results of taking too many
Debunica pills simultaneously. Should you
simultaneously, you may suffer from
nausea, vomiting or vaginal blood loss. If
you find out that a child has taken multiple
pills, contact your doctor for advice.

Common side effects (affects 1 to 10
users in 100) are: mood altered,
decreased sexual drive (libido),
headache, nausea, acne, breast pain,
irregular or no menstruation, increased
body weight.
Uncommon side effects (affects 1 to 10
users in 1,000) are: infection of the
vagina, difficulties in wearing contact
lenses, vomiting, hair loss, painful
menstruation, ovarian cyst, tiredness.
Rare side effects (affects 1 to 10 users
in 10,000) are: rash, hives, painful bluered skin lumps (erythema nodosum).
These are skin conditions.

Apart from these side effects, breast
secretion may occur.
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or

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

Keep out of the sight and reach of children.


This medicinal product does not require any
special storage conditions.

Like all medicines, Debunica can cause side
effects, although not everybody gets them.
Serious undesirable affects associated with
the use of Debunica are described the
"Thrombosis" in section 2 “Before you take
Debunica” Please read this section for
additional information and consult your
doctor at once where appropriate.

Do not use Debunica after the expiry date
which is stated on the carton after ”Do not
use after:” or “EXP:”. The Expiry date
refers to the last day of that month.
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.

Vaginal bleeding may occur at irregular
intervals during the use of Debunica. This
may be just slight staining which may not
even require a pad, or heavier bleeding,
Desogestrel 75 mcg
UK/H/3416-8, 4784/001/DC


What Debunica contains
The active substance is: desogestrel (75
The other ingredients are: lactose
monohydrate, maize starch, povidone K30,
d-α-tocopherol, soybean oil, silica, colloidal
anhydrous, silica, colloidal hydrated, stearic
acid, hypromellose, polyethylene glycol,
titanium dioxide (E 171) (see also
"Important information about some of the
ingredients of Debunica" in section 2).
What Debunica looks like and content of
the pack
One blister pack of Debunica contains 28
white round film-coated tablets. Each
carton contains 1, 3, 6 or 13 blisters.
Not all pack sizes may be available.

Marketing Authorisation Holder and
Marketing Authorisation Holder
Bâtiment le Newton – 9-11, rue Jeanne
Braconnier – 92366 Meudon la Forêt
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera.
C/ La Vallina s/n
24008 - Navatejera, León.
This medicinal product is authorised in the
Member States of the EEA under the
following names:
This leaflet was last approved on

Desogestrel 75 mcg
UK/H/3416-8, 4784/001/DC


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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.