DESOGESTREL 75 MICROGRAM FILM-COATED TABLETS

Active substance: DESOGESTREL

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PATIENT INFORMATION SHEET: INFORMATION FOR THE USER
Desogestrel 75 microgram film-coated tablets
Desogestrel
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:

2. BEFORE YOU TAKE Desogestrel

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

Desogestrel,
like
other
hormonal
contraceptives, does not protect against
HIV infection (AIDS) or any other
sexually transmitted disease.
Do not take Desogestrel
• If you a re a llergic to any of t he
ingredients of Desogestrel.
• If you ha ve a t hrombosis. T hrombosis
is the f ormation of a b lood c lot i n a
blood v essel ( e.g. of the legs (deep
venous t hrombosis) o r t he l ungs
(pulmonary embolism)).
• If y ou ha ve or ha ve h ad jaundice
(yellowing o f t he sk in) o r sev ere liver
disease and your l iver f unction i s st ill
not normal.
• If you h ave or ar e su spected t o h ave a
cancer that is sensitive to progestogens,
such as certain types of breast cancer.
• If you ha ve a ny une xplained v aginal
bleeding.
• If you are allergic to peanut or soya.

1. WHAT Desogestrel IS AND WHAT
IT IS USED FOR
Desogestrel is used to prevent pregnancy.
Desogestrel contains a small amount of one
type of female sex hormone, the
progestogen de sogestrel. For t his reason
Desogestrel is called a progestogen-onlypill (POP), or a mini-pill.
Contrary t o t he combined pill, t he P OP o r
mini-pill do es no t c ontain a n oe strogen
hormone next to the progestogen.
Most P OPs or m inipills w ork p rimarily b y
preventing the sp erm cells from entering
the w omb but do no t a lways pr event t he
egg cell from ripening, which is the primary
action of c ombined pi lls. Desogestrel is
distinct from o ther m ini-pills in h aving a
dose that in m ost c ases i s hi gh e nough to
prevent t he eg g ce ll f rom r ipening. A s a
result,
Desogestrel
provides hi
gh
contraceptive ef ficacy. In co ntrast t o t he
combined pi ll, Desogestrel can b e u sed by
women who do not tolerate oestrogens and
by women who are breastfeeding.
A d isadvantage i s that vaginal b leeding
may o ccur at i rregular intervals d uring th e
use of Desogestrel. You also may not have
any bleeding at all.

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

Tell y ou doc tor b efore y ou s tart to us e
Desogestrel if any of these conditions apply
to you. Your doctor may advise you to use
a non-hormonal method of birth control.
Consult y our doc tor i mmediately if any of
these conditions a ppear for t he f irst time
while using Desogestrel.
Take special care with Desogestrel
Tell your doctor before you start to use
Desogestrel, if
1










the age of 40, there would be 20 extra cases
in addition t o the 160 c ases no rmally
diagnosed.

you have ever had cancer of the breast.
you h ave l iver can cer, s ince a p ossible
effect o f Desogestrel cannot be
excluded.
you have ever had a thrombosis.
you have diabetes.
you su ffer f rom ep ilepsy (see se ction
‘Taking other medicines’).
you suffer from tuberculosis ( see
section ‘Taking other medicines’).
you have high blood pressure.
you ha ve or ha ve ha d c hloasma
(yellowish-brown pi gmentation patches
on the skin, particularly of the face); if
so a void t oo much e xposure to the s un
or ultraviolet radiation.

The r isk o f b reast cancer i n u sers
progestogen-only pills lik e Desogestrel is
believed to be similar to that in women who
use t he P ill, but t he e vidence i s less
conclusive.
Breast c ancers found i n w omen who take
the Pill, seem less likely to have spread than
breast cancers found in women who do not
take t he P ill. It is n ot known whether t he
difference in breast cancer risk is caused by
the P ill. I t may be t hat t he w omen were
examined m ore of ten, s o t hat t he br east
cancer is noticed earlier.

When Desogestrel is used in the presence of
any of these conditions, you may need to be
kept unde r c lose obs ervation. Y our doc tor
can explain what to do.

Desogestrel and thrombosis
See yo ur d octor immediately, i f you notice
possible s igns o f a t hrombosis ( see also
'Regular C heck-ups') T hrombosis i s t he
formation of a blood clot which may block
a bl ood v essel. A t hrombosis s ometimes
occurs i n t he d eep v eins of the l egs ( deep
venous thrombosis). If this clot breaks away
from t he v eins where i t i s f ormed, i t m ay
reach a nd b lock t he arteries o f the l ungs,
causing a so-called “pulmonary embolism”.
As a result, fatal situations may occur. Deep
venous t hrombosis i s a r are o ccurrence. I t
can de velop w hether or n ot you are taking
the Pill. I t c an a lso h appen i f y ou be come
pregnant. T he r isk is higher i n Pill-users
than i n non -users. T he r isk w ith
progestogen-only pills, lik e Desogestrel, i s
believed t o be l ower than in us ers of P ills
that a lso c ontain oestrogens ( combined
Pills).

Desogestrel and breast cancer
Regularly ch eck y our b reasts an d co ntact
your doc tor a s soon a s pos sible i f you f eel
any lump in your breasts. Breast cancer has
been found s lightly m ore often i n women
who t ake t he P ill t han i n w omen of t he
same a ge w ho do not take th e P ill. I f
women s top t aking t he P ill, the r isk
gradually d ecreases, so that 10 years a fter
stopping the risk is the same as f or women
who ha ve ne ver taken the P ill. B reast
cancer is rare under 40 years of age but the
risk increases as t he w oman g ets o lder.
Therefore, t he e xtra nu mber of br east
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.

Taking other medicines

In e very 10 000 w omen w ho t ake t he P ill
for up to 5 y ears but s top t aking i t by the
age of 20, t here would be less than 1 e xtra
case o f breast cancer found up to 1 0 ye ars
after s topping, i n a ddition t o t he 4 cases
normally di agnosed i n t his age gr oup.
Likewise, in 10 000 w omen w ho t ake t he
Pill f or up to 5 years but stop t aking i t by
the age of 30, there would be 5 extra cases
in a ddition t o t he 44 c ases n ormally
diagnosed. In 10 000 w omen w ho t ake t he
Pill f or up to 5 years b ut stop t aking i t by
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 h erbal products, including
medicines obt ained w ithout a prescription.
Some medicines may stop Desogestrel from
working properly.
These i nclude m edicines u sed f or the
treatment of e pilepsy ( e.g. pr imidone,
phenytoin, c arbamazepine, oxc arbazepine,
felbamate an
dP
henobarbital) o
r
tuberculosis
(e.g. r ifampicin), H IV
2

If you are allergic to peanut or soya, do
not use this medicinal product.

infections (e.g. ritonavir) or other infectious
diseases ( e.g. g riseofulvin), s tomach ups et
(medical ch arcoal), d epressive moods ( the
herbal remedy St John's wort).

Use in adolescents
No clinical data on effectiveness and safety
are available in adolescents below 18 years.

Your doctor can tell you if you need to take
additional c ontraceptive precautions and i f
so, for how long.

Regular check-ups

Desogestrel may al so interfere w ith h ow
certain m edicines w ork, c ausing e ither an
increase in effect (e.g. medicines containing
cyclosporine) or a decrease in effect.

While y ou a re us ing Desogestrel you
should see y our d octor r egularly at least
twice a year.

Pregnancy and breast-feeding

Contact your doctor as soon as possible
if:

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



Breast-feeding
Desogestrel may be us ed w hile y ou a re
breast-feeding. Desogestrel does no t
influence the production or the quality of
breast m ilk. H owever, a s mall a mount of
the active su bstance o f Desogestrel passes
over into the milk.





The he alth of c hildren br east-fed fo r 7
months w hose m others w ere u sing
Desogestrel has b een studied u p t o 2.5
years of age. No effects on the growth and
development of the children were observed.



you h ave se vere p ain o r sw elling i n
either of your legs, unexplained pains in
the ch est, b reathlessness, an u nusual
cough, especially w hen you cough up
blood (
possibly i
ndicating a
thrombosis).
you h ave a su dden, sev ere s tomach
ache or l ook j aundiced (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 s tomach a rea
(possibly i ndicating
an e ctopic
pregnancy, t his is a pregnancy out side
the womb);
you are to be immobilised or are to
have s urgery ( consult yo ur d octor a t
least four weeks in advance);
you ha ve unus ual, he avy v aginal
bleeding;
you suspect that you are pregnant.

If you are b reast-feeding a nd w ant to us e
Desogestrel, please contact your doctor.



Driving and using machines



There are no indications of any effect of the
use o f Desogestrel on al ertness a nd
concentration.

3. HOW TO TAKE Desogestrel
When and how you should take
Desogestrel

Important information about some of the
ingredients of Desogestrel

The Desogestrel pack co ntains 2 8 t ablets.
The days of t he w eek a re pr inted i n the
blister a nd a lso ar rows ar e p rinted
indicating the or der t o take the pi lls. E ach
day correspond with one tablet. Every time
you start a new pack of Desogestrel, take a
tablet from the t op r ow. D on’t s tart with
just any tablet. For example if you start on a
Wednesday, y ou must t ake t he tablet from

Desogestrel contains lactose (milk sugar)
and soy bean oil.
If you ha ve be en t old by y our doc tor t hat
you have an intolerance to some sugars,
contact y our doc tor be fore t aking t his
medicinal product.

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

3

additional c ontraceptive m ethod (barrier
method) for the first 7 days of tablet-taking.

the t op r ow marked with ‘ WED’
(Wednesday). Continue to take one tablet a
day u ntil t he p ack i s em pty, al ways
following t he di rection i ndicated by t he
arrows. By looking at the pill pack you can
easily ch eck i f y ou h ave already t aken a
tablet on a particular da y. T ake your t ablet
each day at about the same time.
Swallow the tablet whole, with water. You
may ha ve s ome bl eeding d uring t he use of
Desogestrel, but you must continue t o t ake
your tablets as n ormal. Wh en a p ack is
empty, y ou must s tart w ith a new p ack of
Desogestrel on the next day – thus without
interruption a nd w ithout w aiting f or a
bleed.

When changing from another progestogenonly (mini-pill)
You m ay s top t aking i t a ny da y a nd s tart
taking Desogestrel right a way. Y ou need
not take extra contraceptive precautions.
When changing from an injectable or
implant or a progestogen-releasing
intrauterine device (IUD)
Start u sing Desogestrel when y our ne xt
injection is due or on t he da y t hat y our
implant or your IUD is removed. You need
not take extra contraceptive precautions.

When to start with the first strip
Desogestrel

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

You c an s tart Desogestrel between 21 a nd
28 days after the birth of your baby. If you
start l ater, m ake s ure y ou us e dur ing t he
first cy cle an ad ditional contraceptive
method (barrier method) for the first 7 days
of tablet-taking.
However, i f i ntercourse h as al ready
occurred, p regnancy s hould be e xcluded
before s tarting Desogestrel use. A dditional
information fo r breast-feeding w omen can
be f ound i n 'Pregnancy and Breast-feeding'
in section 2. Your doctor can also advise
you.

Wait f or your pe riod t o be gin. O n t he f irst
day of your period take the first Desogestrel
tablet. Y ou ne ed n ot t ake e xtra
contraceptive precautions.
You m ay also st art o n d ays 2 -5 of y our
cycle, b ut i n that c ase m ake su re y ou also
use a n additional c ontraceptive m ethod
(barrier method) fo r t he fi rst 7 days of
tablet-taking.
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 Desogestrel on the day
after y ou t ake t he l ast tablet f rom t he
present P ill pa ck, or on t he l ast da y of
removal of your vaginal ring or pa tch (this
means no tablet-, ring- or patch-free break).
If your pr esent P ill pa ck a lso contains
inactive tablets you can start Desogestrel on
the day after taking the last active tablet (if
you a re no t sure w hich this is, a sk y our
doctor o r p harmacist). I f you follow t hese
instructions, y ou ne ed not t ake e xtra
contraceptive precautions.

Your doctor will advise you.
If you forget to take Desogestrel
If you are less than 12 hours late in taking
a ta blet, th e r eliability o f Desogestrel is
maintained. Take the missed tablet as soon
as y ou r emember an d t ake t he next tablets
at the usual times.
If y ou a re more than 12 hours late i n
taking a ny ta blet, th e r eliability o f
Desogestrel may b e r educed. The m ore
consecutive tablets you have missed, the
higher t he r isk t hat t he co ntraceptive
efficacy i s d ecreased. T ake t he last missed
tablet as soon as you remember and take the

You can al so s tart a t th e la test th e d ay
following t he t ablet-, r ing-, pa tch-free
break, o r p lacebo t ablet interval, o f y our
present c ontraceptive. I f you f ollow these
instructions, m ake s ure y ou us e a n
Desogestrel 75 mcg
UK/H/3416-8, 4784/001/DC

4

which looks rather like a scanty period and
requires san itary protection. Y ou m ay a lso
not ha ve a ny bl eeding a t a ll. The irregular
bleedings are n ot a sign t hat t he
contraceptive pr otection o f Desogestrel is
decreased. I n general, y ou ne ed not t ake
any a ction; just c ontinue to t ake
Desogestrel. If, however, bleeding is heavy
or prolonged consult your doctor.

next tablets at t he usual times. U se an
additional c ontraceptive m ethod ( barrier
method) t oo f or the ne xt 7 d ays of tablettaking. If you missed one or more tablets in
the first w eek o f tablet-intake a nd ha d
intercourse in t he w eek b efore m issing t he
tablets, there is a p ossibility o f b ecoming
pregnant. Ask your doctor for advice.
If you suffer from gastro-intestinal
disturbances (e.g. vomiting, severe
diarrhoea)



Follow t he a dvice f or missed t ablets in th e
section above. If you vomit or use medical
charcoal within 3 - 4 hours after taking your
Desogestrel tablet or have severe diarrhoea,
the active ingredient may not have been
completely absorbed.



If you take more Desogestrel than you
should



There a re no m entions of s eriously
damaging r esults of t aking t oo many
Desogestrel pills simultaneously. Should
you ha ve t aken a nu mber of pi lls
simultaneously, y ou m ay s uffer from
nausea, v omiting or v aginal b lood loss. I f
you find out that a child has taken multiple
pills, contact your doctor for advice.

Common s ide e ffects (affects 1 t o 10
users in 1 00) are: mood a ltered,
decreased s exual d rive ( libido),
headache, nausea, acn e, b reast pain,
irregular or no m enstruation, i ncreased
body weight.
Uncommon side effects (affects 1 to 10
users in 1,000) are: infection of t he
vagina, d ifficulties in w earing co ntact
lenses, v omiting, ha ir l oss, pa inful
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 t hese s ide ef fects, b reast
secretion may occur.
If any of t he si de effects gets serious, or if
you notice any side effects not listed in this
leaflet, pl ease t ell y our doc tor or
pharmacist.

If you stop taking Desogestrel
You c an s top taking Desogestrel whenever
you want. From the day you stop you are no
longer protected against pregnancy.

5. HOW TO STORE Desogestrel
Keep out of the sight and reach of children.
This medicinal product does not require any
special storage conditions.

4. POSSIBLE SIDE EFFECTS
Like a ll medicines, Desogestrel can ca use
side e ffects, a lthough not e verybody gets
them. Serious undesirable affects associated
with the us e of Desogestrel are described
the p aragraphs " Breast C ancer" an d
"Thrombosis" in section 2 “Before you take
Desogestrel” P lease r ead this se ction for
additional information and consult y our
doctor at once where appropriate.

Do not use Desogestrel after the expiry date
which is stated on the carton after ”Do not
use after:” o r “ EXP:”. T he E xpiry da te
refers to the last day of that month.
Medicines s hould no t be di sposed of v ia
wastewater o r household waste. Ask your
pharmacist how to dispose of medicines no
longer r equired. These m easures w ill h elp
to protect the environment.

Vaginal b leeding m ay o ccur a t i rregular
intervals during the use of Desogestrel. This
may be j ust s light s taining w hich m ay not
even r equire a p ad, o r heavier bleeding,
Desogestrel 75 mcg
UK/H/3416-8, 4784/001/DC

6. FURTHER INFORMATION
5

What Desogestrel contains
The active substance is: desogestrel (75
microgram)
The o ther i ngredients ar e: lactose
monohydrate, maize starch, pov idone K30,
d-α-tocopherol, soybean oil, silica, colloidal
anhydrous, silica, colloidal hydrated, stearic
acid, hypromellose, pol yethylene g lycol,
titanium di oxide (E 1 71) (see a lso
"Important information a bout s ome of t he
ingredients of Desogestrel" in section 2).
What Desogestrel looks like and content
of the pack
One blister pack of Desogestrel contains 28
white round f ilm-coated t ablets. E ach
carton contains 1, 3 or 6 blisters.
Not all pack sizes may be available.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera.
C/ La Vallina s/n
24008 - Navatejera, León.
Spain
Manufacturer
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera.
C/ La Vallina s/n
24008 - Navatejera, León.
Spain
This medicinal product is authorised in t he
Member S tates of t he EEA unde r the
following names:
This leaflet was last approved on 08/2013

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

6

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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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