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DESOGESTREL 75 MICROGRAM FILM-COATED TABLETS

Active substance: DESOGESTREL

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Desogestrel 75 microgram
Film-coated Tablets
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 further questions, please ask your doctor or pharmacist.
•  his medicine has been prescribed for you. It is not suitable for all
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women, so you should not give it to anyone else as it may harm them.
• f you get any side effects, talk to your doctor or pharmacist.
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This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Desogestrel is and what it is used for
2. What you need to know before you take Desogestrel
3. How to take Desogestrel
4. Possible side effects
5. How to store Desogestrel
6. Contents of the pack and other information
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 desogestrel. For this reason Desogestrel 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 as well as the 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 primary action of combined pills. Desogestrel 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, Desogestrel
provides high contraceptive efficacy.
In contrast to the combined pill, Desogestrel 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 Desogestrel. Alternatively, you may not
have any bleeding at all.
2. What you need to know before you take Desogestrel
Desogestrel like other hormonal contraceptives, does not protect
against HIV infection (AIDS) or any other sexually transmitted
disease.
Do not take Desogestrel
•  you are allergic to any of the ingredients of Desogestrel or any of
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the other ingredients of this medicine (listed in section 6).
•  you have a thrombosis. Thrombosis is the formation of a blood
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clot in a blood vessel (e.g. of the legs, a deep vein thrombosis, or
the lungs, a pulmonary embolism).
•  you have or have had jaundice (yellowing of the skin) or severe
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liver disease and your liver function is still not normal.
•  you have or are suspected to have a cancer that is sensitive to
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progestogens, such as certain types of breast cancer.
• If you have any unexplained vaginal bleeding.
• If you are allergic to peanut or soya.
Tell your doctor before you start to use Desogestrel if any of these
conditions apply to you. Your doctor may advise you to use a nonhormonal method of birth control.
Consult your doctor immediately if any of these conditions appear for
the first time while using Desogestrel.
Warnings and precautions
Talk to your doctor or pharmacist before taking Desogestrel, if
• you have ever had breast cancer.
• 
you have liver cancer.
• you have ever had a thrombosis.
• you have diabetes.
• 
you suffer from epilepsy (see section ‘Other medicines and
Desogestrel’).
• 
you suffer from tuberculosis (see section ‘Other medicines and
Desogestrel’).
• 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 Desogestrel 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.
Desogestrel 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 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
Desogestrel 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.
Desogestrel 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
vein 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
“pulmonary embolism”. As a result, fatal situations may occur. Deep
vein 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 Desogestrel, is believed to
be lower than in users of Pills that also contain oestrogens (combined
Pills).
Other medicines and Desogestrel
Tell your doctor or pharmacist 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 Desogestrel
from working properly.
These include medicines used for the treatment of epilepsy (e.g.
primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate and
phenobarbital) or tuberculosis (e.g. rifampicin), HIV infections (e.g.
ritonavir) or other infectious diseases (e.g. griseofulvin), 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.
Desogestrel may also interfere with how certain medicines work,
causing either an increase in effect (e.g. medicines containing
ciclosporin) or a decrease in effect.
Pregnancy and breast-feeding
Pregnancy
Do not use Desogestrel if you are pregnant, or think you may be
pregnant.
Breast-feeding
Desogestrel may be used while you are breast-feeding. Desogestrel
does not influence the production or the quality of breast milk.
However, a small amount of the active substance of Desogestrel
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 Desogestrel, please contact
your doctor.
Driving and using machines
There are no indications of any effect of the use of Desogestrel on
alertness and concentration.
Desogestrel contains lactose (milk sugar) and soy bean oil.
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal product.
If you are allergic to peanut or soya, do not use this medicinal
product.
Use in children and adolescents
There are no clinical data on the effectiveness and safety in children
and adolescents below 18 years.
Regular check-ups
While you are using Desogestrel you should see your doctor regularly
at least twice a year.
Contact your doctor as soon as possible if:
•  ou have severe pain or swelling in either of your legs, unexplained
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pains in the chest, breathlessness, an unusual cough, especially
when you cough up blood (possibly indicating a thrombosis).
•  ou have a sudden, severe stomach ache or look jaundiced
y
(possibly indicating liver problems);
• you feel a lump in your breast (possibly indicating breast cancer);
y
•  ou 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);
•  ou are to be immobilised or are to have surgery (consult your
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doctor at least four weeks in advance);
• you have unusual, heavy vaginal bleeding;
• you suspect that you are pregnant.
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3. How to take Desogestrel
When and how you should take Desogestrel. The Desogestrel pack
contains 28 tablets. The days of the week are printed on the blister,
together with arrows that indicate the order in which to take the tablets.
Each day corresponds with one tablet. Every time you start a new pack
of Desogestrel 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 with ‘WED’ (Wednesday). Continue to
take one tablet a day, returning to the top row if necessary until the
pack is empty, always following the direction indicated by the arrows.
By looking at the blister 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 Desogestrel, but you must continue to take your
tablets as normal. When a pack is empty, you must start with a new
pack of Desogestrel on the next day – without interruption and without
waiting for a bleed.
When to start taking Desogestrel
When no hormonal contraceptive has been used in the past
month
Wait for your period to begin. On the first day of your period take
the first Desogestrel 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 you change from a combined pill, vaginal ring, or
transdermal patch
You can start taking Desogestrel 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
Desogestrel 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 (mini-pill)
You may stop taking it any day and start taking Desogestrel right away.
You need not take extra contraceptive precautions.
When changing from an injectable or implant or a progestogenreleasing intrauterine device (IUD)
Start using Desogestrel 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 Desogestrel between 21 and 28 days after the birth
of your baby. If you start later, make sure you use an additional
contraceptive method (barrier method) for the first 7 days of tablettaking during your first cycle.
However, if intercourse has already occurred, pregnancy should be
excluded before you start to take Desogestrel. Additional information
for breast-feeding women can be found in ‘Pregnancy and Breastfeeding’ in section 2. Your doctor can also advise you.
After a miscarriage or a premature termination of pregnancy
Your doctor will advise you.
If you forget to take Desogestrel
If you are less than 12 hours late in taking a tablet, the reliability of
Desogestrel 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 Desogestrel 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 usual times. Use an additional
contraceptive method (barrier method) for the next 7 days of tablettaking. 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 diarrhoea)
Follow the advice for missed tablets in the 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 are no reports of serious side effects from taking too many
Desogestrel tablets. If you have taken a number of tablets at the same
time, you may suffer from nausea, vomiting or vaginal blood loss. If you
find out that a child has taken multiple tablets, contact your doctor for
advice.

If you stop taking Desogestrel
You can stop taking Desogestrel whenever you want. From the day you
stop you are no longer protected against pregnancy.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them. Serious side effects associated with the use
of Desogestrel are described the paragraphs “Breast Cancer” and
“Thrombosis” in section 2 “What you need to know before you take
Desogestrel.” 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
Desogestrel. This may be just slight staining which may not even
require a pad, or heavier bleeding, which is like a light period and
requires sanitary protection. Alternatively, you may not have any
bleeding at all. Irregular bleeding is not a sign that the contraceptive
protection of Desogestrel has decreased. In general, you need not
take any action; just continue to take Desogestrel. If, however, bleeding
is heavy or prolonged consult your doctor.
• 
Common side effects (affects 1 to 10 users in 100) are: altered
mood, decreased sex 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: Skin
conditions such as rash, hives, painful blue-red skin lumps
(erythema nodosum).
Apart from these side effects, breast secretion may occur.
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 side effects directly via the Yellow Card Scheme at:
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 Desogestrel
Keep out of the sight and reach of children.
This medicinal product does not require any special storage
conditions.
Do not use this medicine 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.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines no longer required.
These measures will help protect the environment.
6. Contents of the pack and other information
What Desogestrel contains
The active substance is: desogestrel (75 microgram)
The other ingredients are: lactose monohydrate, maize starch,
povidone K30, dα-tocopherol, soybean oil, silica, colloidal anhydrous,
silica, colloidal hydrated, stearic acid, hypromellose, polyethylene
glycol, titanium dioxide (E 171) (see also “Desogestrel contains..” in
section 2).
What Desogestrel looks like and content of the pack
One blister pack of Desogestrel contains 28 white round film-coated
tablets.
Each 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 leaflet was last revised in July 2013.

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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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