Skip to Content

DESOREX 75 MICROGRAMS FILM COATED TABLETS

Active substance(s): DESOGESTREL

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Desogestrel
of
using
.
Keep this
You may need to read it again
If you have any further questions, please ask your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this
please tell your doctor or
pharmacist.
In
1.
2.
3.
4.
5.
6.

What Desorex is and what it is used for
Before you take Desorex
How to take Desorex
Possible side effects
How to store Desorex
Further information

1. WHAT DESOREX IS AND WHAT IT IS USED FOR
Desorex is used to prevent pregnancy in women over 18 years.
It contains a small amount of one type of female sex hormone,
the progestogen desogestrel. For this reason Desorex is called
a progestogen-only –pill (POP), or a mini-pill. Unlike the
combined pill, the POP or mini-pill does not contain an oestrogen hormone, only a progestogen.

Somex Pharma
If you are to be
or are to have
your doctor at least four weeks in advance);
If you have
If you suspect that you are

(consult

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.
Increase of
of
cancer
Desorex
The information is calculated on 10,000women:
of

of

Cases of
cancer

age of
20 years
30 years
40 years

Cases of
cancer in women
(max. 5

4 cases
44 cases
160 cases

4-5 cases
49 cases
180 cases

Most POPs or mini-pill work primarily by preventing the sperm
cells from entering the womb. They do not always prevent the
egg cell from ripening, which is the primary action of combined
pills. Desorex 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, Desorex provides high contraceptive
.
ef

The risk of breast cancer in users of progestogen-only pills like
this medicine is believed to be similar to that in women who use
pills that also contain oestrogens (combined pills), but the
evidence is less conclusive.

In contrast to the combined pill, Desorex 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 Desorex. You may not have
any bleeding at all.

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.

2.
Do

BEFORE YOU TAKE DESOREX
If you are
to desogestrel or any of the other
ingredients of Desorex.
If any of these conditions appears for the
time while
using Desorex you should consult your doctor promptly.
If you are
or think you might be pregnant
If you have
. Thrombosis is the formation of a
blood clot in a blood vessel {e.g. of the legs (deep venous
thrombosis), that can among others migrate into the lungs
and cause a pulmonary embolism
If you have had
(yellowing of the skin) or severe
and your liver function is still not normal
If you have or are suspected to have a cancer that is
sensitive to sex-steroids, such as certain types of breast
cancer
If you have any

Tell your doctor before you start to use this medicine 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
time
while using this medicine.
T

care
Desorex
If you have ever had
cancer
If you have
cancer, since a possible effect of Desorex
on liver cancer cannot be excluded
If you have
If you have ever had a
If you have
If you suffer from
(see section 2 “Taking other
medicines”)
If you suffer from
(see section 2 “Taking other
medicines”)
If you have
or your blood pressure
.
increases
If you have or have had
(yellowish-brown
pigmentation patches on the skin, particularly of the face); if
so, avoid too much exposure to the sun or ultraviolet
radiation.

Please tell your doctor if one of these conditions applies to you.
When Desorex 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.
When you are using this medicine, 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.
as soon as
If you have severe
or
in
of
,
unexplained
in
, an
unusual cough, especially when you
(possibly indicating a thrombosis or an embolism
respectively);
If you have a sudden, severe
or
(possibly indicating liver problems);
If you feel a
in
(possibly indicating breast
cancer);
If you have sudden or severe
in
or
area (possibly indicating an ectopic pregnancy,
this is a pregnancy outside the womb);

See your doctor immediately, if you notice possible signs of a
thrombosis (see also section 2 “Do not take this medicine…”
Thrombosis is the
of a
a
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. This causes 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 difference in
the risk of getting a thrombosis with progestogen-only pills like
Desorex compared to pills that also contain oestrogens
(combined Pills ) is unknown
T
Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.
Some medicines may stop your tablets from working properly
and may lead to breakthrough bleeding or contraceptive failure.
These include medicines used for the treatment of
e i e s (e.g. primidone, phenytoin, carbamazepine,
oxcarbazepine, felbamate and phenobarbital),
(e. g. rifampicin, rifabutin),
HIV
(e.g. ritonavir,
or
(e.g. griseofulvin),
(medical Charcoal), depressive moods (the herbal
remedy St. Jones Wort
In cases of
(e.g. ciclosporin).
If you take one of the listed medicines together with Desorex you
need to take
during the
time of concomitant drug administration and for 28 days after
their discontinuation. It may also affect the mode of action of
certain medicines in the body, causing either an increase in effect
(e.g. medicines containing cyclosporine) or a decrease in effect
Desorex
T
You can take this medicine with or without food and drink
Ask your doctor or pharmacist for advice before taking any
medicine.
Do
use Desorex if you are pregnant, or think you might be
pregnant
Desorex may be used while you are breast-feeding. If you are
breast feeding and want to use this medicine, please contact
your doctor
Driving
using
Desorex has no
machines.

on your ability to drive or using

some of
of
Desorex
This medicine contains lactose (milk sugar). If you have been
told by your doctor that you are intolerant to some sugars,
contact your doctor before taking this medicinal product.
There is no data to support the use of Desorex in adolescent
girls under 18 years.
APPDG18
02

3. HOW TO TAKE DESOREX
Always take your tablets exactly as your doctor has told you
respectively as described in this package leaflet. You should
check with your doctor or pharmacist if you are not sure.
Method of administration
• each blister of Desorex contains 28 tablets
• the first tablet should be taken on the first day of your
menstrual bleeding
• take one tablet daily
• Swallow the tablet whole with a sufficient amount of water
Arrows are printed on the front side of the pack between the
tablets. If you turn over your pack and look at the back side, you
will see the days of the week printed on the foil. Each day
corresponds with one tablet. Every time you start a new pack of
your medicine take a tablet from 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 (at the back) with “WED”.
Continue to take one tablet a 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 tablets on a particular day.
Take your tablets each day at about the same time so that the
interval between two tablets is always 24 hours. You may
have some bleeding during the use of Desorex, but you must
continue to take your tablets as normal. When a pack is empty,
you must start with a new pack of your tablets on the next day
thus without interruption and without waiting for a bleed
Starting your first pack of Desorex
• 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 Desorex 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 Desorex 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 interval). If your present Pill pack also contains
inactive tablets you can start Desorex 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 on the day following the tablet-, ring-, patchfree interval, or after the intake of the inactive tablets 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 progesteron-only
containing pill (mini pill) to Desorex
You may stop taking it any day and start taking this medicine
right away. You need not take extra contraceptive
precautions.
When changing from an injectable or implant or a
progestogen-releasing intrauterine device (IUD) to
Desorex
Start using this medicine 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.

If you stop taking Desorex
You can stop taking Desorex 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Desorex can cause side effects, although not
everybody gets them.
Serious undesirable effects associated with the use of Desorex
are described in the paragraphs “Breast cancer” and
“Thrombosis” in section 2 “Before you take Desorex. 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 Desorex. 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 Desorex is decreased. In
general, you need not take any action; just continue to take
Desorex. If, however, bleeding is heavy or prolonged you should
consult your doctor.
The side effects rating was based on the following frequency
data:
Very common:
Common
Uncommon
Rare
Very rare
Not known

more than 1 user in 10
1 to 10 users in 100
1 to 10 users in 1,000
1 to 10 users in 10,000
less than 1 user in 10,000
frequency cannot be estimated from
available data

Users of desogestrel have reported the following side effects:
Common
• Mood altered, decreased sexual drive (libido)
• Headache
• Nausea
• Acne
• Breast pain, irregular or no menstruation
• Increased body weight
Uncommon
• Infection of the vagina
• Difficulties in wearing contact lenses
• Vomiting
• Hair loss
• Painful menstruation, ovarian cyst
• Tiredness
Rare
• Rash, hives, painful blue-red 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
pharmacist.
5. HOW TO STORE DESOREX
Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the carton. The
expiry date refers to the last day of that month.

After having a baby
After delivery you can start taking Desorex before your
menstrual bleeding returns.
If you start later than 21 days after delivery, 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 must be
excluded before starting Desorex use.

Desorex does not require any special storage conditions.

After a miscarriage or an abortion
Your doctor will advise you.

What Desorex contains
• The active substance is: desogestrel (75 microgram).
• The other ingredients are: lactose monohydrate (see also
"Important information about some of the ingredients of
Desorex" in section 2), maize starch, povidone PVP K-30,
stearic acid, all-rac-alpha-tocopherol, silica, colloidal
anydrous,Tabcoat TC-White(Hydroxypropyl Methyl Cellulose,
Polyethylene Glycol, Talc, Titanium Dioxide)

This medicine, like other hormonal contraceptives, does not
protect against HIV infection (AIDS) or any other sexually
transmitted disease.
If you take more Desorex than you should
There have been no reports of serious harmful effects from
taking too many desogestrel-containing 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 forget to take Desorex
If you are less than 12 hours late in taking a tablet, the reliability
of this medicine is maintained. Take the missed tablet as soon as
you remember and take the next tablet at the usual time. If you
are more than 12 hours late in taking any tablet, the reliability of
Desorex 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. This means that you
possibly take 2 tablets on one day. Use an additional
contraceptive method (such as condoms) too for the next 7
days of tablet-taking. If you missed one or more tablets in the first
week of tablet-intake 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)
If you vomit or have severe diarrhoea or if you use medical
charcoal within 3-4 hours after taking your Desorex tablet, the
active ingredient may not have been completely absorbed and
the reliability of Desorex may be reduced. In such a case you
need additional contraceptive methods (such as condoms)
for the next 7 days. Take the next tablet at the usual time.

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.
6. FURTHER INFORMATION

What Desorex looks like and contents of the pack
Desorex tablets are white to off white, circular, biconvex filmcoated tablets without embossing.
One blister pack of Desorex contains 28 film-coated tablets.
Each carton contains 1, 3 or 6 blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Strandhaven Ltd T/A Somex Pharma, Ilford, Essex IG3 8BS
Manufacturer
Helm Pharmaceuticals GmbH, Nordkanalstr. 28, 20097 Hamburg
Germany
This medicinal product is authorised in the Member States
of the EEA under the following names:
Desorex 75 micrograms film-coated tablets.
This leaflet was last approved in 02/2013

APPDG18
02

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