NACREZ 75 MICROGRAMS FILM-COATED TABLETS

Active substance: DESOGESTREL

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Package leaflet: Information for the user

NACREZ
75 micrograms FILM-COATED TABLETS
Desogestrel
Read all of this leaflet carefully before you
start using 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, please
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.
In this leaflet:
1. What Nacrez is and what it is used for
2. What you need to know before you take
Nacrez
3. How to take Nacrez
4. Possible side effects
5. How to store Nacrez
6. Contents of the pack and other information

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. 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 Nacrez is believed
to be similar to that in women who use pills
that also contain oestrogens (combined pills),
Nacrez is used to prevent pregnancy. It
but the evidence is less conclusive.
contains a small amount of one type of
Breast cancers found in women who take the
female sex hormone, the progestogen
desogestrel. For this reason Nacrez is called a Pill, seem less likely to have spread than
breast cancers found in women who do not
progestogen-only-pill (POP), or a mini-pill.
take the Pill. It is not known whether the
Contrary to the combined pill, the POP or
difference in breast cancer risk is caused by
mini-pill does not contain an oestrogen
the Pill. It may be that the women were
hormone next to the progestogen.
examined more often, so that the breast
cancer is noticed earlier.
Most POPs or mini-pills work primarily by
preventing the sperm cells from entering the
Thrombosis
womb. They do not always prevent the egg
cell from ripening, which is the primary action See your doctor immediately, if you notice
possible signs of a thrombosis. For signs, see
of combined pills. Nacrez is distinct from
,
other mini-pills in having a dose that in most “Contact your doctor as soon as possible”
first bullet.
cases is high enough to prevent the egg cell
Thrombosis is the formation of a blood clot,
from ripening. As a result, Nacrez provides
which may block a blood vessel. A
high contraceptive efficacy.
thrombosis sometimes occurs in the deep
veins of the legs (deep venous thrombosis). If
In contrast to the combined pill, Nacrez can
this clot breaks away from the veins where it
be used by women who do not tolerate
is formed, it may reach and block the arteries
oestrogens and by women who are
breast-feeding. A disadvantage is that vaginal of the lungs. This causes a so-called
“pulmonary embolism” As a result,
.
bleeding may occur at irregular intervals
life-threatening situations can occur, which
during the use of Nacrez .You also may not
may led to death. Deep venous thrombosis is
have any bleeding at all.
a rare occurrence. It can develop whether or
not you are taking the Pill. It can also happen
2. What you need to know before you
if you become pregnant.
take Nacrez
The risk of getting a thrombosis is higher in
Pill-users than in non-users. The difference in
Do not take Nacrez
the risk of getting a thrombosis with
- if you are allergic to desogestrel or any of
the other ingredients of this medicine (listed progestogen-only pills like Nacrez compared
to Pills that also contain oestrogens
in section 6)
- if you have a thrombosis. Thrombosis is the (combined Pills) is unknown.
formation of a blood clot in a blood vessel
Children and adolescents under 18 years
(e.g. of the legs (deep venous thrombosis)
There is not enough information about the
that can among others migrate into the
use of Desogestrel in children and
lungs and cause a pulmonary embolism)
- if you have or have had jaundice (yellowing adolescents under 18 years.
of the skin) or severe liver disease and your
Other medicines and Nacrez
liver function is still not normal
Tell your doctor or pharmacist if you are
- if you have or are suspected to have a
cancer that is sensitive to sex-steroids, such taking, have recently taken or might take any
other medicines.
as certain types of breast cancer
- if you have any unexplained vaginal bleeding.
Some medicines may stop Nacrez from
Tell your doctor before you start to use Nacrez working properly and may lead to unexpected
bleeding or being less effective in preventing
if any of these conditions apply to you. Your
pregnancy. These include medicines used for
doctor may advise you to use a
the treatment of non-hormonal method of birth control.
- epilepsy (e.g. primidone, phenytoin,
Consult your doctor immediately if any of
carbamazepine, oxcarbazepine, felbamate,
these conditions appear for the first time
topiramate and phenobarbital)
while using Nacrez.
- tuberculosis (e.g. rifampicin, rifabutin)
- HIV infections (e.g. ritonavir, nelfinavir)
Take special care with Nacrez
- or other infectious diseases (e.g.
- if you have ever had breast cancer
griseofulvin), stomach upset (medical
- if you have liver cancer, since a possible
charcoal), depressive moods (the herbal
effect of Nacrez on liver cancer cannot be
remedy St. John’s wort)
excluded
- in case of transplantations (e.g. ciclosporin).
- if you have a reduced liver function
- if you have ever had a thrombosis
Always tell your doctor which medicines or
- if you have diabetes
herbal products you are already using. Also
- if you suffer from epilepsy (see section 2
tell any other doctor or dentist who prescribes
“Other medicines and Nacrez”)
- if you suffer from tuberculosis (see section another medicine (or the pharmacist) that you
use Nacrez. They can tell you if you need to
2 "Other medicines and Nacrez")
take additional contraceptive precautions (for
- if you have high blood pressure or your
example condoms) and if so, for how long.
blood pressure increases significantly
Nacrez may also affect the mode of action of
- if you have or have had chloasma
(yellowish-brown pigmentation patches on certain medicines in the body, causing either
the skin, particularly of the face); if so, avoid an increase in effect (e.g. medicines
too much exposure to the sun or ultraviolet containing cyclosporine) or a decrease in
effect.
radiation.

50mm

Original Artwork Scale = 1:1 (100%)

1. What Nacrez is and what it is used for

Please tell your doctor if one of these
conditions applies to you.
When Nacrez 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.
Regular Check-ups
When you are using Nacrez, your doctor may
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 pain in the chest,
breathlessness, an unusual cough,
especially when you cough up blood
(possibly indicating a thrombosis or an
embolism respectively)
- if you have a sudden, severe stomach ache
or look jaundiced (possibly indicating liver
problems)
- if you feel a lump in your breast (possibly
indicating breast cancer)
- if 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)
- if you are to be immobilised or are to have
surgery (consult your doctor at least four
weeks in advance)
- if you have unusual, heavy vaginal bleeding
- if you suspect that you are pregnant.
Breast cancer
Regularly check your breasts and contact your
doctor as soon as possible if you feel any
lump in your breasts.

Nacrez with food and drink
You can take Nacrez with or without food and
drink.
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 or pharmacist for
advice before taking this medicine.
Pregnancy
Do not use Nacrez if you are pregnant, or
think you might be pregnant.
Breast-feeding
Nacrez may be used while you are
breast-feeding.
If you are breast-feeding and want to use
Nacrez, please contact your doctor.
Driving and using machines
Nacrez has no influence on your ability to
drive or using machines.
Nacrez contains lactose
Nacrez contains lactose (milk sugar). If you
have been told by your doctor that you have
an intolerance to some sugars, contact your
doctor before taking this medicinal product.

APPDG22
01

3. How to take Nacrez
Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
Method of administration
- the Nacrez pack contains 28 tablets
- 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 Nacrez, 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 (at the back) with “Wed”
.
Continue to take one tablet a day until the
pack is empty. Always follow the direction
indicated by the arrows. By looking at the back
of your pack you can easily check if you have
already taken your tablet on a particular day.

If you stop taking Nacrez
You can stop taking Nacrez 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.
Serious undesirable effects associated with
the use of Nacrez are described in the
paragraphs "Breast cancer" and "Thrombosis"
in section 2 "What you need to know before
you take Nacrez". Please read this section for
additional information and consult your
doctor at once where appropriate.

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Original Artwork Scale = 1:1 (100%)

Vaginal bleeding may occur at irregular
intervals during the use of Nacrez.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
Take your tablet each day at about the same
any bleeding at all. The irregular bleedings are
time so that the interval between two tablets
not a sign that the contraceptive protection of
is always 24 hours. You may have some
Nacrez is decreased. In general, you need not
bleeding during the use of Nacrez, but you
take any action. Just continue to take Nacrez.
must continue to take your tablets as normal.
If, however, bleeding is heavy or prolonged
When a pack is empty, you must start with a
you should consult your doctor.
new pack of Nacrez on the next day - thus
without interruption and without waiting for a
The side effects rating was based on the
bleed.
following frequency data:
Starting your first pack of Nacrez
• 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 Nacrez 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 example a
condom) for the first 7 days of tablet-taking.

Very common: may affect more than 1 in 10
people
Common:
may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100
people
Rare:
may affect up to 1 in 1,000
people
Very rare:
may affect up to 1 in 10,000
people
Not known:
frequency cannot be estimated
from the available data

• When changing from a combined pill,
Users of desogestrel have reported the
vaginal ring, or transdermal patch
following side effects:
You can start taking Nacrez on the day after
you take the last tablet from the present Pill Common
Mood altered, decreased sexual
pack, or on the day of removal of your
drive (libido) , depressed mood
vaginal ring or patch (this means no tablet-,
(feeling sad more than usual)
ring- or patch-free interval). If your present
Headache
Pill pack also contains inactive tablets you
Nausea
can start Nacrez on the day after taking the
Acne
last active tablet (if you are not sure which
Breast pain, irregular or no
this is, ask your doctor or pharmacist). If
menstruation
you follow these instructions, you need not
take extra contraceptive precautions. You
Increased body weight
can also start at the latest on the day
Uncommon
Infection of the vagina
following the tablet-, ring-, patch-free
Difficulties in wearing contact
interval, or after the intake of the inactive
lenses
tablets of your present contraceptive. If you
Vomiting
follow these instructions, make sure you
use an additional contraceptive method
Hair loss
(barrier method, for example a condom) for
Painful menstruation, ovarian
the first 7 days of tablet-taking.
cyst
• When changing from another progesterononly containing pill (mini pill) to Nacrez
You may stop taking it any day and start
taking Nacrez right away. You need not take
extra contraceptive precautions.

Tiredness
Rare

Rash, hives, painful blue-red skin
lumps (erythema nodosum)
(these are skin conditions)

Apart from these side effects, breast secretion
may occur.

• When changing from an injectable or
implant or a progestogen-releasing
If you get any side effects, talk to your doctor
intrauterine device (IUD) to Nacrez
Start using Nacrez when your next injection or pharmacist. This includes any possible side
effects not listed in this leaflet.
is due or on the day that your implant or
your IUD is removed. You need not take
5. How to store Nacrez
extra contraceptive precautions.
• After having a baby
After delivery you can start taking Nacrez
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 example a condom) for the first
7 days of tablet-taking. However, if
intercourse has already occurred, pregnancy
must be excluded before starting Nacrez use.
• After a miscarriage or an abortion
Your doctor will advise you.
Nacrez, like other hormonal contraceptives,
does not protect against HIV infection (AIDS)
or any other sexually transmitted disease.
If you take more Nacrez 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 Nacrez
If you are less than 12 hours late in taking a
tablet, the reliability of Nacrez 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 Nacrez 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.

Keep out of the sight and reach of children.
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.
This medicinal product does not require any
special storage conditions.
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 Nacrez contains
- The active substance is desogestrel. Each
film-coated tablet contains 75 micrograms
of desogestrel.
- The other ingredients are: lactose
monohydrate (see also "Nacrez contains
lactose" in section 2), maize starch,
povidone K30, stearic acid,
all-rac-alpha-tocopherol, silica, colloidal
anydrous, hypromellose, macrogol 400,
talc, titanium dioxide.
What Nacrez looks like and contents of the
pack
Nacrez tablets are white to off white, circular,
biconvex film-coated tablets of 5.4-5.8 mm
diameter without embossing.
One blister pack of Nacrez contains 28
film-coated tablets. Each carton contains 1, 3
or 6 blister packs, each blister pack may or
may not be separately packed in a pouch.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
TEVA UK Limited, Eastbourne, BN22 9AG, UK.
Manufacturer:
Cemelog-BRS ltd., Vasut u. 13., 2040 Budaörs,
Hungary.

This leaflet was last revised in 07/2012
If you suffer from gastro-intestinal
disturbances (e.g. vomiting, severe diarrhoea)
PL 00289/1706
If you vomit or have severe diarrhoea or if
you use medical charcoal within 3-4 hours
after taking your Nacrez tablet, the active
ingredient may not have been completely
absorbed and the reliability of Nacrez may be
reduced. In such a case you need additional
contraceptive methods (such as condoms) for
21226-B
the next 7 days. Take the next tablet at the
212074.01-GB
usual time.
APPDG22
01

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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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