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NACREZ 75 MICROGRAMS FILM-COATED TABLETS

Active substance(s): DESOGESTREL

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TEVA UK Ref:

231-30-70121-D LEA DESOGESTREL (NACREZ) 75MCG FC TABS TUK
Version: 1

10 December 2015

TEVA UK Ref:

231-30-70121-D LEA DESOGESTREL (NACREZ) 75MCG FC TABS TUK
Version: 1

10 December 2015

46030

Package leaflet:
Information for the patient

Nacrez
75 microgram
Film-coated Tablets
Desogestrel
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 any further
questions, ask your doctor or
pharmacist.
- This medicine has been
prescribed for you only. Do not
pass it on to others. It may harm
them, even if their signs of
illness are the same as yours.
- If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet .
See section 4.
In this leaflet
1. What Nacrez is and what it is
used for
2. 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

1. What Nacrez is and what it
is used for
Nacrez is used to prevent
pregnancy. It contains a small
amount of one type of female sex
hormone, the progestogen
desogestrel. For this reason Nacrez
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. They
do not always prevent the egg cell
from ripening, which is the primary
action of combined pills. Nacrez 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, Nacrez
provides high contraceptive efficacy.
In contrast to the combined pill,
Nacrez 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 Nacrez .You also
may not have any bleeding at all.

2. What you need to know
before you take Nacrez
Do not take Nacrez
- if you are allergic to desogestrel
or any of the other ingredients of
this medicine (listed in section 6).
- 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) that can among
others migrate into the lungs and
cause a 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
sex-steroids, such as certain
types of breast cancer.
- if you have any unexplained
vaginal bleeding.
Tell your doctor before you start to
take Nacrez 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 taking Nacrez.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Nacrez
- if you have ever had breast
cancer.
- if you have liver cancer, since a
possible effect of Nacrez on liver
cancer cannot be excluded.
- if you have a reduced liver
function.
- if you have ever had a thrombosis.
- if you have diabetes.
- if you suffer from epilepsy (see
section 2 "Other medicines and
Nacrez").
- if you suffer from tuberculosis
(see section 2 "Other medicines
and Nacrez").
- if you have high blood pressure
or your blood pressure increases
significantly.
- if 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.
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.

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 10000 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 10000 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 10000 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),
but the evidence is less conclusive.

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.
Take your tablet 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 Nacrez,
but you must continue to take your
tablets as normal. When a pack is
empty, you must start with a new
pack of Nacrez on the next day - thus
without interruption and without
waiting for a bleed.
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.


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.
Thrombosis
See your doctor immediately, if you
notice possible signs of a
thrombosis. For signs, see “Contact
your doctor as soon as possible”,
first bullet.
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. This
causes a so-called "pulmonary
embolism". As a result,
life-threatening situations can occur,
which may led to death. 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 of getting a thrombosis is
higher in Pill-users than in
non-users. The difference in the risk
of getting a thrombosis with
progestogen-only pills like Nacrez
compared to Pills that also contain
oestrogens (combined Pills) is
unknown.



When changing from another
progesteron-only 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.



When changing from an
injectable or implant or a
progestogen-releasing
intrauterine device (IUD) to
Nacrez
Start using Nacrez 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.

Children and adolescents
There is not enough information
about the use of desogestrel in
children and adolescents under
18 years.
Other medicines and Nacrez
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.
Some medicines may stop Nacrez
from working properly and may lead
to unexpected bleeding orbeing less
effective in preventing pregnancy.
These include medicines used for
the treatment of - epilepsy (e.g. primidone,
phenytoin, carbamazepine,
oxcarbazepine, felbamate,
topiramate and phenobarbital),
- tuberculosis (e.g. rifampicin,
rifabutin),
- HIV infections (e.g. ritonavir,
nelfinavir),
- or other infectious diseases (e.g.
griseofulvin), stomach upset
(medical charcoal), depressive
moods (the herbal remedy St.
John’s wort),
- in case of transplantations (e.g.
ciclosporin).
Always tell your doctor which
medicines or herbal products you
are already using. Also tell any other
doctor or dentist who prescribes
another medicine (or the
pharmacist) that you use Nacrez.
They can tell you if you need to take
additional contraceptive precautions
(for example condoms) and if so, for
how long. Nacrez 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.
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.

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

When changing from a
combined pill, vaginal ring, or
transdermal patch
You can start taking Nacrez 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 Nacrez 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-,
patch-free 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 example a condom)
for the first 7 days of
tablet-taking.





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.

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.
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 any bleeding at
all. The irregular bleedings are not a
sign that the contraceptive
protection of Nacrez is decreased. In
general, you need not take any
action. Just continue to take Nacrez.
If, however, bleeding is heavy or
prolonged you should consult your
doctor.
Users of desogestrel have reported
the following side effects:
Common: may affect up to 1 in 10
people
Mood altered, decreased sexual
drive (libido), depressed mood
(feedling sad more than usual),
headache, nausea, acne, breast pain,
irregular or no menstruation,
increased body weight.
Uncommon: may affect up to 1 in
100 people
Infection of the vagina, difficulties in
wearing contact lenses, vomiting,
hair loss, painful menstruation,
ovarian cyst, tiredness.
Rare: may affect up to 1 in 1,000
people
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 or pharmacist. 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 Nacrez
Keep this medicine 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.
Storage conditions with pouch:
This medicinal product does not
require any special storage
conditions.
Storage conditions without pouch:
Do not store above 30°C.
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 microgram 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 and
Manufacturer
Teva UK Limited, Eastbourne,
BN22 9AG, UK
Manufacturer:
Merckle, Blaubeuren, Germany.
This leaflet was last revised in
12/2015
PL 00289/1706

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 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 the next 7 days. Take
the next tablet at the usual time.
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.

70121-D
840 x 140
266326.01-GB
46030

10 December 2015

1
Version:

231-30-21226-F LEA DESOGESTREL 75mcg TAB 84 TUK TEVA UK Ref:

Package leaflet: Information for the patient

women of the same age who do not take the
Pill. If women stop taking the Pill, the risk

Nacrez 75 microgram Film-coated Tablets gradually decreases. 10 years after stopping
Desogestrel
the risk is the same as for women who have
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 any further questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
- If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet
. See section 4.
In this leaflet
1. What Nacrez is and what it is used for
2.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

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 10000 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
10000 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 10000 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

1 . What Nacrez is and what it is used for to be similar to that in women who use pills
Nacrez is used to prevent pregnancy. It
contains a small amount of one type of
female sex hormone, the progestogen
desogestrel. For this reason Nacrez 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. They do not always prevent the egg
cell from ripening, which is the primary action
of combined pills. Nacrez 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, Nacrez provides
high contraceptive efficacy.

that also contain oestrogens (combined pills),
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.
Thrombosis
See your doctor immediately, if you notice
possible signs of a thrombosis. For signs, see
“Contact your doctor as soon as possible”,
first bullet.

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. This causes a so-called
"pulmonary embolism". As a result,
life-threatening situations can occur, which
may led to death. Deep venous thrombosis is
a rare occurrence. It can develop whether or
2. What you need to know before you
not you are taking the Pill. It can also happen
take Nacrez
if you become pregnant.
The risk of getting a thrombosis is higher in
Do not take Nacrez
Pill-users than in non-users. The difference in
- if you are allergic to desogestrel or any of
the other ingredients of this medicine (listed the risk of getting a thrombosis with
progestogen-only pills like Nacrez compared
in section 6).
- if you have a thrombosis. Thrombosis is the to Pills that also contain oestrogens
(combined Pills) is unknown.
formation of a blood clot in a blood vessel
(e.g. of the legs (deep venous thrombosis)
Children and adolescents
that can among others migrate into the
There is not enough information about the
lungs and cause a pulmonary embolism).
use of desogestrel in children and
- 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
Some medicines may stop Nacrez from
bleeding.
working properly and may lead to unexpected

50mm

Original Artwork Scale = 1:1 (100%)

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

Tell your doctor before you start to take
Nacrez 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 taking Nacrez.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Nacrez
- if you have ever had breast cancer.
- if you have liver cancer, since a possible
effect of Nacrez on liver cancer cannot be
excluded.
- if you have a reduced liver function.
- if you have ever had a thrombosis.
- if you have diabetes.
- if you suffer from epilepsy (see section 2
"Other medicines and Nacrez").
- if you suffer from tuberculosis (see section
2 "Other medicines and Nacrez").
- if you have high blood pressure or your
blood pressure increases significantly.
- if 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.
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.

bleeding orbeing less effective in preventing
pregnancy. These include medicines used for
the treatment of - epilepsy (e.g. primidone, phenytoin,
carbamazepine, oxcarbazepine, felbamate,
topiramate and phenobarbital),
- tuberculosis (e.g. rifampicin, rifabutin),
- HIV infections (e.g. ritonavir, nelfinavir),
- or other infectious diseases (e.g.
griseofulvin), stomach upset (medical
charcoal), depressive moods (the herbal
remedy St. John’s wort),
- in case of transplantations (e.g.
ciclosporin).
Always tell your doctor which medicines or
herbal products you are already using. Also
tell any other doctor or dentist who prescribes
another medicine (or the pharmacist) that you
use Nacrez. They can tell you if you need to
take additional contraceptive precautions (for
example condoms) and if so, for how long.
Nacrez 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.
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.
Contact your doctor as soon as possible
If you are breast feeding and want to use
- if you have severe pain or swelling in either Nacrez, please contact your doctor.
of your legs, unexplained pain in the chest,
Driving and using machines
breathlessness, an unusual cough,
Nacrez has no influence on your ability to
especially when you cough up blood
drive or using machines.
(possibly indicating a thrombosis or an
embolism respectively);
Nacrez contains lactose
- if you have a sudden, severe stomach ache
Nacrez contains lactose (milk sugar). If you
or look jaundiced (possibly indicating liver
have been told by your doctor that you have
problems);
an intolerance to some sugars, contact your
- if you feel a lump in your breast (possibly
doctor before taking this medicinal product.
indicating breast cancer);
- if you have a sudden or severe pain in the
3. How to take Nacrez
lower abdomen or stomach area (possibly
indicating an ectopic pregnancy, this is a
Always take this medicine exactly as your
pregnancy outside the womb);
doctor has told you. Check with your doctor
- if you are to be immobilised or are to have or pharmacist if you are not sure.
surgery (consult your doctor at least four
Method of administration
weeks in advance);
- the Nacrez pack contains 28 tablets.
- if you have unusual, heavy vaginal
- take one tablet daily.
bleeding;
- Swallow the tablet whole with a sufficient
- if you suspect that you are pregnant.
amount of water.
Breast cancer
Regularly check your breasts and contact your Arrows are printed on the front side of the
pack between the tablets. If you turn over
doctor as soon as possible if you feel any
your pack and look at the back side, you will
lump in your breasts.
see the days of the week printed on the foil.
Breast cancer has been found slightly more
often in women who take the Pill than in
APPDG22 02

10 December 2015

1
Version:

231-30-21226-F LEA DESOGESTREL 75mcg TAB 84 TUK TEVA UK Ref:

50mm

Original Artwork Scale = 1:1 (100%)

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.
Take your tablet 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 Nacrez, but you
must continue to take your tablets as normal.
When a pack is empty, you must start with a
new pack of Nacrez on the next day - thus
without interruption and without waiting for a
bleed.
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.

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
any bleeding at all. The irregular bleedings are
not a sign that the contraceptive protection of
Nacrez is decreased. In general, you need not
take any action. Just continue to take Nacrez.
If, however, bleeding is heavy or prolonged
you should consult your doctor.
Users of desogestrel have reported the
following side effects:
Common: may affect up to 1 in 10 people
Mood altered, decreased sexual drive (libido),
depressed mood (feedling sad more than
usual), headache, nausea, acne, breast pain,
irregular or no menstruation, increased body
weight.
Uncommon: may affect up to 1 in 100 people
Infection of the vagina, difficulties in wearing
contact lenses, vomiting, hair loss, painful
menstruation, ovarian cyst, tiredness.
Rare: may affect up to 1 in 1,000 people
Skin conditions such as: rash, hives, painful
blue-red skin lumps (erythema nodosum)
Apart from these side effects, breast secretion
may occur.

• When changing from a combined pill,
vaginal ring, or transdermal patch
You can start taking Nacrez 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 Nacrez 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-, patch-free 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 example a condom) for the first
7 days of tablet-taking.

Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. 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.

• When changing from another
progesteron-only 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.

Storage conditions without pouch:
Do not store above 30°C.

5. How to store Nacrez
Keep this medicine 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.
Storage conditions with pouch:
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.

• When changing from an injectable or
implant or a progestogen-releasing
intrauterine device (IUD) to Nacrez
6. Contents of the pack and other
Start using Nacrez when your next injection
information
is due or on the day that your implant or
What Nacrez contains
your IUD is removed. You need not take
- The active substance is desogestrel. Each
extra contraceptive precautions.
film-coated tablet contains 75 microgram of
• After having a baby
desogestrel.
After delivery you can start taking Nacrez
- The other ingredients are lactose
before your menstrual bleeding returns.
monohydrate (see also "Nacrez contains
If you start later than 21 days after delivery,
lactose" in section 2), maize starch,
make sure you use during the first cycle an
povidone K30, stearic acid,
additional contraceptive method (barrier
all-rac-alpha-tocopherol, silica, colloidal
method, for example a condom) for the first
anydrous, hypromellose, macrogol 400,
7 days of tablet-taking. However, if
talc, titanium dioxide.
intercourse has already occurred,
What
Nacrez looks like and contents of the
pregnancy must be excluded before starting
pack
Nacrez use.
Nacrez tablets are white to off white, circular,
• After a miscarriage or an abortion
biconvex film-coated tablets of 5.4-5.8 mm
Your doctor will advise you.
diameter without embossing.
Nacrez, like other hormonal contraceptives,
One blister pack of Nacrez contains 28
does not protect against HIV infection (AIDS) film-coated tablets. Each carton contains 1, 3
or any other sexually transmitted disease.
or 6 blister packs, each blister pack may or
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.

may not be separately packed in a pouch.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer:
Merckle, Blaubeuren, Germany.
If you forget to take Nacrez
This leaflet was last revised in 12/2015
If you are less than 12 hours late in taking a
tablet, the reliability of Nacrez is maintained. PL 00289/1706
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.
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 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
the next 7 days. Take the next tablet at the
usual time.
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.

21226-D
212074.02-GB
APPDG22 02

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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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