Skip to Content

NACREZ 75 MICROGRAMS FILM-COATED TABLETS

Active substance(s): DESOGESTREL / DESOGESTREL / DESOGESTREL

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

TEVA UK Ref:

231-30-70121-C LEA DESOGESTREL (NACREZ) 75mcg FC TABS TUK
Version: 2

10 December 2015

TEVA UK Ref:

231-30-70121-C LEA DESOGESTREL (NACREZ) 75mcg FC TABS TUK
Version: 2

10 December 2015

46030

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, 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. 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
use 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 using Nacrez.
Take special care with 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 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),
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.

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.
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.


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.





Children and adolescents under
18 years
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.





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.
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.
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.
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.

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.
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.
The side effects rating was based on
the following frequency data:
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
Users of desogestrel have reported
the following side effects:
Common
Mood altered, decreased sexual
drive (libido), depressed mood
(feeling sad more than usual)
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 you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet.

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 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:
Merckle, Blaubeuren, Germany.
This leaflet was last revised in
12/2015
PL 00289/1706

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.

70121-C
840 x 140
266326.01-GB
46030

10 December 2015

2
Version:

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

50mm

Original Artwork Scale = 1:1 (100%)

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, 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. 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.

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),
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
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.
Children and adolescents under 18 years
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 Tell your doctor before you start to use Nacrez - epilepsy (e.g. primidone, phenytoin,
if any of these conditions apply to you. Your
carbamazepine, oxcarbazepine, felbamate,
doctor may advise you to use a
topiramate and phenobarbital),
non-hormonal method of birth control.
- tuberculosis (e.g. rifampicin, rifabutin),
Consult your doctor immediately if any of
- HIV infections (e.g. ritonavir, nelfinavir),
these conditions appear for the first time
- or other infectious diseases (e.g.
while using Nacrez.
griseofulvin), stomach upset (medical
charcoal), depressive moods (the herbal
Take special care with Nacrez
remedy St. John’s wort),
- if you have ever had breast cancer.
in
case of transplantations (e.g.
- if you have liver cancer, since a possible
ciclosporin).
effect of Nacrez on liver cancer cannot be
excluded.
Always tell your doctor which medicines or
- if you have a reduced liver function.
herbal products you are already using. Also
- if you have ever had a thrombosis.
tell any other doctor or dentist who prescribes
- if you have diabetes.
another medicine (or the pharmacist) that you
- if you suffer from epilepsy (see section 2
use Nacrez. They can tell you if you need to
"Other medicines and Nacrez").
take additional contraceptive precautions (for
- if you suffer from tuberculosis (see
example condoms) and if so, for how long.
section 2 "Other medicines and Nacrez"). Nacrez may also affect the mode of action of
- if you have high blood pressure or your
certain medicines in the body, causing either
blood pressure increases significantly.
an increase in effect (e.g. medicines
- if you have or have had chloasma
containing cyclosporine) or a decrease in
(yellowish-brown pigmentation patches
effect.
on the skin, particularly of the face); if so,
Nacrez with food and drink
avoid too much exposure to the sun or
You can take Nacrez with or without food and
ultraviolet radiation.
drink.
Please tell your doctor if one of these
Pregnancy and breast-feeding
conditions applies to you.
When Nacrez is used in the presence of any of If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have
these conditions, you may need to be kept
a baby, ask your doctor or pharmacist for
under close observation. Your doctor can
advice before taking this medicine.
explain what to do.
Pregnancy
Regular Check-ups
When you are using Nacrez ,your doctor may Do not use Nacrez if you are pregnant, or
think you might be pregnant.
tell you to return for regular check-ups. In
general, the frequency and nature of these
Breast-feeding
check-ups will depend on your personal
Nacrez may be used while you are
situation.
breast-feeding.
If you are breast feeding and want to use
Contact your doctor as soon as possible
Nacrez, please contact your doctor.
- if you have severe pain or swelling in
either of your legs, unexplained pain in
Driving and using machines
the chest, breathlessness, an unusual
Nacrez has no influence on your ability to
cough, especially when you cough up
drive or using machines.
blood (possibly indicating a thrombosis or
Nacrez contains lactose
an embolism respectively);
Nacrez contains lactose (milk sugar). If you
- if you have a sudden, severe stomach
have been told by your doctor that you have
ache or look jaundiced (possibly
an intolerance to some sugars, contact your
indicating liver problems);
- if you feel a lump in your breast (possibly doctor before taking this medicinal product.
indicating breast cancer);
3. How to take Nacrez
- if you have a sudden or severe pain in the
lower abdomen or stomach area (possibly
Always take this medicine exactly as your
indicating an ectopic pregnancy, this is a
doctor has told you. Check with your doctor
pregnancy outside the womb);
or pharmacist if you are not sure.
- if you are to be immobilised or are to have
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
doctor as soon as possible if you feel any
lump in your breasts.
APPDG22 02

10 December 2015

2
Version:

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

50mm

Original Artwork Scale = 1:1 (100%)

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.
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.

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.
The side effects rating was based on the
following frequency data:
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

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
Users of desogestrel have reported the
contraceptive precautions. You may also
following side effects:
start on days 2-5 of your cycle, but in that
case make sure you also use an additional Common
contraceptive method (barrier method, for Mood altered, decreased sexual drive
example a condom) for the first 7 days of
(libido), depressed mood (feeling sad more
tablet-taking.
than usual)
• When changing from a combined pill,
Headache
vaginal ring, or transdermal patch
Nausea
You can start taking Nacrez on the day
Acne
after you take the last tablet from the
present Pill pack, or on the day of removal Breast pain, irregular or no menstruation
of your vaginal ring or patch (this means
Increased body weight
no tablet-, ring- or patch-free interval). If
your present Pill pack also contains
Uncommon
inactive tablets you can start Nacrez on
the day after taking the last active tablet (if Infection of the vagina
Difficulties in wearing contact lenses
you are not sure which this is, ask your
doctor or pharmacist). If you follow these
Vomiting
instructions, you need not take extra
Hair loss
contraceptive precautions. You can also
start at the latest on the day following the
Painful menstruation, ovarian cyst
tablet-, ring-, patch-free interval, or after
Tiredness
the intake of the inactive tablets of your
Rare
present contraceptive. If you follow these
instructions, make sure you use an
Rash, hives, painful blue-red skin lumps
additional contraceptive method (barrier
(erythema nodosum) (these are skin
method, for example a condom) for the
conditions)
first 7 days of tablet-taking.
Apart from these side effects, breast secretion
• When changing from another
may occur.
progesteron-only containing pill (mini pill)
If you get any side effects, talk to your doctor
to Nacrez
or pharmacist. This includes any possible side
You may stop taking it any day and start
effects not listed in this leaflet.
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.
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.

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 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:
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.

21226-E
212074.02-GB
APPDG22 02

Expand Transcript

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