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NORGESTON TABLETS 0.03MG

Active substance(s): LEVONORGESTREL

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Package leaflet: Information for the user

Norgeston®
Levonorgestrel
Four important things to know
about the Pill.
RThe Pill will not protect you against sexually
transmitted diseases.
RThis medicine can increase your risk of
problems such as blood clots and breast
cancer.
RSome women should not take the Pill because
of current medical problems or illnesses.
Please read this leaflet to make sure
Norgeston is right for you.
RTo prevent pregnancy it is important to
take Norgeston as instructed and start each
pack on time. Please make sure that you
understand what to do if you miss a pill or if
you think you are pregnant.
Read all of this leaflet carefully before you
start taking this medicine.
RKeep this leaflet. You may need to read it
again.
RIf you have any further questions, ask your
doctor, family planning nurse or pharmacist.
RThis medicine has been prescribed for you. Do
not pass it on to others. It may harm them.
RIf you get any side effects, talk to your doctor,
family planning nurse or pharmacist. This
includes any possible side effects not listed in
this leaflet. See section 4.

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In this leaflet:
1. What Norgeston does
2. Make sure Norgeston is OK for you
3. Taking Norgeston
3.3 A missed pill
4. Possible side effects
5. How to store Norgeston
6. What is in Norgeston and who makes it

1 What Norgeston does
Norgeston is an oral contraceptive pill
(the ‘mini Pill’). You take it to stop you getting
pregnant.
Norgeston contains a type of female sex
hormone, called a progestogen. This hormone
stops you getting pregnant by working in three
ways: by making the fluid (mucus) in your cervix
thicker, which makes it more difficult for sperm
to enter the womb; by preventing the lining of
your womb thickening enough for an egg to grow
in it; and in some women it also stops the ovary
releasing an egg each month (ovulation).
Norgeston is taken every day without a break.
You take a pill every day for 35 days.
Norgeston needs to be taken as directed to
prevent pregnancy.
The likelihood of getting pregnant is slightly
higher if you take a progestogen-only pill
(POP) such as Norgeston than with some other
medicines for hormonal contraception such as
combined hormonal contraceptives containing
an oestrogen and a progestogen. Your doctor can
provide further information on this. The effect
of Norgeston is similar to that of other POPs. The
failure rate may increase if pills are missed or

taken incorrectly (see section 3).
The benefits of taking the Pill include:
Rit is one of the most reliable reversible
methods of contraception if used correctly
Rit doesn’t interrupt sex
Norgeston will not protect you against sexually
transmitted infections, such as Chlamydia or HIV.
Only condoms can help to do this.
Children and adolescents
Norgeston is not indicated for use before the first
menstrual bleeding (menarche).

2 Make sure Norgeston is OK
for you
It’s important that you understand the benefits
and risks of taking the Pill before you start taking
it, or when deciding whether to carry on taking
it. Although the Pill is suitable for most healthy
women it isn’t suitable for everyone.
. Tell your doctor if you have any of the
illnesses or risk factors mentioned in this
leaflet.
Before you start taking the Pill
RYour doctor will ask about you and your
family’s medical problems and check your
blood pressure and exclude the likelihood of
you being pregnant. You may also need other
checks, such as a breast examination but only
if these examinations are necessary for you or
if you have any special concerns.
While you’re on the Pill
RYou will need regular check-ups with your
doctor or family planning nurse, usually when
you need another prescription of the Pill.
RYou should go for regular cervical smear
tests.

RCheck your breasts and nipples every month
for changes – tell your doctor if you can see or
feel anything odd, such as lumps or dimpling
of the skin.
RIf you need a blood test tell your doctor that
you are taking the Pill, because the Pill can
affect the results of some tests.
RIf you’re going to have an operation, make
sure your doctor knows about it. You may need
to stop taking the Pill about 4–6 weeks before
the operation. This is to reduce the risk of a
blood clot (see section 2.1). Your doctor will
tell you when you can start taking the Pill
again.

2.1 The Pill and blood clots
The Pill may slightly increase your risk of
having a blood clot (called a thrombosis),
especially in the first year of taking it.
A clot in a leg vein – a deep vein thrombosis (or
DVT) – is not always serious. However, if it moves
up the veins and blocks an artery in the lungs, it
can cause chest pain, breathlessness, collapse or
even death. This is called a pulmonary embolism
and is very rare.
Very rarely, blood clots can also form in the blood
vessels of the heart (causing a heart attack) or
the brain (causing a stroke). In healthy young
women the chance of having a heart attack or
stroke is extremely small.
You are more at risk of having a blood clot:
Ras you get older
Rif you smoke
Rif you are seriously overweight
Rif you have some diseases of the heart and
blood vessels
Rif you have diabetes
Rif you suffer from migraines

Rif you’re off your feet for a long time
because of major surgery, injury or illness
Rif you or any of your close family have had
blood clots
Rif you have varicose veins
. Tell your doctor if any of these apply to
you. Taking the Pill may add to this risk so
Norgeston may not be suitable for you.
Signs of a blood clot include:
Ra migraine for the first time, a migraine that
is worse than normal, or unusually frequent
or severe headaches
Rany sudden changes to your eyesight
(such as loss of vision or blurred vision)
Rany sudden changes to your hearing,
speech, sense of smell, taste or touch
Rpain or swelling in your leg
Rstabbing pain when you breathe
Rcoughing for no apparent reason
Rpain and tightness in the chest
Rsudden weakness or numbness in one side or
part of your body
Rdizziness or fainting.
. See a doctor as soon as possible. Do
not take any more Norgeston until your
doctor says you can. Use another method
of contraception, such as condoms, in the
meantime.

2.2 The Pill and cancer
If you have breast cancer, or have had it in the
past, you should not take the Pill. The Pill slightly
increases your risk of breast cancer. This risk
goes up the longer you’re on the Pill, but returns
to normal within about 10 years of stopping
it. Because breast cancer is rare in women
under the age of 40, the extra cases of breast
cancer in current and recent Pill users is small.

For example:
RIn 10,000 women who take progestogenonly pills like Norgeston for up to 5
years but stop taking it by the time they
are aged 20, it is estimated that less than
1 additional case of breast cancer would be
found up to 10 years afterwards, compared
with the number found in 10,000 women who
had never taken the Pill.
RFor 10,000 women who take the Pill like
Norgeston for 5 years and stop it by the
age of 30, there would be 2 or 3 extra
cases of breast cancer found up to 10 years
afterwards (in addition to the 44 cases of
breast cancer found in 10,000 women in this
age group who had never taken the Pill).
RFor 10,000 women who take Norgeston for
5 years and stop it by the age of 40, there
would be about 10 extra cases found up to
10 years afterwards (in addition to 160 cases
of breast cancer found in 10,000 women in
this age group who had never taken the Pill).
Your risk of breast cancer is higher:
Rif you have a close relative (mother, sister or
grandmother) who has had breast cancer
Rif you are seriously overweight
. See a doctor as soon as possible if you
notice any changes in your breasts, such as
dimpling of the skin, changes in the nipple or
any lumps you can see or feel.
Taking the Pill has also been linked to liver
diseases, such as jaundice and non-cancer liver
tumours, but this is rare. Very rarely, the Pill has
also been linked with some forms of liver cancer
in women who have taken it for a long time.
. See a doctor as soon as possible if you get
severe pain in your stomach, or yellow
skin or eyes ( jaundice). You may need to stop
taking Norgeston.

2.3 Norgeston should not be taken
by some women

2.4 Norgeston can make some
illnesses worse

. Tell your doctor or family planning nurse
if you have any medical problems or illnesses.
Do not take Norgeston if any of the following
apply to you. Taking Norgeston would put your
health at risk.
RIf you are pregnant or might be pregnant
RIf you have ever had a severe liver disease
and have been told by your doctor that your
liver function test results are not yet back to
normal
RIf you have ever had liver tumours
RIf you have cancer affected by sex hormones
–such as current or history of breast cancer
RIf you have vaginal bleeding that has not
been explained by your doctor
RIf you have ever had a problem with your
blood circulation. This includes a blood clot
(thrombosis) in the legs (deep vein thrombosis),
lungs (pulmonary embolism), heart (heart
attack), brain (stroke) or any other parts of
the body
RIf you have severe diabetes with changes to
the blood vessels
RIf you are allergic (hypersensitive) to any of
the ingredients in Norgeston.
. If you suffer from any of these, or get them
for the first time while taking Norgeston,
contact your doctor as soon as possible. Do
not take Norgeston and use another method
of contraception.

Some of the conditions listed below can be made
worse by taking Norgeston, or they may mean it
is less suitable for you. Remind your doctor:
RIf you have diabetes
RIf you have ever had a pregnancy develop
outside the womb (an ectopic pregnancy) or
one of your Fallopian tubes is missing
RIf you have ovarian cysts
RIf you have ever suffered from yellowing of
the skin ( jaundice)
RIf you have ever suffered from persistent
itching (pruritus)
RIf you have brown patches on your face
or body (chloasma). If so avoid too much
exposure to the sun or ultraviolet radiation.
. Tell your doctor or family planning
nurse if any of these apply to you. Also
tell them if you get any of these for the
first time while taking Norgeston, or if any
of these or any problems which you had
previously during pregnancy or whilst taking
an oral contraceptive get worse or come
back, because you may need to stop taking
Norgeston.

2.5 Taking other medicines
If you ever need to take another medicine at the
same time as being on the Pill, always tell your
doctor, pharmacist or dentist that you’re taking
Norgeston. Also check the leaflets that come
with all your medicines to see if they can be taken
with hormonal contraceptives.
Some medicines can stop Norgeston from
working properly – for example:
Rsome medicines used to treat epilepsy
Rsome medicines used to treat HIV
Rsome medicines used to treat serious
vomiting (e.g. aprepitant)
Rmedicines used to treat high blood
pressure in the blood vessels in the lungs
(e.g. bosentan)
Rgriseofulvin (an anti-fungal medicine)
Rcertain antibiotics
Rcertain sedatives (called barbiturates)
RSt. John’s Wort (a herbal remedy).
If you do need to take one of these medicines,
Norgeston may not be suitable for you or you
may need to use extra contraception for a while.
Your doctor, pharmacist or dentist can tell you if
this is necessary and for how long.
Norgeston can also affect how well other
medicines work. For example, taking Norgeston
can mean that the levels of some drugs in your
blood may either go up (e.g. ciclosporin) or go
down (e.g. lamotrigine).
Norgeston may also increase or reduce the
effects of some anticoagulant drugs (e.g.
coumarins) or inhibit the anticoagulant effect
(e.g. phenindione).
In addition, Norgeston can also interfere with the
results of some blood tests, so always tell your
doctor that you are taking Norgeston if you have
a blood test.


29.07.2016 07:53:09

Packaging Technology Berlin gfdxo
page 1
Bayer Pharma AG
client: 0021
material-no.: 85148095
PZ: 2547A-4
code-no.: 24
name: LF-Norgeston SCT 35
country: GB/-/BPH
colors: Black
version: 29.07.2016/03
approval:
dimension: 534 x 150 mm

This area must be identical on both sides!

85148095_book_03.indd 2

29.07.2016 07:53:30

This area must be identical on both sides!

2.6 Taking Norgeston with food
and drink
There are no special instructions about food and
drink while on Norgeston.

2.7 Pregnancy and breast-feeding
Do not use Norgeston if you are pregnant. If you
think you might be pregnant, do a pregnancy test
to confirm that you are before you stop taking
Norgeston.
Progestogen-only pills like Norgeston have not
been shown to have any detrimental effect on
breast milk or the growth or development of a
healthy baby.

2.8 Driving and using machines
Packaging Technology Berlin gfdxo
page 2
Bayer Pharma AG
client: 0021
material-no.: 85148095
PZ: 2547A-4
code-no.: 24
name: LF-Norgeston SCT 35
country: GB/-/BPH
colors: Black
version: 29.07.2016/03
approval:
dimension: 534 x 150 mm

Norgeston has no known effect on the ability to
drive or use machines.

2.9 Norgeston contains lactose
and sucrose
If you have been told by your doctor that you
have intolerance to some sugars, contact your
doctor before using Norgeston.

3 Taking Norgeston
3.1 How to take it
To prevent pregnancy, always take Norgeston
as described below. Check with your doctor or
family planning nurse if you are not sure.
Take Norgeston every day for 35 days
Norgeston comes in strips of 35 pills, each
marked with a day of the week.

RTake your pill at the same time every day.
Make sure that you are never more than
three hours late with a pill otherwise the
contraceptive protection may be lost.
RStart by taking a pill marked with the correct
day of the week.
RFollow the direction of the arrows on the strip.
Take one pill each day, until you have finished
all 35 pills.
RSwallow each pill whole, with water if
necessary. Do not chew the pill.
Then start your next strip
Start your next strip of Norgeston the very next
day after finishing the previous pack, again
taking a pill marked with the day of the week.
Always start the new strip on time.
You will be taking pills through your periods
and there must be no break between packs
As long as you take Norgeston correctly, you will
always start each new strip on the same day of
the week.

3.2 Starting Norgeston
As a new user or starting the Pill again after
a break
It is best to take your first Norgeston pill on the
first day of your next period. Another method of
contraception will not be required.
Changing to Norgeston from another
contraceptive Pill
RIf you are currently on a combined oral
contraceptive: start taking Norgeston the
day after your last active pill (discarding the
placebo pills or disregarding the pill-free
interval). Another method of contraception
will not be required.

RChanging from another progestogen-only
pill (POP or ‘mini Pill’): you can start taking
Norgeston at any time without the loss of
contraceptive protection.
RChanging from a progestogen-only
parenteral method (implant, injection):
additional non –hormonal contraceptive
protection (e.g. a condom) are not required
if you start exactly when the next implant or
injection is due.
Starting Norgeston after a miscarriage or
abortion
If you have had a miscarriage or an abortion
during the first three months of pregnancy,
your doctor may tell you to start taking
Norgeston straight away, in which case another
method of contraception will not be required.
Contraception after having a baby
If you have just had a baby your doctor
will advise you to start taking Norgeston
immediately after delivery. If you start taking
Norgeston later than this you should use another
method of contraception, such as a condom
for the first 7 days of pill taking. If you have
already had intercourse, then you should exclude
the possibility of pregnancy before starting
Norgeston or wait until you have your first
period.
If you have just had a baby and you are breast
feeding please refer to section 2.7 Pregnancy and
Breast-feeding.

3.3 A missed pill
If you are less than 3 hours late with a pill,
take it straight away. Keep taking your pills at the
usual time. This may mean taking two pills in one
day. Don’t worry – your contraceptive protection
should not be reduced.
If you are more than 3 hours late with a pill,
or you have missed more than one pill, your
contraceptive protection may be reduced.
RContinue to take your next pills at your usual
time.
RUse extra contraception for the next
7 days, such as condoms.
If you have missed any of the pills in a strip
and had intercourse in the week before
missing the tablets, there is a possibility of
becoming pregnant. The more consecutive
tablets you have missed, the higher the risk
that the contraceptive efficacy is decreased.

3.4 A lost pill
If you lose a pill,
Either take the last pill of the strip in place of
the lost pill. Then take all the other pills on their
proper days. When you start your next pack you
will have a new starting day, one day earlier than
before.
Or if you have another pack and do not want to
change the starting day of your next strip, take a
pill from that pack. Then take all the other pills
from your current strip as usual. You can then
keep the opened spare strip in case you lose any
more pills.

3.5 If you are sick or have
diarrhoea
If you are sick (vomit) within 2 hours of taking
a tablet your body may not get its usual dose
of hormones from that pill and you should take
another pill as soon as possible. Follow the
instructions in section 3.4 A lost pill. If you are
not able to take another pill within 3 hours use
extra contraception for the next 7 days, such
as condoms.
If you are persistently sick or have very bad
diarrhoea, use extra contraception during the
illness and for the 7 days after recovery, such
as condoms.

3.6 Taking more than one pill
should not cause harm
It is unlikely that taking more than one pill will
do you any harm but you may feel sick, vomit or
have some vaginal bleeding. Talk to your doctor if
you have any of these symptoms.

3.7 When you want to get
pregnant
If you are planning a baby, it’s best to use
another method of contraception after stopping
Norgeston until you have had a proper period.
Your doctor or midwife relies on the date of your
last natural period to tell you when your baby is
due. However, it will not cause you or the baby
any harm if you get pregnant straight away.

4 Possible side effects
Like all medicines, Norgeston can cause side
effects, although not everybody gets them.
. Tell your doctor, pharmacist or family
planning nurse if you are worried about any
side effects which you think may be due to
Norgeston.

4.1 Serious side effects – see a
doctor straight away
Signs of a blood clot:
Ra migraine for the first time, a migraine that
is worse than normal, or unusually frequent
or severe headaches
Rany sudden changes to your eyesight (such
as loss of vision or blurred vision)
Rany sudden changes to your hearing,
speech, sense of smell, taste or touch
Rpain or swelling in your leg
Rstabbing pain when you breathe
Rcoughing for no apparent reason
Rpain and tightness in the chest
Rsudden weakness or numbness in one side or
part of your body
Rdizziness or fainting.
Signs of a severe allergic reaction to
Norgeston:
Rswelling of the face, lips, mouth, tongue or
throat.
Signs of breast cancer include:
Rdimpling of the skin
Rchanges in the nipple
Rany lumps you can see or feel.

Signs of severe liver problems include:
Rsevere pain in your upper abdomen
Ryellow skin or eyes ( jaundice)
Rinflammation of the liver (hepatitis)
Ryour whole body starts itching.
. If you think you may have any of these,
see a doctor straight away. You may need
to stop taking Norgeston.

4.2 Less serious side effects
Rbleeding and spotting between your
periods
Rno periods
Rallergic reactions, including wheezing, rash
or reddened skin.
Rdepressive moods, loss of interest in sex
Rheadaches or migraine
Rdizziness
Rfeeling sick or being sick
Rputting on weight or losing weight.
. Tell your doctor, pharmacist or family
planning nurse if you are worried about
any side effects which you think may be due
to Norgeston. Also tell them if any existing
conditions get worse while you are taking
Norgeston.

4.3 If your periods seem different
A few women have irregular periods, a little
unexpected bleeding or spotting or no periods at
all while they are taking Norgeston, especially
during the first few months. Normally, these
changes are nothing to worry about and require
no treatment. Keep taking Norgeston as usual.
The problem should disappear after the first few
strips.
You may also have unexpected bleeding if you are
not taking your pills regularly, so try to take your
pill at the same time every day. Also, unexpected
bleeding can sometimes be caused by other
medicines.
. Make an appointment to see your doctor if
Ryou get breakthrough bleeding or spotting
that:
P carries on for more than the first few
months
P starts after you’ve been taking Norgeston
for a while
P carries on even after you’ve stopped
taking Norgeston.
Ryou have had no period for 6 weeks.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store Norgeston
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 packaging after EXP. The
expiry date refers to the last day of that month.
Do not throw away any medicines down a drain
or into a bin. Ask your pharmacist what to do with
any medicines you do not want. This will help to
protect the environment.

6 What is in Norgeston and who
makes it
What is in Norgeston
Each box of Norgeston contains one memo strip
of 35 white tablets.
Each tablet contains: 30 micrograms of the
progestogen levonorgestrel.
Norgeston also contains the inactive ingredients:
lactose, maize starch, povidone, polyethylene
glycol 6000, calcium carbonate (E170), talc,
magnesium stearate (E 572), sucrose, montan
glycol wax.
The company that holds the product licence
for Norgeston is:
Bayer plc, Bayer House, Strawberry Hill,
Newbury, Berkshire, RG14 1JA.
Norgeston is made by:
Bayer Pharma AG, Berlin, Germany or
Bayer Weimar GmbH & Co KG, Weimar, Germany.
This leaflet was last revised in July 2016.

85148095

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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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