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POSTINOR ONE STEP 1500 MICROGRAM TABLET

Active substance(s): LEVONORGESTREL

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Transcript
Ref: 1177/180216/1/F

Levonelle ® One Step 1500 microgram Tablet
(levonorgestrel)
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
• Always take this medicine exactly as described in
this leaflet or as your pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice. 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.
Your medicine is called Levonelle One Step 1500
microgram Tablets, but will be referred to as
Levonelle One Step throughout the leaflet.

What is in this leaflet:
1 What Levonelle One Step is and what it is
used for
2 What you need to know before you take
Levonelle One Step
3 How to take Levonelle One Step
4 Possible side effects
5 How to store Levonelle One Step
6 Contents of the pack and other information

1

What Levonelle One Step is and what it
is used for

Levonelle One Step is an emergency contraceptive
that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has
failed.
Levonelle One Step contains a synthetic hormone
like substance called levonorgestrel. It prevents
about 84% of expected pregnancies when you take
it within 72 hours of having unprotected sex. It will
not prevent a pregnancy every time and is more
effective if you take it as soon as possible after
unprotected sex. It is better to take it within 12 hours
rather than delay until the third day.
Levonelle One Step is thought to work by:
• stopping your ovaries from releasing an egg;
•preventing sperm from fertilising any egg you may
have already released;
• stopping a fertilised egg from attaching itself to
your womb lining.
Levonelle One Step can only prevent you becoming
pregnant if you take it within 72 hours of unprotected
sex. It does not work if you are already pregnant. If
you have unprotected sex after taking Levonelle
One Step, it will not stop you from becoming
pregnant.
2

What you need to know before you take
Levonelle One Step

Do not use Levonelle One Step if:
• you are allergic to levonorgestrel or any of the
other ingredients of this medicine listed in
section 6.
Warnings and precautions
If any of the following applies to you, talk to your
doctor before taking Levonelle One Step as
emergency contraception may not be suitable for
you. Your doctor may prescribe another type of
emergency contraception for you.
• If you are pregnant or think that you may already
be pregnant. This medicine will not work if you are
already pregnant. If you are already pregnant,
Levonelle One Step cannot terminate pregnancy,
so Levonelle One Step is not an “abortion pill”.
You may already be pregnant if:
• your period is more than 5 days late, or you have
experienced unusual bleeding when your next
period is due
• you have had unprotected sex more than 72 hours
ago, and since your last period.
Children and adolescents
Levonelle One Step is not recommended for young
women under 16 years of age without medical
supervision.
The use of Levonelle One Step is not advised if:
• you have a disease of your small bowel (such as
Crohn’s disease) that inhibits the absorption of the
drug
• you have severe liver problems
• you have a history of ectopic pregnancy (where
the baby develops somewhere outside the womb)
• you have ever had a disease called salpingitis
(inflammation of the Fallopian tubes).
A previous ectopic pregnancy or previous infection
of the fallopian tubes increases the risk of a new
ectopic pregnancy.
Your doctor may decide that Levonelle One Step is
not suitable for you, or that another type of
emergency contraception would be better for you.

In all women, emergency contraception should be
taken as soon as possible after unprotected intercourse. There is some evidence that Levonelle One
Step may be less effective with increasing body
weight or body mass index (BMI), but these data
were limited and inconclusive.
Therefore, Levonelle One Step is still recommended
for all women regardless of their weight or BMI.
You are advised to speak to a healthcare
professional if you are concerned about any
problems related to taking emergency contraception.
If you are worried about sexually transmitted
diseases
If you did not use a condom (or if it has been torn or
slid down) during the intercourse, it might be
possible that you have caught a sexually transmitted
disease or the HIV virus.
This medicine will not protect you against sexually
transmitted diseases, only condoms can do this.
Ask your doctor, nurse, family planning clinic or
pharmacist for advice if you are worried about this.
Other medicines and Levonelle One Step
Tell your pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines may prevent Levonelle One Step
from working properly, these include:
• barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and
carbamazepine)
• medicines used to treat tuberculosis (for example,
rifampicin, rifabutin)
• a treatment for HIV infection (ritonavir)
• a medicine used to treat fungal infections
(griseofulvin)
• herbal remedies containing St John’s wort
(Hypericum perforatum)
• a medicine called ciclosporin (suppresses the
immune system).
How often can you use Levonelle One Step
You should only use Levonelle One Step in
emergencies and not as a regular method of
contraception.
If Levonelle One Step is used more than once in a
menstrual cycle it is more likely to upset your
menstrual cycle (period).
Levonelle One Step does not work as well as
regular methods of contraception. Your doctor,
practice nurse or family planning clinic can tell you
about long-term methods of contraception which are
more effective in preventing you from getting
pregnant.
Pregnancy, breast-feeding and fertility
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
You should not take this medicine if you are already
pregnant. If you do become pregnant even after
taking this medicine, it is important that you see your
doctor. There is no evidence that Levonelle One
Step will harm a baby that develops in your
uterus/womb if you use Levonelle One Step as
described. Nevertheless, your doctor may want to
check that the pregnancy is not ectopic (where the
baby develops somewhere outside the womb). This
is especially important if you develop severe
abdominal pain after taking Levonelle One Step or if
you have previously had an ectopic pregnancy,
Fallopian tube surgery or pelvic inflammatory
disease.
Breast-feeding
Very small amounts of the active ingredient of this
medicine may appear in your breast milk. This is not
thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a
breast-feeding and avoid nursing at least 8 hours
following tablet taking. In this way you are taking
your tablet well before the next feed and reducing
the amount of active ingredient your baby may take
in with the breast milk.
Fertility
Levonelle One Step increases the possibility of menstruation disturbances which can sometimes lead to
earlier or later ovulation date. These changes can
result in modified fertility date, however there are no
fertility data in the long term.
Driving and using machines
Your Levonelle One Step tablet is unlikely to affect
your ability to drive a car or use machines. However,
if you feel tired or dizzy do not drive or operate
machinery.

Levonelle One Step tablet contains lactose
In case of milk sugar (lactose) intolerance it should
be considered that each Levonelle One Step tablet
also contains 142.5 mg lactose monohydrate.
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 Levonelle One Step

Always use this medicine exactly as described in the
leaflet or as your pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
Use in children and adolescents
This medicine is not recommended for use in
children. If you are under 16, you must visit your
doctor or family planning clinic to get emergency
contraception.

• Take the tablet as soon as possible, preferably

within 12 hours, and no later than 72 hours (3
days) after you have had unprotected sex.
Levonelle One Step can be taken at any time in
your menstrual cycle assuming you are not
already pregnant or think you may be pregnant.
Do not chew but swallow the tablet whole with
water. Do not delay taking the tablet. The tablet
works better the sooner you take it after having
unprotected sex.

• If you are already using a regular method of


contraception such as the contraceptive pill, you
can continue to take this at your regular times.
If another unprotected intercourse takes place
after the use of Levonelle One Step (also if this is
during the same menstrual cycle), the tablet will
not exert its contraceptive effect and there is again
the risk of pregnancy.

What to do if you are sick (vomit)
If you are sick (vomit) within three hours of taking
the tablet, you should take another tablet. You will
need to contact your pharmacist, doctor, practice
nurse or family planning clinic immediately for one
more tablet.
After you have taken Levonelle One Step
After you have taken Levonelle One Step, if you
want to have sex, and are not using the
contraceptive pill, you should use condoms or a cap
plus spermicide until your next menstrual period.
This is because Levonelle One Step won’t work if
you have unprotected sex again, before your next
period is due.
After you have taken Levonelle One Step, you are
advised to make an appointment to see your doctor
about three weeks later, to make sure that Levonelle
One Step has worked. If your period is more than 5
days late or is unusually light or unusually heavy,
you should contact your doctor as soon as possible.
If you do become pregnant even after taking this
medicine, it is important that you see your doctor.
Your doctor can also tell you about longer-term
methods of contraception which are more effective
in preventing you from getting pregnant.
If you continue to use regular hormonal
contraception such as the contraceptive pill and you
do not have a bleed in your pill-free period, see your
doctor to make sure you are not pregnant.
Your next period after you took Levonelle One
Step
After the use of Levonelle One Step, your period is
usually normal and will start at the usual day;
however sometimes, this will be a few days later or
earlier. If your period starts more than 5 days later
than expected, an ‘abnormal’ bleeding occurs at that
time or if you think that you might be pregnant, you
should check whether you are pregnant by a
pregnancy test.
If you take more Levonelle One Step than you
should
Although there have been no reports of serious
harmful effects from taking too many tablets at once,
you may feel sick, actually be sick (vomit), or have
vaginal bleeding. You should ask your pharmacist,
doctor, practice nurse or family planning clinic for
advice, especially if you have been sick, as the
tablet may not have worked properly.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Possible side effects

4

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Very common (may affect more than 1 in 10
people):
• Feeling sick (nausea)
• You might have some irregular bleeding until your
next period
• You might have lower abdominal pain
• Tiredness
• Headache.
Common (may affect up to 1 in 10 people):
• Being sick (vomiting). If you are sick, read the
section ‘What to do if you are sick (vomit) ’.
• Your period might be different. Most women will
have a normal period at the expected time, but
some may have their period later or earlier than
normal. You might also have some irregular
bleeding or spotting until your next period. If your
period is more than 5 days late or is unusually light
or unusually heavy, you should contact your
doctor as soon as possible.
• You might have tender breasts, diarrhoea, feel
dizzy after taking this medicine.
Very rare effects (may affect up to 1 in 10000
people):
• Abdominal pain, rash, urticaria, pruritus, swelling
of the face, pelvic pain, painful period.
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 Levonelle One Step

Store in original container.
KEEP THIS MEDICINE OUT OF SIGHT AND
REACH OF CHILDREN.
Do not use Levonelle One Step after the expiry date
which is stated on the package “after EXP “. The
expiry date refers to the last day of the month.
If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist
who will tell you what to do.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protecet the environment.
6

Contents of the pack and other
information

What Levonelle One Step contains
Each pack of Levonelle One Step contains a
complete treatment which is one round, white tablet,
marked "G00" on one side and plain on the other
side.
The tablet contains 1500 micrograms of
Levonorgestrel, which is the active ingredient.
Levonelle One Step also contain potato starch,
maize starch, collodial silica anhydrous, magnesium
stearate, talc and lactose monohydrate.
Manufacturer and Licence Holder
Levonelle One Step is manufactured by Schering
GmbH CO Produktions KG Dobereinerstrasse 20,
D-99427 Weimar Germany and is procured from
within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If after reading this leaflet, you are not sure about
anything or you have any questions, please ask your
pharmacist, doctor, practice nurse or family planning
clinic.

P

PL 15184/1177

Leaflet revision date: 18/02/16
Levonelle is a registered trademark of Bayer
Intellectual Property GmbH
For more information, you can also contact the
company who distribute Levonelle One Step in the
UK.
The address is: Schering Health Care Limited, The
Brow, Burgess Hill, West Sussex, RH15 9NE
The E-mail address is:
customer.care@schering.co.uk (Monday to
Friday)

Ref: 1177/180216/1/B

Ref: 1177/180216/1/F

Postinor ® One Step 1500 microgram Tablet
(levonorgestrel)
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
• Always take this medicine exactly as described in
this leaflet or as your pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice. 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.

Your doctor may decide that Postinor One Step is
not suitable for you, or that another type of
emergency contraception would be better for you.

Your medicine is called Postinor One Step 1500
microgram Tablets, but will be referred to as
Postinor One Step throughout the leaflet.

Therefore, Postinor One Step is still recommended
for all women regardless of their weight or BMI.

What is in this leaflet:

You are advised to speak to a healthcare
professional if you are concerned about any
problems related to taking emergency contraception.

1 What Postinor One Step is and what it is
used for
2 What you need to know before you take
Postinor One Step
3 How to take Postinor One Step
4 Possible side effects
5 How to store Postinor One Step
6 Contents of the pack and other information

1

What Postinor One Step is and what it
is used for

Postinor One Step is an emergency contraceptive
that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has
failed.
Postinor One Step contains a synthetic hormone like
substance called levonorgestrel. It prevents about
84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if
you take it as soon as possible after unprotected
sex. It is better to take it within 12 hours rather than
delay until the third day.
Postinor One Step is thought to work by:
• stopping your ovaries from releasing an egg;
•preventing sperm from fertilising any egg you may
have already released;
• stopping a fertilised egg from attaching itself to
your womb lining.
Postinor One Step can only prevent you becoming
pregnant if you take it within 72 hours of unprotected
sex. It does not work if you are already pregnant. If
you have unprotected sex after taking Postinor One
Step, it will not stop you from becoming
pregnant.
2

What you need to know before you take
Postinor One Step

Do not use Postinor One Step if:
• you are allergic to levonorgestrel or any of the
other ingredients of this medicine listed in
section 6.
Warnings and precautions
If any of the following applies to you, talk to your
doctor before taking Postinor One Step as
emergency contraception may not be suitable for
you. Your doctor may prescribe another type of
emergency contraception for you.
• If you are pregnant or think that you may already
be pregnant. This medicine will not work if you are
already pregnant. If you are already pregnant,
Postinor One Step cannot terminate pregnancy,
so Postinor One Step is not an “abortion pill”.
You may already be pregnant if:
• your period is more than 5 days late, or you have
experienced unusual bleeding when your next
period is due
• you have had unprotected sex more than 72 hours
ago, and since your last period.
Children and adolescents
Postinor One Step is not recommended for young
women under 16 years of age without medical
supervision.
The use of Postinor One Step is not advised if:
• you have a disease of your small bowel (such as
Crohn’s disease) that inhibits the absorption of the
drug
• you have severe liver problems
• you have a history of ectopic pregnancy (where
the baby develops somewhere outside the womb)
• you have ever had a disease called salpingitis
(inflammation of the Fallopian tubes).
A previous ectopic pregnancy or previous infection
of the fallopian tubes increases the risk of a new
ectopic pregnancy.

In all women, emergency contraception should be
taken as soon as possible after unprotected intercourse. There is some evidence that Postinor One
Step may be less effective with increasing body
weight or body mass index (BMI), but these data
were limited and inconclusive.

If you are worried about sexually transmitted
diseases
If you did not use a condom (or if it has been torn or
slid down) during the intercourse, it might be
possible that you have caught a sexually transmitted
disease or the HIV virus.
This medicine will not protect you against sexually
transmitted diseases, only condoms can do this.
Ask your doctor, nurse, family planning clinic or
pharmacist for advice if you are worried about this.
Other medicines and Postinor One Step
Tell your pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines may prevent Postinor One Step
from working properly, these include:
• barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and
carbamazepine)
• medicines used to treat tuberculosis (for example,
rifampicin, rifabutin)
• a treatment for HIV infection (ritonavir)
• a medicine used to treat fungal infections
(griseofulvin)
• herbal remedies containing St John’s wort
(Hypericum perforatum)
• a medicine called ciclosporin (suppresses the
immune system).
How often can you use Postinor One Step
You should only use Postinor One Step in
emergencies and not as a regular method of
contraception.
If Postinor One Step is used more than once in a
menstrual cycle it is more likely to upset your
menstrual cycle (period).
Postinor One Step does not work as well as
regular methods of contraception. Your doctor,
practice nurse or family planning clinic can tell you
about long-term methods of contraception which are
more effective in preventing you from getting
pregnant.
Pregnancy, breast-feeding and fertility
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
You should not take this medicine if you are already
pregnant. If you do become pregnant even after
taking this medicine, it is important that you see your
doctor. There is no evidence that Postinor One Step
will harm a baby that develops in your uterus/womb
if you use Postinor One Step as described.
Nevertheless, your doctor may want to check that
the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe
abdominal pain after taking Postinor One Step or if
you have previously had an ectopic pregnancy,
Fallopian tube surgery or pelvic inflammatory
disease.
Breast-feeding
Very small amounts of the active ingredient of this
medicine may appear in your breast milk. This is not
thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a
breast-feeding and avoid nursing at least 8 hours
following tablet taking. In this way you are taking
your tablet well before the next feed and reducing
the amount of active ingredient your baby may take
in with the breast milk.
Fertility
Postinor One Step increases the possibility of menstruation disturbances which can sometimes lead to
earlier or later ovulation date. These changes can
result in modified fertility date, however there are no
fertility data in the long term.

Driving and using machines
Your Postinor One Step tablet is unlikely to affect
your ability to drive a car or use machines. However,
if you feel tired or dizzy do not drive or operate
machinery.
Postinor One Step tablet contains lactose
In case of milk sugar (lactose) intolerance it should
be considered that each Postinor One Step tablet
also contains 142.5 mg lactose monohydrate.
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 Postinor One Step

Always use this medicine exactly as described in the
leaflet or as your pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
Use in children and adolescents
This medicine is not recommended for use in
children. If you are under 16, you must visit your
doctor or family planning clinic to get emergency
contraception.

• Take the tablet as soon as possible, preferably

within 12 hours, and no later than 72 hours (3
days) after you have had unprotected sex.
Postinor One Step can be taken at any time in
your menstrual cycle assuming you are not
already pregnant or think you may be pregnant.
Do not chew but swallow the tablet whole with
water. Do not delay taking the tablet. The tablet
works better the sooner you take it after having
unprotected sex.

• If you are already using a regular method of


contraception such as the contraceptive pill, you
can continue to take this at your regular times.
If another unprotected intercourse takes place
after the use of Postinor One Step (also if this is
during the same menstrual cycle), the tablet will
not exert its contraceptive effect and there is again
the risk of pregnancy.

What to do if you are sick (vomit)
If you are sick (vomit) within three hours of taking
the tablet, you should take another tablet. You will
need to contact your pharmacist, doctor, practice
nurse or family planning clinic immediately for one
more tablet.
After you have taken Postinor One Step
After you have taken Postinor One Step, if you want
to have sex, and are not using the
contraceptive pill, you should use condoms or a cap
plus spermicide until your next menstrual period.
This is because Postinor One Step won’t work if you
have unprotected sex again, before your next period
is due.
After you have taken Postinor One Step, you are
advised to make an appointment to see your doctor
about three weeks later, to make sure that Postinor
One Step has worked. If your period is more than 5
days late or is unusually light or unusually heavy,
you should contact your doctor as soon as possible.
If you do become pregnant even after taking this
medicine, it is important that you see your doctor.
Your doctor can also tell you about longer-term
methods of contraception which are more effective
in preventing you from getting pregnant.
If you continue to use regular hormonal
contraception such as the contraceptive pill and you
do not have a bleed in your pill-free period, see your
doctor to make sure you are not pregnant.
Your next period after you took Postinor One
Step
After the use of Postinor One Step, your period is
usually normal and will start at the usual day;
however sometimes, this will be a few days later or
earlier. If your period starts more than 5 days later
than expected, an ‘abnormal’ bleeding occurs at that
time or if you think that you might be pregnant, you
should check whether you are pregnant by a
pregnancy test.

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Very common (may affect more than 1 in 10
people):
• Feeling sick (nausea)
• You might have some irregular bleeding until your
next period
• You might have lower abdominal pain
• Tiredness
• Headache.
Common (may affect up to 1 in 10 people):
• Being sick (vomiting). If you are sick, read the
section ‘What to do if you are sick (vomit) ’.
• Your period might be different. Most women will
have a normal period at the expected time, but
some may have their period later or earlier than
normal. You might also have some irregular
bleeding or spotting until your next period. If your
period is more than 5 days late or is unusually light
or unusually heavy, you should contact your
doctor as soon as possible.
• You might have tender breasts, diarrhoea, feel
dizzy after taking this medicine.
Very rare effects (may affect up to 1 in 10000
people):
• Abdominal pain, rash, urticaria, pruritus, swelling
of the face, pelvic pain, painful period.
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 Postinor One Step

Store in original container.
KEEP THIS MEDICINE OUT OF SIGHT AND
REACH OF CHILDREN.
Do not use Postinor One Step after the expiry date
which is stated on the package “after EXP “. The
expiry date refers to the last day of the month.
If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist
who will tell you what to do.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protecet the environment.
6

Contents of the pack and other
information

What Postinor One Step contains
Each pack of Postinor One Step contains a
complete treatment which is one round, white tablet,
marked "G00" on one side and plain on the other
side.
The tablet contains 1500 micrograms of
Levonorgestrel, which is the active ingredient.
Postinor One Step also contain potato starch, maize
starch, collodial silica anhydrous, magnesium
stearate, talc and lactose monohydrate.
Manufacturer and Licence Holder
Postinor One Step is manufactured by Schering
GmbH CO Produktions KG Dobereinerstrasse 20,
D-99427 Weimar Germany and is procured from
within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If after reading this leaflet, you are not sure about
anything or you have any questions, please ask your
pharmacist, doctor, practice nurse or family planning
clinic.

P

PL 15184/1177

Leaflet revision date: 18/02/16
If you take more Postinor One Step than you
should
Although there have been no reports of serious
harmful effects from taking too many tablets at once,
you may feel sick, actually be sick (vomit), or have
vaginal bleeding. You should ask your pharmacist,
doctor, practice nurse or family planning clinic for
advice, especially if you have been sick, as the
tablet may not have worked properly.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Postinor is a registered trademark of Bayer
Intellectual Property GmbH
For more information, you can also contact the
company who distribute Postinor One Step in the
UK.
The address is: Schering Health Care Limited, The
Brow, Burgess Hill, West Sussex, RH15 9NE
The E-mail address is:
customer.care@schering.co.uk (Monday to
Friday)

Ref: 1177/180216/1/B

Ref: 1177/180216/1/F

Levonorgestrel One Step 1500 microgram Tablet
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
• Always take this medicine exactly as described in
this leaflet or as your pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice. 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.
Your medicine is called Levonorgestrel One Step
1500
microgram Tablets, but will be referred to as
Levonorgestrel One Step throughout the leaflet.

What is in this leaflet:
1
2
3
4
5
6

1

What Levonorgestrel One Step is and what it is
used for
What you need to know before you take
Levonorgestrel One Step
How to take Levonorgestrel One Step
Possible side effects
How to store Levonorgestrel One Step
Contents of the pack and other information

What Levonorgestrel One Step is and
what it is used for

Levonorgestrel One Step is an emergency contraceptive that can be used within 72 hours (3 days) of
unprotected sex or if your usual contraceptive
method has failed.
Levonorgestrel One Step contains a synthetic hormone like substance called levonorgestrel. It prevents about 84% of expected pregnancies when you
take it within 72 hours of having unprotected sex. It
will not prevent a pregnancy every time and is more
effective if you take it as soon as possible after
unprotected sex. It is better to take it within 12 hours
rather than delay until the third day.
Levonorgestrel One Step is thought to work by:
• stopping your ovaries from releasing an egg;
•preventing sperm from fertilising any egg you may
have already released;
• stopping a fertilised egg from attaching itself to
your womb lining.
Levonorgestrel One Step can only prevent you
becoming pregnant if you take it within 72 hours of
unprotected sex. It does not work if you are already
pregnant. If you have unprotected sex after taking
Levonorgestrel One Step, it will not stop you from
becoming pregnant.
2

What you need to know before you take
Levonorgestrel One Step

Do not use Levonorgestrel One Step if:
• you are allergic to levonorgestrel or any of the
other ingredients of this medicine listed in
section 6.
Warnings and precautions
If any of the following applies to you, talk to your
doctor before taking Levonorgestrel One Step as
emergency contraception may not be suitable for
you. Your doctor may prescribe another type of
emergency contraception for you.
• If you are pregnant or think that you may already
be pregnant. This medicine will not work if you are
already pregnant. If you are already pregnant,
Levonorgestrel One Step cannot terminate
pregnancy, so Levonorgestrel One Step is not an
“abortion pill”.
You may already be pregnant if:
• your period is more than 5 days late, or you have
experienced unusual bleeding when your next
period is due
• you have had unprotected sex more than 72 hours
ago, and since your last period.
Children and adolescents
Levonorgestrel One Step is not recommended for
young women under 16 years of age without medical supervision.
The use of Levonorgestrel One Step is not advised
if:
• you have a disease of your small bowel (such as
Crohn’s disease) that inhibits the absorption of the
drug
• you have severe liver problems
• you have a history of ectopic pregnancy (where
the baby develops somewhere outside the womb)
• you have ever had a disease called salpingitis
(inflammation of the Fallopian tubes).

A previous ectopic pregnancy or previous infection
of the fallopian tubes increases the risk of a new
ectopic pregnancy.
Your doctor may decide that Levonorgestrel One
Step is not suitable for you, or that another type of
emergency contraception would be better for you.
In all women, emergency contraception should be
taken as soon as possible after unprotected intercourse. There is some evidence that Levonorgestrel
One Step may be less effective with increasing body
weight or body mass index (BMI), but these data
were limited and inconclusive.
Therefore, Levonorgestrel One Step is still recommended for all women regardless of their weight or
BMI.
You are advised to speak to a healthcare
professional if you are concerned about any
problems related to taking emergency contraception.
If you are worried about sexually transmitted
diseases
If you did not use a condom (or if it has been torn or
slid down) during the intercourse, it might be
possible that you have caught a sexually transmitted
disease or the HIV virus.
This medicine will not protect you against sexually
transmitted diseases, only condoms can do this.
Ask your doctor, nurse, family planning clinic or
pharmacist for advice if you are worried about this.
Other medicines and Levonorgestrel One Step
Tell your pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines may prevent Levonorgestrel One
Step from working properly, these include:
• barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and
carbamazepine)
• medicines used to treat tuberculosis (for example,
rifampicin, rifabutin)
• a treatment for HIV infection (ritonavir)
• a medicine used to treat fungal infections
(griseofulvin)
• herbal remedies containing St John’s wort
(Hypericum perforatum)
• a medicine called ciclosporin (suppresses the
immune system).
How often can you use Levonorgestrel One Step
You should only use Levonorgestrel One Step in
emergencies and not as a regular method of
contraception.
If Levonorgestrel One Step is used more than once
in a menstrual cycle it is more likely to upset your
menstrual cycle (period).
Levonorgestrel One Step does not work as well as
regular methods of contraception. Your doctor,
practice nurse or family planning clinic can tell you
about long-term methods of contraception which are
more effective in preventing you from getting
pregnant.
Pregnancy, breast-feeding and fertility
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
You should not take this medicine if you are already
pregnant. If you do become pregnant even after
taking this medicine, it is important that you see your
doctor. There is no evidence that Levonorgestrel
One Step will harm a baby that develops in your
uterus/womb if you use Levonorgestrel One Step as
described. Nevertheless, your doctor may want to
check that the pregnancy is not ectopic (where the
baby develops somewhere outside the womb). This
is especially important if you develop severe
abdominal pain after taking Levonorgestrel One
Step or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory
disease.
Breast-feeding
Very small amounts of the active ingredient of this
medicine may appear in your breast milk. This is not
thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a
breast-feeding and avoid nursing at least 8 hours
following tablet taking. In this way you are taking
your tablet well before the next feed and reducing
the amount of active ingredient your baby may take
in with the breast milk.
Fertility
Levonorgestrel One Step increases the possibility of
menstruation disturbances which can sometimes
lead to earlier or later ovulation date. These
changes can result in modified fertility date, however
there are no fertility data in the long term.

Driving and using machines
Your Levonorgestrel One Step tablet is unlikely to
affect your ability to drive a car or use machines.
However, if you feel tired or dizzy do not drive or
operate machinery.
Levonorgestrel One Step tablet contains lactose
In case of milk sugar (lactose) intolerance it should
be considered that each Levonorgestrel One Step
tablet also contains 142.5 mg lactose monohydrate.
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 Levonorgestrel One Step

Always use this medicine exactly as described in the
leaflet or as your pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
Use in children and adolescents
This medicine is not recommended for use in
children. If you are under 16, you must visit your
doctor or family planning clinic to get emergency
contraception.

• Take the tablet as soon as possible, preferably

within 12 hours, and no later than 72 hours (3
days) after you have had unprotected sex.
Levonorgestrel One Step can be taken at any time
in your menstrual cycle assuming you are not
already pregnant or think you may be pregnant.
Do not chew but swallow the tablet whole with
water. Do not delay taking the tablet. The tablet
works better the sooner you take it after having
unprotected sex.

• If you are already using a regular method of


contraception such as the contraceptive pill, you
can continue to take this at your regular times.
If another unprotected intercourse takes place
after the use of Levonorgestrel One Step (also if
this is during the same menstrual cycle), the tablet
will not exert its contraceptive effect and there is
again the risk of pregnancy.

What to do if you are sick (vomit)
If you are sick (vomit) within three hours of taking
the tablet, you should take another tablet. You will
need to contact your pharmacist, doctor, practice
nurse or family planning clinic immediately for one
more tablet.
After you have taken Levonorgestrel One Step
After you have taken Levonorgestrel One Step, if
you want to have sex, and are not using the
contraceptive pill, you should use condoms or a cap
plus spermicide until your next menstrual period.
This is because Levonorgestrel One Step won’t
work if you have unprotected sex again, before your
next period is due.
After you have taken Levonorgestrel One Step, you
are advised to make an appointment to see your
doctor about three weeks later, to make sure that
Levonorgestrel One Step has worked. If your period
is more than 5 days late or is unusually light or
unusually heavy, you should contact your doctor as
soon as possible. If you do become pregnant even
after taking this medicine, it is important that you see
your doctor.
Your doctor can also tell you about longer-term
methods of contraception which are more effective
in preventing you from getting pregnant.
If you continue to use regular hormonal
contraception such as the contraceptive pill and you
do not have a bleed in your pill-free period, see your
doctor to make sure you are not pregnant.
Your next period after you took Levonorgestrel
One Step
After the use of Levonorgestrel One Step, your period is usually normal and will start at the usual day;
however sometimes, this will be a few days later or
earlier. If your period starts more than 5 days later
than expected, an ‘abnormal’ bleeding occurs at that
time or if you think that you might be pregnant, you
should check whether you are pregnant by a
pregnancy test.
If you take more Levonorgestrel One Step than
you should
Although there have been no reports of serious
harmful effects from taking too many tablets at once,
you may feel sick, actually be sick (vomit), or have
vaginal bleeding. You should ask your pharmacist,
doctor, practice nurse or family planning clinic for
advice, especially if you have been sick, as the
tablet may not have worked properly.

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Very common (may affect more than 1 in 10
people):
• Feeling sick (nausea)
• You might have some irregular bleeding until your
next period
• You might have lower abdominal pain
• Tiredness
• Headache.
Common (may affect up to 1 in 10 people):
• Being sick (vomiting). If you are sick, read the
section ‘What to do if you are sick (vomit) ’.
• Your period might be different. Most women will
have a normal period at the expected time, but
some may have their period later or earlier than
normal. You might also have some irregular
bleeding or spotting until your next period. If your
period is more than 5 days late or is unusually light
or unusually heavy, you should contact your
doctor as soon as possible.
• You might have tender breasts, diarrhoea, feel
dizzy after taking this medicine.
Very rare effects (may affect up to 1 in 10000
people):
• Abdominal pain, rash, urticaria, pruritus, swelling
of the face, pelvic pain, painful period.
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 Levonorgestrel One Step

Store in original container.
KEEP THIS MEDICINE OUT OF SIGHT AND
REACH OF CHILDREN.
Do not use Levonorgestrel One Step after the expiry
date which is stated on the package “after EXP “.
The expiry date refers to the last day of the month.
If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist
who will tell you what to do.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protecet the environment.
6

Contents of the pack and other
information

What Levonorgestrel One Step contains
Each pack of Levonorgestrel One Step contains a
complete treatment which is one round, white tablet,
marked "G00" on one side and plain on the other
side.
The tablet contains 1500 micrograms of
Levonorgestrel, which is the active ingredient.
Levonorgestrel One Step also contain potato starch,
maize starch, collodial silica anhydrous, magnesium
stearate, talc and lactose monohydrate.
Manufacturer and Licence Holder
Levonorgestrel One Step is manufactured by
Schering GmbH CO Produktions KG
Dobereinerstrasse 20, D-99427 Weimar Germany
and is procured from within the EU and repackaged
by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
If after reading this leaflet, you are not sure about
anything or you have any questions, please ask your
pharmacist, doctor, practice nurse or family planning
clinic.

P

PL 15184/1177

Leaflet revision date: 18/02/16
For more information, you can also contact the
company who distribute Levonorgestrel One Step in
the UK.
The address is: Schering Health Care Limited, The
Brow, Burgess Hill, West Sussex, RH15 9NE
The E-mail address is:
customer.care@schering.co.uk (Monday to
Friday)

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Ref: 1177/180216/1/B

Ref: 1177/180216/1/F

Levonelle ® One Step 1500 microgram Tablet
(levonorgestrel)
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
• Always take this medicine exactly as described in
this leaflet or as your pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice. 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.

Your doctor may decide that Levonelle One Step is
not suitable for you, or that another type of
emergency contraception would be better for you.

Your medicine is called Levonelle One Step 1500
microgram Tablets, but will be referred to as
Levonelle One Step throughout the leaflet.

Therefore, Levonelle One Step is still recommended
for all women regardless of their weight or BMI.

What is in this leaflet:

You are advised to speak to a healthcare
professional if you are concerned about any
problems related to taking emergency contraception.

1 What Levonelle One Step is and what it is
used for
2 What you need to know before you take
Levonelle One Step
3 How to take Levonelle One Step
4 Possible side effects
5 How to store Levonelle One Step
6 Contents of the pack and other information

1

What Levonelle One Step is and what it
is used for

Levonelle One Step is an emergency contraceptive
that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has
failed.
Levonelle One Step contains a synthetic hormone
like substance called levonorgestrel. It prevents
about 84% of expected pregnancies when you take
it within 72 hours of having unprotected sex. It will
not prevent a pregnancy every time and is more
effective if you take it as soon as possible after
unprotected sex. It is better to take it within 12 hours
rather than delay until the third day.
Levonelle One Step is thought to work by:
• stopping your ovaries from releasing an egg;
•preventing sperm from fertilising any egg you may
have already released;
• stopping a fertilised egg from attaching itself to
your womb lining.
Levonelle One Step can only prevent you becoming
pregnant if you take it within 72 hours of unprotected
sex. It does not work if you are already pregnant. If
you have unprotected sex after taking Levonelle
One Step, it will not stop you from becoming
pregnant.
2

What you need to know before you take
Levonelle One Step

Do not use Levonelle One Step if:
• you are allergic to levonorgestrel or any of the
other ingredients of this medicine listed in
section 6.
Warnings and precautions
If any of the following applies to you, talk to your
doctor before taking Levonelle One Step as
emergency contraception may not be suitable for
you. Your doctor may prescribe another type of
emergency contraception for you.
• If you are pregnant or think that you may already
be pregnant. This medicine will not work if you are
already pregnant. If you are already pregnant,
Levonelle One Step cannot terminate pregnancy,
so Levonelle One Step is not an “abortion pill”.
You may already be pregnant if:
• your period is more than 5 days late, or you have
experienced unusual bleeding when your next
period is due
• you have had unprotected sex more than 72 hours
ago, and since your last period.
Children and adolescents
Levonelle One Step is not recommended for young
women under 16 years of age without medical
supervision.
The use of Levonelle One Step is not advised if:
• you have a disease of your small bowel (such as
Crohn’s disease) that inhibits the absorption of the
drug
• you have severe liver problems
• you have a history of ectopic pregnancy (where
the baby develops somewhere outside the womb)
• you have ever had a disease called salpingitis
(inflammation of the Fallopian tubes).
A previous ectopic pregnancy or previous infection
of the fallopian tubes increases the risk of a new
ectopic pregnancy.

In all women, emergency contraception should be
taken as soon as possible after unprotected intercourse. There is some evidence that Levonelle One
Step may be less effective with increasing body
weight or body mass index (BMI), but these data
were limited and inconclusive.

If you are worried about sexually transmitted
diseases
If you did not use a condom (or if it has been torn or
slid down) during the intercourse, it might be
possible that you have caught a sexually transmitted
disease or the HIV virus.
This medicine will not protect you against sexually
transmitted diseases, only condoms can do this.
Ask your doctor, nurse, family planning clinic or
pharmacist for advice if you are worried about this.
Other medicines and Levonelle One Step
Tell your pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines may prevent Levonelle One Step
from working properly, these include:
• barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and
carbamazepine)
• medicines used to treat tuberculosis (for example,
rifampicin, rifabutin)
• a treatment for HIV infection (ritonavir)
• a medicine used to treat fungal infections
(griseofulvin)
• herbal remedies containing St John’s wort
(Hypericum perforatum)
• a medicine called ciclosporin (suppresses the
immune system).
How often can you use Levonelle One Step
You should only use Levonelle One Step in
emergencies and not as a regular method of
contraception.
If Levonelle One Step is used more than once in a
menstrual cycle it is more likely to upset your
menstrual cycle (period).
Levonelle One Step does not work as well as
regular methods of contraception. Your doctor,
practice nurse or family planning clinic can tell you
about long-term methods of contraception which are
more effective in preventing you from getting
pregnant.
Pregnancy, breast-feeding and fertility
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
You should not take this medicine if you are already
pregnant. If you do become pregnant even after
taking this medicine, it is important that you see your
doctor. There is no evidence that Levonelle One
Step will harm a baby that develops in your
uterus/womb if you use Levonelle One Step as
described. Nevertheless, your doctor may want to
check that the pregnancy is not ectopic (where the
baby develops somewhere outside the womb). This
is especially important if you develop severe
abdominal pain after taking Levonelle One Step or if
you have previously had an ectopic pregnancy,
Fallopian tube surgery or pelvic inflammatory
disease.
Breast-feeding
Very small amounts of the active ingredient of this
medicine may appear in your breast milk. This is not
thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a
breast-feeding and avoid nursing at least 8 hours
following tablet taking. In this way you are taking
your tablet well before the next feed and reducing
the amount of active ingredient your baby may take
in with the breast milk.
Fertility
Levonelle One Step increases the possibility of menstruation disturbances which can sometimes lead to
earlier or later ovulation date. These changes can
result in modified fertility date, however there are no
fertility data in the long term.

Driving and using machines
Your Levonelle One Step tablet is unlikely to affect
your ability to drive a car or use machines. However,
if you feel tired or dizzy do not drive or operate
machinery.
Levonelle One Step tablet contains lactose
In case of milk sugar (lactose) intolerance it should
be considered that each Levonelle One Step tablet
also contains 142.5 mg lactose monohydrate.
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 Levonelle One Step

Always use this medicine exactly as described in the
leaflet or as your pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
Use in children and adolescents
This medicine is not recommended for use in
children. If you are under 16, you must visit your
doctor or family planning clinic to get emergency
contraception.

• Take the tablet as soon as possible, preferably

within 12 hours, and no later than 72 hours (3
days) after you have had unprotected sex.
Levonelle One Step can be taken at any time in
your menstrual cycle assuming you are not
already pregnant or think you may be pregnant.
Do not chew but swallow the tablet whole with
water. Do not delay taking the tablet. The tablet
works better the sooner you take it after having
unprotected sex.

• If you are already using a regular method of


contraception such as the contraceptive pill, you
can continue to take this at your regular times.
If another unprotected intercourse takes place
after the use of Levonelle One Step (also if this is
during the same menstrual cycle), the tablet will
not exert its contraceptive effect and there is again
the risk of pregnancy.

What to do if you are sick (vomit)
If you are sick (vomit) within three hours of taking
the tablet, you should take another tablet. You will
need to contact your pharmacist, doctor, practice
nurse or family planning clinic immediately for one
more tablet.
After you have taken Levonelle One Step
After you have taken Levonelle One Step, if you
want to have sex, and are not using the
contraceptive pill, you should use condoms or a cap
plus spermicide until your next menstrual period.
This is because Levonelle One Step won’t work if
you have unprotected sex again, before your next
period is due.
After you have taken Levonelle One Step, you are
advised to make an appointment to see your doctor
about three weeks later, to make sure that Levonelle
One Step has worked. If your period is more than 5
days late or is unusually light or unusually heavy,
you should contact your doctor as soon as possible.
If you do become pregnant even after taking this
medicine, it is important that you see your doctor.
Your doctor can also tell you about longer-term
methods of contraception which are more effective
in preventing you from getting pregnant.
If you continue to use regular hormonal
contraception such as the contraceptive pill and you
do not have a bleed in your pill-free period, see your
doctor to make sure you are not pregnant.
Your next period after you took Levonelle One
Step
After the use of Levonelle One Step, your period is
usually normal and will start at the usual day;
however sometimes, this will be a few days later or
earlier. If your period starts more than 5 days later
than expected, an ‘abnormal’ bleeding occurs at that
time or if you think that you might be pregnant, you
should check whether you are pregnant by a
pregnancy test.

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Very common (may affect more than 1 in 10
people):
• Feeling sick (nausea)
• You might have some irregular bleeding until your
next period
• You might have lower abdominal pain
• Tiredness
• Headache.
Common (may affect up to 1 in 10 people):
• Being sick (vomiting). If you are sick, read the
section ‘What to do if you are sick (vomit) ’.
• Your period might be different. Most women will
have a normal period at the expected time, but
some may have their period later or earlier than
normal. You might also have some irregular
bleeding or spotting until your next period. If your
period is more than 5 days late or is unusually light
or unusually heavy, you should contact your
doctor as soon as possible.
• You might have tender breasts, diarrhoea, feel
dizzy after taking this medicine.
Very rare effects (may affect up to 1 in 10000
people):
• Abdominal pain, rash, urticaria, pruritus, swelling
of the face, pelvic pain, painful period.
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 Levonelle One Step

Store in original container.
KEEP THIS MEDICINE OUT OF SIGHT AND
REACH OF CHILDREN.
Do not use Levonelle One Step after the expiry date
which is stated on the package “after EXP “. The
expiry date refers to the last day of the month.
If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist
who will tell you what to do.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protecet the environment.
6

Contents of the pack and other
information

What Levonelle One Step contains
Each pack of Levonelle One Step contains a
complete treatment which is one round, white tablet,
marked "G00" on one side and plain on the other
side.
The tablet contains 1500 micrograms of
Levonorgestrel, which is the active ingredient.
Levonelle One Step also contain potato starch,
maize starch, collodial silica anhydrous, magnesium
stearate, talc and lactose monohydrate.
Manufacturer and Licence Holder
Levonelle One Step is manufactured by Bayer
Schering Pharma AG Mullerstrasse 170-178.
D-13353 Berlin Germany and is procured from
within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If after reading this leaflet, you are not sure about
anything or you have any questions, please ask your
pharmacist, doctor, practice nurse or family planning
clinic.

P PL 15184/1177
Leaflet revision date: 18/02/16

If you take more Levonelle One Step than you
should
Although there have been no reports of serious
harmful effects from taking too many tablets at once,
you may feel sick, actually be sick (vomit), or have
vaginal bleeding. You should ask your pharmacist,
doctor, practice nurse or family planning clinic for
advice, especially if you have been sick, as the
tablet may not have worked properly.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Levonelle is a registered trademark of Bayer
Intellectual Property GmbH
For more information, you can also contact the
company who distribute Levonelle One Step in the
UK.
The address is: Schering Health Care Limited, The
Brow, Burgess Hill, West Sussex, RH15 9NE
The E-mail address is:
customer.care@schering.co.uk (Monday to
Friday)

Ref: 1177/180216/1/B

Ref: 1177/180216/1/F

Postinor ® One Step 1500 microgram Tablet
(levonorgestrel)
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
• Always take this medicine exactly as described in
this leaflet or as your pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice. 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.

Your doctor may decide that Postinor One Step is
not suitable for you, or that another type of
emergency contraception would be better for you.

Your medicine is called Postinor One Step 1500
microgram Tablets, but will be referred to as
Postinor One Step throughout the leaflet.

Therefore, Postinor One Step is still recommended
for all women regardless of their weight or BMI.

What is in this leaflet:

You are advised to speak to a healthcare
professional if you are concerned about any
problems related to taking emergency contraception.

1
2
3
4
5
6

1

What Postinor One Step is and what it is
used for
What you need to know before you take
Postinor One Step
How to take Postinor One Step
Possible side effects
How to store Postinor One Step
Contents of the pack and other information

What Postinor One Step is and what it
is used for

Postinor One Step is an emergency contraceptive
that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has
failed.
Postinor One Step contains a synthetic hormone like
substance called levonorgestrel. It prevents about
84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if
you take it as soon as possible after unprotected
sex. It is better to take it within 12 hours rather than
delay until the third day.
Postinor One Step is thought to work by:
• stopping your ovaries from releasing an egg;
•preventing sperm from fertilising any egg you may
have already released;
• stopping a fertilised egg from attaching itself to
your womb lining.
Postinor One Step can only prevent you becoming
pregnant if you take it within 72 hours of unprotected
sex. It does not work if you are already pregnant. If
you have unprotected sex after taking Postinor One
Step, it will not stop you from becoming
pregnant.
2

What you need to know before you take
Postinor One Step

Do not use Postinor One Step if:
• you are allergic to levonorgestrel or any of the
other ingredients of this medicine listed in
section 6.
Warnings and precautions
If any of the following applies to you, talk to your
doctor before taking Postinor One Step as
emergency contraception may not be suitable for
you. Your doctor may prescribe another type of
emergency contraception for you.
• If you are pregnant or think that you may already
be pregnant. This medicine will not work if you are
already pregnant. If you are already pregnant,
Postinor One Step cannot terminate pregnancy,
so Postinor One Step is not an “abortion pill”.
You may already be pregnant if:
• your period is more than 5 days late, or you have
experienced unusual bleeding when your next
period is due
• you have had unprotected sex more than 72 hours
ago, and since your last period.
Children and adolescents
Postinor One Step is not recommended for young
women under 16 years of age without medical
supervision.
The use of Postinor One Step is not advised if:
• you have a disease of your small bowel (such as
Crohn’s disease) that inhibits the absorption of the
drug
• you have severe liver problems
• you have a history of ectopic pregnancy (where
the baby develops somewhere outside the womb)
• you have ever had a disease called salpingitis
(inflammation of the Fallopian tubes).
A previous ectopic pregnancy or previous infection
of the fallopian tubes increases the risk of a new
ectopic pregnancy.

In all women, emergency contraception should be
taken as soon as possible after unprotected intercourse. There is some evidence that Postinor One
Step may be less effective with increasing body
weight or body mass index (BMI), but these data
were limited and inconclusive.

If you are worried about sexually transmitted
diseases
If you did not use a condom (or if it has been torn or
slid down) during the intercourse, it might be
possible that you have caught a sexually transmitted
disease or the HIV virus.
This medicine will not protect you against sexually
transmitted diseases, only condoms can do this.
Ask your doctor, nurse, family planning clinic or
pharmacist for advice if you are worried about this.
Other medicines and Postinor One Step
Tell your pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines may prevent Postinor One Step
from working properly, these include:
• barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and
carbamazepine)
• medicines used to treat tuberculosis (for example,
rifampicin, rifabutin)
• a treatment for HIV infection (ritonavir)
• a medicine used to treat fungal infections
(griseofulvin)
• herbal remedies containing St John’s wort
(Hypericum perforatum)
• a medicine called ciclosporin (suppresses the
immune system).
How often can you use Postinor One Step
You should only use Postinor One Step in
emergencies and not as a regular method of
contraception.
If Postinor One Step is used more than once in a
menstrual cycle it is more likely to upset your
menstrual cycle (period).
Postinor One Step does not work as well as
regular methods of contraception. Your doctor,
practice nurse or family planning clinic can tell you
about long-term methods of contraception which are
more effective in preventing you from getting
pregnant.
Pregnancy, breast-feeding and fertility
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
You should not take this medicine if you are already
pregnant. If you do become pregnant even after
taking this medicine, it is important that you see your
doctor. There is no evidence that Postinor One Step
will harm a baby that develops in your uterus/womb
if you use Postinor One Step as described.
Nevertheless, your doctor may want to check that
the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe
abdominal pain after taking Postinor One Step or if
you have previously had an ectopic pregnancy,
Fallopian tube surgery or pelvic inflammatory
disease.
Breast-feeding
Very small amounts of the active ingredient of this
medicine may appear in your breast milk. This is not
thought to be harmful to the baby, but if you are
worried you can take your tablet immediately after a
breast-feeding and avoid nursing at least 8 hours
following tablet taking. In this way you are taking
your tablet well before the next feed and reducing
the amount of active ingredient your baby may take
in with the breast milk.
Fertility
Postinor One Step increases the possibility of
menstruation disturbances which can sometimes
lead to earlier or later ovulation date. These
changes can result in modified fertility date, however
there are no fertility data in the long term.

Driving and using machines
Your Postinor One Step tablet is unlikely to affect
your ability to drive a car or use machines. However,
if you feel tired or dizzy do not drive or operate
machinery.
Postinor One Step tablet contains lactose
In case of milk sugar (lactose) intolerance it should
be considered that each Postinor One Step tablet
also contains 142.5 mg lactose monohydrate.
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 Postinor One Step

Always use this medicine exactly as described in the
leaflet or as your pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
Use in children and adolescents
This medicine is not recommended for use in
children. If you are under 16, you must visit your
doctor or family planning clinic to get emergency
contraception.

• Take the tablet as soon as possible, preferably

within 12 hours, and no later than 72 hours (3
days) after you have had unprotected sex.
Postinor One Step can be taken at any time in
your menstrual cycle assuming you are not
already pregnant or think you may be pregnant.
Do not chew but swallow the tablet whole with
water. Do not delay taking the tablet. The tablet
works better the sooner you take it after having
unprotected sex.

• If you are already using a regular method of


contraception such as the contraceptive pill, you
can continue to take this at your regular times.
If another unprotected intercourse takes place
after the use of Postinor One Step (also if this is
during the same menstrual cycle), the tablet will
not exert its contraceptive effect and there is again
the risk of pregnancy.

What to do if you are sick (vomit)
If you are sick (vomit) within three hours of taking
the tablet, you should take another tablet. You will
need to contact your pharmacist, doctor, practice
nurse or family planning clinic immediately for one
more tablet.
After you have taken Postinor One Step
After you have taken Postinor One Step, if you want
to have sex, and are not using the
contraceptive pill, you should use condoms or a cap
plus spermicide until your next menstrual period.
This is because Postinor One Step won’t work if you
have unprotected sex again, before your next period
is due.
After you have taken Postinor One Step, you are
advised to make an appointment to see your doctor
about three weeks later, to make sure that Postinor
One Step has worked. If your period is more than 5
days late or is unusually light or unusually heavy,
you should contact your doctor as soon as possible.
If you do become pregnant even after taking this
medicine, it is important that you see your doctor.
Your doctor can also tell you about longer-term
methods of contraception which are more effective
in preventing you from getting pregnant.
If you continue to use regular hormonal
contraception such as the contraceptive pill and you
do not have a bleed in your pill-free period, see your
doctor to make sure you are not pregnant.
Your next period after you took Postinor One
Step
After the use of Postinor One Step, your period is
usually normal and will start at the usual day;
however sometimes, this will be a few days later or
earlier. If your period starts more than 5 days later
than expected, an ‘abnormal’ bleeding occurs at that
time or if you think that you might be pregnant, you
should check whether you are pregnant by a
pregnancy test.

Possible side effects

4

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Very common (may affect more than 1 in 10
people):
• Feeling sick (nausea)
• You might have some irregular bleeding until your
next period
• You might have lower abdominal pain
• Tiredness
• Headache.
Common (may affect up to 1 in 10 people):
• Being sick (vomiting). If you are sick, read the
section ‘What to do if you are sick (vomit) ’.
• Your period might be different. Most women will
have a normal period at the expected time, but
some may have their period later or earlier than
normal. You might also have some irregular
bleeding or spotting until your next period. If your
period is more than 5 days late or is unusually light
or unusually heavy, you should contact your
doctor as soon as possible.
• You might have tender breasts, diarrhoea, feel
dizzy after taking this medicine.
Very rare effects (may affect up to 1 in 10000
people):
• Abdominal pain, rash, urticaria, pruritus, swelling
of the face, pelvic pain, painful period.
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 Postinor One Step

Store in original container.
KEEP THIS MEDICINE OUT OF SIGHT AND
REACH OF CHILDREN.
Do not use Postinor One Step after the expiry date
which is stated on the package “after EXP “. The
expiry date refers to the last day of the month.
If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist
who will tell you what to do.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protecet the environment.
6 Contents of the pack and other

information

What Postinor One Step contains
Each pack of Postinor One Step contains a
complete treatment which is one round, white tablet,
marked "G00" on one side and plain on the other
side.
The tablet contains 1500 micrograms of
Levonorgestrel, which is the active ingredient.
Postinor One Step also contain potato starch, maize
starch, collodial silica anhydrous, magnesium
stearate, talc and lactose monohydrate.
Manufacturer and Licence Holder
Postinor One Step is manufactured by Bayer
Schering Pharma AG Mullerstrasse 170-178.
D-13353 Berlin Germany and is procured from
within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If after reading this leaflet, you are not sure about
anything or you have any questions, please ask your
pharmacist, doctor, practice nurse or family planning
clinic.

P

PL 15184/1177

Leaflet revision date: 18/02/16
If you take more Postinor One Step than you
should
Although there have been no reports of serious
harmful effects from taking too many tablets at once,
you may feel sick, actually be sick (vomit), or have
vaginal bleeding. You should ask your pharmacist,
doctor, practice nurse or family planning clinic for
advice, especially if you have been sick, as the
tablet may not have worked properly.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Postinor is a registered trademark of Bayer
Intellectual Property GmbH
For more information, you can also contact the
company who distribute Postinor One Step in the
UK.
The address is: Schering Health Care Limited, The
Brow, Burgess Hill, West Sussex, RH15 9NE
The E-mail address is:
customer.care@schering.co.uk (Monday to
Friday)

Ref: 1177/180216/1/B

Ref: 1177/180216/1/F

Levonorgestrel One Step 1500 microgram Tablet
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
• Always take this medicine exactly as described in
this leaflet or as your pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice. 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.

Your doctor may decide that Levonorgestrel One
Step is not suitable for you, or that another type of
emergency contraception would be better for you.

Your medicine is called Levonorgestrel One Step
1500
microgram Tablets, but will be referred to as
Levonorgestrel One Step throughout the leaflet.

Therefore, Levonorgestrel One Step is still recommended for all women regardless of their weight or
BMI.

What is in this leaflet:

You are advised to speak to a healthcare
professional if you are concerned about any
problems related to taking emergency contraception.

1 What Levonorgestrel One Step is and what it is
used for
2 What you need to know before you take
Levonorgestrel One Step
3 How to take Levonorgestrel One Step
4 Possible side effects
5 How to store Levonorgestrel One Step
6 Contents of the pack and other information

1

What Levonorgestrel One Step is and
what it is used for

Levonorgestrel One Step is an emergency
contraceptive that can be used within 72 hours (3
days) of unprotected sex or if your usual
contraceptive method has failed.
Levonorgestrel One Step contains a synthetic
hormone like substance called levonorgestrel. It
prevents about 84% of expected pregnancies when
you take it within 72 hours of having unprotected
sex. It will not prevent a pregnancy every time and is
more effective if you take it as soon as possible after
unprotected sex. It is better to take it within 12 hours
rather than delay until the third day.
Levonorgestrel One Step is thought to work by:
• stopping your ovaries from releasing an egg;
•preventing sperm from fertilising any egg you may
have already released;
• stopping a fertilised egg from attaching itself to
your womb lining.
Levonorgestrel One Step can only prevent you
becoming pregnant if you take it within 72 hours of
unprotected sex. It does not work if you are already
pregnant. If you have unprotected sex after taking
Levonorgestrel One Step, it will not stop you from
becoming
pregnant.
2

What you need to know before you take
Levonorgestrel One Step

Do not use Levonorgestrel One Step if:
• you are allergic to levonorgestrel or any of the
other ingredients of this medicine listed in
section 6.
Warnings and precautions
If any of the following applies to you, talk to your
doctor before taking Levonorgestrel One Step as
emergency contraception may not be suitable for
you. Your doctor may prescribe another type of
emergency contraception for you.
• If you are pregnant or think that you may already
be pregnant. This medicine will not work if you are
already pregnant. If you are already pregnant,
Levonorgestrel One Step cannot terminate
pregnancy, so Levonorgestrel One Step is not an
“abortion pill”.
You may already be pregnant if:
• your period is more than 5 days late, or you have
experienced unusual bleeding when your next
period is due
• you have had unprotected sex more than 72 hours
ago, and since your last period.
Children and adolescents
Levonorgestrel One Step is not recommended for
young women under 16 years of age without
medical supervision.
The use of Levonorgestrel One Step is not advised
if:
• you have a disease of your small bowel (such as
Crohn’s disease) that inhibits the absorption of the
drug
• you have severe liver problems
• you have a history of ectopic pregnancy (where
the baby develops somewhere outside the womb)
• you have ever had a disease called salpingitis
(inflammation of the Fallopian tubes).
A previous ectopic pregnancy or previous infection
of the fallopian tubes increases the risk of a new
ectopic pregnancy.

In all women, emergency contraception should be
taken as soon as possible after unprotected intercourse. There is some evidence that Levonorgestrel
One Step may be less effective with increasing body
weight or body mass index (BMI), but these data
were limited and inconclusive.

If you are worried about sexually transmitted
diseases
If you did not use a condom (or if it has been torn or
slid down) during the intercourse, it might be
possible that you have caught a sexually transmitted
disease or the HIV virus.
This medicine will not protect you against sexually
transmitted diseases, only condoms can do this.
Ask your doctor, nurse, family planning clinic or
pharmacist for advice if you are worried about this.
Other medicines and Levonorgestrel One Step
Tell your pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines may prevent Levonorgestrel One
Step from working properly, these include:
• barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and
carbamazepine)
• medicines used to treat tuberculosis (for example,
rifampicin, rifabutin)
• a treatment for HIV infection (ritonavir)
• a medicine used to treat fungal infections
(griseofulvin)
• herbal remedies containing St John’s wort
(Hypericum perforatum)
• a medicine called ciclosporin (suppresses the
immune system).
How often can you use Levonorgestrel One Step
You should only use Levonorgestrel One Step in
emergencies and not as a regular method of
contraception.
If Levonorgestrel One Step is used more than once
in a menstrual cycle it is more likely to upset your
menstrual cycle (period).
Levonorgestrel One Step does not work as well as
regular methods of contraception. Your doctor,
practice nurse or family planning clinic can tell you
about long-term methods of contraception which are
more effective in preventing you from getting
pregnant.
Pregnancy, breast-feeding and fertility
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
You should not take this medicine if you are already
pregnant. If you do become pregnant even after
taking this medicine, it is important that you see your
doctor. There is no evidence that Levonorgestrel
One Step will harm a baby that develops in your
uterus/womb if you use Levonorgestrel One Step as
described. Nevertheless, your doctor may want to
check that the pregnancy is not ectopic (where the
baby develops somewhere outside the womb). This
is especially important if you develop severe
abdominal pain after taking Levonorgestrel One
Step or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory
disease.
Breast-feeding
Very small amounts of the active ingredient of this
medicine may appear in your breast milk. This is not
thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a
breast-feeding and avoid nursing at least 8 hours
following tablet taking. In this way you are taking
your tablet well before the next feed and reducing
the amount of active ingredient your baby may take
in with the breast milk.
Fertility
Levonorgestrel One Step increases the possibility of
menstruation disturbances which can sometimes
lead to earlier or later ovulation date. These
changes can result in modified fertility date, however
there are no fertility data in the long term.

Driving and using machines
Your Levonorgestrel One Step tablet is unlikely to
affect your ability to drive a car or use machines.
However, if you feel tired or dizzy do not drive or
operate machinery.
Levonorgestrel One Step tablet contains lactose
In case of milk sugar (lactose) intolerance it should
be considered that each Levonorgestrel One Step
tablet also contains 142.5 mg lactose monohydrate.
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 Levonorgestrel One Step

Always use this medicine exactly as described in the
leaflet or as your pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
Use in children and adolescents
This medicine is not recommended for use in
children. If you are under 16, you must visit your
doctor or family planning clinic to get emergency
contraception.

• Take the tablet as soon as possible, preferably




within 12 hours, and no later than 72 hours (3
days) after you have had unprotected sex.
Levonorgestrel One Step can be taken at any time
in your menstrual cycle assuming you are not
already pregnant or think you may be pregnant.
Do not chew but swallow the tablet whole with
water. Do not delay taking the tablet. The tablet
works better the sooner you take it after having
unprotected sex.
If you are already using a regular method of
contraception such as the contraceptive pill, you
can continue to take this at your regular times.
If another unprotected intercourse takes place
after the use of Levonorgestrel One Step (also if
this is during the same menstrual cycle), the tablet
will not exert its contraceptive effect and there is
again the risk of pregnancy.

What to do if you are sick (vomit)
If you are sick (vomit) within three hours of taking
the tablet, you should take another tablet. You will
need to contact your pharmacist, doctor, practice
nurse or family planning clinic immediately for one
more tablet.
After you have taken Levonorgestrel One Step
After you have taken Levonorgestrel One Step, if
you want to have sex, and are not using the
contraceptive pill, you should use condoms or a cap
plus spermicide until your next menstrual period.
This is because Levonorgestrel One Step won’t
work if you have unprotected sex again, before your
next period is due.
After you have taken Levonorgestrel One Step, you
are advised to make an appointment to see your
doctor about three weeks later, to make sure that
Levonorgestrel One Step has worked. If your period
is more than 5 days late or is unusually light or
unusually heavy, you should contact your doctor as
soon as possible. If you do become pregnant even
after taking this medicine, it is important that you see
your doctor.
Your doctor can also tell you about longer-term
methods of contraception which are more effective
in preventing you from getting pregnant.
If you continue to use regular hormonal
contraception such as the contraceptive pill and you
do not have a bleed in your pill-free period, see your
doctor to make sure you are not pregnant.
Your next period after you took Levonorgestrel
One Step
After the use of Levonorgestrel One Step, your period is usually normal and will start at the usual day;
however sometimes, this will be a few days later or
earlier. If your period starts more than 5 days later
than expected, an ‘abnormal’ bleeding occurs at that
time or if you think that you might be pregnant, you
should check whether you are pregnant by a
pregnancy test.

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Very common (may affect more than 1 in 10
people):
• Feeling sick (nausea)
• You might have some irregular bleeding until your
next period
• You might have lower abdominal pain
• Tiredness
• Headache.
Common (may affect up to 1 in 10 people):
• Being sick (vomiting). If you are sick, read the
section ‘What to do if you are sick (vomit) ’.
• Your period might be different. Most women will
have a normal period at the expected time, but
some may have their period later or earlier than
normal. You might also have some irregular
bleeding or spotting until your next period. If your
period is more than 5 days late or is unusually light
or unusually heavy, you should contact your
doctor as soon as possible.
• You might have tender breasts, diarrhoea, feel
dizzy after taking this medicine.
Very rare effects (may affect up to 1 in 10000
people):
• Abdominal pain, rash, urticaria, pruritus, swelling
of the face, pelvic pain, painful period.
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 Levonorgestrel One Step

Store in original container.
KEEP THIS MEDICINE OUT OF SIGHT AND
REACH OF CHILDREN.
Do not use Levonorgestrel One Step after the expiry
date which is stated on the package “after EXP “.
The expiry date refers to the last day of the month.
If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist
who will tell you what to do.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protecet the environment.
6

Contents of the pack and other
information

What Levonorgestrel One Step contains
Each pack of Levonorgestrel One Step contains a
complete treatment which is one round, white tablet,
marked "G00" on one side and plain on the other
side.
The tablet contains 1500 micrograms of
Levonorgestrel, which is the active ingredient.
Levonorgestrel One Step also contain potato starch,
maize starch, collodial silica anhydrous, magnesium
stearate, talc and lactose monohydrate.
Manufacturer and Licence Holder
Levonorgestrel One Step is manufactured by Bayer
Schering Pharma AG Mullerstrasse 170-178.
D-13353 Berlin Germany and is procured from
within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If after reading this leaflet, you are not sure about
anything or you have any questions, please ask your
pharmacist, doctor, practice nurse or family planning
clinic.

P

PL 15184/1177

Leaflet revision date: 18/02/16
If you take more Levonorgestrel One Step than
you should
Although there have been no reports of serious
harmful effects from taking too many tablets at once,
you may feel sick, actually be sick (vomit), or have
vaginal bleeding. You should ask your pharmacist,
doctor, practice nurse or family planning clinic for
advice, especially if you have been sick, as the
tablet may not have worked properly.

For more information, you can also contact the
company who distribute Levonorgestrel One Step in
the UK.
The address is: Schering Health Care Limited, The
Brow, Burgess Hill, West Sussex, RH15 9NE
The E-mail address is:
customer.care@schering.co.uk (Monday to
Friday)

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Ref: 1177/180216/1/B

Ref: 1177/180216/1/F

®

Levonelle One Step 1500 microgram Tablet
(levonorgestrel)
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
• Always take this medicine exactly as described in
this leaflet or as your pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice. 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.

Your doctor may decide that Levonelle One Step is
not suitable for you, or that another type of
emergency contraception would be better for you.

Your medicine is called Levonelle One Step 1500
microgram Tablets, but will be referred to as
Levonelle One Step throughout the leaflet.

Therefore, Levonelle One Step is still recommended
for all women regardless of their weight or BMI.

What is in this leaflet:

You are advised to speak to a healthcare
professional if you are concerned about any
problems related to taking emergency contraception.

1 What Levonelle One Step is and what it is
used for
2 What you need to know before you take
Levonelle One Step
3 How to take Levonelle One Step
4 Possible side effects
5 How to store Levonelle One Step
6 Contents of the pack and other information

1

What Levonelle One Step is and what it
is used for

Levonelle One Step is an emergency contraceptive
that can be used within 72 hours (3 days) of
unprotected sex or if your usual contraceptive
method has failed.
Levonelle One Step contains a synthetic hormone
like substance called levonorgestrel. It prevents
about 84% of expected pregnancies when you take
it within 72 hours of having unprotected sex. It will
not prevent a pregnancy every time and is more
effective if you take it as soon as possible after
unprotected sex. It is better to take it within 12 hours
rather than delay until the third day.
Levonelle One Step is thought to work by:
• stopping your ovaries from releasing an egg;
•preventing sperm from fertilising any egg you may
have already released;
• stopping a fertilised egg from attaching itself to
your womb lining.
Levonelle One Step can only prevent you becoming
pregnant if you take it within 72 hours of unprotected
sex. It does not work if you are already pregnant. If
you have unprotected sex after taking Levonelle
One Step, it will not stop you from becoming
pregnant.
2

What you need to know before you take
Levonelle One Step

Do not use Levonelle One Step if:
• you are allergic to levonorgestrel or any of the
other ingredients of this medicine listed in
section 6.
Warnings and precautions
If any of the following applies to you, talk to your
doctor before taking Levonelle One Step as
emergency contraception may not be suitable for
you. Your doctor may prescribe another type of
emergency contraception for you.
• If you are pregnant or think that you may already
be pregnant. This medicine will not work if you are
already pregnant. If you are already pregnant,
Levonelle One Step cannot terminate pregnancy,
so Levonelle One Step is not an “abortion pill”.
You may already be pregnant if:
• your period is more than 5 days late, or you have
experienced unusual bleeding when your next
period is due
• you have had unprotected sex more than 72 hours
ago, and since your last period.
Children and adolescents
Levonelle One Step is not recommended for young
women under 16 years of age without medical
supervision.
The use of Levonelle One Step is not advised if:
• you have a disease of your small bowel (such as
Crohn’s disease) that inhibits the absorption of the
drug
• you have severe liver problems
• you have a history of ectopic pregnancy (where
the baby develops somewhere outside the womb)
• you have ever had a disease called salpingitis
(inflammation of the Fallopian tubes).
A previous ectopic pregnancy or previous infection
of the fallopian tubes increases the risk of a new
ectopic pregnancy.

In all women, emergency contraception should be
taken as soon as possible after unprotected intercourse. There is some evidence that Levonelle One
Step may be less effective with increasing body
weight or body mass index (BMI), but these data
were limited and inconclusive.

If you are worried about sexually transmitted
diseases
If you did not use a condom (or if it has been torn or
slid down) during the intercourse, it might be
possible that you have caught a sexually transmitted
disease or the HIV virus.
This medicine will not protect you against sexually
transmitted diseases, only condoms can do this.
Ask your doctor, nurse, family planning clinic or
pharmacist for advice if you are worried about this.
Other medicines and Levonelle One Step
Tell your pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines may prevent Levonelle One Step
from working properly, these include:
• barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and
carbamazepine)
• medicines used to treat tuberculosis (for example,
rifampicin, rifabutin)
• a treatment for HIV infection (ritonavir)
• a medicine used to treat fungal infections
(griseofulvin)
• herbal remedies containing St John’s wort
(Hypericum perforatum)
• a medicine called ciclosporin (suppresses the
immune system).
How often can you use Levonelle One Step
You should only use Levonelle One Step in
emergencies and not as a regular method of
contraception.
If Levonelle One Step is used more than once in a
menstrual cycle it is more likely to upset your
menstrual cycle (period).
Levonelle One Step does not work as well as
regular methods of contraception. Your doctor,
practice nurse or family planning clinic can tell you
about long-term methods of contraception which are
more effective in preventing you from getting
pregnant.
Pregnancy, breast-feeding and fertility
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
You should not take this medicine if you are already
pregnant. If you do become pregnant even after
taking this medicine, it is important that you see your
doctor. There is no evidence that Levonelle One
Step will harm a baby that develops in your
uterus/womb if you use Levonelle One Step as
described. Nevertheless, your doctor may want to
check that the pregnancy is not ectopic (where the
baby develops somewhere outside the womb). This
is especially important if you develop severe
abdominal pain after taking Levonelle One Step or if
you have previously had an ectopic pregnancy,
Fallopian tube surgery or pelvic inflammatory
disease.
Breast-feeding
Very small amounts of the active ingredient of this
medicine may appear in your breast milk. This is not
thought to be harmful to the baby, but if you are
worried you can take your tablet immediately after a
breast-feeding and avoid nursing at least 8 hours
following tablet taking. In this way you are taking
your tablet well before the next feed and reducing
the amount of active ingredient your baby may take
in with the breast milk.
Fertility
Levonelle One Step increases the possibility of
menstruation disturbances which can sometimes
lead to earlier or later ovulation date. These
changes can result in modified fertility date, however
there are no fertility data in the long term.

Driving and using machines
Your Levonelle One Step tablet is unlikely to affect
your ability to drive a car or use machines. However,
if you feel tired or dizzy do not drive or operate
machinery.
Levonelle One Step tablet contains lactose
In case of milk sugar (lactose) intolerance it should
be considered that each Levonelle One Step tablet
also contains 142.5 mg lactose monohydrate.
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 Levonelle One Step

Always use this medicine exactly as described in the
leaflet or as your pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
Use in children and adolescents
This medicine is not recommended for use in
children. If you are under 16, you must visit your
doctor or family planning clinic to get emergency
contraception.

• Take the tablet as soon as possible, preferably

within 12 hours, and no later than 72 hours (3
days) after you have had unprotected sex.
Levonelle One Step can be taken at any time in
your menstrual cycle assuming you are not
already pregnant or think you may be pregnant.
Do not chew but swallow the tablet whole with
water. Do not delay taking the tablet. The tablet
works better the sooner you take it after having
unprotected sex.

• If you are already using a regular method of


contraception such as the contraceptive pill, you
can continue to take this at your regular times.
If another unprotected intercourse takes place
after the use of Levonelle One Step (also if this is
during the same menstrual cycle), the tablet will
not exert its contraceptive effect and there is again
the risk of pregnancy.

What to do if you are sick (vomit)
If you are sick (vomit) within three hours of taking
the tablet, you should take another tablet. You will
need to contact your pharmacist, doctor, practice
nurse or family planning clinic immediately for one
more tablet.
After you have taken Levonelle One Step
After you have taken Levonelle One Step, if you
want to have sex, and are not using the
contraceptive pill, you should use condoms or a cap
plus spermicide until your next menstrual period.
This is because Levonelle One Step won’t work if
you have unprotected sex again, before your next
period is due.
After you have taken Levonelle One Step, you are
advised to make an appointment to see your doctor
about three weeks later, to make sure that Levonelle
One Step has worked. If your period is more than 5
days late or is unusually light or unusually heavy,
you should contact your doctor as soon as possible.
If you do become pregnant even after taking this
medicine, it is important that you see your doctor.
Your doctor can also tell you about longer-term
methods of contraception which are more effective
in preventing you from getting pregnant.
If you continue to use regular hormonal
contraception such as the contraceptive pill and you
do not have a bleed in your pill-free period, see your
doctor to make sure you are not pregnant.
Your next period after you took Levonelle One
Step
After the use of Levonelle One Step, your period is
usually normal and will start at the usual day;
however sometimes, this will be a few days later or
earlier. If your period starts more than 5 days later
than expected, an ‘abnormal’ bleeding occurs at that
time or if you think that you might be pregnant, you
should check whether you are pregnant by a
pregnancy test.
If you take more Levonelle One Step than you
should
Although there have been no reports of serious
harmful effects from taking too many tablets at once,
you may feel sick, actually be sick (vomit), or have
vaginal bleeding. You should ask your pharmacist,
doctor, practice nurse or family planning clinic for
advice, especially if you have been sick, as the
tablet may not have worked properly.
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.
Very common (may affect more than 1 in 10
people):
• Feeling sick (nausea)
• You might have some irregular bleeding until your
next period
• You might have lower abdominal pain
• Tiredness
• Headache.
Common (may affect up to 1 in 10 people):
• Being sick (vomiting). If you are sick, read the
section ‘What to do if you are sick (vomit) ’.
• Your period might be different. Most women will
have a normal period at the expected time, but
some may have their period later or earlier than
normal. You might also have some irregular
bleeding or spotting until your next period. If your
period is more than 5 days late or is unusually light
or unusually heavy, you should contact your
doctor as soon as possible.
• You might have tender breasts, diarrhoea, feel
dizzy after taking this medicine.
Very rare effects (may affect up to 1 in 10000
people):
• Abdominal pain, rash, urticaria, pruritus, swelling
of the face, pelvic pain, painful period.
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 Levonelle One Step

Store in original container.
KEEP THIS MEDICINE OUT OF SIGHT AND
REACH OF CHILDREN.
Do not use Levonelle One Step after the expiry date
which is stated on the package “after EXP “. The
expiry date refers to the last day of the month.
If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist
who will tell you what to do.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protecet the environment.
6

Contents of the pack and other
information

What Levonelle One Step contains
Each pack of Levonelle One Step contains a
complete treatment which is one round, white tablet,
marked "G00" on one side and plain on the other
side.
The tablet contains 1500 micrograms of
Levonorgestrel, which is the active ingredient.
Levonelle One Step also contain potato starch,
maize starch, collodial silica anhydrous, magnesium
stearate, talc and lactose monohydrate.
Manufacturer and Licence Holder
Levonelle One Step is manufactured by Gedeon
Richter Plc. Gyomroi ut 19-21. H-1103 Budapest
Hungary and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
If after reading this leaflet, you are not sure about
anything or you have any questions, please ask your
pharmacist, doctor, practice nurse or family planning
clinic.

P

PL 15184/1177

Leaflet revision date: 18/02/16
Levonelle is a registered trademark of Bayer
Intellectual Property GmbH
For more information, you can also contact the
company who distribute Levonelle One Step in the
UK.
The address is: Schering Health Care Limited, The
Brow, Burgess Hill, West Sussex, RH15 9NE
The E-mail address is:
customer.care@schering.co.uk (Monday to
Friday)

Ref: 1177/180216/1/B

Ref: 1177/180216/1/F

®

Postinor One Step 1500 microgram Tablet
(levonorgestrel)
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
• Always take this medicine exactly as described in
this leaflet or as your pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice. 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.

Your doctor may decide that Postinor One Step is
not suitable for you, or that another type of
emergency contraception would be better for you.

Your medicine is called Postinor One Step 1500
microgram Tablets, but will be referred to as
Postinor One Step throughout the leaflet.

Therefore, Postinor One Step is still recommended
for all women regardless of their weight or BMI.

What is in this leaflet:

You are advised to speak to a healthcare
professional if you are concerned about any
problems related to taking emergency contraception.

1 What Postinor One Step is and what it is
used for
2 What you need to know before you take
Postinor One Step
3 How to take Postinor One Step
4 Possible side effects
5 How to store Postinor One Step
6 Contents of the pack and other information

1

What Postinor One Step is and what it
is used for

Postinor One Step is an emergency contraceptive
that can be used within 72 hours (3 days) of
unprotected sex or if your usual contraceptive
method has failed.
Postinor One Step contains a synthetic hormone like
substance called levonorgestrel. It prevents about
84% of expected pregnancies when you take it
within 72 hours of having unprotected sex. It will not
prevent a pregnancy every time and is more
effective if you take it as soon as possible after
unprotected sex. It is better to take it within 12 hours
rather than delay until the third day.
Postinor One Step is thought to work by:
• stopping your ovaries from releasing an egg;
•preventing sperm from fertilising any egg you may
have already released;
• stopping a fertilised egg from attaching itself to
your womb lining.
Postinor One Step can only prevent you becoming
pregnant if you take it within 72 hours of unprotected
sex. It does not work if you are already pregnant. If
you have unprotected sex after taking Postinor One
Step, it will not stop you from becoming
pregnant.
2

What you need to know before you take
Postinor One Step

Do not use Postinor One Step if:
• you are allergic to levonorgestrel or any of the
other ingredients of this medicine listed in
section 6.
Warnings and precautions
If any of the following applies to you, talk to your
doctor before taking Postinor One Step as
emergency contraception may not be suitable for
you. Your doctor may prescribe another type of
emergency contraception for you.
• If you are pregnant or think that you may already
be pregnant. This medicine will not work if you are
already pregnant. If you are already pregnant,
Postinor One Step cannot terminate pregnancy,
so Postinor One Step is not an “abortion pill”.
You may already be pregnant if:
• your period is more than 5 days late, or you have
experienced unusual bleeding when your next
period is due
• you have had unprotected sex more than 72 hours
ago, and since your last period.
Children and adolescents
Postinor One Step is not recommended for young
women under 16 years of age without medical
supervision.
The use of Postinor One Step is not advised if:
• you have a disease of your small bowel (such as
Crohn’s disease) that inhibits the absorption of the
drug
• you have severe liver problems
• you have a history of ectopic pregnancy (where
the baby develops somewhere outside the womb)
• you have ever had a disease called salpingitis
(inflammation of the Fallopian tubes).
A previous ectopic pregnancy or previous infection
of the fallopian tubes increases the risk of a new
ectopic pregnancy.

In all women, emergency contraception should be
taken as soon as possible after unprotected intercourse. There is some evidence that Postinor One
Step may be less effective with increasing body
weight or body mass index (BMI), but these data
were limited and inconclusive.

If you are worried about sexually transmitted
diseases
If you did not use a condom (or if it has been torn or
slid down) during the intercourse, it might be
possible that you have caught a sexually transmitted
disease or the HIV virus.
This medicine will not protect you against sexually
transmitted diseases, only condoms can do this.
Ask your doctor, nurse, family planning clinic or
pharmacist for advice if you are worried about this.
Other medicines and Postinor One Step
Tell your pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines may prevent Postinor One Step
from working properly, these include:
• barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and
carbamazepine)
• medicines used to treat tuberculosis (for example,
rifampicin, rifabutin)
• a treatment for HIV infection (ritonavir)
• a medicine used to treat fungal infections
(griseofulvin)
• herbal remedies containing St John’s wort
(Hypericum perforatum)
• a medicine called ciclosporin (suppresses the
immune system).
How often can you use Postinor One Step
You should only use Postinor One Step in
emergencies and not as a regular method of
contraception.
If Postinor One Step is used more than once in a
menstrual cycle it is more likely to upset your
menstrual cycle (period).
Postinor One Step does not work as well as
regular methods of contraception. Your doctor,
practice nurse or family planning clinic can tell you
about long-term methods of contraception which are
more effective in preventing you from getting
pregnant.
Pregnancy, breast-feeding and fertility
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
You should not take this medicine if you are already
pregnant. If you do become pregnant even after
taking this medicine, it is important that you see your
doctor. There is no evidence that Postinor One Step
will harm a baby that develops in your uterus/womb
if you use Postinor One Step as described.
Nevertheless, your doctor may want to check that
the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe
abdominal pain after taking Postinor One Step or if
you have previously had an ectopic pregnancy,
Fallopian tube surgery or pelvic inflammatory
disease.
Breast-feeding
Very small amounts of the active ingredient of this
medicine may appear in your breast milk. This is not
thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a
breast-feeding and avoid nursing at least 8 hours
following tablet taking. In this way you are taking
your tablet well before the next feed and reducing
the amount of active ingredient your baby may take
in with the breast milk.
Fertility
Postinor One Step increases the possibility of menstruation disturbances which can sometimes lead to
earlier or later ovulation date. These changes can
result in modified fertility date, however there are no
fertility data in the long term.

Driving and using machines
Your Postinor One Step tablet is unlikely to affect
your ability to drive a car or use machines. However,
if you feel tired or dizzy do not drive or operate
machinery.
Postinor One Step tablet contains lactose
In case of milk sugar (lactose) intolerance it should
be considered that each Postinor One Step tablet
also contains 142.5 mg lactose monohydrate.
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 Postinor One Step

Always use this medicine exactly as described in the
leaflet or as your pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
Use in children and adolescents
This medicine is not recommended for use in
children. If you are under 16, you must visit your
doctor or family planning clinic to get emergency
contraception.

• Take the tablet as soon as possible, preferably

within 12 hours, and no later than 72 hours (3
days) after you have had unprotected sex.
Postinor One Step can be taken at any time in
your menstrual cycle assuming you are not
already pregnant or think you may be pregnant.
Do not chew but swallow the tablet whole with
water. Do not delay taking the tablet. The tablet
works better the sooner you take it after having
unprotected sex.

• If you are already using a regular method of


contraception such as the contraceptive pill, you
can continue to take this at your regular times.
If another unprotected intercourse takes place
after the use of Postinor One Step (also if this is
during the same menstrual cycle), the tablet will
not exert its contraceptive effect and there is again
the risk of pregnancy.

What to do if you are sick (vomit)
If you are sick (vomit) within three hours of taking
the tablet, you should take another tablet. You will
need to contact your pharmacist, doctor, practice
nurse or family planning clinic immediately for one
more tablet.
After you have taken Postinor One Step
After you have taken Postinor One Step, if you want
to have sex, and are not using the
contraceptive pill, you should use condoms or a cap
plus spermicide until your next menstrual period.
This is because Postinor One Step won’t work if you
have unprotected sex again, before your next period
is due.
After you have taken Postinor One Step, you are
advised to make an appointment to see your doctor
about three weeks later, to make sure that Postinor
One Step has worked. If your period is more than 5
days late or is unusually light or unusually heavy,
you should contact your doctor as soon as possible.
If you do become pregnant even after taking this
medicine, it is important that you see your doctor.
Your doctor can also tell you about longer-term
methods of contraception which are more effective
in preventing you from getting pregnant.
If you continue to use regular hormonal
contraception such as the contraceptive pill and you
do not have a bleed in your pill-free period, see your
doctor to make sure you are not pregnant.
Your next period after you took Postinor One
Step
After the use of Postinor One Step, your period is
usually normal and will start at the usual day;
however sometimes, this will be a few days later or
earlier. If your period starts more than 5 days later
than expected, an ‘abnormal’ bleeding occurs at that
time or if you think that you might be pregnant, you
should check whether you are pregnant by a
pregnancy test.
If you take more Postinor One Step than you
should
Although there have been no reports of serious
harmful effects from taking too many tablets at once,
you may feel sick, actually be sick (vomit), or have
vaginal bleeding. You should ask your pharmacist,
doctor, practice nurse or family planning clinic for
advice, especially if you have been sick, as the
tablet may not have worked properly.
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.
Very common (may affect more than 1 in 10
people):
• Feeling sick (nausea)
• You might have some irregular bleeding until your
next period
• You might have lower abdominal pain
• Tiredness
• Headache.
Common (may affect up to 1 in 10 people):
• Being sick (vomiting). If you are sick, read the
section ‘What to do if you are sick (vomit) ’.
• Your period might be different. Most women will
have a normal period at the expected time, but
some may have their period later or earlier than
normal. You might also have some irregular
bleeding or spotting until your next period. If your
period is more than 5 days late or is unusually light
or unusually heavy, you should contact your
doctor as soon as possible.
• You might have tender breasts, diarrhoea, feel
dizzy after taking this medicine.
Very rare effects (may affect up to 1 in 10000
people):
• Abdominal pain, rash, urticaria, pruritus, swelling
of the face, pelvic pain, painful period.
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 Postinor One Step

Store in original container.
KEEP THIS MEDICINE OUT OF SIGHT AND
REACH OF CHILDREN.
Do not use Postinor One Step after the expiry date
which is stated on the package “after EXP “. The
expiry date refers to the last day of the month.
If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist
who will tell you what to do.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protecet the environment.
6

Contents of the pack and other
information

What Postinor One Step contains
Each pack of Postinor One Step contains a
complete treatment which is one round, white tablet,
marked "G00" on one side and plain on the other
side.
The tablet contains 1500 micrograms of
Levonorgestrel, which is the active ingredient.
Postinor One Step also contain potato starch, maize
starch, collodial silica anhydrous, magnesium
stearate, talc and lactose monohydrate.
Manufacturer and Licence Holder
Postinor One Step is manufactured by Gedeon
Richter Plc. Gyomroi ut 19-21. H-1103 Budapest
Hungary and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
If after reading this leaflet, you are not sure about
anything or you have any questions, please ask your
pharmacist, doctor, practice nurse or family planning
clinic.

P

PL 15184/1177

Leaflet revision date: 18/02/16
Postinor is a registered trademark of Bayer
Intellectual Property GmbH
For more information, you can also contact the
company who distribute Postinor One Step in the
UK.
The address is: Schering Health Care Limited, The
Brow, Burgess Hill, West Sussex, RH15 9NE
The E-mail address is:
customer.care@schering.co.uk (Monday to
Friday)

Ref: 1177/180216/1/B

Ref: 1177/180216/1/F

Levonorgestrel One Step 1500 microgram Tablet
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
• Always take this medicine exactly as described in
this leaflet or as your pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice. 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.

Your doctor may decide that Levonorgestrel One
Step is not suitable for you, or that another type of
emergency contraception would be better for you.

Your medicine is called Levonorgestrel One Step
1500
microgram Tablets, but will be referred to as
Levonorgestrel One Step throughout the leaflet.

Therefore, Levonorgestrel One Step is still recommended for all women regardless of their weight or
BMI.

What is in this leaflet:

You are advised to speak to a healthcare
professional if you are concerned about any
problems related to taking emergency contraception.

1 What Levonorgestrel One Step is and what it is
used for
2 What you need to know before you take
Levonorgestrel One Step
3 How to take Levonorgestrel One Step
4 Possible side effects
5 How to store Levonorgestrel One Step
6 Contents of the pack and other information

1

What Levonorgestrel One Step is and
what it is used for

Levonorgestrel One Step is an emergency
contraceptive that can be used within 72 hours (3
days) of unprotected sex or if your usual
contraceptive method has failed.
Levonorgestrel One Step contains a synthetic hormone like substance called levonorgestrel. It prevents about 84% of expected pregnancies when you
take it within 72 hours of having unprotected sex. It
will not prevent a pregnancy every time and is more
effective if you take it as soon as possible after
unprotected sex. It is better to take it within 12 hours
rather than delay until the third day.
Levonorgestrel One Step is thought to work by:
• stopping your ovaries from releasing an egg;
•preventing sperm from fertilising any egg you may
have already released;
• stopping a fertilised egg from attaching itself to
your womb lining.
Levonorgestrel One Step can only prevent you
becoming pregnant if you take it within 72 hours of
unprotected sex. It does not work if you are already
pregnant. If you have unprotected sex after taking
Levonorgestrel One Step, it will not stop you from
becoming pregnant.
2

What you need to know before you take
Levonorgestrel One Step

Do not use Levonorgestrel One Step if:
• you are allergic to levonorgestrel or any of the
other ingredients of this medicine listed in
section 6.
Warnings and precautions
If any of the following applies to you, talk to your
doctor before taking Levonorgestrel One Step as
emergency contraception may not be suitable for
you. Your doctor may prescribe another type of
emergency contraception for you.
• If you are pregnant or think that you may already
be pregnant. This medicine will not work if you are
already pregnant. If you are already pregnant,
Levonorgestrel One Step cannot terminate
pregnancy, so Levonorgestrel One Step is not an
“abortion pill”.
You may already be pregnant if:
• your period is more than 5 days late, or you have
experienced unusual bleeding when your next
period is due
• you have had unprotected sex more than 72 hours
ago, and since your last period.
Children and adolescents
Levonorgestrel One Step is not recommended for
young women under 16 years of age without
medical supervision.
The use of Levonorgestrel One Step is not advised
if:
• you have a disease of your small bowel (such as
Crohn’s disease) that inhibits the absorption of the
drug
• you have severe liver problems
• you have a history of ectopic pregnancy (where
the baby develops somewhere outside the womb)
• you have ever had a disease called salpingitis
(inflammation of the Fallopian tubes).
A previous ectopic pregnancy or previous infection
of the fallopian tubes increases the risk of a new
ectopic pregnancy.

In all women, emergency contraception should be
taken as soon as possible after unprotected intercourse. There is some evidence that Levonorgestrel
One Step may be less effective with increasing body
weight or body mass index (BMI), but these data
were limited and inconclusive.

If you are worried about sexually transmitted
diseases
If you did not use a condom (or if it has been torn or
slid down) during the intercourse, it might be
possible that you have caught a sexually transmitted
disease or the HIV virus.
This medicine will not protect you against sexually
transmitted diseases, only condoms can do this.
Ask your doctor, nurse, family planning clinic or
pharmacist for advice if you are worried about this.
Other medicines and Levonorgestrel One Step
Tell your pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines may prevent Levonorgestrel One
Step from working properly, these include:
• barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and
carbamazepine)
• medicines used to treat tuberculosis (for example,
rifampicin, rifabutin)
• a treatment for HIV infection (ritonavir)
• a medicine used to treat fungal infections
(griseofulvin)
• herbal remedies containing St John’s wort
(Hypericum perforatum)
• a medicine called ciclosporin (suppresses the
immune system).
How often can you use Levonorgestrel One Step
You should only use Levonorgestrel One Step in
emergencies and not as a regular method of
contraception.
If Levonorgestrel One Step is used more than once
in a menstrual cycle it is more likely to upset your
menstrual cycle (period).
Levonorgestrel One Step does not work as well as
regular methods of contraception. Your doctor,
practice nurse or family planning clinic can tell you
about long-term methods of contraception which are
more effective in preventing you from getting
pregnant.
Pregnancy, breast-feeding and fertility
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
You should not take this medicine if you are already
pregnant. If you do become pregnant even after
taking this medicine, it is important that you see your
doctor. There is no evidence that Levonorgestrel
One Step will harm a baby that develops in your
uterus/womb if you use Levonorgestrel One Step as
described. Nevertheless, your doctor may want to
check that the pregnancy is not ectopic (where the
baby develops somewhere outside the womb). This
is especially important if you develop severe
abdominal pain after taking Levonorgestrel One
Step or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory
disease.
Breast-feeding
Very small amounts of the active ingredient of this
medicine may appear in your breast milk. This is not
thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a
breast-feeding and avoid nursing at least 8 hours
following tablet taking. In this way you are taking
your tablet well before the next feed and reducing
the amount of active ingredient your baby may take
in with the breast milk.
Fertility
Levonorgestrel One Step increases the possibility of
menstruation disturbances which can sometimes
lead to earlier or later ovulation date. These
changes can result in modified fertility date, however
there are no fertility data in the long term.

Driving and using machines
Your Levonorgestrel One Step tablet is unlikely to
affect your ability to drive a car or use machines.
However, if you feel tired or dizzy do not drive or
operate machinery.
Levonorgestrel One Step tablet contains lactose
In case of milk sugar (lactose) intolerance it should
be considered that each Levonorgestrel One Step
tablet also contains 142.5 mg lactose monohydrate.
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 Levonorgestrel One Step

Always use this medicine exactly as described in the
leaflet or as your pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
Use in children and adolescents
This medicine is not recommended for use in
children. If you are under 16, you must visit your
doctor or family planning clinic to get emergency
contraception.

• Take the tablet as soon as possible, preferably

within 12 hours, and no later than 72 hours (3
days) after you have had unprotected sex.
Levonorgestrel One Step can be taken at any time
in your menstrual cycle assuming you are not
already pregnant or think you may be pregnant.
Do not chew but swallow the tablet whole with
water. Do not delay taking the tablet. The tablet
works better the sooner you take it after having
unprotected sex.

• If you are already using a regular method of


contraception such as the contraceptive pill, you
can continue to take this at your regular times.
If another unprotected intercourse takes place
after the use of Levonorgestrel One Step (also if
this is during the same menstrual cycle), the
tablet will not exert its contraceptive effect and
there is again the risk of pregnancy.

What to do if you are sick (vomit)
If you are sick (vomit) within three hours of taking
the tablet, you should take another tablet. You will
need to contact your pharmacist, doctor, practice
nurse or family planning clinic immediately for one
more tablet.
After you have taken Levonorgestrel One Step
After you have taken Levonorgestrel One Step, if
you want to have sex, and are not using the
contraceptive pill, you should use condoms or a cap
plus spermicide until your next menstrual period.
This is because Levonorgestrel One Step won’t
work if you have unprotected sex again, before your
next period is due.
After you have taken Levonorgestrel One Step, you
are advised to make an appointment to see your
doctor about three weeks later, to make sure that
Levonorgestrel One Step has worked. If your period
is more than 5 days late or is unusually light or
unusually heavy, you should contact your doctor as
soon as possible. If you do become pregnant even
after taking this medicine, it is important that you see
your doctor.
Your doctor can also tell you about longer-term
methods of contraception which are more effective
in preventing you from getting pregnant.
If you continue to use regular hormonal
contraception such as the contraceptive pill and you
do not have a bleed in your pill-free period, see your
doctor to make sure you are not pregnant.
Your next period after you took Levonorgestrel
One Step
After the use of Levonorgestrel One Step, your period is usually normal and will start at the usual day;
however sometimes, this will be a few days later or
earlier. If your period starts more than 5 days later
than expected, an ‘abnormal’ bleeding occurs at that
time or if you think that you might be pregnant, you
should check whether you are pregnant by a
pregnancy test.
If you take more Levonorgestrel One Step than
you should
Although there have been no reports of serious
harmful effects from taking too many tablets at once,
you may feel sick, actually be sick (vomit), or have
vaginal bleeding. You should ask your pharmacist,
doctor, practice nurse or family planning clinic for
advice, especially if you have been sick, as the
tablet may not have worked properly.

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Very common (may affect more than 1 in 10
people):
• Feeling sick (nausea)
• You might have some irregular bleeding until your
next period
• You might have lower abdominal pain
• Tiredness
• Headache.
Common (may affect up to 1 in 10 people):
• Being sick (vomiting). If you are sick, read the
section ‘What to do if you are sick (vomit) ’.
• Your period might be different. Most women will
have a normal period at the expected time, but
some may have their period later or earlier than
normal. You might also have some irregular
bleeding or spotting until your next period. If your
period is more than 5 days late or is unusually light
or unusually heavy, you should contact your
doctor as soon as possible.
• You might have tender breasts, diarrhoea, feel
dizzy after taking this medicine.
Very rare effects (may affect up to 1 in 10000
people):
• Abdominal pain, rash, urticaria, pruritus, swelling
of the face, pelvic pain, painful period.
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 Levonorgestrel One Step

Store in original container.
KEEP THIS MEDICINE OUT OF SIGHT AND
REACH OF CHILDREN.
Do not use Levonorgestrel One Step after the expiry
date which is stated on the package “after EXP “.
The expiry date refers to the last day of the month.
If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist
who will tell you what to do.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protecet the environment.
6

Contents of the pack and other
information

What Levonorgestrel One Step contains
Each pack of Levonorgestrel One Step contains a
complete treatment which is one round, white tablet,
marked "G00" on one side and plain on the other
side.
The tablet contains 1500 micrograms of
Levonorgestrel, which is the active ingredient.
Levonorgestrel One Step also contain potato starch,
maize starch, collodial silica anhydrous, magnesium
stearate, talc and lactose monohydrate.
Manufacturer and Licence Holder
Levonorgestrel One Step is manufactured by
Gedeon Richter Plc. Gyomroi ut 19-21. H-1103
Budapest Hungary and is procured from within the
EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If after reading this leaflet, you are not sure about
anything or you have any questions, please ask your
pharmacist, doctor, practice nurse or family planning
clinic.

P

PL 15184/1177

Leaflet revision date: 18/02/16
For more information, you can also contact the
company who distribute Levonorgestrel One Step in
the UK.
The address is: Schering Health Care Limited, The
Brow, Burgess Hill, West Sussex, RH15 9NE
The E-mail address is:
customer.care@schering.co.uk (Monday to
Friday)

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Ref: 1177/180216/1/B

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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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