POSTINOR ONE STEP 1500 MICROGRAM TABLET

Active substance: LEVONORGESTREL

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Transcript
Ref: 1177/141112/1/F

®

Levonelle One Step 1500 microgram Tablet
(levonorgestrel)
Patient Information Leaflet
Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to take Levonelle One Step
carefully to get the best results from it.
Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information
or advice.
- You must contact a doctor if your symptoms
worsen or do not improve.
- If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Your medicine is called Levonelle One Step 1500
microgram Tablets, but will be referred to as
Levonelle One Step throughout the leaflet.

In this leaflet:
1 What Levonelle One Step is and what it is
used for
2 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 Further 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 72hrs 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 12hrs
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; or
• 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 72hrs 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

Before you take Levonelle One Step

Do not use Levonelle One Step if:
• you are allergic (hypersensitive) to levonorgestrel
or any of the other ingredients of Levonelle One
Step (see section 6)
Take special care with Levonelle One Step
If any of the following points apply to you, tell your
doctor before you take Levonelle One Step as
emergency contraception may not be suitable for
you.
• you are pregnant or think that you may already
be pregnant, as this medicine will not work if you
are already pregnant.
You may already be pregnant if:
• your period is more than 5 days late, or you have
suffered unusual bleeding when your next period
is due
• you have had unprotected sex more than 72
hours ago, and since your last period
You should also tell your doctor if:
you have a disease of your small bowel (such as
Crohn’s disease) that interferes with the way you
digest your food
• you have severe liver problems






you have ever had an ectopic pregnancy (where
the baby develops somewhere outside the womb)
you have ever had a disease called salpingitis
(inflammation of the Fallopian tubes).

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.
If you under 16, you must visit your doctor or family
planning clinic to get emergency contraception.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Tell your pharmacist if you are taking any of the
medicines listed below, as these medicines may
prevent Levonelle One Step from working properly
• 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)
If you are worried about sexually transmitted
diseases
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.
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 and breast-feeding
Ask your pharmacist for advice before taking any
medicine.
You should not take this medicine if you are already
pregnant. If you have had unprotected sex which
was more than 72 hours ago, and since your last
period, you may already be pregnant and the
treatment won’t work. If your last period was more
than 5 days late or was unusually light or unusually
heavy, you should check with your doctor that you
are not 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 but
your doctor may want to check that the pregnancy is
not ectopic. 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.
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-feed. 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.

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.
Important information about some of the
ingredients of Levonelle One Step
Each Levonelle One Step tablet contains lactose.
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.
3

How to take Levonelle One Step

Always use Levonelle One Step exactly as your
pharmacist has told you. You should check with your
doctor or pharmacist if you are not sure. This
medicine is not recommended for use in children
• 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.
Swallow the tablet whole, with water if necessary.
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.
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
advice and another 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.
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.
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.

4

Possible side effects

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, headaches,
diarrhoea, feel dizzy after taking this medicine.
These symptoms should get better within a few
days.
Very rare (less than 1 in 10000 women ):
• Skin reactions can occur: generalised itching,
rash, itchy rash, swelling of the face.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

How to store Levonelle One Step

5

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

Further information

What Levonelle One Step contains
Each pack contains 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
Hellas ABEE, 18-20 Sorou Street, 15125 Marousi,
Athens, Greece 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: 14/11/12
Levonelle is a registered trademark of Bayer
Schering Pharma Aktiengesellschaft.
For more information, you can also contact the
company who distribute Levonelle One Step in the
UK.

Like all medicines, Levonelle One Step can cause
side effects, although not everybody gets them.

The address is: Schering Health Care Limited, The
Brow, Burgess Hill, West Sussex, RH15 9NE

Very common (equal or more than 1 in 10 women):
• Feeling sick (nausea)
• You might have some irregular bleeding until your
next period.
• You might have lower abdominal (tummy) pain
• Tiredness (fatigue)

The E-mail address is:
customer.care@schering.co.uk (Monday to
Friday)

Common (equal or more than 1 in 100 women, but
less than 1 in 10):
• 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.
Ref: 1177/141112/1/B

Ref: 1177/141112/1/F

®

Postinor One Step 1500 microgram Tablet
(levonorgestrel)
Patient Information Leaflet
Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to take Postinor One Step
carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information
or advice.
- You must contact a doctor if your symptoms
worsen or do not improve.
- If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Your medicine is called Postinor One Step 1500
microgram Tablets, but will be referred to as
Postinor One Step throughout the leaflet.

In this leaflet
1 What Postinor One Step is and what it is
used for
2 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 Further 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 72hrs 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 12hrs
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; or
• 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 72hrs 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 Before you take Postinor One Step
Do not use Postinor One Step if:
• you are allergic (hypersensitive) to levonorgestrel
or any of the other ingredients of Postinor One
Step (see section 6)
Take special care with Postinor One Step
If any of the following points apply to you, tell your
doctor before you take Postinor One Step as
emergency contraception may not be suitable for
you.
• you are pregnant or think that you may already
be pregnant, as this medicine will not work if you
are already pregnant.
You may already be pregnant if:
• your period is more than 5 days late, or you have
suffered unusual bleeding when your next period
is due
• you have had unprotected sex more than 72
hours ago, and since your last period
You should also tell your doctor if:
you have a disease of your small bowel (such as
Crohn’s disease) that interferes with the way you
digest your food
• you have severe liver problems
• you have ever had an ectopic pregnancy (where
the baby develops somewhere outside the womb)





you have ever had a disease called salpingitis
(inflammation of the Fallopian tubes).

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.
If you under 16, you must visit your doctor or family
planning clinic to get emergency contraception.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Tell your pharmacist if you are taking any of the
medicines listed below, as these medicines may
prevent Postinor One Step from working properly
• 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)
If you are worried about sexually transmitted
diseases
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.
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 and breast-feeding
Ask your pharmacist for advice before taking any
medicine.
You should not take this medicine if you are already
pregnant. If you have had unprotected sex which
was more than 72 hours ago, and since your last
period, you may already be pregnant and the
treatment won’t work. If your last period was more
than 5 days late or was unusually light or unusually
heavy, you should check with your doctor that you
are not 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 but
your doctor may want to check that the pregnancy is
not ectopic. 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.
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-feed. 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.
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.

Important information about some of the
ingredients of Postinor One Step
Each Postinor One Step tablet contains lactose.
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.

Very rare (less than 1 in 10000 women ):
• Skin reactions can occur: generalised itching,
rash, itchy rash, swelling of the face.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

3 How to take Postinor One Step
Always use Postinor One Step exactly as your
pharmacist has told you. You should check with your
doctor or pharmacist if you are not sure. This
medicine is not recommended for use in children
• 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.
Swallow the tablet whole, with water if necessary.
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.
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
advice and another 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.
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.
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.
4 Possible side effects

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 Further information
What Postinor One Step contains
Each pack contains 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 Hellas
ABEE, 18-20 Sorou Street, 15125 Marousi, Athens,
Greece 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: 14/11/12
Postinor is a registered trademark of Bayer Schering
Pharma Aktiengesellschaft.
For more information, you can also contact the
company who distribute Postinor One Step in the
UK.

Like all medicines, Postinor One Step can cause
side effects, although not everybody gets them.

The address is: Schering Health Care Limited, The
Brow, Burgess Hill, West Sussex, RH15 9NE

Very common (equal or more than 1 in 10 women):
• Feeling sick (nausea)
• You might have some irregular bleeding until your
next period.
• You might have lower abdominal (tummy) pain
• Tiredness (fatigue)

The E-mail address is:
customer.care@schering.co.uk (Monday to
Friday)

Common (equal or more than 1 in 100 women, but
less than 1 in 10):
• 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, headaches,
diarrhoea, feel dizzy after taking this medicine.
These symptoms should get better within a few
days.
Ref: 1177/141112/1/B

Ref: 1177/141112/1/F

®

Levonorgestrel One Step 1500 microgram Tablet
(levonorgestrel)
Patient Information Leaflet
Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to take Levonorgestrel One
Step carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information
or advice.
- You must contact a doctor if your symptoms
worsen or do not improve.
- If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Your medicine is called Levonorgestrel One Step
1500 microgram Tablets, but will be referred to as
Levonorgestrel One Step throughout the leaflet.

In this leaflet
1 What Levonorgestrel One Step is and what it
is used for
2 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 Further 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 72hrs 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 12hrs
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; or
• 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 72hrs 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 Before you take Levonorgestrel One

Step
Do not use Levonorgestrel One Step if:
• you are allergic (hypersensitive) to levonorgestrel
or any of the other ingredients of Levonorgestrel
One Step (see section 6)
Take special care with Levonorgestrel One Step
If any of the following points apply to you, tell your
doctor before you take Levonorgestrel One Step as
emergency contraception may not be suitable for
you.
• you are pregnant or think that you may already
be pregnant, as this medicine will not work if you
are already pregnant.
You may already be pregnant if:
• your period is more than 5 days late, or you have
suffered unusual bleeding when your next period
is due
• you have had unprotected sex more than 72
hours ago, and since your last period
You should also tell your doctor if:
you have a disease of your small bowel (such as
Crohn’s disease) that interferes with the way you
digest your food
• you have severe liver problems






you have ever had an ectopic pregnancy (where
the baby develops somewhere outside the womb)
you have ever had a disease called salpingitis
(inflammation of the Fallopian tubes).

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.
If you under 16, you must visit your doctor or family
planning clinic to get emergency contraception.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Tell your pharmacist if you are taking any of the
medicines listed below, as these medicines may
prevent Levonorgestrel One Step from working
properly
• 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)
If you are worried about sexually transmitted
diseases
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.
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 and breast-feeding
Ask your pharmacist for advice before taking any
medicine.
You should not take this medicine if you are already
pregnant. If you have had unprotected sex which
was more than 72 hours ago, and since your last
period, you may already be pregnant and the
treatment won’t work. If your last period was more
than 5 days late or was unusually light or unusually
heavy, you should check with your doctor that you
are not 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
but your doctor may want to check that the
pregnancy is not ectopic. 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.
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-feed. 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.
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.

Important information about some of the
ingredients of Levonorgestrel One Step
Each Levonorgestrel One Step tablet contains
lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact
your doctor before taking this medicine.
3 How to take Levonorgestrel One Step
Always use Levonorgestrel One Step exactly as
your pharmacist has told you. You should check with
your doctor or pharmacist if you are not sure. This
medicine is not recommended for use in children
• 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.
Swallow the tablet whole, with water if necessary.
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.
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
advice and another 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.
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.
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, Levonorgestrel One Step can
cause side effects, although not everybody gets
them.
Very common (equal or more than 1 in 10 women):
• Feeling sick (nausea)
• You might have some irregular bleeding until your
next period.
• You might have lower abdominal (tummy) pain
• Tiredness (fatigue)

• You might have tender breasts, headaches,
diarrhoea, feel dizzy after taking this medicine.
These symptoms should get better within a few
days.
Very rare (less than 1 in 10000 women ):
• Skin reactions can occur: generalised itching,
rash, itchy rash, swelling of the face.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

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 Further information
What Levonorgestrel One Step contains
Each pack contains 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
Hellas ABEE, 18-20 Sorou Street, 15125 Marousi,
Athens, Greece 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: 14/11/12
Levonorgestrel is a registered trademark of Bayer
Schering Pharma Aktiengesellschaft.
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)

Common (equal or more than 1 in 100 women, but
less than 1 in 10):
• 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

Ref: 1177/141112/1/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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