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LEVONORGESTREL ONE STEP 1.5MG TABLET

Active substance(s): LEVONORGESTREL / LEVONORGESTREL / LEVONORGESTREL

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Package leaflet: Information for the user

Levonelle® One Step 1.5mg tablet
(levonorgestrel)
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.
The name of your medicine is Levonelle One Step 1.5mg tablet but will
be referred to as Levonelle One Step throughout this 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.
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.
Levonelle One Step is not indicated for use before the first menstrual
bleeding (menarche).
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
If you are under 16, you must visit your doctor or family planning clinic to
get emergency contraception.
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 or doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription
or herbal medicines.
Some medicines may prevent Levonelle One Step from working
effectively. If you have used any of the medicines below during the last 4
weeks, Levonelle One Step may be less suitable for you. Your doctor
may prescribe another type of (non-hormonal) emergency contraceptive,
i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you
or if you are unable to see your doctor promptly, you can take a double
dose of Levonelle One Step:
► 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 (ritonavir, efavirenz)
► a medicine used to treat fungal infections (griseofulvin)
► herbal remedies containing St John’s wort (Hypericum perforatum)
Speak to your pharmacist or doctor if you need further advice on the
correct dose for you.
Consult your doctor as soon as possible after taking the tablets for
further advice on a reliable form of regular contraception and to exclude
a pregnancy. (See section also 3 ‘How to take Levonelle One Step’ for
further advice).
Levonelle One Step may also affect how well other medicines work
► a medicine called cyclosporin (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 breastfeeding 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 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.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

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

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.

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
Levonelle One Step is not indicated for use before the first menstrual
bleeding (menarche).
► 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 best the sooner you
take it after having unprotected sex.
► If you are using one of the medicines that may prevent Levonelle
One Step from working properly (see section above ‘Other
medicines and Levonelle One Step’) or if you have used one of
these medicines in the past 4 weeks, Levonelle One Step may work
less effectively for you. Your doctor may prescribe another type of
(non-hormonal) emergency contraceptive, i.e. a copper intrauterine
device (Cu-IUD). If this is not an option for you or if you are unable to
see your doctor promptly, you can take a double dose of Levonelle
One Step (i.e. 2 tablets taken together at the same time).
► 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.

4. Possible side effects

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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report any 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
Keep out of the sight and reach of children.
Store in the original package in order to protect from light.
Do not take the tablet after the expiry date which is stated on the carton
and blister label after ‘Exp’. The expiry date refers to the last day of that
month.
If the tablet become discoloured or show any signs of deterioration, seek
the advice of your pharmacist.
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 protect the environment.
6. Contents of pack and the other information
What Levonelle One Step contains
The active ingredient in Levonelle One Step is levonorgestrel.
Each tablet contains 1.5mg levonorgestrel.
The other ingredients are potato starch, maize starch, colloidal
anhydrous silica, magnesium stearate, talc, lactose monohydrate.
What Levonelle One Step looks like and contents of the pack
Each tablet is round, white and embossed with ‘G00’ on one side and
plain on other side. Levonelle One Step comes in blister pack containing
1 tablet.
Manufactured by: Gedeon Richter Ltd., Gyömrői Út 19-21 1103
Budapest, Hungary.

Your doctor can also tell you about longer-term methods of
contraception which are more effective in preventing you from getting
pregnant.

Procured from within the EU and repackaged by Product Licence
holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.

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.

Levonelle One Step 1.5mg tablet; PL 18799/2319
Leaflet date: 01.06.2017

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.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the
leaflet in a format suitable for you.

®

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.

P

Levonelle One Step is a registered trademark of the Bayer group.

Package leaflet: Information for the user

Levonorgestrel One Step 1.5mg tablet
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.
The name of your medicine is Levonorgestrel One Step 1.5mg tablet but
will be referred to as Levonorgestrel One Step throughout this leaflet.
What is in this leaflet
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.
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.
Levonorgestrel One Step is not indicated for use before the first
menstrual bleeding (menarche).
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
If you are under 16, you must visit your doctor or family planning clinic to
get emergency contraception.
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 or doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription
or herbal medicines.
Some medicines may prevent Levonorgestrel One Step from working
effectively. If you have used any of the medicines below during the last 4
weeks, Levonorgestrel One Step may be less suitable for you. Your
doctor may prescribe another type of (non-hormonal) emergency
contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an
option for you or if you are unable to see your doctor promptly, you can
take a double dose of Levonorgestrel One Step:
► 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 (ritonavir, efavirenz)
► a medicine used to treat fungal infections (griseofulvin)
► herbal remedies containing St John’s wort (Hypericum perforatum)
Speak to your pharmacist or doctor if you need further advice on the
correct dose for you.
Consult your doctor as soon as possible after taking the tablets for
further advice on a reliable form of regular contraception and to exclude
a pregnancy. (See section also 3 ‘How to take Levonorgestrel One Step’
for further advice).
Levonorgestrel One Step may also affect how well other medicines work
► a medicine called cyclosporin (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 breastfeeding 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 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 contains lactose
In case of milk sugar (lactose) intolerance it should be considered that
each Levonorgestrel One Step tablet also contains 142.5mg 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
Levonorgestrel One Step is not indicated for use before the first
menstrual bleeding (menarche).
► 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 best the sooner you
take it after having unprotected sex.
► If you are using one of the medicines that may prevent
Levonorgestrel One Step from working properly (see section above
‘Other medicines and Levonorgestrel One Step’) or if you have used
one of these medicines in the past 4 weeks, Levonorgestrel One
Step may work less effectively for you. Your doctor may prescribe
another type of (non-hormonal) emergency contraceptive, i.e. a
copper intrauterine device (Cu-IUD). If this is not an option for you or
if you are unable to see your doctor promptly, you can take a double
dose of Levonorgestrel One Step (i.e. 2 tablets taken together at the
same time).
► 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.
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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report any 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
Keep out of the sight and reach of children.
Store in the original package in order to protect from light.
Do not take the tablet after the expiry date which is stated on the carton
and blister label after ‘Exp’. The expiry date refers to the last day of that
month.
If the tablet become discoloured or show any signs of deterioration, seek
the advice of your pharmacist.
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 protect the environment.
6. Contents of pack and the other information
What Levonorgestrel One Step contains
The active ingredient in Levonorgestrel One Step is levonorgestrel.
Each tablet contains 1.5mg levonorgestrel.
The other ingredients are potato starch, maize starch, colloidal
anhydrous silica, magnesium stearate, talc, lactose monohydrate.
What Levonorgestrel One Step looks like and contents of the pack
Each tablet is round, white and embossed with ‘G00’ on one side and
plain on other side. Levonorgestrel One Step comes in blister pack
containing 1 tablet.
Manufactured by: Gedeon Richter Ltd., Gyömrői Út 19-21 1103
Budapest, Hungary.
Procured from within the EU and repackaged by Product Licence
holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
P
Levonorgestrel One Step 1.5mg tablet; PL 18799/2319
Leaflet date: 01.06.2017

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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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