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LEVONORGESTREL 1500 MICROGRAMS TABLETS

Active substance(s): LEVONORGESTREL

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Levonelle One Step 1500 micrograms Tablets/
Postinor One Step 1500 micrograms Tablets
(levonorgestrel)
Patient Information Leaflet
Your medicine is known by one of the above names but will be referred to
as Levonelle One Step throughout this 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.
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 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 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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5) How to store Levonelle One Step
• Keep all medicines out of the 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.
• Store in the original package. Protect from light.
• If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of 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 protect the environment.

6) Contents of the pack and other information
What Levonelle One Step contains
The active substance is levonorgestrel.
Each tablet contains 1500 micrograms of levonorgestrel.
The other ingredients are potato starch, maize starch, colloidal silica
anhydrous, magnesium stearate, talc and lactose monohydrate.
What Levonelle One Step looks like and contents of the pack
Each pack of Levonelle One Step contains a complete treatment which is
one white round tablet embossed with “G00” on one side and plain on the
other.
Levonelle One Step is available as a blister pack containing one tablet.
PL 10383/2025

Levonelle One Step 1500micrograms Tablets/
Levonorgestrel 1500micrograms Tablets P

Who makes and repackages your medicine?
Your medicine is manufactured by Gedeon Richter Ltd. Budapest, Hungary.
Procured from within the EU and repackaged by the Product Licence
Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Northolt, Middlesex
UB5 5QS.
Leaflet date: 03.11.2015
Levonelle® is a registered trademark of the Bayer Group.

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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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