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LEVONELLE ONE STEP 1500 MICROGRAMS TABLET

Active substance(s): LEVONORGESTREL

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T06572

LEVONELLE® ONE STEP 1500 micrograms tablet
(levonorgestrel)

Patient Information Leaflet
Your medicine is called LEVONELLE ONE STEP 1500 micrograms tablet 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 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.

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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.

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
• Keep out of the sight and reach of children.
• Do not use Levonelle One Step after the expiry date which is stated on the carton label
and blister foil after EXP. The expiry date refers to the last day of that month.
• Store in the original package in order to protect from light.
• 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 (E572), talc (E533b) 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 round, white
tablet marked ‘G00’ on one side.
Manufacturer and Product Licence Holder
This medicine is manufactured by Gedeon Richter Plc. Budapest, Hungary. It is procured
from within the EU by the Product Licence Holder: Swinghope Limited, Brandon House,
Marlowe Way, Croydon CR0 4XS, U K .
P

PL No: 10380/1404
Leaflet revision date: 05/05/2016
Levonelle® is a registered trademark of Bayer Schering Pharma AG.

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.

T06572

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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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