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LEVONELLE ONE STEP TABLET

Active substance(s): LEVONORGESTREL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

LEVONELLE® ONE STEP TABLET
(levonorgestrel)
This medicine is available as the above name but will be referred to as Levonelle One Step throughout the
following 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.
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
• Store in the original package.
• Keep out of the sight and reach of children.
• Do not take the tablets after the use by date, which is printed on the pack. The expiry date refers to the last day
of the month.
• 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 protect the environment.
• If you notice that your tablets have become discoloured or show any other signs of deterioration, speak to your
pharmacist.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Levonelle One Step contains
Each tablet contains 1500 micrograms of levonorgestrel, which is the active ingredient.
Levonelle One Step also contains the inactive ingredients: potato starch, maize starch, colloidal silica anhydrous,
magnesium stearate, talc and lactose monohydrate.
What Levonelle One Step looks like and contents of the pack
Levonelle One Step is round, white tablets marked ‘G00’ on one side and plain on the reverse.
The pack contains a complete course of one tablet.
Levonelle One Step is available in a blister pack containing 1 tablet.
Levonelle One Step is manufactured by:
Medimpex UK Limited, 127 Shirland Road, London, W9 2EP, UK
Bayer Schering Pharma AG, Berlin, Germany
Schering GmbH und CO Produktions KG, Weimar, Germany
Gedeon Richter Plc, Budapest, Hungary
Levonelle One Step is procured from within the EU and repackaged by the Product Licence Holder O.P.D.
Laboratories Ltd, Watford, Herts WD24 4PR.
PL No: 15814/0933

Levonelle® One Step Tablet

P.

Leaflet issue and revision date (Ref.) 18.05.2015.
Levonelle® is a trademark of Bayer Intellectual Property GmbH.
The emergency contraceptive helpline number is: 08456 – 035 – 035
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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