LEVONELLE 1500 MICROGRAM TABLET

Active substance: LEVONORGESTREL

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Package leaflet: Information for the user
Levonelle 1500 microgram tablet
Levonorgestrel
The Package leaflet includes alternative texts for different legal status in different countries as follows:
- Boxed texts are only applicable for OTC versions.
- [Grey-shaded texts in brackets] are only applicable for prescription versions.
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.
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Keep this leaflet. You may need to read it again.
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Ask your pharmacist if you need more information or advice.
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If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
[Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
­
Keep this leaflet. You may need to read it again.
­
If you have any further questions, ask your doctor.
­
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
­
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.]
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Levonelle 1500 microgram tablet (hereinafter Levonelle 1500) is and what it is used for
What you need to know before you take Levonelle 1500
How to take Levonelle 1500
Possible side effects
How to store Levonelle 1500
Contents of the pack and other information

1.

What Levonelle 1500 is and what it is used for

Levonelle 1500 is an emergency contraceptive that can be used within 72 hours (3 days) of
unprotected sex or if your usual contraceptive method has failed.
It is about the following cases:
No contraception was used during the sexual intercourse.
The contraception measure was used incorrectly, for example as if a condom was penetrated,
slipped away or used in a wrong way, if vaginal pessary or diaphragm changed position, burst, was
broken or taken out ahead of time, in the case of a failed interruption during coitus interruptus (e.g.
sperm ejaculated in vagina or on external genitalia).
Levonelle 1500 contains a synthetic hormone like active 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 1500 is thought to work by:

stopping your ovaries from releasing an egg.

preventing sperm from fertilising any egg you may have already released; or

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Levonelle 1500 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 another unprotected intercourse takes place after
the use of Levonelle 1500 (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.

2.

What you need to know before you take Levonelle 1500

Do not use Levonelle 1500:
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 1500 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 1500 cannot terminate pregnancy, so
Levonelle 1500 is not an “abortion pill”.
You may already be pregnant if:
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your period is more than 5 days late, or you have experienced unusual bleeding when your next
period is due
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you have had unprotected sex more than 72 hours ago, and since your last period.
The use of Levonelle 1500 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 a history of salpingitis (inflammation of the Fallopian tubes).
A previous ectopic pregnancy or previous infection of the fallopian tubes increase the risk of a new
ectopic pregnancy.

Children and adolescents
This medicine is not recommended for use in children. Very limited data are available in women under
16 years of age.
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 1500
Tell your pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may prevent Levonelle 1500 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).
Consult a doctor or pharmacist before using Levonelle 1500 if you use any of the above mentioned
medicines.
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How often can you use Levonelle 1500
You should only use Levonelle 1500 in emergencies and not as a regular method of contraception. If
Levonelle 1500 is used more than once in a menstrual cycle, it is less reliable and it is more likely to
upset your menstrual cycle (period).
Levonelle 1500 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 any medicine.
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 1500
will harm a baby that develops in your uterus/womb if you use Levonelle 1500 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 1500 or if you have previously had an ectopic pregnancy, Fallopian tube
surgery or pelvic inflammatory disease.
The active ingredient of this medicine is excreted into your breast milk. Therefore, it is suggested that
you take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following
levonorgestrel administration then drain your milk with a breast pump for 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.
Levonelle 1500 increases the possibility of menstruation disturbances which can sometimes lead to
earlier or later ovulation date resulting in modified fertility date. Although there are no fertility data in
the long term, after treatment with Levonelle 1500 a rapid return to fertility is expected and therefore,
regular contraception should be continued or initiated as soon as possible after Levonelle 1500 use.
Driving and using machines
Your Levonelle 1500 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 1500 contains lactose
In case of milk sugar (lactose) intolerance it should be considered that each Levonelle 1500 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 1500

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.

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 1500 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.

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If another unprotected intercourse takes place after the use of Levonelle 1500 (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.

Use in children and adolescents
This medicine is not recommended for use in children. Very limited data are available in women under
16 years of age.
What to do if you are sick (vomit)
If you are sick (vomit) within three hours of taking the tablet, you should immediately take another
tablet.
After you have taken Levonelle 1500
After you have taken Levonelle 1500, 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 1500 won’t work if you have unprotected sex again, before your next period is due.
After you have taken Levonelle 1500, you are advised to make an appointment to see your doctor
about three weeks later, to make sure that Levonelle 1500 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 1500
After the use of Levonelle 1500, 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 1500 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).
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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 10,000 people):

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 national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of
this medicine.

5.

How to store Levonelle 1500

Keep this medicine out of the sight and reach of children.
Do not use Levonelle 1500 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 packaging in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Levonelle 1500 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,
Lactose monohydrate.
What Levonelle 1500 looks like and contents of the pack
Tablet: almost white, flat, rimmed tablet of about 8 mm diameter with an impressed mark of “G00” on
one side.
Packaging: one tablet in PVC//aluminium blister and cardboard cartons.
Marketing Authorisation Holder
Medimpex UK Limited
127 Shirland Road, London, W9 2EP, UK
Manufacturer
Bayer Pharma AG
Mullerstrasse 178., D-13353 Berlin, Germany
or
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Bayer Weimar GmBH und Co.KGDöbereinerstrasse 20, D-99427 Weimar, Germany
or
Gedeon Richter Plc.
Gyömrői út 19-21., H-1103 Budapest, Hungary
This leaflet was last approved in January 2014

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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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