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LEVONELLE 1500 MICROGRAMME TABLET

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Package leaflet: Information for the user

Levonelle 1500 microgram
tablet
(levonorgestrel)
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. What Levonelle 1500 microgram tablet
(hereinafter Levonelle 1500) is and what it is
used for
2. What you need to know before you take
Levonelle 1500
3. How to take Levonelle 1500
4. Possible side effects
5. How to store Levonelle 1500
6. 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;
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:
• 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.
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.
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 breastfeeding 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 142.5mg 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 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.
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) .
• 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,
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 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 (E572), Talc (E553b), Lactose
monohydrate.
What Levonelle 1500 looks like and contents of
the pack
Tablet: almost white, flat, tablet with an impressed
mark of “G00” on one side.
Packaging: one tablet in a PVC/aluminium blister in
a carton
Procured from within the EU by PL holder
PilsCo Ltd, 10-16 Colvilles Place, East Kilbride,
G75 0SN.
Manufacturer
Bayer Pharma AG, Mullerstrasse 178., D-13353
Berlin, Germany
or
Bayer Weimar GmBH und Co.KG
Döbereinerstrasse 20, D-99427 Weimar, Germany
or
Gedeon Richter Plc. Gyömrői út 19-21., H-1103
Budapest, Hungary
PL 39467/0133 Levonelle 1500 microgram tablet
Levonelle® is a registered trademark of Bayer
Pharma AG.
This leaflet was last revised in 12/05/2014

POM

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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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