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LEVONELLE 1500 MICROGRAM TABLET

Active substance(s): LEVONORGESTREL

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Levonelle®

1500 microgram tablet
Levonorgestrel

Package leaflet: Information for the user

Levonelle®

1500 microgram tablet
Levonorgestrel
b
(1]

Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
RR Keep this leaflet. You may need to read it again.
RR If you have any further questions, ask your doctor.
C
[2)

RR 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.

d
(3]

What is in this leaflet:
1. What Levonelle 1500 microgram tablet
(hereinafter Levonelle 1500) is and what
it is used for
E
[4)

7

2. What you need to know before you take
Levonelle 1500
3. How to take Levonelle 1500
4. Possible side effects

14
44
59
f
(5]

5. How to store Levonelle 1500
6. Contents of the pack and other
information
G
[6)

67
70

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.

h
(7]

It is about the following cases:
RR No contraception was used during the sexual
intercourse.
RR The contraception measure was used incorrectly, for
example as if a condom was penetrated, slipped away
I
[8)

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).
j
(9]

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
[10)

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:
RR stopping your ovaries from releasing an egg;
(11]

RR 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
[12)

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.
Levonelle 1500 is not indicated for use before the first
menstrual bleeding (menarche).
(13]

2. What you need to know before you take
Levonelle 1500
Do not use Levonelle 1500
RR if you are allergic to levonorgestrel or any of the other
ingredients of this medicine listed in section 6.
[14)

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.
(15]

RR 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”.
[16)

You may already be pregnant if:
RR your period is more than 5 days late, or you have
experienced unusual bleeding when your next period
is due
RR you have had unprotected sex more than 72 hours
ago, and since your last period.
(17]

The use of Levonelle 1500 is not advised if:
RR you have a disease of your small bowel (such as Crohn’s
disease) that inhibits the absorption of the drug;
RR you have severe liver problems;
[18)

RR you have a history of ectopic pregnancy (where the
baby develops somewhere outside the womb);
RR you have a history of salpingitis (inflammation of the
Fallopian tubes).
(19]

A previous ectopic pregnancy or previous infection of the
fallopian tubes increase the risk of a new ectopic pregnancy.
In all women, emergency contraception should be taken
as soon as possible after unprotected intercourse. There
is some evidence that Levonelle 1500 may be less
[20)

effective with increasing body weight or body mass index
(BMI), but these data were limited and inconclusive.
Therefore, Levonelle 1500 is still recommended for all
women regardless of their weight or BMI.
(21]

You are advised to speak to a healthcare professional if
you are concerned about any problems related to taking
emergency contraception.

[22)

Children and adolescents
Levonelle 1500 is not indicated for use before the first
menstrual bleeding (menarche).

(23]

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.
[24)

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.
(25]

Other medicines and Levonelle 1500
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription or herbal medicines.
[26)

Some medicines may prevent Levonelle 1500 from
working effectively. If you have used any of the medicines
below during the last 4 weeks, Levonelle 1500 may be
less suitable for you. Your doctor may prescribe another
type of (non-hormonal) emergency contraceptive, i.e. a
copper intrauterine device (Cu-IUD). If this is not an

(27]

option for you or if you are unable to see your doctor
promptly, you can take a double dose of Levonelle 1500:
RR barbiturates and other medicines used to treat
epilepsy (for example primidone, phenytoin, and
carbamazepine)
[28)

RR medicines used to treat tuberculosis (for example,
rifampicin, rifabutin)
RR treatment for HIV (ritonavir, efavirenz)
RR a medicine used to treat fungal infections
(griseofulvin)
(29]

RR herbal remedies containing St John’s wort (Hypericum
perforatum).
Speak to your pharmacist or doctor if you need further
advice on the correct dose for you.
[30)

Consult a doctor as soon as possible after taking the
tablets for further advice on a reliable form of regular
contraception and to exclude a pregnancy.

(31]

(See also section 3 “How to take Levonelle 1500” for
further advice).
Levonelle 1500 may also affect how well other
medicines work
[32)

RR a medicine called cyclosporin (suppresses the
immune system).
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
(33]

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
[34)

contraception which are more effective in preventing you
from getting pregnant.
Pregnancy and 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. (35]

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
[36)

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.
(37]

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
[38)

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
(39]

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.
[40)

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.
(41]

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.
[42)

If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

(43]

3. How to take Levonelle 1500
Always use this medicine exactly as described in the
leaflet or as your pharmacist or doctor has told you.
Check with your doctor or pharmacist if you are not sure.
[44)

RR 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

(45]

with water. Do not delay taking the tablet. The tablet
works best the sooner you take it after having
unprotected sex.
RR If you are using one of the medicines that may
prevent Levonelle 1500 from working properly (see
section above “Other medicines and Levonelle 1500”)

[46)

or if you have used one of these medicines in the past
4 weeks, Levonelle 1500 may work less effectively for
you. Your doctor may prescribe another type of
(non-hormonal) emergency contraceptive, i.e. a
copper intrauterine device (Cu-IUD). If this is not an
option for you or if you are unable to see your doctor

(47]

promptly, you can take a double dose of Levonelle 1500
(i.e. 2 tablets taken together at the same time).
RR 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.
[48)

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.
(49]

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.

[50)

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 will not
(51]

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
[52)

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.
(53]

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
[54)

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
(55]

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.
[56)

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,
(57]

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.
[58)

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
(59]

Very common (may affect more than 1 in 10 people):
RR Feeling sick (nausea)
RR You might have some irregular bleeding until your
next period
RR You might have lower abdominal pain
[60)

RR Tiredness
RR Headache
Common (may affect up to 1 in 10 people):
RR Being sick (vomiting). If you are sick, read the section
‘What to do if you are sick (vomit)’.
(61]

RR 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
[62)

5 days late or is unusually light or unusually heavy,
you should contact your doctor as soon as possible.
RR You might have tender breasts, diarrhoea, feel dizzy
after taking this medicine.
(63]

Very rare effects (may affect up to 1 in
10000 people):
RR Rash, urticaria, pruritus, swelling of the face pelvic
pain, painful period.
[64)

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.
(65]

By reporting side effects you can help provide more
information on the safety of this medicine.

[66)

5. How to store Levonelle 1500
Keep this medicine out of the sight and reach of
children.
(67]

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.
[68)

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.
(69]

6. Contents of the pack and other
information

[70)

What Levonelle 1500 contains
The active substance is levonorgestrel. Each tablet
contains 1500 micrograms of levonorgestrel.
The other ingredients are
Potato starch,
(71]

Maize starch,
Colloidal silica anhydrous,
Magnesium stearate,
Talc,
Lactose monohydrate.
[72)

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.
(73]

Marketing Authorisation Holder
Medimpex UK Limited
127 Shirland Road, London, W9 2EP, UK

[74)

Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21., H-1103 Budapest, Hungary
Levonelle 1500 is distributed in the UK by
Bayer plc
(75]

Bayer House, Strawberry Hill, Newbury, Berkshire
RG14 1JA. UK
Levonelle® is a registered trademark of the Bayer
Group
This leaflet was last revised in 10/2016
[76)

K-22185-1.8, 00000000

név/name: LEVONELLE 1500
szám/number: K-22185-1.8
méret/size: 66x27 mm
színek/colour:
P Black
P 520
betűméret/font size: 8pt
karakter/character: 14400

ország/country: UK
típus/type: pil
dátum/date: 2016.10.28.
technical info
matrix code
grafikus:

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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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