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LEVONELLE-2 750 MICROGRAM TABLET

Active substance(s): LEVONORGESTREL / LEVONORGESTREL / LEVONORGESTREL

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Package leaflet: Information for the user

Levonelle ®-2
Levonorgestrel

750 micrograms tablets

Read all of this leaflet carefully before you start taking 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 or pharmacist.
–– This medicine has been prescribed for you only. Do not pass it on to others.
–– If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
What is in this leaflet:
1. What Levonelle-2 is and what it is used for
2. What you need to know before you take Levonelle-2
3. How to take Levonelle-2
4. Possible side effects
5. How to store Levonelle-2
6. Contents of the pack and other information

How often can you use Levonelle-2
You should only use Levonelle-2 in emergencies and not as a
regular method of contraception. If Levonelle-2 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-2 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.

1. What Levonelle-2 is and what it is used for
Levonelle-2 is an emergency contraceptive that can be used
within 72 hours (3 days) of unprotected sex or if your usual
contraceptive method has failed.

Pregnancy, breast-feeding and fertility

Pregnancy
You should not take this medicine if you are already
Levonelle-2 contains a synthetic hormone like active substance pregnant. If you have had unprotected sex which was more
called levonorgestrel. It prevents about 84% of expected
than 72 hours ago, and since your last period, you may
pregnancies when you take it within 72hrs of having
already be pregnant and the treatment won’t work. If your
unprotected sex. It will not prevent a pregnancy every time
last period was more than 5 days late or was unusually light
and is more effective if you take it as soon as possible after
or unusually heavy, you should check with your doctor that
unprotected sex. It is better to take it within 12hrs rather than you are not already pregnant.
delay until the third day.
If you are already pregnant, Levonelle-2 can not break down
the pregnancy, Levonelle-2 is thus not an “abortion pill”.
Levonelle-2 is thought to work by:
If you do become pregnant even after taking this medicine,
–– stopping your ovaries from releasing an egg;
it is important that you see your doctor. There is no evidence
–– preventing sperm from fertilising any egg you may have
that Levonelle-2 will harm a baby that develops in your
already released;
uterus/womb if you use Levonelle-2 as described, but there
are no clinical data that if you have taken more than two
Levonelle-2 can only prevent you becoming pregnant if you
tablets of Levonelle-2 it might harm your baby. Nevertheless,
take it within 72hrs of unprotected sex. It does not work if you your doctor may want to check that the pregnancy is not
are already pregnant. If you have unprotected sex after taking ectopic (where the baby develops somewhere outside the
Levonelle-2, it will not stop you from becoming pregnant.
womb). This is especially important if you develop severe
abdominal pain after taking Levonelle-2 or if you have
Levonelle-2 is not indicated for use before the first menstrual
previously had an ectopic pregnancy, Fallopian tube surgery
bleeding (menarche).
or pelvic inflammatory disease.
2. What you need to know before you take Levonelle-2
Do not use Levonelle-2
–– 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 points apply to you, tell your doctor
before you take Levonelle-2 as emergency contraception may
not be suitable for you.
–– you are pregnant or think that you may already be
pregnant; as this medicine will not work if you are already
pregnant. If you are already pregnant, Levonelle-2 cannot
terminate pregnancy, so Levonelle-2 is not an “abortion pill”.
You may already be pregnant if:
–– your period is more than 5 days late, or you have
sufferered unusual bleeding when your next period is due
–– you have had unprotected sex more than 72 hours ago,
and since your last period.
You should also tell your doctor if:
–– you have a disease of your small bowel (such as Crohn’s
disease) that interferes with the way you digest your food;
–– 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 inflamed fallopian tubes (salpingitis).
Your doctor may decide that Levonelle-2 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-2 may be less effective with
increasing body weight or body mass index (BMI), but these
data were limited and inconclusive. Therefore, Levonelle-2 is
still recommended for all women regardless of their weight or
BMI.

Breast-feeding
Women who breast-feed can use Levonelle-2 but should take
the following measures.
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-2 can alter your menstruational cycle (period) 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-2 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-2 contains lactose
Each Levonelle-2 tablets contains 71.25 mg lactose. If you
have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine.
3. How to take Levonelle-2
Always use this medicine exactly as described in the leaflet
or as your pharmacisthas told you. Check with your doctor or
pharmacist if you are not sure.

•• Take the two tablets at the same time as soon as
possible, preferably within 12 hours, and no later than
72 hours (3 days) after you have had unprotected sex.
Levonelle-2 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
You are advised to speak to a healthcare professional if
works best the sooner you take it after having unprotected
you are concerned about any problems related to taking
sex.
emergency contraception.
•• If you are using one of the medicines that may prevent
Levonelle-2 from working properly (see section above “Other
Children and adolescents
medicines and Levonelle-2”) or if you have used one of these
Levonelle-2 is not indicated for use before the first menstrual
medicines in the past 4 weeks, Levonelle-2 may work less
bleeding (menarche).
effectively for you. Your doctor may prescribe another type
of (non-hormonal) emergency contraceptive, i.e. a copper
Other medicines and Levonelle-2
intrauterine device (Cu-IUD). If this is not an option for you or
Tell your pharmacist or doctor if you are taking or have
if you are unable to see your doctor promptly, you can take a
recently taken any other medicines, including medicines
double dose of Levonelle-2 (i.e. 4 tablets taken together at the
obtained without a prescription or herbal medicines.
same time).
•• If you are already using a regular method of contraception
Some medicines may prevent Levonelle-2 from working
such as the contraceptive pill, you can continue to take this at
effectively. If you have used any of the medicines below during your regular times.
the last 4 weeks, Levonelle-2 may be less suitable for you. Your
doctor may prescribe another type of (non-hormonal) emergency If another unprotected intercourse takes place after the use of
contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this Levonelle-2 (also if this is during the same menstrual cycle), the
is not an option for you or if you are unable to see your doctor tablets will not exert its contraceptive effect and there is again
promptly, you can take a double dose of Levonelle-2:
the risk of pregnancy.
–– barbiturates and other medicines used to treat epilepsy (for
example, primidone, phenytoin, and carbamazepine).
Use in children and adolescents
–– medicines used to treat tuberculosis (for example,
There is no relevant use of Levonelle-2 in children below the
rifampicin, rifabutin).
age at which menstruation begins.
–– a treatment for HIV infection (ritonavir, efavirenz).
–– a medicine used to treat fungal infections (griseofulvin).
What to do if you are sick (vomit)
–– herbal remedies containing St John’s wort (Hypericum
If you are sick (vomit) within three hours of taking the tablets,
perforatum).
you should take another two tablets. You will need to contact
your pharmacist, doctor, practice nurse or family planning
Speak to your pharmacist or doctor if you need further advice clinic immediately for more tablets.
on the correct dose for you.
After you have taken Levonelle-2
Consult your doctor as soon as possible after taking the tablets After you have taken Levonelle-2, if you want to have sex, and
for further advice on a reliable form of regular contraception
are not using the contraceptive pill, you should use condoms
and to exclude a pregnancy. (See section also 3 “How to
or a cap plus spermicide. This is because Levonelle-2 will
take Levonelle-2” for further advice).
not work if you have unprotected sex again, before your next
period is due.
Levonelle-2 may also affect how well other medicines work
–– a medicine called cyclosporin (suppresses the immune system). After you have taken Levonelle-2, you are advised to make
an appointment to see your doctor about three weeks later,
If you are worried about sexually transmitted diseases
to make sure that Levonelle-2 has worked. If your period is
This medicine will not protect you against sexually transmitted more than 5 days late or is unusually light or unusually heavy,
diseases, only condoms can do this. Ask your doctor, nurse,
you should contact your doctor as soon as possible. If you
family planning clinic or pharmacist for advice if you are
do become pregnant even after taking this medicine, it is
worried about this.
important that you see your doctor.

LEVONELLE-2 750mcg

K-11697-2.4

P Black

UK
Futura AOT (11 pt) [13,2 pt]

P 185

v_02
Mucius Scaevola Kft.
2016.11.03.
VASTAG Bea

UTAS

213 × 660 (±0,5)/27 × 66 (±1) mm PIL_RTU_66x27_213x660

/Page01 HORVÁTH Győző/ 2016.07.18.

VAD Márta /2016.07.18.

Your doctor can also tell you about longer-term methods of
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
contraception which are more effective in preventing you from effects you can help provide more information on the safety of
getting pregnant.
this medicine.
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-2
After the use of Levonelle-2, 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, ‘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.

5. How to store Levonelle-2
Keep this medicine out of the reach and sight of children.
Do not use this medicine 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.
Do not store above 25°C.
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 protect
the environment.

If you take more Levonelle-2 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 6. Contents of the pack and other information
clinic for advice, especially if you have been sick, as the
tablets may not have worked properly.
What Levonelle-2 contains
The active substance is levonorgestrel. Each tablet contains
If you have any further questions on the use of this product, ask 750 micrograms of levonorgestrel.
your doctor or pharmacist.
The other ingredients are potato starch, maize starch, colloidal
silica anhydrous, magnesium stearate (E572), talc (E533b)
and lactose monohydrate.
4. Possible side effects
What Levonelle-2 looks like and contents of the pack
Like all medicines, this medicine can cause side effects,
Each pack contains two round and white tablets with an
although not everybody gets them.
imprinted mark of “INOR” on one side.
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 (tummy) pain.
–– Tiredness (fatigue)
–– Headache

Marketing Authorisation Holder and Manufacturer

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, face edema, 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

The Marketing Authorisation Holder is:
Medimpex UK Limited
127 Shirland Road
London
W9 2EP
United Kingdom
Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21.
H-1103 Budapest
Hungary
Levonelle-2 is distributed in the UK by:
For more information, you can also contact the company who
distribute Levonelle-2 in the UK.
The E-mail address is:
This leaflet was last revised in October 2016

00000000

Levonelle ®-2

00000000

Levonelle ®-2

K-11697-2.4

LEVONELLE-2 750mcg

K-11697-2.4

P Black

UK
Futura AOT (11 pt) [13,2 pt]

P 185

v_02
Mucius Scaevola Kft.
2016.11.03.
VASTAG Bea

UTAS

213 × 660 (±0,5)/27 × 66 (±1) mm PIL_RTU_66x27_213x660

/Page02 HORVÁTH Győző/ 2016.07.18.

VAD Márta /2016.07.18.

Expand Transcript

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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