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LEVONELLE-2 750 MICROGRAM TABLET

Active substance(s): LEVONORGESTREL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

LEVONELLE-2 750 micrograms tablets
Levonorgestrel

Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Levonelle-2 is and what it is used for
2. Before you take Levonelle-2
3. How to take Levonelle-2
4. Possible side effects
5. How to store Levonelle-2
6. Further information

Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Tell your doctor if you are taking any of the
medicines listed below, as these medicines
may prevent Levonelle-2 from working
properly:
1. WHAT LEVONELLE-2 IS AND WHAT IT IS
–– Barbiturates and other medicines used
USED FOR
to treat epilepsy (for example, primidone,
phenytoin, and carbamazepine).
Levonelle-2 is an emergency contraceptive
–– Medicines used to treat tuberculosis (for
that can be used within 72 hours (3 days) of
example, rifampicin, rifabutin).
unprotected sex or if your usual contraceptive
–– A treatment for HIV infection (ritonavir).
method has failed.
–– A medicine used to treat fungal infections
(griseofulvin).
Levonelle-2 contains a synthetic hormone like
–– Herbal remedies containing St John’s wort
substance called levonorgestrel. It prevents
(Hypericum perforatum).
about 84% of expected pregnancies when you –– A medicine called cyclosporin (used to help
take it within 72hrs of having unprotected sex. It the immune system).
will not prevent a pregnancy every time and is
more effective if you take it as soon as possible If you are worried about sexually transmitted
after unprotected sex. It is better to take it within diseases
12hrs rather than delay until the third day.
This medicine will not protect you against
sexually transmitted diseases, only condoms
Levonelle-2 is thought to work by:
can do this. Ask your doctor, nurse, family
–– stopping your ovaries from releasing an egg; planning clinic or pharmacist for advice if you
–– preventing sperm from fertilising any egg
are worried about this.
you may have already released; or
–– stopping a fertilised egg from attaching itself How often can you use Levonelle-2
to your womb lining.
You should only use Levonelle-2 in
emergencies and not as a regular method of
Levonelle-2 can only prevent you becoming
contraception. If Levonelle-2 is used more than
pregnant if you take it within 72hrs of
once in a menstrual cycle, it is less reliable
unprotected sex. It does not work if you are
and it is more likely to upset your menstrual
already pregnant. If you have unprotected sex cycle (period).
after taking Levonelle-2, it will not stop you from Levonelle-2 does not work as well as regular
becoming pregnant.
methods of contraception. Your doctor, practice
nurse or family planning clinic can tell you
about long-term methods of contraception
2. BEFORE YOU TAKE LEVONELLE-2
which are more effective in preventing you from
getting pregnant.
Do not use Levonelle-2:
–– if you are allergic (hypersensitive) to
Pregnancy and breast-feeding
levonorgestrel or any of the other ingredients of Pregnancy
Levonelle-2 (see section 6).
You should not take this medicine if you are
already pregnant. If you have had unprotected
Take special care with Levonelle-2
sex which was more than 72 hours ago, and
If any of the following points apply to you, tell
since your last period, you may already be
your doctor before you take Levonelle-2 as
pregnant and the treatment won’t work. If your
emergency contraception may not be suitable
last period was more than 5 days late or was
for you.
unusually light or unusually heavy, you should
–– you are pregnant or think that you may
check with your doctor that you are not already
already be pregnant; as this medicine will not
pregnant.
work if you are already pregnant.
If you do become pregnant even after taking
You may already be pregnant if:
this medicine, it is important that you see your
–– your period is more than 5 days late, or you doctor. There is no evidence that Levonelle-2
have sufferered unusual bleeding when your
will harm a baby that develops in your uterus/
next period is due
womb if you use Levonelle-2 as described,
–– you have had unprotected sex more than
but there are no clinical data that if you have
72 hours ago, and since your last period
taken more than two tablets of Levonelle-2
it might harm your baby. Nevertheless, your
You should also tell your doctor if:
doctor may want to check that the pregnancy
–– you have a disease of your small bowel
is not ectopic (where the baby develops
(such as Crohn’s disease) that interferes with the somewhere outside the womb). This is
way you digest your food;
especially important if you develop severe
–– you have severe liver problems;
abdominal pain after taking Levonelle-2
–– you have a history of ectopic pregnancy;
or if you have previously had an ectopic
–– you have a history of inflamed fallopian
pregnancy, Fallopian tube surgery or pelvic
tubes (salpingitis).
inflammatory disease.
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.
In all women, emergency contraception
This is not thought to be harmful to the baby.
should be taken as soon as possible after
However if you are worried you can take your
unprotected intercourse. There is some
tablets immediately after a breast-feed and then
evidence that Levonelle-2 may be less effective drain your milk with a breast pump for 6 hours
with increasing body weight or body mass
after taking of Levonelle-2 and throw away the
index (BMI), but these data were limited and
milk. In this way you can reduce the amount of
inconclusive. Therefore, Levonelle-2 is still
active ingredient your baby may take in with
recommended for all women regardless of their the breast milk.
weight or BMI.
Driving and using machines
You are advised to speak to a healthcare
Your Levonelle-2 tablet is unlikely to affect
professional if you are concerned about
your ability to drive a car or use machines.
any problems related to taking emergency
However, if you feel tired or dizzy do not drive
contraception.
or operate machinery.
Your doctor may decide that Levonelle-2 is
not suitable for you, or that another type of
emergency contraception would be better for
you.

Important information about some of the
ingredients of Levonelle-2
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

Very common (affects more than 1 user in 10):
• Feeling sick (nausea)
• You might have some irregular bleeding until
your next period.
• You might have lower abdominal (tummy)
pain, feel tired after taking this medicine.
• Tiredness (fatigue)
• Headache

Common (affects 1 to 10 users in 100):
• 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
–– Take the two tablets at the same time as
earlier than normal. You might also have some
soon as possible, preferably within 12 hours,
irregular bleeding or spotting until your next
and no later than 72 hours (3 days) after you
period. If your period is more than 5 days late
have had unprotected sex. Levonelle-2 can
or is unusually light or unusually heavy, you
be taken at any time in your menstrual cycle
should contact your doctor as soon as possible.
assuming you are not already pregnant or think • You might have tender breasts, diarrhoea,
you may be pregnant. Swallow each tablet
feel dizzy after taking this medicine. These
whole with water. Do not delay taking the
symptoms should get better within a few days.
tablet. The tablet work better the sooner you
take them after having unprotected sex.
Very rare effects (affects less than 1 user in
–– If you are already using a regular method
10,000):
of contraception such as the contraceptive pill, • rash, urticaria, pruritus, face edema
you can continue to take this at your regular
times.
If any of the side effects gets serious, or if you
–– If another unprotected intercourse takes
notice any side effects not listed in this leaflet,
place after the use of Levonelle-2 (also if this
please tell your doctor or pharmacist.
is during the same menstrual cycle), the tablets
will not exert its contraceptive effect and there is
again the risk of pregnancy.
5. HOW TO STORE LEVONELLE-2
Always use Levonelle-2 exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure. This medicine
is not recommended for use in children.

What to do if you are sick (vomit)
If you are sick (vomit) within three hours of
taking the tablets, you should take another
two tablets. You will need to contact your
pharmacist, doctor, practice nurse or family
planning clinic immediately for more tablets.

Keep out of the reach and sight of children.

After you have taken Levonelle-2
After you have taken Levonelle-2, if you want to
have sex, and are not using the contraceptive
pill, you should use condoms or a cap plus
spermicide. This is because Levonelle-2 will not
work if you have unprotected sex again, before
your next period is due.

Do not store above 25°C.

After you have taken Levonelle-2, you are
advised to make an appointment to see your
doctor about three weeks later, to make sure
that Levonelle-2 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 longerterm 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-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.
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 clinic for advice, especially
if you have been sick, as the tablets may not
have worked properly.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

Do not use Levonelle-2 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 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 to
protect the environment.
6. FURTHER INFORMATION
What Levonelle-2 contains
The active substance is levonorgestrel.
Each tablet contains 750 micrograms of
levonorgestrel.
The other ingredients are potato starch, maize
starch, colloidal silica anhydrous, magnesium
stearate (E572), talc (E533b) and lactose
monohydrate.
What Levonelle-2 looks like and contents of the
pack
Each pack contains two round and white
tablets with an imprinted mark of “INOR” on
one side.
Marketing Authorisation Holder and
Manufacturer
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:
The emergency contraceptive helpline number is:
This leaflet was last approved in: 09/2014

4. POSSIBLE SIDE EFFECTS
Like all medicines, Levonelle-2 can cause side
effects, although not everybody gets them.

RG 0000, K-11697-1.7, 00000000

UK

LEVONELLE-2

pil

K-11697-1.7
148x420 mm
P Black
9 pt
2014.10.03.
Móni

P 185
12670

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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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