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LEVONORGESTREL 1500 MICROGRAM TABLET

Active substance(s): LEVONORGESTREL / LEVONORGESTREL / LEVONORGESTREL

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Levonelle® 1500 microgram tablet

2631
10.07.17[9]

(levonorgestrel)
PATIENT INFORMATION 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.
This medicine will be referred to as Levonelle 1500 throughout the following
leaflet.
What is in this leaflet:
1. What 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.
Levonelle 1500 is not indicated for use before the first menstrual bleeding
(menarche).
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.
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 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.
You are advised to speak to a healthcare professional if you are concerned
about any problems related to taking emergency contraception.
Children and adolescents
Levonelle 1500 is not indicated for use before the first menstrual bleeding
(menarche).
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 doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription or
herbal medicines.
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 option for you or if you are
unable to see your doctor promptly, you can take a double dose of
Levonelle 1500:
- barbiturates and other medicines used to treat epilepsy (for example,
primidone, phenytoin, and carbamazepine)
- medicines used to treat tuberculosis (for example, rifampicin, rifabutin)
- treatment for HIV (ritonavir, efavirenz)
- a medicine used to treat fungal infections (griseofulvin)
- 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.
Consult your doctor as soon as possible after taking the tablets for further
advice on a reliable form of regular contraception and to exclude a
pregnancy. (See also section 3 “How to take Levonelle 1500” for further
advice).
Levonelle 1500 may also affect how well other medicines work
- 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 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 longterm methods of 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.
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 or doctor 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 best the sooner you take it after having
unprotected sex.
- If you are using one of the medicines that may prevent Levonelle 1500
from working properly (see section above “Other medicines and Levonelle
1500”) 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 promptly, you can take a double dose of
Levonelle 1500 (i.e. 2 tablets taken together at the same time).
- 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.
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
will not 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 10000 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 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 package in order to protect from light.
If the tablet becomes discoloured or shows any other signs of deterioration,
consult your pharmacist who will tell you what to do.
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 anhydrous
silica, magnesium stearate, talc and lactose monohydrate.
What Levonelle 1500 looks like and contents of the pack
Levonelle 1500 is a round, white tablet engraved with ‘G00’ on one side and
plain on the reverse.
Packaging: one tablet in PVC//aluminium blister and cardboard cartons.
Manufacturer and Product Licence Holder
Levonelle 1500 is manufactured by Gedeon Richter SA, Gyomroi UTCA 1921, HU-1013 Budapest, Hungary and is procured from within the EU by
Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close,
Harrow, HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2631

Leaflet revision and issue date (Ref.) 10.07.17[9]
Levonelle is a trademark of Bayer Intellectual Property GmbH.

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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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