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UPOSTELLE 1500 MICROGRAM TABLETS

Active substance(s): LEVONORGESTREL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

UPOSTELLE®

1500 microgram tablet
levonorgestrel

limited and inconclusive. Therefore, Upostelle is
still recommended for all women regardless of
their weight or BMI.
You are advised to speak to a healthcare
• Keep this leaflet. You may need to read it again.
professional if you are concerned about any
• If you have any further questions, ask your
problems related to taking emergency
doctor.
contraception.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
If you are worried about sexually transmitted
even if their signs of illness are the same as yours. diseases
• If you get any side effects, talk to your doctor or If you did not use a condom (or if it has been torn
pharmacist. This includes any possible side
or slid down) during the intercourse, it might be
effects not listed in this leaflet. See section 4.
possible that you have caught a sexually
transmitted disease or the HIV virus.
What is in this leaflet:
This medicine will not protect you against sexually
1. What Upostelle 1500 microgram tablet
transmitted diseases, only condoms can do this.
(hereinafter Upostelle) is and what it is used for
Ask your doctor, nurse, family planning clinic or
2. What you need to know before you take
pharmacist for advice if you are worried about this.
Upostelle
Other medicines and Upostelle
3. How to take Upostelle
Tell your pharmacist or doctor if you are taking or
4. Possible side effects
have recently taken any other medicines, including
5. How to store Upostelle
medicines obtained without a prescription or
6. Contents of the pack and other information
herbal medicines.
1. WHAT UPOSTELLE IS AND WHAT IT IS USED Some medicines may prevent Upostelle from
FOR
working effectively. If you have used any of the
Upostelle is an emergency contraceptive that can medicines below during the last 4 weeks, Upostelle
may be less suitable for you. Your doctor may
be used within 72 hours of unprotected sex or if
prescribe another type of (non-hormonal)
your usual contraceptive method has failed.
emergency contraceptive, i.e. a copper intrauterine
Upostelle contains a synthetic hormone-like active device (Cu-IUD). If this is not an option for you or
substance called levonorgestrel. It prevents about if you are unable to see your doctor promptly, you
84% of expected pregnancies when you take it
can take a double dose of Upostelle:
within 72 hours of having unprotected sex. It will
• barbiturates and other medicines used to treat
not prevent a pregnancy every time and is more
epilepsy (for example, primidone, phenytoin, and
effective if you take it as soon as possible after
carbamazepine)
unprotected sex. It is better to take it within
• medicines used to treat tuberculosis (for
12 hours rather than delay until the third day.
example, rifampicin, rifabutin)
Upostelle is thought to work by:
• a treatment for HIV (ritonavir, efavirenz)
• stopping your ovaries from releasing an egg;
• a medicine used to treat fungal infections
• preventing sperm from fertilising any egg you
(griseofulvin)
may have already released.
• herbal remedies containing St John’s wort
(Hypericum perforatum).
Upostelle can only prevent you becoming
pregnant if you take it within 72 hours of
Speak to your pharmacist or doctor if you need
unprotected sex. It does not work if you are
further advice on the correct dose for you.
already pregnant. If you have unprotected sex
Consult your doctor as soon as possible after
after taking Upostelle, it will not stop you from
taking the tablets for further advice on a reliable
becoming pregnant.
form of regular contraception and to exclude a
Upostelle is not indicated for use before the first
pregnancy (also see section 3 “How to take
menstrual bleeding (menarche).
Upostelle” for further advice).
Upostelle may also affect how well other
2. WHAT YOU NEED TO KNOW BEFORE YOU
medicines work:
TAKE UPOSTELLE
• a medicine used to suppress the immune system
Do not use Upostelle
(cyclosporine).
• if you are allergic to levonorgestrel or any of the
How often can you use Upostelle
other ingredients of this medicine listed in
You should only use Upostelle in emergencies and
section 6.
not as a regular method of contraception.
Warnings and precautions
If Upostelle is used more than once in a menstrual
If any of the following applies to you, talk to your
cycle, it is less reliable and it is more likely to upset
doctor before taking Upostelle as emergency
your menstrual cycle (period).
contraception may not be suitable for you.
Upostelle does not work as well as regular
Your doctor may prescribe another type of
methods of contraception. Your doctor, practice
emergency contraception for you:
nurse or family planning clinic can tell you about
• if you are pregnant or think that you may already long-term methods of contraception which are
be pregnant. This medicine will not work if you
more effective in preventing you from getting
are already pregnant. If you are already pregnant, pregnant.
Upostelle cannot terminate pregnancy, so
Pregnancy, breast-feeding and fertility
Upostelle is not an “abortion pill”.
If you are pregnant or breast-feeding, think you
You may already be pregnant if:
may be pregnant or are planning to have a baby,
­ – your period is more than 5 days late, or you
ask your doctor or pharmacist for advice before
have experienced unusual bleeding when
taking any medicine.
your next period is due
Pregnancy
­ – you have had unprotected sex more than
You should not take this medicine if you are
72 hours ago, and since your last period.
already pregnant. If you do become pregnant even
The use of Upostelle is not advised if:
after taking this medicine, it is important that you
• you have a disease of your small bowel (such
see your doctor. There is no evidence that
as Crohn’s disease) that inhibits the absorption
Upostelle will harm a baby that develops in your
of the drug
uterus/womb if you use Upostelle as described.
• you have severe liver problems
Nevertheless, your doctor may want to check that
• you have a history of ectopic pregnancy
the pregnancy is not ectopic (where the baby
(where the baby develops somewhere outside
develops somewhere outside the womb). This is
the womb)
especially important if you develop severe
• you have ever had a disease called salpingitis
abdominal pain after taking Upostelle or if you
(inflammation of the fallopian tubes).
have previously had an ectopic pregnancy, fallopian
A previous ectopic pregnancy or previous
tube surgery or pelvic inflammatory disease.
infection of the fallopian tubes increases the risk of Breast-feeding
a new ectopic pregnancy.
Very small amounts of the active ingredient of this
In all women, emergency contraception should be medicine may appear in your breast milk. This is
taken as soon as possible after unprotected
not thought to be harmful to the baby, but if you
intercourse. There is some evidence that Upostelle are worried you can take your tablet immediately
may be less effective with increasing body weight
after a breast-feeding and avoid nursing at least
or body mass index (BMI), but these data were
8 hours following tablet taking. In this way you are
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.

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
Upostelle increases the possibility of menstruation
disturbances which can some-times 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
No studies on the effects on the ability to drive
and use machines have been performed.
Upostelle contains lactose
In case of milk sugar (lactose) intolerance it
should be considered that each Upostelle 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 UPOSTELLE
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.
Upostelle 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 Upostelle from working properly (see
section above “Other medicines and Upostelle”)
or if you have used one of these medicines in the
past 4 weeks, Upostelle 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 Upostelle (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 Upostelle (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 take another tablet.
After you have taken Upostelle
After you have taken Upostelle, 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
Upostelle won’t work if you have unprotected sex
again, before your next period is due.
After you have taken Upostelle, you are advised to
make an appointment to see your doctor about
three weeks later, to make sure that Upostelle 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 Upostelle
After the use of Upostelle, 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 Upostelle 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, abdominal pain.
Reporting on 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 UPOSTELLE
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.
Store in the original package 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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Upostelle contains
The active substance is levonorgestrel. Each tablet
contains 1500 micrograms of levonorgestrel.
The other ingredients are:
Potato starch,
Maize starch,
Silica, colloidal anhydrous,
Magnesium stearate,
Talc,
Lactose monohydrate.
What Upostelle 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.
Marketing Authorisation Holder and
Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21,
H-1103 Budapest
Hungary
Distributor:
Consilient Health (UK) Ltd.,
No.1 Church Road, Richmond upon Thames,
Surrey. TW9 2QE.
This leaflet was last revised in October 2016

P0511

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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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