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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

In all women, emergency contraception should
be taken as soon as possible after unprotected
intercourse. There is some evidence that
Upostelle may be less effective with increasing
• Keep this leaflet. You may need to read it again. body weight or body mass index (BMI), but these
• If you have any further questions, ask your
data were limited and inconclusive. Therefore,
doctor.
Upostelle is still recommended for all women
• This medicine has been prescribed for you only.
regardless of their weight or BMI.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
You are advised to speak to a healthcare
yours.
professional if you are concerned about
• If you get any side effects, talk to your doctor
any problems related to taking emergency
or pharmacist. This includes any possible side
contraception.
effects not listed in this leaflet. See section 4.
If you are worried about sexually transmitted
diseases
What is in this leaflet:
If you did not use a condom (or if it has been
1. What Upostelle 1500 microgram tablet
(hereinafter Upostelle) is and what it is used for torn or slid down) during the intercourse, it
might be possible that you have caught a sexually
2. What you need to know before you take
transmitted disease or the HIV virus.
Upostelle
This medicine will not protect you against
3. How to take Upostelle
sexually transmitted diseases, only condoms can
4. Possible side effects
do this. Ask your doctor, nurse, family planning
5. How to store Upostelle
clinic or pharmacist for advice if you are worried
6. Contents of the pack and other information
about this.
1. What Upostelle is and what it is
Other medicines and Upostelle
used for
Tell your pharmacist if you are taking, have
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.

Upostelle is an emergency contraceptive that
can be used within 72 hours of unprotected sex
or if your usual contraceptive method has failed.
Upostelle 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.
Upostelle is thought to work by:
• stopping your ovaries from releasing an egg;
• preventing sperm from fertilising any egg you
may have already released.
Upostelle 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 you have unprotected sex
after taking Upostelle, it will not stop you from
becoming pregnant.
Upostelle is not indicated for use before the first
menstrual bleeding (menarche).
2. What you need to know before you
take Upostelle
Do not use Upostelle
• 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 Upostelle 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, Upostelle cannot terminate
pregnancy, so Upostelle 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 Upostelle 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 ever had a disease called salpingitis
(inflammation of the Fallopian tubes).
A previous ectopic pregnancy or previous
infection of the fallopian tubes increases the risk
of a new ectopic pregnancy.

recently taken or might take any other
medicines.
Some medicines may prevent Upostelle from
working properly, these include:
• barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin,
and carbamazepine)
• medicines used to treat tuberculosis (for
example, rifampicin, rifabutin)
• a treatment for HIV infection (ritonavir,
efavirenz)
• a medicine used to treat fungal infections
(griseofulvin)
• herbal remedies containing St John’s wort
(Hypericum perforatum).
Upostelle may also affect how well other
medicines work, therefore taking the below
medicine together with Upostelle is not
recommended:
• a medicine used to suppress the immune
system (cyclosporine).
Consult a doctor or pharmacist before using
Upostelle if you use any of the above mentioned
medicine.

How often can you use Upostelle
You should only use Upostelle in emergencies
and not as a regular method of contraception. If
Upostelle is used more than once in a menstrual
cycle, it is less reliable and it is more likely to
upset your menstrual cycle (period).
Upostelle 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.
Pregnancy, 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.
Pregnancy
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 Upostelle will harm a baby that develops
in your uterus/womb if you use Upostelle 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
Upostelle or if you have previously had an
ectopic pregnancy, Fallopian tube surgery or
pelvic inflammatory disease.
Breast-feeding
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
Upostelle increases the possibility of menstruation
disturbances 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
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 better the sooner you take it after
having unprotected sex.
• 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.

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
If another unprotected intercourse takes place
reporting side effects you can help provide more
after the use of Upostelle (also if this is during the information on the safety of this medicine.
same menstrual cycle), the tablet will not exert
its contraceptive effect and there is again the risk 5. How to store Upostelle
of pregnancy.
Keep this medicine out of the sight and reach of
Use in children and adolescents
children.
This medicine is not recommended for use
Do not use this medicine after the expiry date
in children. Very limited data are available in
which is stated on the carton. The expiry date
women under 16 years of age.
refers to the last day of that month.
What to do if you are sick (vomit)
Store in the original package in order to protect
If you are sick (vomit) within three hours of
taking the tablet, you should take another tablet. from light.
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.

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

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.

What Upostelle contains

and you do not have a bleed in your pill-free
period, see your doctor to make sure you are not
pregnant.

Tablet: almost white, flat, rimmed tablet of about
8 mm diameter with an impressed mark of “G00”
on one side.

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.

Packaging: one tablet in PVC//aluminium blister
and cardboard cartons.

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

Distributor:
Consilient Health (UK) Ltd.,
No.1 Church Road, Richmond upon Thames,
Surrey. TW9 2QE.

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,
Your doctor can also tell you about longer-term
Talc,
methods of contraception which are more
effective in preventing you from getting pregnant. Lactose monohydrate.
What Upostelle looks like and contents of the
If you continue to use regular hormonal
pack
contraception such as the contraceptive pill

Marketing Authorisation Holder and
Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21,
H-1103 Budapest
Hungary

This leaflet was last revised in June 2016
P0473

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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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