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UPOSTELLE 1500 MICROGRAM TABLETS

Active substance(s): LEVONORGESTREL / LEVONORGESTREL / LEVONORGESTREL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

UPOSTELLE®

1500 microgram tablet
levonorgestrel

Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist
has told you.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need more
information or advice.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

You are advised to speak to a healthcare
professional if you are concerned about any
problems related to taking emergency
contraception.

Do not use Upostelle
• if you are allergic to levonorgestrel or any of
the other ingredients of this medicine (listed
in section 6).

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.

Children and adolescents
Upostelle 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.
What is in this leaflet:
This medicine will not protect you against
1. What Upostelle 1500 microgram tablet
(hereinafter Upostelle) is and what it is used for sexually transmitted diseases, only condoms can
do this. Ask your doctor, nurse, family planning
2. What you need to know before you take
clinic or pharmacist for advice if you are worried
Upostelle
about this.
3. How to take Upostelle
4. Possible side effects
Other medicines and Upostelle
5. How to store Upostelle
Tell your doctor or pharmacist if you are taking,
6. Contents of the pack and other information
have recently taken or might take any other
medicines.
1. What Upostelle is and what it is
Some medicines may prevent Upostelle from
used for
working effectively. If you have used any of the
medicines below during the last 4 weeks,
Upostelle is an emergency contraceptive that
Upostelle may be less suitable for you. Your
can be used within 72 hours of unprotected sex doctor may prescribe another type of (nonor if your usual contraceptive method has failed. hormonal) emergency contraceptive, i.e. a
copper intrauterine device (Cu-IUD). If this is
Upostelle contains a synthetic hormone-like
not an option for you or if you are unable to see
active substance called levonorgestrel. It
your doctor promptly, you can take a double
prevents about 84% of expected pregnancies
dose of Upostelle:
when you take it within 72 hours of having
unprotected sex. It will not prevent a pregnancy • barbiturates and other medicines used to
treat epilepsy (for example, primidone,
every time and is more effective if you take it as
phenytoin, and carbamazepine)
soon as possible after unprotected sex. It is
• medicines used to treat tuberculosis (for
better to take it within 12 hours rather than
example, rifampicin, rifabutin)
delay until the third day.
• a treatment for HIV (ritonavir, efavirenz)
Upostelle is thought to work by:
• a medicine used to treat fungal infections
• stopping your ovaries from releasing an egg;
(griseofulvin)
• preventing sperm from fertilising any egg you • herbal remedies containing St John’s wort
may have already released.
(Hypericum perforatum).
Upostelle can only prevent you becoming
Speak to your pharmacist or doctor if you need
pregnant if you take it within 72 hours of
further advice on the correct dose for you.
unprotected sex. It does not work if you are
Consult your doctor as soon as possible after
already pregnant. If you have unprotected sex
taking the tablets for further advice on a reliable
after taking Upostelle, it will not stop you from
form of regular contraception and to exclude a
becoming pregnant.
pregnancy. (See section 3. “How to take
Upostelle is not indicated for use before the first Upostelle” for further advice).
menstrual bleeding (menarche).
Upostelle may also affect how well other
medicines work:
2. What you need to know before
• a medicine used to suppress the immune
you take Upostelle
system (ciclosporin).

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.
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
body weight or body mass index (BMI), but
these data were limited and inconclusive.
Therefore, Upostelle is still recommended for all
women regardless of their weight or BMI.

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.

planning clinic for advice, especially if you have
been sick, as the tablet may not have worked
properly.

Driving and using machines
No studies on the effects on the ability to drive
and use machines have been performed.

4. Possible side effects

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 doctor or 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.
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 have any further questions on the use of
this medicine, ask your doctor or pharmacist.

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 (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 or
search for MHRA Yellow Card in the Google
Play or Apple App Store. 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.

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, Packaging: one tablet in PVC//aluminium blister
and cardboard cartons.
see your doctor to make sure you are not
pregnant.
Marketing Authorisation Holder and
Manufacturer
Your next period after you took Upostelle
After the use of Upostelle, your period is usually Gedeon Richter Plc.
Gyömrői út 19-21,
normal and will start at the usual day; however
sometimes, this will be a few days later or earlier. H-1103 Budapest,
If your period starts more than 5 days later than Hungary
expected, an ‘abnormal’ bleeding occurs at that Distributor
time or if you think that you might be pregnant, Consilient Health (UK) Ltd.,
you should check whether you are pregnant by No.1 Church Road,
a pregnancy test.
Richmond upon Thames,
Surrey,
If you take more Upostelle than you should
Although there have been no reports of serious TW9 2QE
harmful effects from taking too many tablets at
once, you may feel sick, actually be sick (vomit), This leaflet was last revised in August 2017
or have vaginal bleeding. You should ask your
pharmacist, doctor, practice nurse or family
P0667

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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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