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EMERGENCY CONTRACEPTIVE CONSILIENT 1500 MICROGRAM TABLET

Active substance(s): LEVONORGESTREL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

EMERGENCY
CONTRACEPTIVE CONSILIENT
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 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.
What is in this leaflet:
1. What Emergency Contraceptive Consilient
1500 microgram tablet (hereinafter
Emergency Contraceptive Consilient) is and
what it is used for
2. What you need to know before you take
Emergency Contraceptive Consilient
3. How to take Emergency Contraceptive
Consilient
4. Possible side effects
5. How to store Emergency Contraceptive
Consilient
6. Contents of the pack and other information
1. WHAT EMERGENCY CONTRACEPTIVE
CONSILIENT IS AND WHAT IT IS USED FOR
Emergency Contraceptive Consilient is an
emergency contraceptive that can be used
within 72 hours (3 days) of unprotected sex or
if your usual Contraceptive method has failed.
Emergency Contraceptive Consilient 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.
Emergency Contraceptive Consilient is thought
to work by:
• stopping your ovaries from releasing an egg;
• preventing sperm from fertilising any egg you
may have already released.
Emergency Contraceptive Consilient 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 Emergency
Contraceptive Consilient, it will not stop you
from becoming pregnant.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE EMERGENCY CONTRACEPTIVE
CONSILIENT
Do not use Emergency Contraceptive
Consilient
• 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 Emergency
Contraceptive Consilient 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, Emergency Contraceptive
Consilient cannot terminate pregnancy, so
Emergency Contraceptive Consilient 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.
• Levonorgestrel is not recommended for
young women under 16 years of age without
medical supervision.
The use of Emergency Contraceptive Consilient
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
Emergency Contraceptive Consilient may be
less effective with increasing body weight or
body mass index (BMI), but these data were
limited and inconclusive. Therefore, Emergency
Contraceptive Consilient 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.
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 Emergency
Contraceptive Consilient
Tell your pharmacist if you are taking, have
recently taken or might take any other
medicines.
Some medicines may prevent Emergency
Contraceptive Consilient 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)
• a medicine used to treat fungal infections
(griseofulvin)
• herbal remedies containing St John’s wort
(Hypericum perforatum)
• a medicine called ciclosporin (suppresses the
immune system).
Consult a doctor or pharmacist before using
Emergency Contraceptive Consilient if you use
any of the above mentioned medicine.
How often can you use Emergency
Contraceptive Consilient
You should only use Emergency Contraceptive
Consilient in emergencies and not as a regular
method of contraception. If Emergency
Contraceptive Consilient is used more than
once in a menstrual cycle, it is less reliable and it
is more likely to upset your menstrual cycle
(period).
Emergency Contraceptive Consilient 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, 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 Emergency Contraceptive Consilient will
harm a baby that develops in your uterus/
womb if you use Emergency Contraceptive
Consilient 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 Emergency
Contraceptive Consilient 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
Emergency Contraceptive Consilient 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.

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.

Driving and using machines
Your Emergency Contraceptive Consilient
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.

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

Emergency Contraceptive Consilient
contains lactose
In case of milk sugar (lactose) intolerance it
should be considered that each Emergency
Contraceptive Consilient 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 EMERGENCY
CONTRACEPTIVE CONSILIENT
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.
Use in children and adolescents
This medicine is not recommended for use in
children. If you are under 16, you must visit
your doctor or family planning clinic to get
emergency contraception.
• 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.
Emergency Contraceptive Consilient 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.
If another unprotected intercourse takes place
after the use of Emergency Contraceptive
Consilient (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. You will need to contact your
pharmacist, doctor, practice nurse or family
planning clinic immediately for one more
tablet.
After you have taken Emergency
Contraceptive Consilient
After you have taken Emergency Contraceptive
Consilient, 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
Emergency Contraceptive Consilient won’t
work if you have unprotected sex again, before
your next period is due.
After you have taken Emergency Contraceptive
Consilient, you are advised to make an
appointment to see your doctor about three
weeks later, to make sure that Emergency
Contraceptive Consilient 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 Emergency
Contraceptive Consilient
After the use of Emergency Contraceptive
Consilient, 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Some side effects may be serious. Speak to
your doctor immediately if you notice any of
the following:
Very rare effects (may affect up to 1 in 10000
people):
• Rash, urticaria, pruritus, swelling of the face,
pelvic pain, painful period.
Other side effects may include:
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.
If you get any side effects, talk to your doctor
or pharmacist. This includes any side effects
not listed in this leaflet.
Also you can help to make sure that medicines
remain as safe as possible by reporting any
unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively
you can call Freephone 0808 100 3352 (available
from 10 a.m. to 2 p.m. Mondays to Fridays) or
fill in a paper form available from your local
pharmacy.
5. HOW TO STORE EMERGENCY
CONTRACEPTIVE CONSILIENT
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 to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Emergency Contraceptive Consilient
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 Emergency Contraceptive Consilient
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.
Gyömröi 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 January 2015.

If you take more Emergency Contraceptive
Consilient than you should
Although there have been no reports of serious
P0319

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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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