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EMERGENCY CONTRACEPTIVE CONSILIENT 1500 MICROGRAM TABLET

Active substance(s): LEVONORGESTREL / LEVONORGESTREL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

EMERGENCY
CONTRACEPTIVE CONSILIENT
1500 microgram tablet
levonorgestrel

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.
Children and adolescents
What is in this leaflet
Emergency Contraceptive Consilient is not
1. What Emergency Contraceptive Consilient
indicated for use before the first menstrual
1500 microgram tablet (hereinafter Emergency bleeding (menarche).
Contraceptive Consilient) is and what it is used
If you are worried about sexually transmitted
for
diseases
2. What you need to know before you take
If you did not use a condom (or if it has been
Emergency Contraceptive Consilient
torn or slid down) during the intercourse, it
3. How to take Emergency Contraceptive
might be possible that you have caught a sexually
Consilient
transmitted disease or the HIV virus.
4. Possible side effects
This medicine will not protect you against
5. How to store Emergency Contraceptive
sexually transmitted diseases, only condoms can
Consilient
do this. Ask your doctor, nurse, family planning
6. Contents of the pack and other information
clinic or pharmacist for advice if you are worried
about this.
1. WHAT EMERGENCY CONTRACEPTIVE
CONSILIENT IS AND WHAT IT IS USED FOR
Other medicines and Emergency Contraceptive
Consilient
Emergency Contraceptive Consilient is an
Tell your pharmacist if you are taking or have
emergency contraceptive that can be used within recently taken any other medicines, including
72 hours (3 days) of unprotected sex or
medicines obtained without a prescription or
if your usual contraceptive method has failed.
herbal medicines.
Emergency Contraceptive Consilient contains a
Some medicines may prevent Emergency
synthetic hormone-like active substance called
Contraceptive Consilient from working
levonorgestrel. It prevents about 85 % of expected effectively. If you have used any of the medicines
pregnancies when you take it within 72 hours
below during the last 4 weeks, Emergency
of having unprotected sex. It will not prevent a
Contraceptive Consilient may be less suitable for
pregnancy every time and is more effective if you you. Your doctor may prescribe another type of
take it as soon as possible after unprotected sex.
(non-hormonal) emergency contraceptive, i.e. a
It is better to take it within 12 hours rather than
copper intrauterine device (Cu-IUD). If this is not
delay until the third day.
an option for you or if you are unable to see your
Emergency Contraceptive Consilient is thought
doctor promptly, you can take a double dose of
to work by:
Emergency Contraceptive Consilient:
• stopping your ovaries from releasing an egg;
• barbiturates and other medicines used to treat
• preventing sperm from fertilising any egg you
epilepsy (for example, primidone, phenytoin,
may have already released.
and carbamazepine)
• medicines used to treat tuberculosis (for
Emergency Contraceptive Consilient can only
example, rifampicin, rifabutin)
prevent you becoming pregnant if you take
• a treatment for HIV infection (ritonavir,
it within 72 hours of unprotected sex. It does
efavirenz)
not work if you are already pregnant. If you
• a medicine used to treat fungal infections
have unprotected sex after taking Emergency
(griseofulvin)
Contraceptive Consilient, it will not stop you
• herbal remedies containing St John’s wort
from becoming pregnant.
(Hypericum perforatum).
Emergency Contraceptive Consilient is not
Speak to your pharmacist or doctor if you need
indicated for use before the first menstrual
further advice on the correct dose for you.
bleeding (menarche).
Consult your doctor as soon as possible after
taking the tablets for further advice on a reliable
2. WHAT YOU NEED TO KNOW BEFORE
form of regular contraception and to exclude
YOU TAKE EMERGENCY CONTRACEPTIVE
a pregnancy (also see section 3 “How to take
CONSILIENT
Emergency Contraceptive Consilient” for
Do not use Emergency Contraceptive
further advice).
Consilient
• if you are allergic to levonorgestrel or any of the Emergency Contraceptive Consilient may also
affect how well other medicines work:
other ingredients of this medicine (listed
• a medicine called cyclosporin (suppresses the
in section 6).
immune system).
Warnings and precautions
Consult
a doctor or pharmacist before using
If any of the following applies to you, talk to
Emergency Contraceptive Consilient if you use
your doctor before taking Emergency
any of the above mentioned medicines.
Contraceptive Consilient as emergency
contraception may not be suitable for you.
How often can you use Emergency
Your doctor may prescribe another type of
Contraceptive Consilient
emergency contraception for you:
You should only use Emergency Contraceptive
• if you are pregnant or think that you may
Consilient in emergencies and not as a regular
already be pregnant. This medicine will not
method of contraception. If Emergency
work if you are already pregnant. If you are
Contraceptive Consilient is used more than
already pregnant, Emergency Contraceptive
once in a menstrual cycle, it is less reliable and
Consilient cannot terminate pregnancy, so
it is more likely to upset your menstrual cycle
Emergency Contraceptive Consilient is not an
(period).
“abortion pill”.
Emergency Contraceptive Consilient does not
You may already be pregnant if:
work as well as regular methods of contraception.
­– your period is more than 5 days late, or you
Your doctor, practice nurse or family planning
have experienced unusual bleeding when
clinic can tell you about long-term methods
your next period is due
of contraception which are more effective in
­– you have had unprotected sex more than 72
preventing you from getting pregnant.
hours ago, and since your last period.
Pregnancy, breast-feeding and fertility
• levonorgestrel is not recommended for young
If you are pregnant or breast-feeding, think you
women under 16 years of age without medical
may be pregnant or are planning to have a baby,
supervision.
ask your doctor or pharmacist for advice before
The use of Emergency Contraceptive Consilient is taking this medicine.
not advised if:
Pregnancy
• you have a disease of your small bowel (such as
You should not take this medicine if you are
Crohn’s disease) that inhibits the absorption of
already pregnant. If you do become pregnant
the drug
even after taking this medicine, it is important
• you have severe liver problems
• you have a history of ectopic pregnancy (where that you see your doctor. There is no evidence
that Emergency Contraceptive Consilient will
the baby develops somewhere outside the
harm a baby that develops in your uterus/womb
womb)
if you use Emergency Contraceptive Consilient
• you have ever had a disease called salpingitis
as described. Nevertheless, your doctor may
(inflammation of the Fallopian tubes).
want to check that the pregnancy is not ectopic
A previous ectopic pregnancy or previous
(where the baby develops somewhere outside the
infection of the fallopian tubes increases the risk
womb). This is especially important if you develop
of a new ectopic pregnancy.
severe abdominal pain after taking Emergency
Contraceptive Consilient or if you have previously
In all women, emergency contraception should
had an ectopic pregnancy, fallopian tube surgery
be taken as soon as possible after unprotected
or pelvic inflammatory disease.
intercourse. There is some evidence that
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. See section 4.

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.
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.
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.

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.
If you take more Emergency Contraceptive
Consilient 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
3. HOW TO TAKE EMERGENCY
• Tiredness
CONTRACEPTIVE CONSILIENT
• Headache
Always use this medicine exactly as described in
Common (may affect up to 1 in 10 people):
the leaflet or as your pharmacist has told you.
• Being sick (vomiting). If you are sick, read the
Check with your doctor or pharmacist if you are
section ‘What to do if you are sick (vomit) ’.
not sure.
• Your period might be different. Most women
• Take the tablet as soon as possible, preferably
will have a normal period at the expected
within 12 hours, and no later than 72 hours
time, but some may have their period later or
(3 days) after you have had unprotected sex.
earlier than normal. You might also have some
Emergency Contraceptive Consilient can be
irregular bleeding or spotting until your next
taken at any time in your menstrual cycle
period. If your period is more than 5 days late or
assuming you are not already pregnant or think
is unusually light or unusually heavy, you should
you may be pregnant. Do not chew but swallow
contact your doctor as soon as possible.
the tablet whole with water. Do not delay taking • You might have tender breasts, diarrhoea, feel
the tablet. The tablet works best the sooner you
dizzy after taking this medicine.
take it after having unprotected sex.
Very rare effects (may affect up to 1 in 10000
• If you are using one of the medicines that may
people):
prevent Emergency Contraceptive Consilient
• Rash, urticaria, pruritus, swelling of the face,
from working properly (see section above
pelvic pain, painful period, abdominal pain.
“Other medicines and Emergency Contraceptive
Reporting
of side effects
Consilient”) or if you have used one of these
If you get any side effects, talk to your doctor,
medicines in the past 4 weeks, Emergency
pharmacist or nurse. This includes any possible
Contraceptive Consilient may work less
side effects not listed in this leaflet. You can also
effectively for you. Your doctor may prescribe
report side effects directly via the Yellow Card
another type of (non-hormonal) emergency
Scheme at: www.mhra.gov.uk/yellowcard. By
contraceptive, i.e. a copper intrauterine device
(Cu-IUD). If this is not an option for you or if you reporting side effects you can help provide more
are unable to see your doctor promptly, you can information on the safety of this medicine.
take a double dose of Emergency Contraceptive
5. HOW TO STORE EMERGENCY
Consilient (i.e. 2 tablets taken together at the
CONTRACEPTIVE CONSILIENT
same time).
Keep this medicine out of the sight and reach of
• If you are already using a regular method of
children.
contraception such as the contraceptive pill,
you can continue to take this at your regular
Do not use this medicine after the expiry date
times.
which is stated on the carton. The expiry date
refers to the last day of that month.
If another unprotected intercourse takes place
after the use of Emergency Contraceptive
Store in the original package in order to protect
Consilient (also if this is during the same
from light.
menstrual cycle), the tablet will not exert its
Do not throw away any medicines via wastewater
contraceptive effect and there is again the risk
or household waste. Ask your pharmacist how to
of pregnancy.
throw away medicines you no longer use. These
What to do if you are sick (vomit)
measures will help protect the environment.
If you are sick (vomit) within three hours of taking
the tablet, you should take another tablet. You will 6. CONTENTS OF THE PACK AND OTHER
need to contact your pharmacist, doctor, practice INFORMATION
nurse or family planning clinic immediately for one
What Emergency Contraceptive Consilient
more tablet.
contains
After you have taken Emergency Contraceptive
The active substance is levonorgestrel. Each tablet
Consilient
contains 1500 micrograms of levonorgestrel.
After you have taken Emergency Contraceptive
Consilient, if you want to have sex, and are not
The other ingredients are:
using the contraceptive pill, you should use
Potato starch, Maize starch, Silica, colloidal
condoms or a cap plus spermicide until your next anhydrous, Magnesium stearate, Talc, Lactose
menstrual period. This is because Emergency
monohydrate.
Contraceptive Consilient won’t work if you have
What Emergency Contraceptive Consilient
unprotected sex again, before your next period
looks like and contents of the pack
is due.
Tablet: almost white, flat, rimmed tablet of about
After you have taken Emergency Contraceptive
Consilient, you are advised to make an appointment 8 mm diameter with an impressed mark of “G00”
to see your doctor about three weeks later, to make on one side.
sure that Emergency Contraceptive Consilient has
Packaging: one tablet in PVC//aluminium blister
worked. If your period is more than 5 days late or
and cardboard cartons.
is unusually light or unusually heavy, you should
Marketing Authorisation Holder and
contact your doctor as soon as possible. If you do
become pregnant even after taking this medicine, it Manufacturer
Gedeon Richter Plc.
is important that you see your doctor.
Gyömrői út 19-21,
Your doctor can also tell you about longer-term
H-1103 Budapest
methods of contraception which are more
Hungary
effective in preventing you from getting pregnant.
Distributor:
If you continue to use regular hormonal
Consilient Health (UK) Ltd.,
contraception such as the contraceptive pill
No.1 Church Road,
and you do not have a bleed in your pill-free
Richmond Upon Thames,
period, see your doctor to make sure you are not
Surrey. TW9 2QE
pregnant.
This leaflet was last revised in November 2016.

P0472

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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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