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EZINELLE 1.5 MG TABLET

Active substance(s): LEVONORGESTREL

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Package leaflet: Information for the user

Ezinelle 1.5 mg Tablet
(levonorgestrel)

Read all of this leaflet carefully before you start
taking 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.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Ezinelle is and what it is used for
What you need to know before you take Ezinelle
How to take Ezinelle
Possible side effects
How to store Ezinelle
Contents of the pack and other information

1. What Ezinelle is and what it is used for
Ezinelle is an emergency contraceptive that can be used
within 72 hours (3 days) of unprotected sex or if your usual
contraceptive method has failed.

Ezinelle 1.5 mg Tablet
(levonorgestrel)

Ezinelle contains a synthetic hormone-like 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.
Ezinelle is thought to work by:
• stopping your ovaries from releasing an egg;
• preventing sperm from fertilising any egg you may have
already released.
Ezinelle 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
this medicine, it will not stop you from becoming pregnant.
Ezinelle is not indicated for use before the first menstrual
bleeding (menarche).

2. What you need to know before you take Ezinelle
Do not take Ezinelle:

• if you are allergic to levonorgestrel or any of the other
ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Ezinelle.
If any of the following applies to you, talk to your doctor
before taking Ezinelle as emergency contraception may not
be suitable for you. Your doctor may prescribe another type of
emergency contraception for you.
• 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, Ezinelle cannot
terminate pregnancy, so Ezinelle 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

Children and adolescents

Ezinelle is not recommended for young women under
16 years of age without medical supervision.
The use of Ezinelle 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 a previous infection of the
fallopian tubes increases the risk of a new ectopic pregnancy.
Your doctor may decide that Ezinelle is not suitable for you,
or that another type of emergency contraception would be
better for you.

Other medicines and Ezinelle

Tell your pharmacist if you are taking, have recently taken or
might take any other medicines.
Some medicines may prevent Ezinelle 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)
• medicines used to treat HIV infection (for example,
ritonavir, efavirenz)
• a medicine used to treat fungal infections (griseofulvin)
• herbal remedies containing St John’s wort
(Hypericum perforatum)
• a medicine used to suppress the immune
system (ciclosporin)

How often can you use Ezinelle

You should only use Ezinelle in emergencies and not as a
regular method of contraception.
If Ezinelle is used more than once in a menstrual cycle, it is
more likely to upset your menstrual cycle (period).
Ezinelle 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 this medicine.

Pregnancy

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

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
Ezinelle will harm a baby that develops in your uterus/womb
if you use Ezinelle 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
Ezinelle or if you have previously had an ectopic pregnancy,
Fallopian tube surgery or pelvic inflammatory disease.

If you are worried about sexually transmitted diseases

Breast-feeding

In all women, emergency contraception should be taken
as soon as possible after unprotected intercourse. There
is some evidence that Ezinelle may be less effective with
increasing body weight or body mass index (BMI), but this
data was limited and inconclusive. Therefore, Ezinelle is still
recommended for all women regardless of their weight or BMI.

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.

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 the tablet well before the next feed and reducing the
amount of active ingredient your baby may take in with the
breast milk.

Fertility

Ezinelle 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 Ezinelle 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.

Ezinelle contains lactose

If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicine.

3. How to take Ezinelle
Always take 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.
• Ezinelle 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 Ezinelle (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 Ezinelle

After you have taken Ezinelle, 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 Ezinelle won’t work if you have unprotected sex
again, before your next period is due.

After you have taken Ezinelle, you are advised to make an
appointment to see your doctor about three weeks later, to
make sure that Ezinelle 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.

Very rare (may affect up to 1 in 10,000 people):
• Abdominal pain
• Rash
• Hives (urticaria)
• Itching (pruritus)
• Swelling of the face (facial oedema)
• Pain in the hips (pelvic pain)
• Painful periods

Reporting of side effects

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.

If you get any side effects, talk to your doctor or pharmacist.
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

Your next period after you took Ezinelle

By reporting side effects you can help provide more
information on the safety of this medicine.

After the use of Ezinelle, 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 Ezinelle 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)
• Lower abdominal pain
• Tiredness (fatigue)
• Headache
• Irregular bleeding until your next period
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)’ (see section 3)
• 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.

5. How to store Ezinelle
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 after EXP. The expiry date refers to the last day
of that month.
This medicinal product does not require any special
storage conditions.
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 Ezinelle contains

• The active substance is levonorgestrel. Each tablet
contains 1.5 mg of levonorgestrel.
• The other ingredients are povidone K-25, lactose
monohydrate (see section 2, “Ezinelle contains
lactose”), maize starch, colloidal anhydrous silica and
magnesium stearate.

What Ezinelle looks like and contents of the pack

Your medicine comes as a round, white to off-white, uncoated
flat tablet marked ‘145’ on one side and plain on the other side.
Ezinelle is available in a blister pack containing 1 tablet.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturers

Accord Healthcare Limited, 319 Pinner Road, North Harrow,
HA1 4HF, Middlesex, United Kingdom.
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft., Mylan Utca 1., Komarom 2900, Hungary.
This leaflet was last revised in 05/2016.

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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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