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EMERRES UNA 1.5 MG TABLET

Active substance(s): LEVONORGESTREL / LEVONORGESTREL / LEVONORGESTREL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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
Do not take Emerres Una
virus.
Levonorgestrel
If you are allergic (hypersensitive) to levonorgestrel or
!
This medicine will not protect you against sexually
any of the other ingredients of Emerres Una (see
transmitted diseases, only condoms can do this. Ask your
section 6).
doctor, nurse, family planning clinic or pharmacist for
Read all of this leaflet carefully before you start taking
advice if you are worried about this.
this medicine because it contains important
Warnings and precautions
information for you.
Talk to your doctor or pharmacist or nurse before taking
Other medicines and Emerres Una
Always use this medicine exactly as described in this
Emerres Una.
Tell your doctor or pharmacist if you are taking or have
leaflet or as your doctor, pharmacist or nurse has told you.
recently taken any other medicines, including medicines
Keep this leaflet. You may need to read it again.
!
In all women, emergency contraception should be taken
obtained without a prescription or herbal medicines.
Ask your pharmacist if you need more information or
!
as soon as possible after unprotected intercourse. There
advice.
is some evidence that Emerres Una may be less effective
Some medicines may prevent Emerres Una from working
If you get any side effects, talk to your doctor,
!
with increasing body weight or body mass index (BMI), but
effectively. If you have used any of the medicines below
pharmacist or nurse. This includes any possible side
these data were limited and inconclusive. Therefore,
during the last 4 weeks, Emerres Una may be less
effects not listed in this leaflet. See section 4.
Emerres Una is still recommended for all women
suitable for you. Your doctor may prescribe another type
You must talk to a doctor if you do not feel better or if
!
regardless of their weight or BMI.
of (non-hormonal) emergency contraceptive, i.e. a copper
you feel worse.
intrauterine device (Cu-IUD). If this is not an option for you
You are advised to speak to a healthcare professional if
or if you are unable to see your doctor promptly, you can
What is in this leaflet:
you are concerned about any problems related to taking
take a double dose of Emerres Una:
1. What Emerres Una is and what it is used for
emergency contraception.
!
barbiturates and other medicines used to treat epilepsy
2. What you need to know before you take Emerres Una
(for example, primidone, phenytoin, and
3. How to take Emerres Una
If any of the following applies to you, talk to your doctor
carbamazepine),
4. Possible side effects
before taking this medication as emergency contraception
!
medicines used to treat tuberculosis (for example,
5. How to store Emerres Una
may not be suitable for you. Your doctor may prescribe
rifampicin, rifabutin),
6. Contents of the pack and other information
another type of emergency contraception for you.
!
a treatment for HIV (ritonavir, efavirenz),
If you are pregnant or think that you may already be
!
!
a medicine used to treat fungal infections (griseofulvin),
1. What Emerres Una is and what it is used for
pregnant. This medicine will not work if you are already
!
herbal remedies containing St John's wort (Hypericum
pregnant. If you are already pregnant, Emerres Una
perforatum).
Emerres Una is commonly known as 'the morning after
cannot terminate pregnancy, as Emerres Una is not an
Pill'. It is used to reduce the chances of becoming
“abortion Pill”.
Speak to your pharmacist or doctor if you need further
pregnant after unprotected sex or failure of a
advice on the correct dose for you.
contraceptive method.
You may already be pregnant if:
your period is more than 5 days late, or you have
!
Consult your doctor as soon as possible after taking the
Emerres Una contains the active ingredient
experienced unusual bleeding when your next period is
tablets for further advice on a reliable form of regular
levonorgestrel, which is a synthetic derivative of the
due.
contraception and to exclude a pregnancy. (See section
naturally occurring female sex hormone and it is not fully
you have had unprotected sex more than 72 hours ago,
!
also 3 "How to take Emerres Una" for further advice).
understood how this medicine prevents pregnancy. It is
and since your last period.
thought to work by preventing ovulation and fertilisation
Emerres Una may also affect how well other medicines
and also by altering the lining of the womb, depending on
The use of Emerres Una is not advised if:
work:
which stage of the menstrual cycle the woman is at.
you have a disease of your small bowel (such as
!
!
a medicine called cyclosporin (suppresses the immune
Crohn's disease) that inhibits the absorption of the
system).
Emerres Una is not indicated for use before the first
drug.
menstrual bleeding (menarche).
you have severe liver problems.
!
Pregnancy, breast-feeding and fertility
you have a history of ectopic pregnancy (where the
!
If you are pregnant or breast-feeding, think you may be
It is estimated that 84 per cent of pregnancies will be
baby develops somewhere outside the womb).
pregnant or are planning to have a baby, ask your doctor
prevented if this morning-after Pill is taken within 72 hours
!
you have a history of salpingitis (inflammation of the
or pharmacist for advice before taking any medicine.
of unprotected sex. The tablet is more effective at
Fallopian tubes).
preventing pregnancy the earlier it is taken, so it is
A previous ectopic pregnancy and a previous infection of
Pregnancy
important to take it as soon as possible after unprotected
the fallopian tubes increase the risk of a new ectopic
You should not take this medicine if you are already
sex, rather than delay to the third day.
pregnancy.
pregnant. If you do become pregnant even after taking
this medicine, it is important that you see your doctor.
If you are under 16, you must visit your doctor or family
There is no evidence that Emerres Una will harm a baby
planning clinic to get emergency contraception.
that develops in your uterus/womb if you use Emerres
Una as described.

Emerres Una 1.5 mg Tablet

Emerres Una 1.5mg Tablet

2. What you need to know before you take Emerres
Una

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 Emerres Una 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. If you are worried you
can take your tablet immediately after a breast-feed and
avoid nursing for at least 8 hours after taking Emerres
Una. In this way you can reduce the amount of active
ingredient your baby may take in with the breast milk.
Fertility
Emerres Una increases the chances of menstruation
disturbances which can alter when your egg is released
and therefore effect when you can become pregnant,
however, there are no fertility data in the long term.
Driving and using machines
Emerres Una 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 another unprotected intercourse takes place after the
use of Emerres Una (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 immediately take another tablet.
Once you have taken this medicine, talk to a pharmacist
or doctor if your next period is more than 5 days late or
you suspect you may be pregnant.
If you get any lower stomach pain or discomfort, talk to a
doctor straight away.
If you take more Emerres Una 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.
4. Possible side effects
Like all medicines, Emerres Una can cause side effects,
although not everybody gets them.

Reporting of side effects
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.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Emerres Una
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

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

What Emerres Una contains
The active substance is levonorgestrel.
!
Very common (may affect more than 1 in 10 people):
The other ingredients are lactose monohydrate,
!
Feeling sick (nausea).
!
povidone (E1201), maize starch, silica colloidal
You might have some irregular bleeding until your next
!
anhydrous (E551) and magnesium stearate (E572).
period.

3. How to take Emerres Una

You might have lower abdominal pain.
!
What Emerres Una looks like and contents of the pack
Tiredness.
!
Emerres Una is a round, white to off-white, uncoated flat
Headache.
!

Always use this medicine exactly as described in the
tablet debossed '145' on one side and plain on the other
leaflet or as your pharmacist has told you. Check with
side.
your doctor or pharmacist if you are not sure.
Common (may affect up to 1 in 10 people):
Each pack contains a blister with one tablet.
!
Take the tablet as soon as possible, preferably within
Being sick (vomiting). If you are sick, read the section
!
12 hours, and no later than 72 hours (3 days) after you
'What to do if you are sick' (vomit).
Marketing Authorisation Holder
have had unprotected sex. Emerres Una can be taken
Your period might be different. Most women will have a
!
Morningside Healthcare Ltd
at any time in your menstrual cycle assuming you are
normal period at the expected time, but some may
115 Narborough Road
not already pregnant or think you may be pregnant. Do
have their period later or earlier than normal. You might
Leicester, LE3 0PA, UK
not chew but swallow the tablet whole with water. Do
also have some irregular bleeding or spotting until your
not delay taking the tablet. The tablet works best the
next period. If your period is more than 5 days late or is
Manufacturer
sooner you take it after having unprotected sex.
unusually light or unusually heavy, you should contact
Morningside Pharmaceuticals Ltd
!
If you are using one of the medicines that may prevent
your doctor as soon as possible.
5 Pavilion Way
Emerres Una from working properly (see section above
!
You might have tender breasts, diarrhoea, feel dizzy
Loughborough, UK
"Other medicines and Emerres Una") or if you have
after taking this medicine.
used one of these medicines in the past 4 weeks,
This leaflet was last revised in November 2016.
Emerres Una may work less effectively for you. Your
Very rare effects (may affect up to 1 in 10000 people):
doctor may prescribe another type of (non-hormonal)
!
Rash, urticaria, pruritus, swelling of the face, pelvic
emergency contraceptive, i.e. a copper intrauterine
pain, painful period.
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
If you get any of the side effects or if you notice any side
double dose of Emerres Una (i.e. 2 tablets taken
effects not listed in this leaflet, please tell your doctor or
together at the same time).
pharmacist.
!
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.

Expand Transcript

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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