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LEVONELLE ONE STEP

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1500 microgram tablet
• Levonorgestrel

Package leaflet: Information for the user

Levonelle® One Step
1500 microgram tablet
Levonorgestrel

b
(1]

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.
C
[2)

RR Keep this leaflet. You may need to read it again.
RR Ask your pharmacist if you need more information or
advice.
RR 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.
d
(3]

What is in this leaflet
1. What Levonelle One Step is and what it is used for 6
2. What you need to know before you take
Levonelle One Step
11
E
[4)

3. How to take Levonelle One Step
4. Possible side effects
5. How to store Levonelle One Step
6. Contents of the pack and other information

41
57
65
67
f
(5]

1. What Levonelle One Step is and what it
is used for
Levonelle One Step is an emergency contraceptive that
can be used within 72 hours (3 days) of unprotected sex
or if your usual contraceptive method has failed.
G
[6)

Levonelle One Step 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
h
(7]

possible after unprotected sex. It is better to take it within
12 hours rather than delay until the third day.
Levonelle One Step is thought to work by:
RR stopping your ovaries from releasing an egg;
I
[8)

RR preventing sperm from fertilising any egg you may
have already released.
Levonelle One Step can only prevent you becoming
pregnant if you take it within 72 hours of
unprotected sex. It does not work if you are already
j
(9]

pregnant. If you have unprotected sex after taking
Levonelle One Step, it will not stop you from
becoming pregnant.
Levonelle One Step is not indicated for use before the first
menstrual bleeding (menarche).
[10)

2. What you need to know before you take
Levonelle One Step
Do not use Levonelle One Step if:
RR you are allergic to levonorgestrel or any of the other
ingredients of this medicine listed in section 6.

(11]

Warnings and precautions
If any of the following applies to you, talk to your doctor
before taking Levonelle One Step as emergency
contraception may not be suitable for you. Your doctor may
prescribe another type of emergency contraception for you.
[12)

RR 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,
Levonelle One Step cannot terminate pregnancy, so
Levonelle One Step is not an “abortion pill”.
(13]

You may already be pregnant if:
RR your period is more than 5 days late, or you have
experienced unusual bleeding when your next period
is due
[14)

RR you have had unprotected sex more than 72 hours
ago, and since your last period.
Children and adolescents
If you are under 16, you must visit your doctor or family
planning clinic to get emergency contraception.
(15]

The use of Levonelle One Step is not advised if:
RR you have a disease of your small bowel (such as
Crohn’s disease) that inhibits the absorption of the
drug
RR you have severe liver problems
[16)

RR you have a history of ectopic pregnancy (where the
baby develops somewhere outside the womb)
RR you have ever had a disease called salpingitis
(inflammation of the Fallopian tubes).
(17]

A previous ectopic pregnancy or previous infection of the
fallopian tubes increases the risk of a new ectopic pregnancy.
Your doctor may decide that Levonelle One Step is not
suitable for you, or that another type of emergency
contraception would be better for you.
[18)

In all women, emergency contraception should be taken
as soon as possible after unprotected intercourse. There
is some evidence that Levonelle One Step may be less
effective with increasing body weight or body mass index
(BMI), but these data were limited and inconclusive.
(19]

Therefore, Levonelle One Step 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.
[20)

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.
(21]

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.
[22)

Other medicines and Levonelle One Step
Tell your pharmacist or doctor if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription or herbal medicines.
(23]

Some medicines may prevent Levonelle One Step from
working effectively. If you have used any of the
medicines below during the last 4 weeks,
Levonelle One Step may be less suitable for you. Your
doctor may prescribe another type of (non-hormonal)
emergency contraceptive, i.e. a copper intrauterine
[24)

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 Levonelle One Step:
RR barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and
carbamazepine)
(25]

RR medicines used to treat tuberculosis (for example,
rifampicin, rifabutin)
RR a treatment for HIV (ritonavir, efavirenz)
RR a medicine used to treat fungal infections (griseofulvin)
[26)

RR herbal remedies containing St John’s wort
(Hypericum perforatum).
Speak to your pharmacist or doctor if you need further
advice on the correct dose for you.
(27]

Consult your doctor as soon as possible after taking
the tablets for further advice on a reliable form of
regular contraception and to exclude a pregnancy.
(See section also 3 “How to take Levonelle One Step”
for further advice).
[28)

Levonelle One Step may also affect how well other
medicines work
RR a medicine called cyclosporin (suppresses the
immune system).
(29]

How often can you use Levonelle One Step
You should only use Levonelle One Step in emergencies
and not as a regular method of contraception.
If Levonelle One Step is used more than once in a
menstrual cycle it is more likely to upset your menstrual
cycle (period).
[30)

Levonelle One Step 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.
(31]

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.
[32)

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 Levonelle One Step will harm a
(33]

baby that develops in your uterus/womb if you use
Levonelle One Step 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 Levonelle One Step or if you
[34)

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
(35]

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.
[36)

Fertility
Levonelle One Step 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.
(37]

Driving and using machines
Your Levonelle One Step 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.
[38)

Levonelle One Step tablet contains lactose
In case of milk sugar (lactose) intolerance it should be
considered that each Levonelle One Step tablet also
contains 142.5 mg lactose monohydrate.
(39]

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

[40)

3. How to take Levonelle One Step
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.
(41]

Use in children and adolescents
Levonelle One Step is not indicated for use before the first
menstrual bleeding (menarche).

[42)

RR 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. Levonelle One Step 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
(43]

whole with water. Do not delay taking the tablet. The
tablet works best the sooner you take it after having
unprotected sex.
RR If you are using one of the medicines that may
prevent Levonelle One Step from working properly
(see section above “Other medicines and

[44)

Levonelle One Step”) or if you have used one of these
medicines in the past 4 weeks, Levonelle One Step
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
(45]

you are unable to see your doctor promptly, you can
take a double dose of Levonelle One Step
(i.e. 2 tablets taken together at the same time).
RR 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.

[46)

If another unprotected intercourse takes place after the
use of Levonelle One Step (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.
(47]

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.
[48)

After you have taken Levonelle One Step
After you have taken Levonelle One Step, 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 Levonelle One Step
(49]

won’t work if you have unprotected sex again, before your
next period is due.
After you have taken Levonelle One Step, you are advised
to make an appointment to see your doctor about three
weeks later, to make sure that Levonelle One Step has
[50)

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.
(51]

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
[52)

in your pill-free period, see your doctor to make sure you
are not pregnant.
Your next period after you took Levonelle One Step
After the use of Levonelle One Step, your period is usually
normal and will start at the usual day; however
(53]

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.
[54)

If you take more Levonelle One Step 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,
(55]

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.
[56)

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
(57]

Very common (may affect more than 1 in 10 people):
RR Feeling sick (nausea)
RR You might have some irregular bleeding until your
next period
RR You might have lower abdominal pain
[58)

RR Tiredness
RR Headache
Common (may affect up to 1 in 10 people):
RR Being sick (vomiting). If you are sick, read the section
‘What to do if you are sick (vomit)’.

(59]

RR 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
[60)

5 days late or is unusually light or unusually heavy,
you should contact your doctor as soon as possible.
RR You might have tender breasts, diarrhoea, feel dizzy
after taking this medicine.
(61]

Very rare effects (may affect up to 1 in 10000 people):
RR Abdominal pain, rash, urticaria, pruritus, swelling of
the face, pelvic pain, painful period.

[62)

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.

(63]

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

[64)

5. How to store Levonelle One Step
Keep out of the sight and reach of children.
Do not use Levonelle One Step after the expiry date which
is stated on the package after “EXP”. The expiry date
refers to the last day of the month.

(65]

Store in original packaging in order to protect from light.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.
[66)

6. Contents of the pack and other information
What Levonelle One Step contains
The active substance is levonorgestrel. One tablet contains
1500 micrograms of levonorgestrel.
(67]

The other ingredients are potato starch, maize starch,
colloidal silica anhydrous, magnesium stearate, talc,
lactose monohydrate.

[68)

What Levonelle One Step looks like and contents of
the pack
Each pack of Levonelle One Step contains a complete
treatment which is one round, white tablet with an
impressed mark of “G00” on one side.
(69]

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest,
Hungary
[70)

Manufacturer:
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
(71]

Levonelle One Step is distributed in the UK by:
Bayer plc
Bayer House, Strawberry Hill
Newbury, Berkshire
RG14 1JA
United Kingdom
[72)

The emergency contraceptive helpline number is:
08456 – 035 – 035
This leaflet was last revised 02/2017
Levonelle® is a Registered trademark of
Bayer Group.
(73]

K-22182-2.7, 00000000

00000000

név/name:
LEVONELLE ONE STEP
szám/number: K-22182-2.7
méret/size: 66x27 mm
színek/colour:
P 526
CMK

betűméret/font size: 8 pt
karakter/character: 15420
ország/country: UK
típus/type: pil
dátum/date: 2017.03.02.
technical info
matrix code
grafikus:

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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