Skip to Content

UK Edition. Click here for US version.

LEVONELLE ONE STEP 1500 MICROGRAM TABLET

Active substance(s): LEVONORGESTREL

View full screen / Print PDF » Download PDF ⇩
Transcript
1.5 mg tablets • levonorgestrel

Package leaflet: Information for the user

Levonelle® One Step 1.5 mg tablets
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

38
53
61
63
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;
RR stopping a fertilised egg from attaching itself to your
womb lining.
j
(9]

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 pregnant. If you
have unprotected sex after taking Levonelle One Step, it
will not stop you from becoming pregnant.
[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
RR you have had unprotected sex more than 72 hours
ago, and since your last period.
[14)

Children and adolescents
Levonelle One Step is not recommended for young women
under 16 years of age without medical supervision.

(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
[16)

RR you have severe liver problems
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 if you are taking, have recently
taken or might take any other medicines.
Some medicines may prevent Levonelle One Step from
working properly, these include:
(23]

RR barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and
carbamazepine)
RR medicines used to treat tuberculosis (for example,
rifampicin, rifabutin)
[24)

RR a treatment for HIV infection (ritonavir)
RR a medicine used to treat fungal infections
(griseofulvin)
RR herbal remedies containing St John’s wort (Hypericum
perforatum)
(25]

RR a medicine called ciclosporin (suppresses the immune
system).
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.
[26)

If Levonelle One Step is used more than once in a
menstrual cycle it is more likely to upset your menstrual
cycle (period).

(27]

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.
[28)

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.
(29]

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
[30)

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

(31]

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
[32)

thought to be harmful to the baby, but if you are worried
you can take your tablet immediately after a breastfeeding 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.

(33]

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.
[34)

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.
(35]

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.
[36)

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

(37]

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.
[38)

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.
(39]

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
[40)

whole with water. Do not delay taking the tablet. The
tablet works better the sooner you take it after
having unprotected sex.
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.

(41]

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.
[42)

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.
(43]

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
[44)

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
(45]

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.
[46)

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
(47]

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
[48)

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.
(49]

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,
[50)

practice nurse or family planning clinic for advice,
especially if you have been sick, as the tablet may not
have worked properly.

(51]

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

[52)

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
(53]

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
[54)

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) ’.

(55]

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
[56)

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.
(57]

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.

[58)

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:
(59]

www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.

[60)

5. How to store Levonelle One Step
Keep out of the reach and sight 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.

(61]

Store in the original packaging.
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.
[62)

6. Contents of the pack and other information
What Levonelle One Step contains
The active substance is levonorgestrel. One tablet contains
1.5 mg of levonorgestrel.
(63]

The other ingredients are potato starch, maize starch,
colloidal silica anhydrous, magnesium stearate (E572),
talc (E533b), lactose monohydrate.

[64)

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.
(65]

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom
[66)

Manufacturer:
Gedeon Richter Plc.
Gyömrői út 19-21.
H-1103 Budapest
Hungary
(67]

Levonelle One Step is distributed in the UK by:
Bayer plc.
Bayer House, Strawberry Hill
Newbury, Berkshire
RG14 1JA
United Kingdom
[68)

The emergency contraceptive helpline number is:
08456 – 035 – 035
This leaflet was last revised 03/2015

(69]

Levonelle® is a Registered trademark of the Bayer Group.

[70)

K-22182-1.5, 00000000

84250341

név/name:
LEVONELLE ONE STEP
szám/number: K-22182-1.5
méret/size: 66x27 mm
színek/colour:
P Black
P 526
CMYK

betűméret/font size: 8pt
karakter/character: 13960
ország/country: UK
típus/type: pil
dátum/date: 2015.03.30.
technical info
matrix code
grafikus: Móni

Expand view ⇕

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.

Hide