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BOOTS EMERGENCY CONTRACEPTIVE 1.5 MG TABLET

Active substance: LEVONORGESTREL

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Levonelle®
1.5 mg tablets • levonorgestrel

one step

patient information booklet

(1]

Packaging Technology Berlin dy
page U 1
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C / cyan / magenta
version: 18.06.2013/02
approval:

81627444_02.indd cover:1
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:03
13:17:0

Packaging Technology Berlin dy
page U 2
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C / cyan / magenta
version: 18.06.2013/02
approval:

81627444_02.indd cover:2
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:34
13:17:3

Packaging Technology Berlin dy
page U 3
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C / cyan / magenta
version: 18.06.2013/02
approval:

81627444_02.indd cover:3
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:34
13:17:3

81627444

Packaging Technology Berlin dy
page U 4
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C / cyan / magenta
version: 18.06.2013/02
approval:

81627444_02.indd cover:4
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:34
13:17:3

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levonelle® One Step 1.5 mg tablets
levonorgestrel

b
(1]

Packaging Technology Berlin dy
page 1
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 1
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:35
13:17:3

Read all of this leaflet carefully beceause it
contains important information for you.
This medicine is available without prescription.
However, you still need to take Levonelle One Step
carefully to get the best results from it.
C
[2)

Packaging Technology Berlin dy
page 2
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 2
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:35
13:17:3

R Keep this leaflet. You may need to read it again.
R Ask your pharmacist if you need more information
or advice.
R You must contact a doctor if your symptoms
worsen or do not improve.
d
(3]

Packaging Technology Berlin dy
page 3
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 3
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:35
13:17:3

R If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

E
[4)

Packaging Technology Berlin dy
page 4
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 4
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:36
13:17:3

In this leaflet:
1. What Levonelle One Step is
and what it is used for
2. Before you take Levonelle One Step
3. How to take Levonelle One Step

7
11
31
f
(5]

Packaging Technology Berlin dy
page 5
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 5
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:36
13:17:3

In this leaflet:
4. Possible side effects
5. How to store Levonelle One Step
6. Further information

40
46
48

G
[6)

Packaging Technology Berlin dy
page 6
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 6
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:36
13:17:3

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.
h
(7]

Packaging Technology Berlin dy
page 7
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 7
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:36
13:17:3

Levonelle One Step contains a synthetic hormone
like substance called levonorgestrel. It prevents
about 84% of expected pregnancies when you take it
within 72hrs 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
I
[8)

Packaging Technology Berlin dy
page 8
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 8
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:36
13:17:3

unprotected sex. It is better to take it within 12hrs
rather than delay until the third day.
Levonelle One Step is thought to work by
R stopping your ovaries from releasing an egg
R preventing sperm from fertilising any egg you
may have already released
j
(9]

Packaging Technology Berlin dy
page 9
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 9
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:36
13:17:3

R stopping a fertilised egg from attaching itself to
your womb lining.
Levonelle One Step can only prevent you becoming
pregnant if you take it within 72hrs of unprotected
sex. It does not work if you are already pregnant. If
[10)

Packaging Technology Berlin dy
page 10
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 10
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:36
13:17:3

you have unprotected sex after taking Levonelle One
Step, it will not stop you from becoming pregnant.

2. BEFORE YOU TAKE LEVONELLE ONE STEP
Do not use Levonelle One Step if:
R you are allergic (hypersensitive) to levonorgestrel
(11]

Packaging Technology Berlin dy
page 11
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 11
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:36
13:17:3

or any of the other ingredients of Levonelle One
Step (see section 6)
Take special care with Levonelle One Step
If any of the following points apply to you, tell your
doctor before you take Levonelle One Step as
emergency contraception may not be suitable for you.
[12)

Packaging Technology Berlin dy
page 12
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 12
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:36
13:17:3

R you are pregnant or think that you may already
be pregnant, as this medicine will not work if you
are already pregnant.
You may already be pregnant if:
R your period is more than 5 days late, or you have
(13]

Packaging Technology Berlin dy
page 13
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 13
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:36
13:17:3

suffered unusual bleeding when your next period
is due
R you have had unprotected sex more than
72 hours ago, and since your last period
You should also tell your doctor if:
R you have a disease of your small bowel (such as
[14)

Packaging Technology Berlin dy
page 14
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 14
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:37
13:17:3

Crohn’s disease) that interferes with the way you
digest your food
R you have severe liver problems
R you have ever had an ectopic pregnancy (where
the baby develops somewhere outside the womb)
(15]

Packaging Technology Berlin dy
page 15
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 15
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:37
13:17:3

R you have ever had a disease called salpingitis
(inflammation of the Fallopian tubes).
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.
[16)

Packaging Technology Berlin dy
page 16
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 16
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:37
13:17:3

If you under 16, you must visit your doctor or family
planning clinic to get emergency contraception.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
(17]

Packaging Technology Berlin dy
page 17
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 17
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:37
13:17:3

Tell your pharmacist if you are taking any of the
medicines listed below, as these medicines may
prevent Levonelle One Step from working properly
R barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and
carbamazepine)
[18)

Packaging Technology Berlin dy
page 18
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 18
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:37
13:17:3

R medicines used to treat tuberculosis (for example,
rifampicin, rifabutin)
R a treatment for HIV infection (ritonavir)
R a medicine used to treat fungal infections
(griseofulvin)
(19]

Packaging Technology Berlin dy
page 19
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 19
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:37
13:17:3

R herbal remedies containing St John’s wort
(Hypericum perforatum)
R a medicine called ciclosporin (suppresses the
immune system)

[20)

Packaging Technology Berlin dy
page 20
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 20
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:37
13:17:3

If you are worried about sexually transmitted
diseases
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.
(21]

Packaging Technology Berlin dy
page 21
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 21
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:37
13:17:3

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).
[22)

Packaging Technology Berlin dy
page 22
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 22
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:37
13:17:3

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.
(23]

Packaging Technology Berlin dy
page 23
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 23
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:37
13:17:3

Pregnancy and breast-feeding
Ask your pharmacist for advice before taking any
medicine.
You should not take this medicine if you are already
pregnant. If you have had unprotected sex which
was more than 72 hours ago, and since your last
[24)

Packaging Technology Berlin dy
page 24
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 24
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:38
13:17:3

period, you may already be pregnant and the
treatment won’t work. If your last period was more
than 5 days late or was unusually light or unusually
heavy, you should check with your doctor that you
are not already pregnant.
If you do become pregnant even after taking this
(25]

Packaging Technology Berlin dy
page 25
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 25
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:38
13:17:3

medicine, it is important that you see your doctor.
There is no evidence that Levonelle One Step will
harm a baby that develops in your uterus/womb but
your doctor may want to check that the pregnancy is
not ectopic. This is especially important if you
develop severe abdominal pain after taking
Levonelle One Step or if you have previously had an
[26)

Packaging Technology Berlin dy
page 26
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 26
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:38
13:17:3

ectopic pregnancy, Fallopian tube surgery or pelvic
inflammatory disease.
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
(27]

Packaging Technology Berlin dy
page 27
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 27
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:38
13:17:3

breast-feed. 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.
Driving and using machines
Your Levonelle One Step tablet is unlikely to affect
[28)

Packaging Technology Berlin dy
page 28
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 28
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:38
13:17:3

your ability to drive a car or use machines. However,
if you feel tired or dizzy do not drive or operate
machinery.
Important information about some of the
ingredients of Levonelle One Step
Each Levonelle One Step tablet contains lactose. If
(29]

Packaging Technology Berlin dy
page 29
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 29
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:38
13:17:3

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

[30)

Packaging Technology Berlin dy
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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 30
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:38
13:17:3

3. HOW TO TAKE LEVONELLE ONE STEP
Always use Levonelle One Step exactly as your
pharmacist has told you. You should check with your
doctor or pharmacist if you are not sure. This medicine
is not recommended for use in children
R Take the tablet as soon as possible, preferably
(31]

Packaging Technology Berlin dy
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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 31
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:38
13:17:3

within 12 hours, and no later than 72 hours
(3 days) after you have had unprotected sex.
Swallow the tablet whole, with water if necessary.
Do not delay taking the tablet. The tablet works
better the sooner you take it after having
unprotected sex.
[32)

Packaging Technology Berlin dy
page 32
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 32
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:38
13:17:3

R 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.
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
(33]

Packaging Technology Berlin dy
page 33
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 33
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:38
13:17:3

need to contact your pharmacist, doctor, practice
nurse or family planning clinic immediately for
advice and another tablet.
After you have taken Levonelle One Step
After you have taken Levonelle One Step, if you want
[34)

Packaging Technology Berlin dy
page 34
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 34
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:39
13:17:3

to have sex, and are not using the contraceptive pill,
you should use condoms or a cap plus spermicide.
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 worked. If your period is more than
(35]

Packaging Technology Berlin dy
page 35
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 35
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:39
13:17:3

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
[36)

Packaging Technology Berlin dy
page 36
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

81627444_02.indd 36
7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:39
13:17:3

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 in your pill-free period, see your
doctor to make sure you are not pregnant.
(37]

Packaging Technology Berlin dy
page 37
client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:39
13:17:3

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
[38)

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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code-no.: 115
country: GB BPH

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

(39]

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:39
13:17:3

4. POSSIBLE SIDE EFFECTS
Like all medicines, Levonelle One Step can cause side
effects, although not everybody gets them.
Very common (equal or more than 1 in 10 women):
R Feeling sick (nausea)
[40)

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item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

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R You might have some irregular bleeding until your
next period.
R You might have lower abdominal (tummy) pain
R Tiredness (fatigue)
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item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

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Common (equal or more than 1 in 100 women, but
less than 1 in 10):
R Being sick (vomiting). If you are sick, read the
section ‘What to do if you are sick (vomit)(page 33)’.
R Your period might be different. Most women will
have a normal period at the expected time, but
[42)

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:39
13:17:3

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.
(43]

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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7444_02.indd

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:39
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R You might have tender breasts, headaches,
diarrhoea, feel dizzy after taking this medicine.
These symptoms should get better within a few
days.

[44)

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:39
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Very rare (less than 1 in 10000 women ):
R Skin reactions can occur: generalised itching,
rash, itchy rash, swelling of the face.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
(45]

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:40
13:17:4

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.
[46)

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:40
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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.
(47]

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:40
13:17:4

6. FURTHER INFORMATION
What Levonelle One Step contains
The active substance is levonorgestrel. One tablet
contains 1.5 mg of levonorgestrel.
The other ingredients are potato starch, maize
[48)

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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code-no.: 115
country: GB BPH

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starch, colloidal silica anhydrous, magnesium
stearate (E572), talc (E533b), lactose monohydrate.
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.
(49]

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:40
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Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Medimpex UK Limited
127 Shirland Road
London W9 2EP
United Kingdom
[50)

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:40
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Manufacturer:
Bayer Weimar GmbH und Co. KG
Döbereinerstrasse 20, D-99427 Weimar
Germany

(51]

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:40
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or
Gedeon Richter Plc.
Gyömrői út 19-21.
H-1103 Budapest
Hungary
[52)

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:40
13:17:4

Levonelle One Step is distributed in the UK by:
Bayer plc
Bayer House, Strawberry Hill
Newbury, Berkshire
RG14 1JA
United Kingdom
(53]

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:40
13:17:4

The emergency contraceptive helpline number is:
08456 – 035 – 035
This leaflet was last revised 05/2013.
Levonelle® is a registered trademark of the Bayer
Group.
[54)

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:40
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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:41
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[56)

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client: 0086
item-no.: 81627444
PZ: 2534A-4E
name: LF-BRO-Levonelle one step TAB
colors: Black / PANT526C
version: 18.06.2013/02
approval:

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7444_02.indd

81627444

Bayer Pharma AG
code-no.: 115
country: GB BPH

18.06.2013 13:17:41
13:17:4

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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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