LEVONELLE 1500 MICROGRAM TABLET

Active substance: LEVONORGESTREL

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Levonelle®

1500 microgram tablet
levonorgestrel

Packaging Technology Berlin pewi
page U 1
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 1

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:15 P

Packaging Technology Berlin pewi
page U 2
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 2

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:39 P

Packaging Technology Berlin pewi
page U 3
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 3

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:39 P

81627436

Packaging Technology Berlin pewi
page U 4
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 4

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:39 P

Package leaflet: Information for the user

Levonelle®
1500 microgram tablet
Levonorgestrel



Packaging Technology Berlin pewi
page 1
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 1

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:39 P

Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
R Keep this leaflet. You may need to read it again.
R If you have any further questions, ask your
doctor.



Packaging Technology Berlin pewi
page 2
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 2

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:39 P

R This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
R If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.



Packaging Technology Berlin pewi
page 3
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 3

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:39 P

What is in this leaflet:
1. What Levonelle 1500 microgram tablet
(hereinafter Levonelle 1500) is and what
it is used for

7




Packaging Technology Berlin pewi
page 4
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 4

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:39 P

2. What you need to know before you take
Levonelle 1500
3. How to take Levonelle 1500
4. Possible side effects
5. How to store Levonelle 1500

14
36
49
56



Packaging Technology Berlin pewi
page 5
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 5

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:39 P

6. Contents of the pack and other
information

59




Packaging Technology Berlin pewi
page 6
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 6

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:39 P

1. What Levonelle 1500 is and what it is
used for
Levonelle 1500 is an emergency contraceptive that
can be used within 72 hours (3 days) of unprotected
sex or if your usual contraceptive method has failed.



Packaging Technology Berlin pewi
page 7
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 7

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:39 P

It is about the following cases:
R No contraception was used during the sexual
intercourse.
R The contraception measure was used incorrectly,
for example as if a condom was penetrated,
slipped away or used in a wrong way, if vaginal



Packaging Technology Berlin pewi
page 8
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 8

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:39 P

pessary or diaphragm changed position, burst,
was broken or taken out ahead of time, in the
case of a failed interruption during coitus
interruptus (e.g. sperm ejaculated in vagina or on
external genitalia).



Packaging Technology Berlin pewi
page 9
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 9

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:40 P

Levonelle 1500 contains a synthetic hormone like
active 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


Packaging Technology Berlin pewi
page 10
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 10

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:40 P

unprotected sex. It is better to take it within
12 hours rather than delay until the third day.
Levonelle 1500 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; or


Packaging Technology Berlin pewi
page 11
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 11

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:40 P

R stopping a fertilised egg from attaching itself to
your womb lining.
Levonelle 1500 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 another unprotected intercourse takes


Packaging Technology Berlin pewi
page 12
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 12

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:40 P

place after the use of Levonelle 1500 (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



Packaging Technology Berlin pewi
page 13
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 13

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:40 P

2. What you need to know before you
take Levonelle 1500
Do not use Levonelle 1500



Packaging Technology Berlin pewi
page 14
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 14

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:40 P

R if you are allergic to levonorgestrel or any of the
other ingredients of this medicine listed in
section 6.
Warnings and precautions
If any of the following applies to you, talk to your
doctor before taking Levonelle 1500 as emergency


Packaging Technology Berlin pewi
page 15
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 15

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:40 P

contraception may not be suitable for you. Your
doctor may prescribe another type of emergency
contraception for you.
R 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,


Packaging Technology Berlin pewi
page 16
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 16

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:40 P

Levonelle 1500 cannot terminate pregnancy, so
Levonelle 1500 is not an “abortion pill”.
You may already be pregnant if:
R your period is more than 5 days late, or you have
experienced unusual bleeding when your next
period is due


Packaging Technology Berlin pewi
page 17
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 17

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:40 P

R you have had unprotected sex more than
72 hours ago, and since your last period
The use of Levonelle 1500 is not advised if:
R you have a disease of your small bowel (such as
Crohn’s disease) that inhibits the absorption of
the drug.


Packaging Technology Berlin pewi
page 18
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 18

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:40 P

R you have severe liver problems
R you have a history of ectopic pregnancy (where
the baby develops somewhere outside the womb)
R you have a history of salpingitis (inflammation of
the Fallopian tubes).


Packaging Technology Berlin pewi
page 19
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 19

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

A previous ectopic pregnancy or previous infection
of the fallopian tubes increase the risk of a new
ectopic pregnancy.
If you are worried about sexually transmitted
diseases
If you did not use a condom (or if it has been torn or


Packaging Technology Berlin pewi
page 20
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 20

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

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


Packaging Technology Berlin pewi
page 21
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 21

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

your doctor, nurse, family planning clinic or
pharmacist for advice if you are worried about this.
Other medicines and Levonelle 1500
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.


Packaging Technology Berlin pewi
page 22
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 22

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

Some medicines may prevent Levonelle 1500 from
working properly, these include:
R barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and
carbamazepine)


Packaging Technology Berlin pewi
page 23
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 23

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

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)


Packaging Technology Berlin pewi
page 24
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 24

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

R herbal remedies containing St John’s wort
(Hypericum perforatum)
R a medicine called ciclosporin (suppresses the
immune system)
Consult a doctor or pharmacist before using


Packaging Technology Berlin pewi
page 25
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 25

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

Levonelle 1500 if you use any of the above
mentioned medicine.
How often can you use Levonelle 1500
You should only use Levonelle 1500 in emergencies
and not as a regular method of contraception. If
Levonelle 1500 is used more than once in a


Packaging Technology Berlin pewi
page 26
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 26

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

menstrual cycle, it is less reliable and it is more
likely to upset your menstrual cycle (period).
Levonelle 1500 does not work as well as regular
methods of contraception. Your doctor, practice
nurse or family planning clinic can tell you about


Packaging Technology Berlin pewi
page 27
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 27

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

long-term methods of contraception which are more
effective in preventing you from getting pregnant.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your


Packaging Technology Berlin pewi
page 28
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 28

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

doctor or pharmacist for advice before taking any
medicine
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


Packaging Technology Berlin pewi
page 29
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 29

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

your doctor. There is no evidence that Levonelle
1500 will harm a baby that develops in your uterus/
womb if you use Levonelle 1500 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


Packaging Technology Berlin pewi
page 30
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 30

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

especially important if you develop severe
abdominal pain after taking Levonelle 1500 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


Packaging Technology Berlin pewi
page 31
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 31

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

medicine may appear in your breast milk. This is not
thought to be harmful to the baby. However if you
are worried you can take your tablet immediately
after a breast-feed and avoid nursing following
levonorgestrel administration then drain your milk
with a breast pump for 6 hours after taking Levonelle


Packaging Technology Berlin pewi
page 32
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 32

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

1500 and throw away the milk. In this way you can
reduce the amount of active ingredient your baby
may take in with the breast milk.
Driving and using machines
Your Levonelle 1500 tablet is unlikely to affect your
ability to drive a car or use machines. However, if


Packaging Technology Berlin pewi
page 33
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 33

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

you feel tired or dizzy do not drive or operate
machinery.
Levonelle 1500 contains lactose
In case of milk sugar (lactose) intolerance it should
be considered that each Levonelle 1500 tablet also
contains 142.5 mg lactose monohydrate. If you have


Packaging Technology Berlin pewi
page 34
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 34

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

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



Packaging Technology Berlin pewi
page 35
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 35

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

3. How to take Levonelle 1500
Always use this medicine exactly as described in the
leaflet or as your pharmacist or doctor has told you.
Check with your doctor or pharmacist if you are not
sure.


Packaging Technology Berlin pewi
page 36
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 36

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:41 P

R 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 1500 can be taken at any time in your
menstrual cycle assuming you are not already
pregnant or think you may be pregnant. Do not


Packaging Technology Berlin pewi
page 37
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 37

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

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.
R If you are already using a regular method of


Packaging Technology Berlin pewi
page 38
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 38

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

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 Levonelle 1500 (also if this is during the
same menstrual cycle), the tablet will not exert its


Packaging Technology Berlin pewi
page 39
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 39

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

contraceptive effect and there is again the risk of
pregnancy.
Use in children and adolescents
This medicine is not recommended for use in
children. Very limited data are available in women
under 16 years of age.


Packaging Technology Berlin pewi
page 40
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 40

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

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.
After you have taken Levonelle 1500
After you have taken Levonelle 1500, if you want to


Packaging Technology Berlin pewi
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client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 41

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

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 1500 will not work if you have
unprotected sex again, before your next period is
due.


Packaging Technology Berlin pewi
page 42
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 42

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

After you have taken Levonelle 1500, you are
advised to make an appointment to see your doctor
about three weeks later, to make sure that Levonelle
1500 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


Packaging Technology Berlin pewi
page 43
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 43

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

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.
If you continue to use regular hormonal


Packaging Technology Berlin pewi
page 44
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 44

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

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.
Your next period after you took Levonelle 1500
After the use of Levonelle 1500, your period is
usually normal and will start at the usual day;


Packaging Technology Berlin pewi
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client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 45

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

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.


Packaging Technology Berlin pewi
page 46
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 46

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

If you take more Levonelle 1500 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


Packaging Technology Berlin pewi
page 47
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 47

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

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.



Packaging Technology Berlin pewi
page 48
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 48

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

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



Packaging Technology Berlin pewi
page 49
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 49

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

Very common (may affect more than 1 in 10
people):
R Feeling sick (nausea)
R You might have some irregular bleeding until
your next period
R You might have lower abdominal pain


Packaging Technology Berlin pewi
page 50
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 50

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

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

Packaging Technology Berlin pewi
page 51
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 51

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

 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


Packaging Technology Berlin pewi
page 52
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 52

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

unusually light or unusually heavy, you should
contact your doctor as soon as possible.
R You might have tender breasts, diarrhoea, feel
dizzy after taking this medicine.



Packaging Technology Berlin pewi
page 53
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 53

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:42 P

Very rare effects (may affect up to 1 in 10000
people):
R Rash, urticaria, pruritus, swelling of the face,
pelvic pain, painful period
If you get any side effects, talk to your doctor or


Packaging Technology Berlin pewi
page 54
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 54

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:43 P

pharmacist. This includes any possible side effects
not listed in this leaflet.



Packaging Technology Berlin pewi
page 55
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 55

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:43 P

5. How to store Levonelle 1500
Keep this medicine out of the sight and reach of
children
Do not use Levonelle 1500 after the expiry date


Packaging Technology Berlin pewi
page 56
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 56

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:43 P

which is stated on the package after EXP. The expiry
date refers to the last day of the month
Store in the original packaging in order to protect
from light.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw


Packaging Technology Berlin pewi
page 57
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 57

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:43 P

away medicines you no longer use. These measures
will help to protect the environment.



Packaging Technology Berlin pewi
page 58
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 58

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:43 P

6. Contents of the pack and other
information
What Levonelle 1500 contains
The active substance is levonorgestrel. Each tablet
contains 1500 micrograms of levonorgestrel.


Packaging Technology Berlin pewi
page 59
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 59

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:43 P

The other ingredients are
Potato starch,
Maize starch,
Colloidal silica anhydrous,
Magnesium stearate,


Packaging Technology Berlin pewi
page 60
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 60

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:43 P

Talc,
Lactose monohydrate.
What Levonelle 1500 looks like and contents of
the pack
Tablet: almost white, flat, rimmed tablet of about


Packaging Technology Berlin pewi
page 61
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 61

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:43 P

8 mm diameter with an impressed mark of “G00” on
one side.
Packaging: one tablet in PVC//aluminium blister and
cardboard cartons.



Packaging Technology Berlin pewi
page 62
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 62

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:43 P

Marketing Authorisation Holder
Medimpex UK Limited
127 Shirland Road, London, W9 2EP, UK



Packaging Technology Berlin pewi
page 63
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 63

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:44 P

Manufacturer
Bayer Weimar GmBH und Co.KG
Döbereinerstrasse 20, D-99427 Weimar, Germany
or
Gedeon Richter Plc.
Gyömroi út 19-21., H-1103 Budapest, Hungary


Packaging Technology Berlin pewi
page 64
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 64

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:44 P

Levonelle 1500 is distributed in the UK by
Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire
RG14 1JA. UK



Packaging Technology Berlin pewi
page 65
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 65

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:44 P

Levonelle® is a registered trademark of the Bayer
Group.
This leaflet was last revised in 05/2013.



Packaging Technology Berlin pewi
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client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 66

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:44 P



Packaging Technology Berlin pewi
page 67
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 67

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:44 P

81627436


Packaging Technology Berlin pewi
page 68
client: 0086
item-no.: 81627436
PZ: 2534A-4E
name: LF-BRO-Levonelle 1500 TAB
colors: Black / Pantone 520 C
version: 22.05.2013/01
approval:

7436_01.indd 68

Bayer Pharma AG
code-no.: 98
country: GB BPH

5/22/2013 3:10:44 P

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.

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