Skip to Content

UK Edition. Click here for US version.

LEVONORGESTREL 1.5MG TABLETS

Active substance(s): LEVONORGESTREL

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Levonorgestrel 1.5mg Tablets
Levonorgestrel
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• 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.
• 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.
What is in this leaflet
1. What Levonorgestrel 1.5mg tablets are and what
they are used for
2. What you need to know before you take
Levonorgestrel 1.5mg tablets
3. How to take Levonorgestrel 1.5mg tablets
4. Possible side effects
5. How to store Levonorgestrel 1.5mg tablets
6. Contents of the pack and other information

Levonorgestrel 1.5mg Tablets

1st Fold 141 mm
45 mm

45 mm

238711

2227

1. What Levonorgestrel 1.5mg tablets are and
what they are used for

A Levonorgestrel 1.5mg tablet is an emergency
contraceptive that can be used within 72 hours (3
days) of unprotected sex or if your usual contraceptive
method has failed.
It is about the following cases:
o No contraception was used during the sexual
intercourse.
o The contraception measure was used incorrectly,
for example if a condom was penetrated, slipped
away or used in the wrong way, if vaginal 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).
Levonorgestrel 1.5mg tablets contain 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
unprotected sex. It is better to take it within 12 hours
rather than delay until the third day.
Levonorgestrel 1.5mg tablets are thought to work by:
stopping your ovaries from releasing an egg;
preventing sperm from fertilising any egg you
may have already released; or
stopping a fertilised egg from attaching itself to
your womb lining.
Levonorgestrel 1.5mg tablets 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
place after the use of Levonorgestrel 1.5mg tablets

(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.

2. What you need to know before you take
Levonorgestrel 1.5mg tablets

Do not take Levonorgestrel 1.5mg tablets
- 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 Levonorgestrel 1.5mg tablets as
emergency contraception may not be suitable for you.
Your doctor may prescribe another type of emergency
contraception for you.
o 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,
Levonorgestrel 1.5mg tablets cannot terminate
pregnancy, so Levonorgestrel 1.5mg tablets are
not an “abortion pill”
You may already be pregnant if:
o your period is more than 5 days late, or you have
experienced unusual bleeding when your next
period is due
o you have had unprotected sex more than 72
hours ago, and since your last period
The use of Levonorgestrel 1.5mg tablets are not
advised if:
o you have a disease of your small bowel (such as
Crohn’s disease) that inhibits the absorption of
the drug.
o you have severe liver problems
o you have a history of ectopic pregnancy (where
the baby develops somewhere outside the womb)
o you have a history of salpingitis (inflamation of
the fallopian tubes)
A previous ectopic pregnancy and a 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
slid down) during 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 your doctor, nurse, family planning clinic or
pharmacist for advice if you are worried about this.
Other medicines and Levonorgestrel 1.5mg tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Some medicines may prevent Levonorgestrel 1.5mg
tablets from working properly, these include:
barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and
carbamazepine).
medicines used to treat tuberculosis (for
example, rifampicin, rifabutin).

70 mm

SAP Code: 40100005017
238711 Levonorgestrel (POM) UK_V11.pdf
Issued For Final Production :Issued For Re-Approval

:-

Issued For Approval

:- 15-OCT-15 17:38:22

TEMPLE Packaging Pvt. Ltd.

Tel:- 28476601, Email:- info@templepackaging.co.in

:- 40100005017

Customer

:- Lupin - GERMANY HORMOSAN

SAP Code

Location

:- Indore

File No.

:- 36316

Product Name

:- INS LEVONORGESTRL 1.5MG 1’S

Artwork Sr. No.

:- 44/08/14

Product Code

:- 238711

Customer A/W No. :- NA

Version No.

:- 11

Old File No.

Date

:- 15-OCT-15

Old Product Code :- NA

Artwork Status

:- IN PROCESS

Barcode

:- NA

Open Size

:- 280 X 230 MM(LXW)

Pharmacode

:- 2227

Folding Size

:- 70 X 45 MM(WxL)

Perforation

:- NA

Substrate

:- 40 GSM BIBLE PAPER

Gluing

:- YES

Cover Page (PAD) :- NA

Font Name

:- HELVETICA CONDENSED

Cover Pg Substrate :- NA

Font Size

:- 9PT

:- NA

No.of Pages / PAD :- NA
Remark
Printing Colours
K

15-OCT-15
shaji

:-

1

a treatment for HIV infection (ritonavir)
a medicine used to treat fungal infections
(griseofulvin)
herbal remedies containing St John’s wort
(Hypericum perforatum)
a medicine called ciclosporin (suppresses the
immune system)
Consult a doctor or pharmacist before using
Levonorgestrel 1.5mg tablets if you use any of the
above mentioned medicine.
How often can you use Levonorgestrel 1.5mg tablets
You should only use Levonorgestrel 1.5mg tablets
in emergencies and not as a regular method of
contraception. If Levonorgestrel 1.5mg tablets are
used more than once in a menstrual cycle, it is less
reliable and it is more likely to upset your menstrual
cycle (period).
Levonorgestrel 1.5mg tablets do 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.
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 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 your
doctor. There is no evidence that Levonorgestrel
1.5mg tablets will harm a baby that develops in your
uterus/womb if you use Levonorgestrel 1.5mg tablets
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 Levonorgestrel 1.5mg tablets or
if you have previously had an ectopic pregnancy,
fallopian tube surgery or pelvic inflammatory disease.
Breast-feeding
Very small amounts of the active ingredient of this
medicine may appear in your breast milk. This is not
thought to be harmful to the baby. 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 Levonorgestrel 1.5mg
tablets 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.
Fertility
Levonorgestrel increases the possibility of
menstruation disturbance which can sometimes lead
to an earlier or later ovulation date. These changes can
result in a modified fertility date; however, there are no
fertility data in the long term.

Driving and using machines
Your Levonorgestrel 1.5mg tablets are 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.
Levonorgestrel 1.5mg tablets contain lactose
In case of milk sugar (lactose) intolerance it should be
considered that each Levonorgestrel 1.5mg tablet also
contains 140.1mg lactose monohydrate. If you have
been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this
medicine.

3. How to take Levonorgestrel 1.5mg tablets

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
• 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.
Levonorgestrel 1.5mg tablets 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
whole with water. Do not delay taking the tablet.
The tablet works better the sooner you take it
after having unprotected sex.
• 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.
If another unprotected intercourse takes place after
the use of Levonorgestrel 1.5mg tablets (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.
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.
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 Levonorgestrel 1.5mg tablets
After you have taken Levonorgestrel 1.5mg tablets,
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 Levonorgestrel 1.5mg tablets will not work
if you have unprotected sex again, before your next
period is due.
After you have taken Levonorgestrel 1.5mg tablets,
you are advised to make an appointment to see your
doctor about three weeks later, to make sure that
Levonorgestrel 1.5mg tablets have 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.
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 in your pill-free period, see your doctor to make
sure you are not pregnant.
Your next period after you took Levonorgestrel
1.5mg tablets
After the use of Levonorgestrel 1.5mg tablets, your
period is usually normal and will start on the usual
day; 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.
If you take more Levonorgestrel 1.5mg tablets than
you should
Although there have been no reports of serious
harmful effects from taking too many tablets at once,
you may feel sick, actually be sick (vomit), or have
vaginal bleeding. You should ask your pharmacist,
doctor, practice nurse or family planning clinic for
advice, especially if you have been sick, as the tablet
may not have worked properly.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
• Feeling sick (nausea)
• You might have some irregular bleeding until
your next period
• You might have lower abdominal pain
• Tiredness
• Headache
Common (may affect up to 1 in 10 people):
• Being sick (vomiting). If you are sick, read the
section ‘What to do if you are sick’ (vomit).
• 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 unusually
light or unusually heavy, you should contact your
doctor as soon as possible.
• You might have tender breasts, diarrhoea, feel
dizzy after taking this medicine.
Very rare effects (may affect up to 1 in 10,000
people):
• Rash, urticaria, pruritus, swelling of the face,
pelvic pain, painful period
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not

SAP Code: 40100005017
238711 Levonorgestrel (POM) UK_V11.pdf
Issued For Final Production :Issued For Re-Approval

:-

Issued For Approval

:- 15-OCT-15 17:38:23

TEMPLE Packaging Pvt. Ltd.

Tel:- 28476601, Email:- info@templepackaging.co.in

:- 40100005017

Customer

:- Lupin - GERMANY HORMOSAN

SAP Code

Location

:- Indore

File No.

:- 36316

Product Name

:- INS LEVONORGESTRL 1.5MG 1’S

Artwork Sr. No.

:- 44/08/14

Product Code

:- 238711

Customer A/W No. :- NA

Version No.

:- 11

Old File No.

Date

:- 15-OCT-15

Old Product Code :- NA

Artwork Status

:- IN PROCESS

Barcode

:- NA

Open Size

:- 280 X 230 MM(LXW)

Pharmacode

:- 2227

Folding Size

:- 70 X 45 MM(WxL)

Perforation

:- NA

Substrate

:- 40 GSM BIBLE PAPER

Gluing

:- YES

Cover Page (PAD) :- NA

Font Name

:- HELVETICA CONDENSED

Cover Pg Substrate :- NA

Font Size

:- 9PT

:- NA

No.of Pages / PAD :- NA
Remark
Printing Colours
K

15-OCT-15
shaji

:-

1

listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme, website: www.
mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of
this medicine.

5. How to store Levonorgestrel 1.5mg tablets

Keep this medicine out of the sight and reach of
children.
Do not use Levonorgestrel 1.5mg tablets after the
expiry date which is stated on the package after EXP.
The expiry date refers to the last day of the month
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.
Store below 25°C. Store in the original package in
order to protect from light.

6. Contents of the pack and other information

What Levonorgestrel 1.5mg tablets contain
- The active substance is levonorgestrel. Each
tablet contains 1.5mg of levonorgestrel.
- The other ingredients are:
Lactose monohydrate
Maize starch
Povidone K30
Silica, colloidal anhydrous
Magnesium stearate
What Levonorgestrel 1.5mg tablets look like and
contents of the pack
White to off-white round shaped tablets, debossed
with “LV1” on one side and plain on the other side.
PVC/PVDC/aluminium blister containing one tablet,
which is further packed in to a carton.

Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited
Victoria Court
Bexton Road
Knutsford
Cheshire
WA16 0PF
United Kingdom
This leaflet was last revised in 01/2014
Code No.: MP/DRUGS/28/6/2010
ID#: 238711

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