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LEVONORGESTREL 1.5MG TABLETS

Active substance(s): LEVONORGESTREL / LEVONORGESTREL / LEVONORGESTREL

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Package leaflet: Information for the user
Levonorgestrel 1.5mg Tablets
Levonorgestrel

Levonorgestrel 1.5mg Tablets
251069

4115

Pharmacode Direction

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
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.
When should emergency contracption be used?
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.

Levonorgestrel 1.5mg tablets are not indicated for use
before the first menstrual bleeding (menarche).
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 pharmacist or doctor if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription or herbal medicines.
Some medicines may prevent Levonorgestrel 1.5mg
tablets from working effectively. If you have used any of
the medicines below during the last 4 weeks,
Levonorgestrel 1.5mg tablets may be less suitable for
you. Your doctor may prescribe another type of (nonhormonal) emergency contraceptive, i.e. a copper
intrauterine device (Cu-IUD). If this is not an option for
you or if you are unable to see your doctor promptly, you
can take a double dose of Levonorgestrel 1.5mg tablets:
 barbiturates and other medicines used to treat
epilepsy (for example, primidone, phenytoin, and

carbamazepine).
 medicines used to treat tuberculosis (for
example, rifampicin, rifabutin).
 a treatment for HIV (ritonavir, efavirenz)
 a medicine used to treat fungal infections
(griseofulvin)
 herbal remedies containing St John's wort
(Hypericum perforatum)
Speak to your pharmacist or doctor if you need further
advice on the correct dose for you.
Consult your doctor as soon as possible after taking the
tablets for further advice on a reliable form of regular
contraception and to exclude a pregnancy (See also
section 3 “How to take Levonorgestrel 1.5mg tablets”
for further advice).
Levonorgestrel 1.5mg tablets may also affect how well
other medicines work
 a medicine called cyclosporin (suppresses the
immune system).
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 longterm 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

230 mm

280 mm

251069 INS LEVONORGESTRL 1.5MG 1'S - POM UK R2 (FRONT)
Market/Customer :

UK

Location :

Prepared On :

17/02/2017

Version No. :

Product Name :

INS LEVONORGESTRL 1.5MG 1'S - POM UK R2

Material Code :

251069

Supersedes Material code :

250395

Open Size :

280 x 230 MM (L x W)

Barcode value :

NA

Folded Size :

70 x 45 (W x L)

Barcode Type (Ex. NDC, PZN, EAN-13)

NA

Substrate :

GSM : 40 gsm

Component :

Leaflet

Paper : Bible Paper

Font Size :

9 PT

Font Name :

HELVETICA CONDENSED

Gluing :

YES

Perforation :

NA

Pharmacode :

4115

Colour :
Reason for Change :

Black
Correction in textmatter as per customer requirement.

02

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 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.
·
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 best the sooner you take it after
having unprotected sex.
·
If you are using one of the medicines that may
prevent Levonorgestrel 1.5mg tablets from
working properly (see section above “Other
medicines and Levonorgestrel 1.5mg tablets”) or
if you have used one of these medicines in the
past 4 weeks, Levonorgestrel 1.5mg tablets may
work less effectively for you. Your doctor may
prescribe another type of (non-hormonal)
emergency contraceptive, i.e. a copper
intrauterine device (Cu-IUD). If this is not an
option for you or if you are unable to see your
doctor promptly, you can take a double dose of
Levonorgestrel 1.5mg tablets (i.e. 2 tablets taken
together at the same time).
·
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
Levonorgestrel 1.5mg tablets are not indicated for use
before the first menstrual bleeding (menarche).
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
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 medicinal product is authorised in the Member
States of the EEA under the following names:
Spain: Levonorgestrel-Lupin 1500 microgramos
Comprimidos
United Kingdom: Levonorgestrel 1.5mg Tablets
This leaflet was last revised in 02/2017
Code No.: MP/DRUGS/28/6/2010
ID#: 251069

230 mm

280 mm

251069 INS LEVONORGESTRL 1.5MG 1'S - POM UK R2 (BACK)
Market/Customer :

UK

Location :

Prepared On :

17/02/2017

Version No. :

Product Name :

INS LEVONORGESTRL 1.5MG 1'S - POM UK R2

Material Code :

251069

Supersedes Material code :

250395

Open Size :

280 x 230 MM (L x W)

Barcode value :

NA

Folded Size :

70 x 45 (W x L)

Barcode Type (Ex. NDC, PZN, EAN-13)

NA

Substrate :

GSM : 40 gsm

Component :

Leaflet

Paper : Bible Paper

Font Size :

9 PT

Font Name :

HELVETICA CONDENSED

Gluing :

YES

Perforation :

NA

Pharmacode :

4115

Colour :
Reason for Change :

Black
Correction in textmatter as per customer requirement.

02

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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