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LEVONORGESTREL 1.5 MG TABLETS

Active substance(s): LEVONORGESTREL

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PACKAGE LEAFLET
Package leaflet: Information for the user
Levonorgestrel 1.5 mg tablet
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, pharmacist or nurse.
- 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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Levonorgestrel 1.5 mg Tablet is and what it is used for
2. What you need to know before you use Levonorgestrel 1.5 mg Tablet
3. How to use Levonorgestrel 1.5 mg Tablet
4. Possible side effects
5. How to store Levonorgestrel 1.5 mg Tablet
6. Contents of the pack and other information
1. What Levonorgestrel 1.5 mg Tablet is and what it is used for
Levonorgestrel 1.5 mg Tablet is an oral emergency contraceptive.
What is emergency contraception?
Emergency contraception is a rescue method intended to prevent pregnancy after
unprotected intercourse or failure of contraception.
When should emergency contraception be used?
You should take Levonorgestrel 1.5 mg Tablet as soon as possible, preferably
within 12 hours and no later than 72 hours (3 days) after unprotected intercourse
or after failure of a contraceptive method. Levonorgestrel 1.5 mg Tablet is most
effective if you take it as soon as possible after unprotected intercourse.
Levonorgestrel 1.5 mg Tablet can only prevent you from becoming pregnant if
you take it within 72 hours after unprotected intercourse. It will not work if you
are already pregnant. If you have had unprotected sex after you have taken
Levonorgestrel 1.5 mg tablet, it will not stop you from becoming pregnant.
If you suspect that you are pregnant because of:
• If you have had sex without contraception;
• If you forget to take your pill on time;
• If your partner’s condom has broken, slipped or traveled by;
• If you think your IUD (intrauterine contraceptive) has been expelled;

• If your diaphragm has come out of alignment or if you have taken out too early;
• If you are afraid of interrupted intercourse or calendar method has not worked;
• In the case of rape.
The precise mode of action of Levonorgestrel 1.5 mg Tablet is not known. Most
likely it stops your ovaries from the release of an egg. Perhaps there are other
processes involved, including the prevention of implantation of a fertilized ovum
into the uterus. It is not effective once the process of nidation has begun.
This tablet is intended only as emergency contraception, not as a regular
contraceptive method because these are less effective than the 'normal' birth
control pill ("the pill").
2. What you need to know before you use Levonorgestrel 1.5 mg Tablet
Do not use Levonorgestrel 1.5 mg Tablet
- If you are allergic (hypersensitive) to levonorgestrel or any of the other
ingredients of Levonorgestrel 1.5 mg Tablet (see section 6).
Warnings and precautions
The use of Levonorgestrel 1.5 mg Tablet is not recommended in the following
cases:
- If you have had a pregnancy outside the uterus (ectopic pregnancy)
- If you have had a pelvic inflammatory disease (salpingitis)
- If you or someone in your family has a known risk factor for thrombosis (blood
clotting)
- If you have a serious digestive disorder that impairs the absorption of food and
drugs
- If you have severe liver disease or any serious illness in the small intestine, such
as Crohn’s disease.
A history of tubal (ectopic) pregnancy and a previous infection of the fallopian
tubes increase the risk of a (new) ectopic pregnancy. Therefore if you previously
had a tubal (ectopic) pregnancy or an infection of the fallopian tubes you should
contact your doctor before taking Levonorgestrel 1.5 mg Tablet
Emergency contraception must be used only occasionally and should not replace
a regular contraceptive method because:
- It is not always prevent pregnancy;
- The risk of an excess of hormones may cause disruption of the cycle.
Because emergency contraception can not interrupt a pregnancy.
If you have had another unprotected intercourse for more than 72 hours ago,
conception may have occurred. Treatment with Levonorgestrel 1.5 mg Tablet
after the second act of intercourse may therefore be ineffective in preventing

pregnancy.
In all women, emergency contraception should be taken as soon as possible after
unprotected intercourse. There is some evidence that Levonorgestrel 1.5 mg
Tablet may be less effective with increasing body weight or body mass index
(BMI), but these data were limited and inconclusive. Therefore, Levonorgestrel
1.5 mg Tablet is still recommended for all women regardless of their weight or
BMI.
You are advised to speak to a healthcare professional if you are concerned about
any problems related to taking emergency contraception.

Repeated administration of Levonorgestrel 1.5 mg Tablet within a menstrual
cycle is not advisable because it can disrupt your cycle.
Levonorgestrel 1.5 mg Tablet does not work as well as regular methods of
contraception (the pill, condoms). Your doctor can talk about long-term methods
of contraception which are more effective in preventing from getting pregnant.
After using this medicine: It is mandatory to exclude pregnancy by performing a
pregnancy test:
• when your next menstrual period is delayed more than five days;
• in case of abnormal bleeding, including the expected period date.
If you are not using a condom during intercourse (or if it is torn or slipped) it is
possible that you have contracted a STD (sexually transmitted disease, STD) or
the HIV virus. The use of emergency contraceptive pills does not protect against
sexually transmitted diseases or from infection with the HIV virus and cannot
replace the necessary precautions and measures to be taken in case of risk of
transmission (see "Additional Information" below this leaflet).
Children and adolescents
Paediatric population:
Levonorgestrel 1.5 mg Tablet is not recommended in children.
Very limited data are available in women under 16 years of age.
Other medicines and Levonorgestrel 1.5 mg Tablet
The medicines listed below, including non-prescription drugs, can reduce or
inhibit the effect or inhibit the effect of Levonorgestrel 1.5 mg Tablet:
− Some drugs used to treat epilepsy (phenobarbitol, phenytoin, primidone,
carbamazepine);
− Some drugs to treat HIV infection (ritonavir);
− Some drugs used to treat infections (rifabutin, rifampicin, griseofulvin)

− Herbal products containing St. John's Wort (Hypericum perforatum).
− A medicine called cyclosporin (suppresses the immune system)
Levonorgestrel 1.5 mg Tablet should not be used together with emergency
contraceptives containing ulipristal acetate.
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility
If you are pregnant:
If you are pregnant, this drug cannot abort an ongoing pregnancy.
If you are taking this medicine and get pregnant, studies have so far shown no
risk of malformation of the fetus. However you should not take this medication if
you are pregnant.
If you become pregnant after taking Levonorgestrel 1.5 mg Tablet you should
contact your doctor. Your doctor will perhaps check if you have no ectopic
pregnancy (the fetus develops somewhere outside of your uterus). This is
especially important if you have severe pain in your stomach gets after
Levonorgestrel 1.5 mg Tablet intake or if you have previously ectopic (ectopic)
pregnancy or surgery on your fallopian tubes or have had pelvic inflammatory
disease.
If you are breastfeeding:
Breast-feeding is possible but because levonorgestrel is excreted in human milk.
You should breastfeed immediately before taking Levonorgestrel 1.5 mg Tablet
and refrain from nursing for at least 8 hours following Levonorgestrel 1.5 mg
Tablet administration.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
After taking Levonorgestrel 1.5 mg Tablet, some women experience fatigue and
dizziness (see section 4 "Possible side effects'): do not drive or use machinery if
you suffer from these symptoms.
No studies on the effects of Levonorgestrel 1.5 mg Tablet on driving and ability
to operate machinery.
Levonorgestrel 1.5 mg Tablet contains Lactose
Levonorgestrel 1.5 mg Tablet contains lactose monohydrate. If your doctor has
told you that you have intolerance to sugars, contact with him / her before you
take this medicine to use.

3. How to use Levonorgestrel 1.5 mg Tablet
Always use this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Levonorgestrel 1.5 mg Tablet is intended for oral use. The tablet should be
swallowed with a glass of water and should not be chewed.
Take the tablet as soon as possible, preferably within 12 hours after
unprotected intercourse, but not later than 72 hours (3 days) after intercourse.
You can take Levonorgestrel 1.5 mg Tablet at any time during the menstrual
cycle.
If you vomit within three hours after taking tablet, you should take another tablet.
Contact your doctor if there are more than 72 hours have elapsed since
unprotected intercourse.
After using Levonorgestrel 1.5 mg Tablet use a contraceptive (condom,
spermicide, and diaphragm) until the next menstrual period begins. If you have
further unprotected intercourse after you have taken Levonorgestrel 1.5 mg
Tablet (even during the same menstrual cycle), the tablets are not to have
contraception and the risk is that you become pregnant. If you use a regular
method of contraception and such as oral contraceptives, you should continue to
use this as normal.
If you use oral contraceptives ("the pill"), after taking Levonorgestrel 1.5 mg
Tablet you just continue with the pill. If you have no menstrual bleeding during
your next tablet-free interval, you should take a pregnancy test to exclude
pregnancy. Your doctor can advise you about birth control methods for the longer
term that is effective to prevent you from becoming pregnant.
If you continue to use regular hormonal contraception like birth control pills and
you have not had any bleeding during your tablet-free interval, contact your
doctor to check that you are not pregnant.
Your next period after you have taken Levonorgestrel 1.5 mg Tablet
After using Levonorgestrel 1.5 mg Tablet your period is usually normal and will
on the expected day, but sometimes it can be a few days late or early. If your
period is more than 5 days late or is unusually light or extensive, or if you think
you may be pregnant for some other reason, check if you are pregnant with a
pregnancy test. If you become pregnant even after you have taken this drug, it is
important that you contact your doctor.
If you take more Levonorgestrel 1.5 mg Tablet than you should
There are no reports of acute poisoning or severe adverse effects after taking

Levonorgestrel 1.5 mg Tablet too much doses at once. You can, however nausea,
vomiting or vaginal bleeding. You should contact your doctor or pharmacist for
advice.
4. Possible side effects
Like all medicines, Levonorgestrel 1.5 mg Tablet cause side effects, although not
everybody gets them.
The occurrence of possible side effects listed below are defined as follows:
Very common (affects more than 1 in 10 users)
Common (affects 1 to 10 of 100)
Very rare (affects less than 1 in 10,000 users)
Not known (frequency cannot be estimated from the available data).

The following adverse reactions have been observed:
Very common side effects:
- Dizziness, headache
- Nausea, abdominal pain
- Breast tenderness, delayed period, heavy periods, bleeding
- Tiredness
Common side effects:
- Diarrhea,
- vomiting
Not known:
- Post-marketing cases of thromboembolic events (blood clots) have been
reported.
- Hypersensitivity to the skin may occur after taking this medicine.
If any of the side effects or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: 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 1.5 mg Tablet
Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton. The
expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration, the product
should then be returned to your pharmacist.
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.
6. Contents of the pack and other information
What Levonorgestrel 1.5 mg Tablet contains
The active substance is levonorgestrel.
- The other ingredients are Lactose monohydrate, Povidone (E1201), Maize
starch, Silica colloidal anhydrous (E551) and Magnesium stearate (E572).
Levonorgestrel belongs to a group of medicines called as emergency
contraception.
What Levonorgestrel 1.5 mg Tablet looks like and contents of the pack
Levonorgestrel 1.5 mg Tablet is a round, white to off-white, uncoated flat tablet
debossed 145 on one side and other side plain.
Each pack contains one tablet Levonorgestrel 1.5 mg Tablet of levonorgestrel.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Famy Care Europe Ltd.
One Wood Street,
London, EC2V 7WS
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House,
319 Pinner Road,
North Harrow,
Middlesex- HA1 4HF
United Kingdom

This leaflet was last revised in 10/2014.
a) Some information about the menstrual cycle and contraception
The menstrual cycle
The menstrual cycle is the time between two menstrual periods. Usually, the life
cycle 28 days, but the duration may vary from woman to woman. Menstrual
periods occur when a woman is not pregnant.
Fertilization
In the middle of each cycle, an egg (ovum) into one of the two ovaries (currently
is called "ovulation"). Typically, ovulation mid-cycle position, but this may at
any other time during the Performance cycle.
After intercourse, male sperm (sperm cells) near the exposed egg, and fertilize the
egg (i.e., a fusion of a sperm with the egg which an embryo is formed). After a
few days the fertilized egg implants in the uterus and pregnancy begins.
Contraceptives (birth control)
Contraceptive methods are aimed to prevent:
- Ovulation: using the contraceptive pill
- Fertilization (fusion of a sperm with the egg): using a condom
- Implantation of a fertilized ovum into the uterus: use of the IUD.
Emergency contraception
Emergency contraception acts by blocking ovulation or preventing implantation
following sexual intercourse. It is not effective if implantation has already started.
When a woman has intercourse without using a contraceptive method the chance
of pregnancy can not be excluded. If this medicine, but not normal contraceptive
method used, strongly advised to seek medical or visit the Public Health Service.
You will receive advice on the contraceptive method that suits you best.
b) Advise on risk of transmission of a sexually transmitted disease
If you have unprotected sexual intercourse you may be at risk of contracting a
sexually transmitted disease, particularly if you are unaware of your partner’s
sexual history or have multiple partners. For questions, please contact your
doctor, pharmacist or family planning clinic.
GLOSSARY
• Ectopic (ectopic) pregnancy: a pregnancy that develops outside the uterus,
usually in the fallopian tubes. Symptoms include persistent abdominal
pain, missed menstrual periods, vaginal bleeding, signs of pregnancy
(nausea, sensitivity breasts). If you have these symptoms, you should
immediately consult your doctor.
• Salpingitis: infection of the fallopian tubes. Symptoms include abdominal

pain, fever and severe vaginal discharge.

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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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