LIVOPILL

Package leaflet: Information for the patient

Livopill, 1500 micrograms, tablet
levonorgestrelum
Read the entire leaflet carefully before taking the medicine, as it contains important information for you.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents

1. What Livopill is and what it is used for
2. Important information before taking Livopill
3. How to take Livopill
4. Possible side effects
5. How to store Livopill
6. Contents of the pack and other information

1. What Livopill is and what it is used for

Livopill is an emergency contraceptive medicine that can be used within 72 hours (3 days) after unprotected sexual intercourse or contraceptive failure.
This includes the following situations:

• When no contraception was used during sexual intercourse;
• When contraception was used incorrectly, for example, if a condom slipped or was used improperly, if a contraceptive cap or vaginal ring has moved, torn, broken, or been removed at the wrong time, or if the penis was not withdrawn from the vagina at the appropriate moment during withdrawal method (e.g. ejaculation occurred inside the vagina or onto external genital organs).

Livopill contains as its active substance a synthetic hormone called levonorgestrel. When taken within 72 hours after unprotected sexual intercourse, this medicine prevents pregnancy in approximately 84% of cases.
It does not prevent pregnancy in every case, and its effectiveness is greater the sooner it is taken after unprotected intercourse. It is best to take the medicine within the first 12 hours, rather than waiting until the third day after unprotected intercourse.
Livopill is believed to work by:

• Inhibiting the release of an egg from the ovaries;
• Preventing fertilization of an already released egg by sperm.

Livopill prevents pregnancy only when used within 72 hours after unprotected sexual intercourse. This medicine is not effective if the woman is already pregnant.
If another unprotected sexual intercourse occurs after taking Livopill (even within the same menstrual cycle), the tablet may not provide contraceptive protection, and there may again be a risk of pregnancy.
Livopill is not indicated for use before the first menstrual bleeding (menarche).

2. Important information before using Livopill

When not to use Livopill
if the patient is allergic to levonorgestrel or any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions
If any of the following apply to the patient, she should inform her doctor
before using Livopill, as emergency contraception may not be suitable for her.
The doctor may prescribe another type of emergency contraception.
If the patient is pregnant or suspects she may be pregnant. This medicine is not effective
if the patient is already pregnant. If the patient is already pregnant, Livopill cannot
terminate the pregnancy, so Livopill is not an abortion pill.

The patient may already be pregnant if:
her menstrual bleeding is delayed by more than 5 days or there is unusual bleeding
on the expected day of menstruation;
more than 72 hours have passed since unprotected sexual intercourse in the same menstrual cycle.

Livopill is not recommended if:
the patient has a small intestine disease (e.g. Crohn's disease) that impairs absorption of the medicine;
the patient has severe liver function disorders;
the patient has ever had an ectopic pregnancy (a pregnancy developing outside the uterus);
the patient has had salpingitis (inflammation of the fallopian tubes).

A previous ectopic pregnancy or tubal infection increases the risk of another ectopic pregnancy.

For all women, emergency contraception should be used as soon as possible after unprotected intercourse.
There is evidence that Livopill may be less effective with increasing body weight or body mass index (BMI),
but these data are limited and inconclusive. Therefore, Livopill is still recommended for all women,
regardless of body weight or BMI.

If there are any doubts regarding the use of emergency contraception, consult a doctor, pharmacist, or nurse.

Children and adolescents
Livopill is not indicated for use before the first menstrual period (menarche).

If the patient is concerned about sexually transmitted infections
If a condom was not used during intercourse (or it broke or slipped off), the patient may have been exposed to a sexually transmitted infection or HIV. This medicine does not protect against sexually transmitted infections. Only using condoms can prevent infection. If in doubt, consult a doctor, nurse, family planning specialist, or pharmacist.

Livopill and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including over-the-counter medicines or herbal remedies.

Some medicines may reduce the effectiveness of Livopill. If the patient has taken any of the following medicines within the last 4 weeks, Livopill may not be suitable for her. The doctor may prescribe another type of (non-hormonal) emergency contraception (after unprotected intercourse), such as a copper intrauterine device (Cu-IUD). If this does not apply to the patient or she cannot see a doctor immediately, she may take a double dose of Livopill.

• Barbiturates and other medicines used to treat epilepsy (e.g. primidone, phenytoin, and carbamazepine);
• Medicines used to treat tuberculosis (e.g. rifampicin, rifabutin);
• Medicines used to treat HIV infection (ritonavir, efavirenz);
• Medicines used to treat fungal infections (griseofulvin);
• Herbal remedies containing St. John's wort (Hypericum perforatum).

For additional information on the correct dosage, consult a doctor or pharmacist.

After taking the tablet, the patient should contact a doctor or pharmacist as soon as possible for further advice on regular contraception and to rule out pregnancy (see also section 3 "How to use Livopill" for further advice).

Livopill may also affect the action of other medicines:

• cyclosporine (a medicine that suppresses the immune system).

How often can Livopill be used
Livopill should only be used in emergency situations and not as a regular method of
contraception. If Livopill is used more than once in the same menstrual cycle, its contraceptive effect is reduced, and there is a higher risk of menstrual cycle disturbances (period irregularities).

Livopill is not as effective as regular contraceptive methods. For information on long-term contraceptive methods that are more effective in preventing pregnancy, consult a doctor, nurse, or family planning specialist.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Pregnant women should not use this medicine. If the patient becomes pregnant despite using the medicine, it is important to contact a doctor. There is no evidence that Livopill has harmful effects on the developing fetus if used according to instructions.

However, the doctor may want to rule out an ectopic pregnancy (a pregnancy developing outside the uterus). This is particularly important if the patient experiences severe abdominal pain after taking Livopill, or if she has had an ectopic pregnancy in the past, previous tubal surgery, or pelvic inflammatory disease.

Breastfeeding
The active ingredient of this medicine passes into breast milk. Therefore, it is recommended that the patient take the tablet immediately after breastfeeding and then avoid breastfeeding for at least 8 hours after taking levonorgestrel. During this time, milk should be expressed and discarded using a breast pump. By taking the tablet well before the next feeding, the amount of active substance transferred to the infant through breast milk can be minimized.

Fertility
Taking Livopill may increase the likelihood of menstrual cycle disturbances, which may sometimes delay or accelerate ovulation, thereby affecting the fertile period. Although there are no data on long-term effects on fertility, fertility is expected to return quickly after taking Livopill. Therefore, after taking Livopill, the patient should continue using regular contraception or start using it as soon as possible.

Driving and operating machinery
It is unlikely that Livopill affects the ability to drive or operate machinery. However, if the patient experiences fatigue or dizziness, she should not drive or operate machinery.

Livopill contains lactose and sodium
If the patient has been previously diagnosed with an intolerance to certain sugars, she should consult her doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Livopill

This medicine should always be taken as directed by a doctor. If in doubt, consult a doctor or pharmacist.
The tablet should be taken as soon as possible, preferably within 12 hours, and no later than
72 hours (3 days) after unprotected sexual intercourse. Do not delay taking the tablet. The
earlier the tablet is taken after unprotected intercourse, the more effective it will be. The tablet
can prevent pregnancy only if taken within 72 hours after unprotected intercourse.

• Livopill may be used on any day of the menstrual cycle, provided the patient is not pregnant and does not suspect she might be pregnant. The tablet must not be chewed; it should be swallowed whole with water.
• If the patient is taking any medicines that may reduce the effectiveness of Livopill (see section above "Livopill and other medicines") or if she has taken any of these medicines within the past 4 weeks, Livopill may not be suitable. The doctor may instead prescribe another type of (non-hormonal) emergency contraception, such as a copper intrauterine device (Cu-IUD). If this option is unsuitable or the patient cannot see a doctor immediately, a double dose of Livopill may be taken (i.e. 2 tablets taken at the same time).
• If the patient is using regular contraception, such as oral contraceptive pills, she may continue taking them as directed.

If further unprotected sexual intercourse occurs after taking Livopill (including within the same menstrual cycle), the tablet will not provide contraceptive protection, and there is again a risk of pregnancy.
What to do if vomiting occurs
If vomiting occurs within three hours of taking the tablet, another tablet should be taken immediately.
After using Livopill
If the patient is not using any contraceptive method and plans to have sexual intercourse after taking Livopill, she should use condoms or a diaphragm together with spermicidal agents until the next menstrual bleeding occurs. This is necessary because Livopill is not effective in preventing pregnancy from any further unprotected intercourse before the next expected menstrual period.
Approximately three weeks after taking Livopill, the patient should visit a doctor to confirm that Livopill has been effective. If menstrual bleeding is delayed by more than 5 days, or if bleeding is unusually light or unusually heavy, the patient should contact a doctor as soon as possible. If the patient becomes pregnant despite taking Livopill, it is important to consult a doctor.
The doctor may also provide information about long-term contraceptive methods that offer more effective protection against pregnancy.
If the patient continues using regular hormonal contraception, such as oral contraceptive pills, and does not experience menstrual bleeding during the tablet-free interval, she should consult a doctor to rule out pregnancy.
Next menstrual bleeding after using Livopill
After taking Livopill, menstrual bleeding is usually normal and occurs around the usual time, although it may sometimes start a few days earlier or later. If menstrual bleeding starts more than 5 days later than expected, if bleeding is unusual, or if the patient suspects she might be pregnant, she should confirm whether she is pregnant using a pregnancy test.
Taking more than the recommended dose of Livopill
Although severe adverse effects have not been reported after taking too many tablets at once, nausea, vomiting, and vaginal bleeding may occur. A pharmacist, doctor, nurse, or family planning specialist should be consulted, especially if vomiting has occurred, as the tablet may not have been effective in such cases.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
The possible adverse effects listed below are categorized according to their frequency of occurrence:

Very common (may occur in more than 1 in 10 users):

• Nausea;
• Irregular intermenstrual bleeding may occur until the next menstrual bleeding;
• Pain in the lower abdomen may occur;
• Feeling of fatigue;
• Headache.

Common (may occur in up to 1 in 10 users):

• Vomiting. If vomiting occurs, please refer to the information provided in the section "What to do if vomiting occurs".
• Menstrual bleeding may differ from usual. Most women will have normal menstrual bleeding at the expected time, but in some women it may occur earlier or later than usual. Irregular bleeding or intermenstrual spotting may also occur. If menstrual bleeding is delayed by more than 5 days, or is unusually light or unusually heavy, the patient should contact her doctor as soon as possible.
• Breast tenderness, diarrhoea, or dizziness may occur after taking the medicine.

Very rare (may occur in up to 1 in 10,000 users):

• Rash, urticaria, itching, facial swelling, pelvic pain, painful menstruation.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Livopill

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after:
"EXP". The expiry date refers to the last day of the stated month. The batch number is shown on
the packaging after "Lot".
No special storage conditions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Livopill contains

• The active substance is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, poloxamer 188, sodium croscarmellose, magnesium stearate.

What the medicine looks like and contents of the pack
Each pack contains one complete dose in the form of a round, white tablet with a diameter of approximately 6 mm, marked with the letter "C" on one side and "1" on the other side.

Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
Szamocka Street 8
01-748 Warsaw, Poland

Manufacturer
Laboratorios León Farma, S.A.
C/La Vallina s/n, Poligono Industrial Navatejera
24193 Villaquilambre, León
Spain

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Austria: Navela 1,5 mg Tabletten
Estonia: Labella
France: Levunique 1,5 mg comprimé
Spain: Navela 1,5 mg comprimido EFG
Netherlands: Levonorgestrel Xiromed 1,5 mg tabletten
Lithuania: Labella 1.5 mg tabletes tabletė
Germany: Navela 1.5 mg Tabletten
Poland: Livopill
Portugal: Navela 1,5 mg comprimido
Czech Republic: Navela
Slovakia: Navela 1,5 mg tableta
United Kingdom: Melkine 1.5 mg tablet
Italy: Afterel