Livopill

Leaflet attached to the packaging: patient information

Livopill, 1500 micrograms, tablet

Levonorgestrel

You should read the leaflet carefully before taking the medicine, as it contains important information for the patient.

You should keep this leaflet so that you can read it again if you need to. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms 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.

Table of contents of the leaflet

• 1. What is Livopill and what is it 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 is Livopill and what is it used for

Livopill is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or when a contraceptive method has failed. This includes the following situations:

• If no contraceptive method was used during sex;
• If the contraceptive method was not used correctly, for example, if the condom slipped or was not used correctly, if the diaphragm or contraceptive cap was displaced, torn, damaged, or removed at the wrong time, or if the penis was not withdrawn from the vagina at the right time during interrupted sex (e.g., ejaculation occurred in the vagina or on the external genitalia).

Livopill contains a synthetic hormone called levonorgestrel as the active substance. If taken within 72 hours of unprotected sex, it prevents pregnancy in about 84%. However, it will not prevent pregnancy in every case, and its effectiveness is greater if taken as soon as possible after unprotected sex. It is best to take the medicine within the first 12 hours, rather than waiting until the third day after unprotected sex. It is thought that Livopill works by:

• inhibiting the release of an egg from the ovaries;
• preventing fertilization of an already released egg by sperm.

Livopill will only prevent pregnancy if taken within 72 hours of unprotected sex. The medicine is not effective if you are already pregnant. If you have unprotected sex again after taking Livopill (even during the same menstrual cycle), the tablet may not work as a contraceptive, and you may become pregnant again. Livopill is not indicated for use before the first menstrual period (menarche).

2. Important information before taking Livopill

When not to take Livopill

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 apply to you, tell your doctor before taking Livopill, as emergency contraception may not be suitable for you. Your doctor may prescribe a different type of emergency contraception for you. If you are pregnant or think you might be pregnant. This medicine is not effective if you are already pregnant. If you are already pregnant, Livopill will not terminate the pregnancy, so Livopill is not an abortion pill. You might be pregnant if: your period is more than 5 days late, or you have unusual bleeding at the time of your expected period; more than 72 hours have passed since you had unprotected sex in this menstrual cycle. It is not recommended to take Livopill if: you have a disease of the small intestine (e.g., Crohn's disease) that impairs the absorption of the medicine; you have severe liver dysfunction; you have had an ectopic pregnancy (where the embryo develops outside the womb); you have had inflammation of the fallopian tubes. Having had an ectopic pregnancy or inflammation of the fallopian tubes increases the risk of having another ectopic pregnancy. In all women, emergency contraception should be taken as soon as possible after unprotected sex. There is evidence that Livopill may be less effective with increasing body weight or body mass index (BMI), but the data are limited and inconclusive. Therefore, Livopill is still recommended for all women, regardless of their weight or BMI. If you have any doubts about emergency contraception, ask your doctor, pharmacist, or nurse.

Children and adolescents

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

If you are worried about sexually transmitted diseases

If you did not use a condom (or it was damaged or slipped), you may have been exposed to a sexually transmitted disease or HIV. This medicine does not protect against sexually transmitted diseases. Only the use of condoms can protect against infection. If you have any doubts, ask your doctor, nurse, family planning specialist, or pharmacist.

Livopill and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, including those obtained without a prescription or herbal medicines. Some medicines may reduce the effectiveness of Livopill. If you have taken any of the following medicines in the last 4 weeks, Livopill may not be suitable for you. Your doctor may prescribe a different type of emergency contraception (non-hormonal), such as a copper intrauterine device (Cu-IUD). If this is not an option for you, or you cannot see a doctor immediately, you can take a double dose of Livopill (i.e., 2 tablets at the same time). 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 medicines containing St. John's Wort (Hypericum perforatum). For further information on the correct dose, consult your doctor or pharmacist. After taking the tablets for further advice on regular contraception and to rule out pregnancy, you should see your doctor or pharmacist as soon as possible (see also section 3 "How to take Livopill" for further advice). Livopill may also affect the action of other medicines: the medicine cyclosporin (which suppresses the immune system).

How often can Livopill be taken

Livopill should only be taken in emergency situations, not as a regular method of contraception. If Livopill is taken more than once in the same menstrual cycle, its contraceptive effect is reduced, and the risk of menstrual disturbances (menstruation) is increased. Livopill is not as effective as regular contraceptive methods. For information on long-term contraceptive methods that are more effective in preventing pregnancy, ask your doctor, nurse, or family planning specialist.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. PregnancyWomen who are pregnant should not take this medicine. If you become pregnant despite taking the medicine, it is important to see a doctor. There is no evidence that Livopill has a harmful effect on the unborn baby if taken according to the instructions. However, your doctor will want to check that the pregnancy is not ectopic (where the embryo develops outside the womb). This is especially important if you have severe abdominal pain after taking Livopill or if you have had an ectopic pregnancy, had surgery on your fallopian tubes, or had inflammation in the pelvic area. BreastfeedingThe active substance of this medicine passes into breast milk. Therefore, it is recommended that you take the tablet after breastfeeding, and then avoid breastfeeding for at least 8 hours after taking the tablet. You should express and discard the milk during this time. By taking the tablet much earlier before the next feed, you can reduce the amount of active substance that may pass into your baby's body through breast milk. FertilityTaking Livopill increases the possibility of menstrual disturbances, which can sometimes lead to delayed or advanced ovulation, affecting the fertility period. Although there is no data on the long-term effect on fertility, after taking Livopill, you should expect a quick return to fertility, and therefore, after taking Livopill, you should continue or start using regular contraception as soon as possible.

Driving and using machines

It is unlikely that Livopill will affect your ability to drive or use machines. However, if you feel tired or dizzy, you should not drive or operate machinery.

Livopill contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to take Livopill

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your 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 sex. Do not delay taking the tablet. The sooner the tablet is taken after unprotected sex, the more effective it will be. The tablet will only prevent pregnancy if taken within 72 hours of unprotected sex.

The tablet may prevent pregnancy only if taken within 72 hours of unprotected sex.

• Livopill can be taken at any time during the menstrual cycle, provided you are not pregnant or do not think you might be pregnant. The tablet should be swallowed whole, with water, without chewing.
• If you are taking any medicines that may reduce the effectiveness of Livopill (see "Livopill and other medicines" above) or if you have taken any of these medicines in the last 4 weeks, Livopill may not be suitable for you. Your doctor may prescribe a different type of emergency contraception (non-hormonal), such as a copper intrauterine device (Cu-IUD). If this is not an option for you, or you cannot see a doctor immediately, you can take a double dose of Livopill (i.e., 2 tablets at the same time).
• If you are using a regular contraceptive method, such as the contraceptive pill, you can continue to take it as directed.

If you have unprotected sex again after taking Livopill (even during the same menstrual cycle), the tablet will not have a contraceptive effect, and you may become pregnant again.

What to do if you vomit

If you vomit within 3 hours of taking the tablet, you should take another tablet as soon as possible.

After taking Livopill

If you are not using a contraceptive method and plan to have sex after taking Livopill, you should use a condom or diaphragm with spermicides until your next menstrual period. This is necessary because Livopill will not be effective if you have unprotected sex again before your next menstrual period. About 3 weeks after taking Livopill, you should see your doctor to ensure that the medicine has been effective. If your period is more than 5 days late, or you experience unusual bleeding, you should see your doctor as soon as possible. If you become pregnant despite taking the medicine, it is important to see a doctor. Your doctor may also provide information on long-term contraceptive methods that are more effective in preventing pregnancy. If you continue to use regular hormonal contraception, such as the pill, and do not have a period during the pill-free interval, you should see your doctor to rule out pregnancy.

Next menstrual period after taking Livopill

After taking Livopill, your period is usually normal and starts on the expected date, but it may start a few days earlier or later than usual. If your period is more than 5 days late, or you experience unusual bleeding, you should see your doctor as soon as possible to rule out pregnancy.

Overdose of Livopill

Although no serious side effects have been reported when taking too many tablets at once, you may experience nausea, vomiting, and bleeding from the genital tract. You should consult your pharmacist, doctor, nurse, or family planning specialist, especially if you vomit, as the tablet may not work. If you have any further questions about 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. The possible side effects are listed below, according to their frequency:

Very common (may affect more than 1 in 10 women):

• Nausea (sickness);
• Until the next menstrual period, you may experience irregular bleeding or spotting;
• You may have lower abdominal pain;
• You may feel tired;
• You may have a headache.

Common (may affect up to 1 in 10 women):

• Vomiting. If you vomit, see the section "What to do if you vomit".
• Your period may be different from normal. Most women have a normal period at the expected time, but some may experience a delayed or early period. You may also experience irregular bleeding or spotting. If your period is more than 5 days late, or you experience unusual bleeding, you should see your doctor as soon as possible.
• You may experience breast tenderness, diarrhea, or dizziness after taking the medicine.

Very rare (may affect up to 1 in 10,000 women):

• Rash, hives, itching, swelling of the face, pelvic pain, painful periods.

Reporting 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 to the Department of Drug Safety, 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this 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 packaging and blister after "EXP". The expiry date refers to the last day of the month stated. The batch number is stated on the packaging after "Lot". There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 Livopill looks like and contents of the pack

Each pack contains one complete treatment in the form of a round, white tablet, approximately 6 mm in diameter, marked with "C" on one side and "1" on the other.

Marketing authorization holder

Exeltis Poland Sp. z o.o., ul. Szamocka 8, 01-748 Warsaw

Manufacturer

Laboratorios León Farma, S.A., C/La Vallina s/n, Poligono Industrial Navatejera, 24008 Villaquilambre, León, Spain

This medicinal product is authorized in the Member States of the European Economic Area 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 tabletės, 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, Date of last revision of the leaflet: 16.01.2023