Package Insert: Information for the User

Levonorgestrel Aurovitas 1.5 mg Tablet EFG

Levonorgestrel

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Follow exactly the medication administration instructions contained in this package insert or those provided by your doctor or pharmacist.
• Keep this package insert, as you may need to refer to it again.
• For advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve.

Levonorgestrel Aurovitasis an emergency contraceptive that can be used within 72 hours (3 days) after having unprotected sex or if the usual contraceptive method has failed.

It is used in the following cases:

• No contraceptive was used during sex.
• The contraceptive method was not used correctly, for example if a condom broke, slipped, or was used incorrectly, if the diaphragm or vaginal pessary was changed, perforated, broken, or removed too early, or if the withdrawal method failed (e.g. semen was ejaculated into the vagina or external genitals).

Levonorgestrel Aurovitascontains a synthetic substance called levonorgestrel, which is similar to a hormone. It prevents approximately 85% of expected pregnancies when taken within 72 hours after having unprotected sex. It does not always prevent pregnancy and is more effective if taken as soon as possible after having unprotected sex. It is better to take it in the first 12 hours than to delay taking it until the third day.

It is thought thatlevonorgestrelacts in the following way:

• preventing the release of an egg from your ovaries;
• preventing sperm from fertilizing any egg that may already have been released; or
• preventing a fertilized egg from adhering to the uterine wall.

Levonorgestrelcan only prevent pregnancy if taken within 72 hours after having unprotected sex. It does not work if you are already pregnant. If you have sex again without protection after takinglevonorgestrel(also if this occurs during the same menstrual cycle), the pill will not exercise its contraceptive effect and the risk of pregnancy returns.

This pill should only be used as an emergency contraceptive, not as a regular contraceptive, as it is less effective than regular contraceptive pills.

Levonorgestrel is not indicated for use before the first menstrual bleeding (menarche).

Do not takeLevonorgestrel Aurovitas

• if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to takelevonorgestrel.

If you are in any of the following situations, talk to your doctor before taking levonorgestrel as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraceptive.

• If you are pregnant or think you may be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, levonorgestrel cannot interrupt the pregnancy, so levonorgestrel is not an “abortive pill”.

You may already be pregnant if:

• your period has been delayed by more than 5 days, or you have had abnormal bleeding when your next period was due;
• since your last period, you have had unprotected sex and more than 72 hours have passed.

Levonorgestrel is not recommended if:

• you have a condition of the small intestine (such as Crohn's disease) that inhibits the absorption of the medicine;
• you have severe liver problems;
• you have a history of ectopic pregnancy (where the baby develops in some place other than the uterus);
• you have a history of salpingitis (inflammation of the Fallopian tubes).

A history of ectopic pregnancy or previous salpingitis increases the risk of a new ectopic pregnancy.

Emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence thatlevonorgestrelmay be less effective with increasing weight or body mass index (BMI), but these data were limited and inconclusive. Therefore,levonorgestrelis recommended for all women, regardless of their weight or BMI.

Mental health disorders:

Some women who use hormonal contraceptives like levonorgestrel have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

You are advised to consult a healthcare professional if you are concerned about any problem related to emergency contraception.

If you are concerned about sexually transmitted diseases
If you did not use a condom (or if it broke or slipped) during sex, you may have contracted a sexually transmitted disease or HIV.

This medicine will not protect you against sexually transmitted diseases; only the use of a condom can do so. Consult your doctor, nurse, family planning center, or pharmacist for advice if this concerns you.

Other medicines andLevonorgestrel Aurovitas

Inform your doctor or pharmacist if you aretaking, or have recentlytakenany other medicine, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent levonorgestrel from working effectively. If you have used any of the following medicines in the last 4 weeks, levonorgestrel may not be suitable for you. Your doctor may prescribe another type of emergency contraceptive (non-hormonal), that is, a copper intrauterine device (IUD-Cu). If this is not an option for you or if you cannot see your doctor quickly, you may take a double dose of levonorgestrel:

• barbiturates and other medicines used to treat epilepsy (e.g., primidone, phenytoin, and carbamazepine).
• medicines used to treat tuberculosis (e.g., rifampicin and rifabutin).
• a treatment for HIV (ritonavir, efavirenz).
• a medicine to treat fungal infections (griseofulvin).
• herbal medicines containing St. John's Wort (Hypericum perforatum).

Consult your doctor or pharmacist if you need additional information about the correct dose for you.

Consult your doctor as soon as possible after taking the tablets, so that they can inform you about reliable methods of regular contraception and avoid pregnancy (see also section 3 ‘How to take Levonorgestrel Aurovitas’ for more information).

Levonorgestrel Aurovitas may also affect the proper functioning of other medicines:

• a medicine called cyclosporin (inhibits the immune system).

How often you can useLevonorgestrel Aurovitas

You should only use Levonorgestrel Aurovitas in emergencies and not as a regular contraceptive method. If you use Levonorgestrel Aurovitas more than once in a menstrual cycle, it is less effective and more likely to disrupt your menstrual cycle (period).

Levonorgestrel Aurovitas is not as effective as regular contraceptive methods. Your doctor, nurse, or family planning center may inform you about long-term contraceptive methods that are more effective to prevent pregnancy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not take this medicine if you are already pregnant. If you become pregnant even after taking this medicine, it is essential to see your doctor. There is no evidence that levonorgestrel can harm a baby developing in your uterus if you take levonorgestrel as described.

However, your doctor may want to confirm that your pregnancy is not ectopic (when the baby develops in some place other than the uterus). This is especially important if you have had severe abdominal pain after takinglevonorgestrelor if you have had a previous ectopic pregnancy, tubal surgery, or pelvic inflammatory disease.

Breastfeeding

Small amounts of the active ingredient in this medicine may appear in your breast milk. It is not thought to be harmful to your baby. However, if this concerns you, take the tablet as soon as possible after a feed and avoid breastfeeding for at least 8 hours after takinglevonorgestrel; then express your milk with a breast pump during the 8 hours after takinglevonorgestreland discard this milk. This way, you can reduce the amount of active ingredient that your baby may take with the milk.

Fertility

Levonorgestrel increases the likelihood of menstrual irregularities that may lead to advancing or delaying ovulation, thereby altering the date of fertility. Although there are no long-term fertility data, it is expected that fertility will return quickly after treatment with levonorgestrel, and therefore, you should continue with regular contraceptive methods or start them as soon as possible after using levonorgestrel.

Driving and operating machines

It is unlikely thatlevonorgestrelwill affect your ability to drive a car or use machines. However, if you feel tired or dizzy, do not drive or use machinery.

Levonorgestrel Aurovitas contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

Levonorgestrel Aurovitas contains sodium

This medicine contains less than 1 mmolof sodium (23 mg) per tablet; that is, it is essentially “sodium-free”.

Use this medication exactly as described in the package insert or as directed by your pharmacist. Consult your doctor or pharmacist if you have any doubts.

• You can take levonorgestrel at any time during your menstrual cycle, except if you are already pregnant or think you may be pregnant. Do not chew and swallow the tablet whole with water. Do not delay taking the tablet.
• If you are taking one of the medications that can prevent levonorgestrel from working correctly (see section ‘Other medications and Levonorgestrel Aurovitas’) or if you have used one of these medications in the last 4 weeks, levonorgestrel may be less effective for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), that is a copper intrauterine device (IUD-Cu). If this is not an option for you or if you cannot see your doctor quickly, you can take a double dose of levonorgestrel (i.e., 2 tablets taken at the same time).
• If you are already using a regular contraceptive method, such as the birth control pill, you can continue taking it with the same regularity.

If you have another unprotected sex after takinglevonorgestrel(also if this occurs during the same menstrual cycle), the tablet will not exert its contraceptive effect and there is again a risk of pregnancy.

Use in children and adolescents

Levonorgestrel is not indicated for use before the first menstrual bleeding (menarche).

What to do if you vomit

If you vomit within the next three hours after taking the tablet, you must take another tablet immediately.

After takingLevonorgestrel Aurovitas

If you want to have sex after takinglevonorgestreland are not using the birth control pill, you must use condoms or a diaphragm with spermicide until your next menstruation. The reason is thatlevonorgestrelwill not work if you have sex again without protection before your next menstruation.

After takinglevonorgestrel, it is recommended to schedule an appointment to see your doctor three weeks later to confirm thatlevonorgestrelhas worked. If your menstruation is delayed by more than 5 days or is exceptionally light or heavy, you must contact your doctor as soon as possible. If you become pregnant even after taking this medication, it is essential to see your doctor.

Your doctor may also inform you about long-term contraceptive methods that are more effective in preventing pregnancy.

If you continue using hormonal contraception, such as the birth control pill, and do not have bleeding during the pill-free period, see your doctor to ensure you are not pregnant.

Your next period after takingLevonorgestrel Aurovitas

After usinglevonorgestrel, your period usually returns to normal and will start on the usual day; however, in some cases, it may start a few days earlier or later. If your period starts 5 days later than expected, if you experience abnormal bleeding at that time, or if you think you may be pregnant, a pregnancy test should be performed.

If you take moreLevonorgestrel Aurovitasthan you should

Although no serious adverse effects have been reported after taking several tablets at the same time, you may feel nausea, vomit, or experience vaginal bleeding. You should consult your doctor, pharmacist, nurse, or family planning center for advice, especially if you have vomited, as the tablet may not have worked properly.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have any other doubts about the use of this medication, ask your doctororpharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The possible adverse effects are described below according to their frequency:

Adverse effects very frequent (may affect more than 1 in 10 people)

• Nausea.
• You may have irregular bleeding until the next menstrual period.
• You may have lower abdominal pain.
• Fatigue.
• Headache.

Adverse effects frequent (may affect up to 1 in 10 people)

• Vomiting. If you vomit, read the section “What to do if you vomit”.
• Your period may 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 may also experience irregular or spotting bleeding until your next period. If your period is delayed by more than 5 days or is exceptionally light or heavy, you should contact your doctor as soon as possible.
• Increased sensitivity to palpation in the breasts, diarrhea, or dizziness after taking this medication.

Adverse effects very rare (may affect up to 1 in 10,000 people)

• Rash, urticaria, itching, swelling of the face, pelvic pain, painful menstruation.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and the blister packafter CAD. The expiration date is the last day of the month indicated.

This medicationdoes not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levonorgestrel Aurovitas

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

Appearance of the product and content of the packaging

Each package contains a complete treatment, consisting of a white, round tablet, approximately 6 mm in diameter, and engraved with a "C" on one face and "1" on the other.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible for manufacturing

Laboratorios Leon Farma, S.A

Pol. Ind. Navatejera

C/ La Vallina s/n, 24193 - Navatejera, León

Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Spain Levonorgestrel Aurovitas 1.5 mg tablet EFG

Netherlands Etos emergency contraceptive levonorgestrel, 1.5 mg tablet

Last review date of this prospectus: September 2024

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .