LEVONORGESTREL AUROVITAS 1.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Levonorgestrel Aurovitas 1.5 mg tablet EFG

Levonorgestrel

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

• Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.
• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve.

Contents of the Package Leaflet

1. What is Levonorgestrel Aurovitas and what is it used for
2. What you need to know before taking Levonorgestrel Aurovitas
3. How to take Levonorgestrel Aurovitas
4. Possible side effects
5. Storage of Levonorgestrel Aurovitas
6. Package contents and additional information

1. What is Levonorgestrel Aurovitas and what is it used for

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

It is used in the following cases:

• No contraceptive was used during sexual intercourse.
• The contraceptive method was not used correctly, for example, if a condom broke, slipped, or was used incorrectly, if the diaphragm or vaginal pesary was displaced, perforated, broken, or removed prematurely, or if coitus interruptus failed (e.g., semen was ejaculated into the vagina or external genitals).

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

It is thought that levonorgestrel works as follows:

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

Levonorgestrel can only prevent you from becoming pregnant if taken within 72 hours after unprotected sex. It does not work if you are already pregnant. If you have unprotected sex again after taking levonorgestrel (even if it occurs during the same menstrual cycle), the tablet will not have a contraceptive effect, and there is a risk of pregnancy again.

This tablet 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 period (menarche).

2. What you need to know before taking Levonorgestrel Aurovitas

Do not takeLevonorgestrel Aurovitas

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take levonorgestrel.

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 medication will not work if you are already pregnant. If you are already pregnant, levonorgestrel cannot interrupt the pregnancy, so levonorgestrel is not a "morning-after pill".

You may already be pregnant if:

• your period is more than 5 days late, or you have had abnormal bleeding when your next period was due;
• after your last period, you had unprotected sex and more than 72 hours have passed.

Levonorgestrel is not recommended if:

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

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

In all women, emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that levonorgestrel may be less effective with increasing weight or body mass index (BMI), but these data were limited and not conclusive. Therefore, levonorgestrel is recommended for all women, regardless of their weight or BMI.

Psychiatric disorders:

Some women who use hormonal contraceptives like levonorgestrel have reported depression or a depressed mood. Depression can be severe and sometimes can 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 issues 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 sexual intercourse, you may have contracted a sexually transmitted disease or HIV.

This medication will not protect you from 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 medications andLevonorgestrel Aurovitas

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those obtained without a prescription or herbal medicines.

Some medications may prevent levonorgestrel from working effectively. If you have used any of the following medications in the last 4 weeks, levonorgestrel may be less suitable for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), i.e., 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:

• barbiturates and other medications used to treat epilepsy (e.g., primidone, phenytoin, and carbamazepine).
• medications used to treat tuberculosis (e.g., rifampicin and rifabutin).
• a treatment for HIV (ritonavir, efavirenz).
• a medication for treating 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 to inform you about reliable methods of regular contraception and to avoid pregnancy (see also section 3 'How to take Levonorgestrel Aurovitas' for more information).

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

• a medication called cyclosporine (inhibits the immune system).

How often can you useLevonorgestrel Aurovitas

You should only use Levonorgestrel Aurovitas for 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 does not work as well as regular contraceptive methods. Your doctor, nurse, or family planning center can inform you about long-term contraceptive methods that are more effective in preventing pregnancy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

However, your doctor may want to confirm that your pregnancy is not ectopic (where the baby develops in a place outside the uterus). This is especially important if you have severe abdominal pain after taking levonorgestrel or if you have had an ectopic pregnancy, fallopian tube surgery, or pelvic inflammatory disease.

Breastfeeding

Very small amounts of the active ingredient of this medication may appear in your breast milk. It is not thought to be harmful to the baby. However, if this concerns you, you can take the tablet immediately after a feed and avoid breastfeeding for at least 8 hours after taking levonorgestrel; then express and discard the milk for the next 8 hours after taking levonorgestrel. This way, you can reduce the amount of active ingredient that your child may take with the breast milk.

Fertility

Levonorgestrel increases the possibility of menstrual disturbances that can sometimes lead to advancing or delaying the date of ovulation, modifying fertility accordingly. Although there is no long-term fertility data after treatment with levonorgestrel, a rapid return to fertility is expected, and regular contraceptive methods should be continued or started as soon as possible after using levonorgestrel.

Driving and using machines

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

Levonorgestrel Aurovitascontains lactose

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

Levonorgestrel Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Levonorgestrel Aurovitas

Always use this medication exactly as described in the package leaflet or as your pharmacist has told you. 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 using one of the medications that may 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), i.e., 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 contraceptive pill, you can continue taking it with the same regularity.

If you have unprotected sex again after taking levonorgestrel (even if it occurs during the same menstrual cycle), the tablet will not have a contraceptive effect, and there is a risk of pregnancy again.

Use in childrenand adolescents

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

What to do if you vomit

If you vomit within 3 hours of taking the tablet, you should take another tablet immediately.

After takingLevonorgestrel Aurovitas

If you want to have sex after taking levonorgestrel and are not using the contraceptive pill, you should use condoms or a diaphragm with spermicide until your next period. The reason is that levonorgestrel will not work if you have unprotected sex again before your next period.

After taking levonorgestrel, it is recommended that you make an appointment to see your doctor about 3 weeks later to confirm that levonorgestrel has worked. If your period is more than 5 days late or is exceptionally light or heavy, you should contact your doctor as soon as possible. If you become pregnant even after taking this medication, it is essential that you see your doctor.

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

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

Your next period after takingLevonorgestrel Aurovitas

After using levonorgestrel, your period usually starts normally and on the expected day; however, sometimes it may start a few days earlier or later. If your period starts more than 5 days later than expected, if you experience abnormal bleeding at that time, or if you think you may be pregnant, you should take a pregnancy test.

If you take moreLevonorgestrel Aurovitasthan you should

Although no serious harmful effects have been reported after taking several tablets at once, you may feel nauseous, vomit, or have 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 further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Possible side effects are described below by frequency:

Very common side effects (may affect more than 1 in 10 people)

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

Common side effects (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 usual. You may also experience irregular bleeding or spotting until your next period. If your period is more than 5 days late or is exceptionally light or heavy, you should contact your doctor as soon as possible.
• Increased breast tenderness, diarrhea, or dizziness after taking this medication.

Very rare side effects (may affect up to 1 in 10,000 people)

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

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Levonorgestrel Aurovitas

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

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, sodium croscarmellose, and magnesium stearate.

Appearance of the Product and Package Contents

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

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 marketing authorization holder:

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 under the following names:

Spain Levonorgestrel Aurovitas 1.5 mg tablet EFG

Netherlands Etos noodanticonceptie levonorgestrel, 1.5 mg tablet

Date of the last revision of thisleaflet: September 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.