LEVONORGESTREL EXELTIS 0.75 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FORTHEPATIENT

Levonorgestrel Exeltis 0.75 mg tablets EFG

Levonorgestrel

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

This medication can be obtained without a prescription. However, you must take Levonorgestrel Exeltis with caution to achieve the best results.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

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

When to use emergency contraception

• If you did not use contraception during sex.
• If the contraceptive method was not used correctly, for example, if the condom broke, slipped, or was used incorrectly, if the diaphragm was displaced or perforated, or if the withdrawal method failed (e.g., sperm was ejaculated into the vagina or external genitalia).

Levonorgestrel Exeltis contains the active ingredient levonorgestrel, a synthetic 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 best to take it within the first 12 hours, rather than delaying until the third day.

It is believed that Levonorgestrel Exeltis works by:

• preventing the ovaries from releasing an egg;
• preventing sperm from fertilizing any egg that may have been released; or
• preventing a fertilized egg from implanting in the uterus.

Levonorgestrel Exeltis can only prevent pregnancy 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 Exeltis (even during the same menstrual cycle), the medication will not have a contraceptive effect, and there is a risk of pregnancy.

This tablet is only used as an emergency contraceptive and not as a regular contraceptive method, as it is less effective than regular contraceptive pills.

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

2. What you need to know before taking Levonorgestrel Exeltis

Do not take Levonorgestrel Exeltis

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

Warnings and precautions

If any of the following points apply to you, inform your doctor before taking Levonorgestrel Exeltis, 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 may be pregnant; this medication will not work if you are already pregnant. If you are already pregnant, Levonorgestrel Exeltis cannot interrupt the pregnancy, as Levonorgestrel Exeltis is not an "abortion pill".

You may already be pregnant if:

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

Levonorgestrel Exeltis 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 (when the fertilized egg implants outside the uterus)
• you have a history of inflammation of the fallopian tubes (salpingitis).

A previous ectopic pregnancy and a previous infection of the fallopian tubes increase 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 Exeltis may be less effective in cases of increased weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, Levonorgestrel Exeltis is recommended for all women, regardless of their weight or BMI.

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 sex, you may have acquired a sexually transmitted disease or HIV. This medication will not protect you from sexually transmitted diseases, as only the use of condoms can do so. Consult your doctor or pharmacist or visit your family planning center for advice if you are concerned about this.

Use of Levonorgestrel Exeltis and other medications

Inform your doctor or pharmacist if you are taking, or have taken, any other medications, including those obtained without a prescription or herbal remedies.

Some medications may prevent Levonorgestrel Exeltis from working effectively. If you have used any of the medications listed below in the last 4 weeks, Levonorgestrel Exeltis may be less suitable for you. Your doctor may prescribe a different type of emergency contraception (non-hormonal), such as a copper intrauterine device (IUD). If this is not an option for you or if you cannot see your doctor quickly, you can take a double dose of Levonorgestrel Exeltis (i.e., 4 tablets taken at the same time):

• 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 remedies containing St. John's Wort (Hypericum perforatum).

Consult your doctor or pharmacist if you need further advice on the correct dose for you.

Consult your doctor as soon as possible after taking the tablets for advice on reliable regular contraceptive methods and to avoid pregnancy (see also section 3 "How to take Levonorgestrel Exeltis" for more information).

Levonorgestrel Exeltis may also affect the way other medications work:

• A medication called cyclosporin (which suppresses the immune system).

How often can Levonorgestrel Exeltis be taken

Levonorgestrel Exeltis should only be used in emergency situations and never as a regular contraceptive method. If you use Levonorgestrel Exeltis more than once during the same menstrual cycle, its effectiveness is reduced, and you may experience changes in your menstrual cycle (period).

Levonorgestrel Exeltis is not as effective as regular contraceptive methods. Your doctor may advise you on 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 must not take this medication if you are pregnant. If you become pregnant after taking this medication, it is essential to consult your doctor. There is no evidence that Levonorgestrel Exeltis can harm the developing baby if used as advised.

However, your doctor may want to confirm that your pregnancy is not ectopic. This is especially important if you experience severe abdominal pain after taking Levonorgestrel Exeltis or if you have had an ectopic pregnancy, fallopian tube surgery, or pelvic inflammatory disease.

Breastfeeding

Small amounts of the active ingredient of this medication may appear in breast milk, although it is not thought to be harmful to the baby. However, if you are concerned, you can take the tablet immediately after breastfeeding and express and discard milk for the next 6 hours after taking Levonorgestrel Exeltis. This will reduce the amount of active ingredient your baby receives through breast milk.

Driving and using machines

It is unlikely that Levonorgestrel Exeltis will affect your ability to drive or use machines. However, if you feel dizzy or drowsy, do not drive or operate machinery.

Levonorgestrel Exeltis contains lactose and sodium

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

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

3. How to take Levonorgestrel Exeltis

Take the two tablets as soon as possible, preferably within the first 12 hours and no later than 72 hours (3 days) after unprotected sex. Do not delay taking the tablets. The tablets work best when taken as soon as possible after unprotected sex. They can only prevent pregnancy if taken within 72 hours of unprotected sex.

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• You can take Levonorgestrel Exeltis at any time during your menstrual cycle, except if you are already pregnant or think you may be pregnant. Take the tablet whole with a little water and do not chew it.
• If you are using one of the medications that may prevent Levonorgestrel Exeltis from working correctly (see section "Use of other medications and Levonorgestrel Exeltis") in the last 4 weeks, Levonorgestrel Exeltis may be less effective for you. Your doctor may prescribe a different type of emergency contraception (non-hormonal), such as a copper intrauterine device (IUD). If this is not an option for you or if you cannot see your doctor quickly, you can take a double dose of Levonorgestrel Exeltis (i.e., 4 tablets taken at the same time).
• If you are already using a regular contraceptive method, such as oral contraceptives, you can continue taking it as usual.

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

Use in girls and adolescents

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

What to do in case of vomiting

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

After taking Levonorgestrel Exeltis

If you want to have sex after taking Levonorgestrel Exeltis and are not taking the contraceptive pill, you should use condoms or a diaphragm with spermicide until your next period, as Levonorgestrel Exeltis will not work if you have unprotected sex again before your next period.

After taking Levonorgestrel Exeltis, it is recommended that you make an appointment to see your doctor about 3 weeks later to confirm that you are not pregnant. If your period is more than 5 days late or is unusually light or heavy, you should contact your doctor as soon as possible. If you become pregnant after taking this medication, it is essential to consult your doctor.

Your doctor will also advise you on long-term contraceptive methods that are more effective in preventing pregnancy.

If you continue to use hormonal contraception, such as oral contraceptives, and do not have a period during the pill-free period, you should consult your doctor to ensure you are not pregnant.

Your next period after taking Levonorgestrel Exeltis

After using Levonorgestrel Exeltis, your period usually returns to normal and starts on the expected day; however, it may start a few days earlier or later 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 unusually light or heavy, you should contact your doctor as soon as possible.

If you take more Levonorgestrel Exeltis than you should

Although no serious harmful effects have been observed after taking several tablets at once, you may feel dizzy, vomit, or experience vaginal bleeding. You should consult your doctor or pharmacist or visit your 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 quantity taken.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Levonorgestrel Exeltis can cause side effects, although not everyone will experience them.

Possible side effects are listed below by frequency:

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

• Nausea
• Irregular bleeding until the next period
• 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 in case of vomiting".
• Your period may be different. Most women will have a normal period at the expected time, but some may have their period earlier or later 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 unusually 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, and swelling of the face, pelvic pain, painful menstruation.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Levonorgestrel Exeltis

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

Do not use Levonorgestrel Exeltis 0.75 mg tablets EFG after the expiration date stated on the packaging and blister. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Content and Additional Information

Composition ofLevonorgestrel Exeltis

The active ingredient is levonorgestrel. Each tablet contains 0.75 mg of levonorgestrel.

The other components are microcrystalline cellulose, lactose monohydrate, poloxamer 188, sodium croscarmellose, and magnesium stearate.

Appearance of the Product and Packaging Content

Each package contains a complete treatment consisting of two round, white tablets, approximately 6 mm in diameter, with an imprint that says "C" on one side and "2" on the other.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Exeltis Healthcare S.L.

Avenida Miralcampo 7, Poligono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Manufacturer:

Laboratorios Leon Farma, S.A

Pol. Ind. Navatejera

C/ La Vallina s/n, 24193 - Villaquilambre, León.

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands Tansy 750 microgram tablets

Lithuania Elistrel 750 mikrogramu tablets

Spain Levonorgestrel Exeltis 0.75mg tablet EFG

Date ofthelast revisionof this prospectus:February 2021

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