NAVELA 1.5 mg TABLETS

Introduction

Leaflet:Informationforthe user

Navela1.5 mg EFG tablet

levonorgestrel

Read the entire leaflet carefullybefore starting to take thismedication,as it contains important informationfor you.

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this 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 not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Navela and what is it used for 2. What you need to know before taking Navela 3. How to take Navela 4. Possible side effects 5. Storage of Navela

1. Package contents and additional information

1. What is Navela and what is it used for

Navela is an emergency contraceptive that can be used within 72 hours (3 days) after unprotected sex or if your regular contraceptive method has failed. It is used in the following cases:

• If you did not use contraception during sex.
• If the contraceptive 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 genitals).

Navela contains the active ingredient levonorgestrel, a synthetic hormone. It prevents approximately 84% 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.

Navela may work by:

• preventing the ovaries from releasing an egg;
• preventing sperm from fertilizing any egg that may have been released.

Navela can only prevent you from becoming pregnant if you take it within 72 hours after unprotected sex. It does not work if you are already pregnant.

If you have unprotected sex after taking Navela (even if it's during the same menstrual cycle), the medication will not have its contraceptive effect, and there will be a risk of pregnancy again.

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

2. What you need to know before taking Navela

Do not take Navela

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Navela. If any of the following points apply to you, tell your doctor before taking Navela, as emergency contraception may not be suitable for you. Your doctor may prescribe a different 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 pregnant, Navela will not interrupt the pregnancy, so Navela is not an "abortion pill."

You may already be pregnant if:

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

Navela is not recommended if:

• you have a disease of the small intestine (such as Crohn's disease) that inhibits drug absorption;
• 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 salpingitis (inflammation of the fallopian tubes).

A previous ectopic pregnancy or salpingitis increases the risk of another ectopic pregnancy.

In all women, emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that Navela may be less effective with increasing weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, Navela 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.

Girls and adolescents

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

If you are concerned about sexually transmitted diseases

If you did not use a condom (or 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 condom use can do that.

Consult your doctor, pharmacist, or family planning center for advice if you are concerned about this.

Other medications and Navela

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

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

• 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 more information about the correct dose for you.

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

Navela may also affect the proper functioning of other medications:

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

How often can you use Navela

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

Navela does not work as well as regular contraceptive methods. Your doctor, nurse, or family planning center can advise you on long-term contraceptive methods that are more effective in preventing pregnancy.

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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 pregnant. If you become pregnant after taking this medication, it is essential to consult your doctor. Available data do not indicate that Navela can harm the embryo if used as advised.

However, your doctor may want to confirm that your pregnancy is not ectopic (when the egg implants outside the uterus). This is especially important if you experience severe abdominal pain after taking Navela or if you have had an ectopic pregnancy, fallopian tube surgery, or pelvic inflammatory disease.

Breastfeeding

The active ingredient of this medication is excreted in breast milk. Therefore, it is recommended to take the tablet immediately after breastfeeding and avoid breastfeeding for at least 8 hours after administration of levonorgestrel; then express and discard the milk for the next 8 hours after taking the tablet. This way, you will be taking your tablet well before the next feeding and reducing the amount of active ingredient that your child could ingest with breast milk.

Fertility

Navela increases the possibility of changes in menstruation, which 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 Navela, a rapid return to fertility is expected, and you should continue with regular contraceptive methods or start them as soon as possible after using Navela.

Driving and using machines

Navela is unlikely to affect your ability to drive or use machines. However, if you feel tired or dizzy, do not drive or operate machinery.

Navelacontainslactose and sodium

This medication contains lactose. 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 Navela

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. If in doubt, ask your doctor or pharmacist.

• You can take Navela 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 Navela from working correctly (see section "Other medications and Navela") or if you have used one of these medications in the last 4 weeks, Navela may be less effective for you. Your doctor may prescribe a different type of emergency contraception (non-hormonal), i.e., 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 Navela (i.e., 2 tablets taken at the same time).
• If you are already using a regular contraceptive method, such as oral contraceptives, you can continue taking it with the same regularity.

If you have unprotected sex again after taking Navela (even if it's during the same menstrual cycle), the tablet will not have its contraceptive effect, and there will be a risk of pregnancy again.

You are advised to consult a healthcare professional if you are concerned about any issues related to taking emergency contraceptives.

What to do in case of vomiting

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

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

After taking Navela, 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 week when you are not taking the contraceptive, you should consult your doctor to ensure you are not pregnant.

Your next period after taking Navela

After using Navela, your period usually 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 Navela 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 the amount ingested.

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

4. Possible side effects

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

Very common (mayaffectmorethan1in10people):

• Nausea
• Irregular bleeding until the next period
• Lower abdominal pain
• Fatigue
• Headache

Common (mayaffectupto1in10people):

• 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 (mayaffectupto1in10,000people):

• Rash, urticaria, itching, 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 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 Navela

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

Do not use this medication 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. Dispose of the packaging and any unused medication in the pharmacy's SIGRE point. If in doubt, 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 ofNavela

The active ingredient is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.

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

Appearance of Navelaand Package Contents

Each package contains a complete treatment, which is a round, white tablet approximately 6 mm in diameter with an imprint that says "C" on one side and "1" on the other.

Marketing Authorization Holder:

Exeltis Healthcare S.L.

Avda. Miralcampo 7.

Miralcampo Industrial Estate

19200 Azuqueca de Henares, Guadalajara.

Spain

Manufacturer:

Laboratorios Leon Farma, S.A.

C/ La Vallina, s/n, Navatejera Industrial Estate,

24193 Villaquilambre (León), Spain

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

Netherlands Levonorgestrel Xiromed 1.5 mg tablets

Austria Navela 1.5 mg tablets

Czech Republic Navela

Estonia Labella

France Levunique 1.5 mg tablet

Germany Navela 1.5 mg tablets

Lithuania Labella 1.5mg tablets

Slovakia Navela 1.5mg tablet

Spain Navela 1.5 mg tablet EFG

United Kingdom Melkine 1.5 mg tablet

Poland Livopill

Portugal Navela 1.5 mg tablet

Date of Text Revision:January 2023

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/