Label:Informationforthe User

Navela1,5 mg tablet EFG

levonorgestrel

Read the entire label carefullybefore starting to take thismedicine,because it contains important informationfor you.

Follow exactly the administration instructions of the medicine contained in this label or those indicated by your doctor or pharmacist.

-Keep this label, as you may need to read it again.

-If you need advice or more information, consult your pharmacist.

-If you experience adverse effects, consult your doctor or pharmacist,even if they are not listed in this label. See section 4.

1.What isNavelaand for what it is used
2.What you need to knowbefore starting to takeNavela
3.How to takeNavela
4.Possible adverse effects
5.Storage ofNavela

6.Contents of the package and additional information

Navelais 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:

• If no contraceptives were used during sex.
• If the contraceptive was not used properly, for example if the condom broke, slipped, or was used incorrectly, if the diaphragm was altered in position or if it was perforated, broken, or removed too early, or if the withdrawal method failed (e.g., semen was ejaculated into the vagina or external genitals).

Navelacontains a synthetic hormone called levonorgestrel as its active ingredient. It prevents approximately 84% 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 within the first 12 hours than to delay it until the third day.

Navelamay work::

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

Navelacan only prevent pregnancy if you take it within 72 hours after having unprotected sex.

Navelawill not work if you are already pregnant.

If you have unprotected sex after taking Navela (also if this occurs during the same menstrual cycle), the medication will not exert its contraceptive effect and the risk of pregnancy will return.

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

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. Ifanyofthefollowingpointsaffectsyou,notifyyourdoctorbeforetakingNavelaasthe 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. This medication will not work if you are already pregnant. If you are already pregnant, Navela does not interrupt the pregnancy, so Navela is not an “abortive pill”.

You may already be pregnant if:

• your menstruation has been delayed for more than 5 days, or if you have had abnormal bleeding when your next menstruation was due;
• after your last menstruation, you have had unprotected sex 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 the absorption of the drug;
• 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 a new ectopic pregnancy.

Emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that Navela may be less effective with increased 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 problem related to emergency contraception.

Girls and adolescents

Navela is not indicated for use before the first menstrual bleeding (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 against sexually transmitted diseases, as only the use of a condom can do so.

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

Other medications and Navela

Inform yourdoctoror pharmacist if you are taking,have takenrecently or may need to takeany other medication.

Some medications may prevent Navela from working properly. If you have used any of the following medications during the past 4 weeks, Navela may be less 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 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 fungal infections (griseofulvin),
• medications based on plants 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 pills, 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 cyclosporine (inhibits the immune system).

How often can you use Navela

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

Navela is not as effective as regular contraceptive methods. Your doctor, nurse, or family planning center may advise you about long-term contraceptive methods that are more effective in preventing pregnancy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend 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 see your doctor.The available data do not indicate that Navela can harm the embryo if used as recommended.

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 Navelaor if you have ever had an ectopic pregnancy, tubal surgery, or pelvic inflammatory disease.

Breastfeeding

The active ingredient of this medication is excreted in breast milk. Therefore, it is recommended to take the pill immediately after feeding and avoid breastfeeding for at least 8 hours after administering levonorgestrel; after that, express milk with a breast pump during the 8 hours following the pill intake, and discard it. In this way, you are taking your pill well before the next feeding and reducing the amount of active ingredient that your child may ingest with breast milk.

Fertility

Navela increases the likelihood of changes in menstruation that, in some cases, may lead to advancing or delaying ovulation, thereby modifying the date of fertility. Although there are no long-term fertility data,after treatment with Navela, a rapid return to fertility is expected, and therefore, regular contraceptive methods or initiation of them as soon as possible after using Navela should be continued.

Driving and operating machinery

It is unlikely that Navelawill affect your ability to drive or operate machinery. 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 with them before taking this medication.

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. 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 entire tablet with a little water and do not chew it.
• If you are using one of the medications that can 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 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 Navela (that is, 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 (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.

We recommend that you consult a healthcare professional if you are concerned about any problem related to the use of emergency contraceptives.

What to do in case of vomiting

Ifyou vomitbeforethree hourshave passedsince taking the tablet,you must take another tablet immediately.

After taking Navela
If you want to have sex again after taking Navela, and you are not using oral contraceptives, you must use condoms or a diaphragm with spermicide until your next menstruation, since Navela will not work if you have sex again without protection before your next menstruation.

After taking Navela, it is advisable to schedule an appointment to see your doctor three weeks later to confirm that you are not pregnant. If your menstruation is delayed by more than 5 days or is exceptionally light or heavy, you should contact your doctor as soon as possible. If you become pregnant after taking this medication, it is essential that you consult your doctor.

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

If you continue using hormonal contraceptives such as oral contraceptives and do not have bleeding during the period when you do not take the contraceptive, go to your doctor to make sure you are not pregnant.

Your next period after taking Navela

After using Navela, your period usually will be 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 more than 5 days later than expected, if there is abnormal bleeding at that time, or if you think you may be pregnant, a pregnancy test should be performed.

If you take more Navela than you should

Although no serious adverse effects have been observed after taking several tablets at once, you may feel dizzy, vomit, or have vaginal bleeding. You should consult your doctor or pharmacist or 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 other questions about the use of this medication, ask your doctor or pharmacist.

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

Very common (mayaffectmorethan1in10people):

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

Common (mayaffectupto1in10people):

• Vomiting. If you experience vomiting, 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 later or earlier than usual. 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 breast tenderness, diarrhea, or dizziness after taking this medication.

Rare side effects (mayaffectupto1in10,000people):

• Exanthema, urticaria, pruritus, facial swelling, pelvic pain, painful menstruation.

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the packaging and in the blister pack. The expiration date is the last day of the month indicated.

Itdoesnotrequirespecialstorageconditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment

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.

Appearanceof Navelaand contents of the package

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

Holderofthemarketing authorization:

Exeltis Healthcare S.L.

Avda. Miralcampo 7.

Polígono Industrial Miralcampo

19200 Azuqueca de Henares. Guadalajara.

Spain

Responsible for manufacturing:

Laboratorios Leon Farma, S.A.

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

24193 Villaquilambre (León),
Spain

This medication is authorized in the member states of the European Economic Area with 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 mgtablet EFG

United Kingdom Melkine 1.5 mg tablet

Poland Livopill

Portugal Navela 1.5 mg tablet

Revision date of the text:January 2023

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