Navela 1.5 mg tablet EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Navela 1.5 mg tablet EFG
levonorgestrel
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use of this medicine as described in this leaflet or as provided by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Navela is and what it is used for
- What you need to know before taking Navela
- How to take Navela
- Possible side effects
- How to store Navela
- Contents of the pack and other information
1. What Navela is and what it is used for
Navela is an emergency contraceptive that can be used within 72 hours (3 days) after having unprotected sex or if the regular contraceptive method has failed. It is used in the following cases:
- If contraceptives were not used during sexual intercourse.
- If the contraceptive was not used correctly, for example if the condom broke, slipped, or was used incorrectly, if the diaphragm was displaced, or if it was perforated, torn, or removed too early, or if withdrawal during coitus interruptus failed (e.g., semen was ejaculated into the vagina or onto the external genitals).
Navela contains as its active ingredient a synthetic hormone called levonorgestrel. 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 the sooner it is taken 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 having unprotected sex. It does not work if you are already pregnant.
If you have unprotected sex after taking Navela (including if this occurs during the same menstrual cycle), the medicine will not provide contraceptive protection, and there will again be a risk of pregnancy.
Navela is not indicated for use before the first menstrual bleeding (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 medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Navela. If any of the following apply to you, tell your doctor before taking Navela, 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, 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 abnormal bleeding around the time your next period was expected;
- you have had unprotected sex after your last period and more than 72 hours have passed.
The use of Navela is not recommended if:
- you have a small intestine disorder (such as Crohn's disease) that impairs 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 a tubal infection 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 have concerns about any issues related to emergency contraception.
Children and adolescents
Navela is not indicated for use before the first menstrual bleeding (menarche).
If you are concerned about sexually transmitted infections
If you did not use a condom (or it broke or slipped) during sex, you may have contracted a sexually transmitted infection (STI) or HIV. This medicine will not protect you from sexually transmitted infections, as only condom use can do so.
Consult your doctor or pharmacist or your family planning clinic for advice if you are concerned about this.
Other medicines and Navela
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Some medicines may prevent Navela from working effectively. If you have taken any of the following medicines within the last 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 (Cu-IUD). If this is not an option for you or if you cannot see your doctor quickly, a double dose of Navela may be taken:
- 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 used to treat fungal infections (griseofulvin);
- herbal medicines containing St. John's wort (Hypericum perforatum).
Consult your doctor or pharmacist if you need further information on the correct dose for you.
Consult your doctor as soon as possible after taking the tablets, to receive advice on reliable methods of regular contraception to prevent pregnancy. (See also section 3 “How to take Navela” for more information.)
Navela may also affect the proper functioning of other medicines:
- a medicine called cyclosporine (which suppresses the immune system).
How often can Navela be used
Navela should only be used in emergency situations and never as a regular contraceptive method. If you use Navela more than once in the same menstrual cycle, its effectiveness is reduced and menstrual cycle disturbances (period) may occur.
Navela is not as effective as regular contraceptive methods. Your doctor, nurse, or family planning clinic can advise you on long-acting contraceptive methods that are more effective at preventing pregnancy.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not take this medicine if you are pregnant. If you become pregnant after taking this medicine, it is important that you see a doctor. Available data do not indicate that Navela can harm the embryo when used as directed.
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 ever had an ectopic pregnancy, fallopian tube surgery, or pelvic inflammatory disease.
Breastfeeding
The active ingredient in this medicine is excreted in breast milk. Therefore, it is recommended that you take the tablet immediately after breastfeeding and avoid breastfeeding for at least 8 hours after taking levonorgestrel. During the 8 hours following the tablet, express milk with a breast pump and discard it. This way, you take the tablet well before the next feeding, reducing the amount of active ingredient that your baby might ingest through breast milk.
Fertility
Navela may cause menstrual disturbances, which can sometimes lead to earlier or delayed ovulation, thereby altering the timing of fertility. Although there are no long-term fertility data, fertility is expected to return rapidly after treatment with Navela; therefore, regular contraceptive methods should be continued or initiated as soon as possible after using Navela.
Driving and using machines
It is unlikely that Navela will affect your ability to drive or use machines. However, if you feel tired or dizzy, do not drive or operate machinery.
Navela contains lactose and sodium
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".
3. How to take Navela
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after having unprotected sex. Do not delay taking the tablet. The medicine works best the sooner you take it after having unprotected sex. It can only prevent pregnancy if taken within 72 hours after unprotected sex. |
- You may take Navela at any time during your menstrual cycle, except if you are already pregnant or think you might be pregnant. Take the whole tablet with some water and do not chew it.
- If you are taking any of the medicines that may reduce the effectiveness of Navela (see section “Other medicines and Navela”) or if you have taken any of these medicines within the last 4 weeks, Navela may be less effective for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), namely a copper intrauterine device (Cu-IUD). If this is not an option for you or if you cannot see your doctor quickly, you may 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 may continue taking it as usual.
If you have another unprotected sexual intercourse after taking Navela (even if it occurs during the same menstrual cycle), the tablet will not provide contraceptive protection, and there is again a risk of pregnancy.
It is recommended that you consult a healthcare professional if you are concerned about any issues related to taking emergency contraception.
What to do in case of vomiting
If you vomit within three hours after taking the tablet, you should take another tablet immediately.
After taking Navela
If you wish to have sexual intercourse after taking Navela and you are not using an oral contraceptive, you must use condoms or a diaphragm with spermicide until your next menstrual period, since Navela will not work if you have unprotected sex again before your next period.
After taking Navela, it is advisable to schedule an appointment with your doctor about three weeks later to confirm that you are not pregnant. If your period is delayed by more than 5 days, or is unusually light or heavy, you should contact your doctor as soon as possible. If you become pregnant after taking this medicine, it is important that you consult your doctor.
Your doctor will also advise you about long-acting contraceptive methods that are more effective in preventing pregnancy.
If you continue using your regular hormonal contraception, such as oral contraceptives, and do not have bleeding during the pill-free interval, contact your doctor to ensure you are not pregnant.
Your next period after taking Navela
After using Navela, your period will usually be normal and start on the expected day; however, sometimes it may occur 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 might be pregnant, you should take a pregnancy test.
If you take more Navela than you should
Although no serious harmful effects have been observed after taking several tablets at once, you may experience dizziness, vomiting, or 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Navela can cause adverse effects, although not everyone will experience them.
Very common (may affect more than 1 in 10 people):
- Nausea
- Irregular bleeding until the next menstrual period
- Pain in the lower abdomen
- Tiredness
- Headache
Common (may affect up to 1 in 10 people):
- 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 earlier or later than expected. You may also experience irregular bleeding or spotting until your next period. If your period is delayed by more than 5 days, or is unusually light or heavy, you should contact your doctor as soon as possible.
- Increased breast tenderness, diarrhea, or dizziness after taking this medicine.
Very rare adverse effects (may affect up to 1 in 10,000 people):
- Rash, urticaria, itching, facial swelling, pelvic pain, painful menstruation.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Navela
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the blister. The expiry date refers to the last day of the month indicated. No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be handed over at the pharmacy's SIGRE collection point 
. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Navela
The active substance is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.
The other components are microcrystalline cellulose, monohydrate lactose (lactose), poloxamer 188, sodium croscarmellose, and magnesium stearate.
Appearance of Navela and contents of the pack
Each pack contains one complete treatment consisting of one white, round tablet approximately 6 mm in diameter, with an imprint showing “C” on one side and “1” on the other.
Marketing Authorization Holder:
Exeltis Healthcare S.L.
Avda. Miralcampo 7.
Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara, Spain
Manufacturer:
Laboratorios Leon Farma, S.A.
C/ La Vallina, s/n, Polígono Industrial Navatejera,
24193 Villaquilambre (León), Spain
This medicine is authorized in the Member States of the European Economic Area under the following names:
Netherlands: Levonorgestrel Xiromed 1.5 mg tabletten
Austria: Navela 1.5 mg tabletten
Czech Republic: Navela
Estonia: Labella
France: Levunique 1.5 mg comprimé
Germany: Navela 1.5 mg Tabletten
Lithuania: Labella 1.5 mg tabletes
Slovakia: Navela 1.5 mg tableta
Spain: Navela 1.5 mg comprimido EFG
United Kingdom: Melkine 1.5 mg tablet
Poland: Livopill
Portugal: Navela 1.5 mg comprimido
Date of text revision: January 2023
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/