Levonorgestrel Aurovitas 1.5 mg tablet EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Levonorgestrel Aurovitas 1.5 mg tablet EFG

Levonorgestrel

Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Follow exactly the instructions for taking this medicine as described in this leaflet or as directed 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 side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve.

Contents of this leaflet

1. What Levonorgestrel Aurovitas is and what it is used for
2. What you need to know before taking Levonorgestrel Aurovitas
3. How to take Levonorgestrel Aurovitas
4. Possible side effects
5. How to store Levonorgestrel Aurovitas
6. Contents of the pack and other information

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

Levonorgestrel Aurovitas is 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:

• 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 position of a diaphragm or vaginal pessary changed, or if it was perforated, torn or removed too early, or if withdrawal during coitus interruptus failed (e.g. sperm was ejaculated into the vagina or onto the 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 until the third day.

Levonorgestrel is thought to work in the following ways:

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

Levonorgestrel 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 (including if this occurs during the same menstrual cycle), the tablet will not provide contraceptive protection and there is again a risk of pregnancy.

This tablet should only be used as emergency contraception, not as a regular contraceptive method, because it is less effective than regular contraceptive pills.

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

2. What you need to know before taking Levonorgestrel Aurovitas

Do not take Levonorgestrel Aurovitas

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

Warnings and precautions

Talk to your doctor or pharmacist before taking levonorgestrel.

If you are in any of the following situations, speak with your doctor before taking levonorgestrel, as emergency contraception may not be suitable for you. Your doctor may prescribe you another type of emergency contraceptive.

• If you are pregnant or think you may already be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, levonorgestrel cannot interrupt the pregnancy, so levonorgestrel 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 when your next period was expected;
• after your last period, you had unprotected sex and more than 72 hours have passed.

Use of levonorgestrel is not recommended if:

• you have a small intestine disorder (such as Crohn's disease) that impairs absorption of the medicine;
• you have severe liver problems;
• you have a history of ectopic pregnancy (in which the baby develops outside the uterus);
• you have a history of salpingitis (inflammation of the Fallopian tubes).

A previous ectopic pregnancy or Fallopian tube 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 levonorgestrel may be less effective with increasing weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, levonorgestrel is recommended for all women, regardless of their weight or BMI.

Psychiatric disorders

Some women using hormonal contraceptives such as levonorgestrel have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for further 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 infections (STIs)

If you did not use a condom (or if it broke or slipped off) during sex, you may have contracted a sexually transmitted infection or HIV virus.

This medicine will not protect you against sexually transmitted infections; only condom use can do so. Speak to your doctor, nurse, family planning clinic, or pharmacist for advice if this concerns you.

Other medicines and Levonorgestrel Aurovitas

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

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

See 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 Levonorgestrel Aurovitas' for more information).

Levonorgestrel Aurovitas may also affect how other medicines work:

• a medicine called cyclosporine (which suppresses the immune system).

How often can you use Levonorgestrel 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 your menstrual cycle (period) is more likely to become irregular.

Levonorgestrel Aurovitas is not as effective as regular contraceptive methods. Your doctor, nurse, or family planning clinic can 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 medicine.

Pregnancy

Do not take this medicine if you are already pregnant. If you become pregnant despite taking this medicine, it is important that you see your doctor. There is no evidence that levonorgestrel can harm a baby developing in your womb when taken as directed.

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

Breastfeeding

Very small amounts of the active ingredient of this medicine may pass into your breast milk. This is not thought to be harmful to the baby. However, if you are concerned, you may take the tablet immediately after a feed and avoid breastfeeding for at least 8 hours after taking levonorgestrel; during the 8 hours after taking levonorgestrel, express your milk with a breast pump and discard it. This way, you can reduce the amount of active ingredient that your baby might receive through breast milk.

Fertility

Levonorgestrel may increase the likelihood of 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 levonorgestrel. Therefore, regular contraceptive methods should be continued or initiated as soon as possible after using levonorgestrel.

Driving and using machines

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

Levonorgestrel Aurovitas contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Levonorgestrel Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".

3. How to take Levonorgestrel Aurovitas

Always use this medicine exactly as described in this leaflet or as your pharmacist has instructed you. Consult your doctor or pharmacist if you have any doubts.

• You may take levonorgestrel at any time during your menstrual cycle, except if you are already pregnant or think you may be pregnant. Do not chew; swallow the tablet whole with water. Do not delay taking the tablet.
• If you are taking any of the medicines that may reduce the effectiveness of levonorgestrel (see section 'Other medicines and Levonorgestrel Aurovitas') or if you have taken any of these medicines within 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 (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 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 may continue taking it as usual.

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

Use in children and adolescents

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

If you vomit

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

After taking Levonorgestrel Aurovitas

If you wish to have sexual intercourse after taking levonorgestrel and you are not using the contraceptive pill, you should use condoms or a diaphragm with spermicide until your next menstrual period. This is because levonorgestrel will not be effective if you have unprotected intercourse again before your next period.

After taking levonorgestrel, it is advisable to schedule an appointment with your doctor about three weeks later to confirm that levonorgestrel has worked. 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 despite taking this medicine, it is important that you see your doctor.

Your doctor may also inform you about long-acting reversible contraceptive methods, which are more effective at preventing pregnancy.

If you continue using your regular hormonal contraception, such as the contraceptive pill, and do not have bleeding during the tablet-free interval, consult your doctor to ensure you are not pregnant.

Your next period after taking Levonorgestrel Aurovitas

After using levonorgestrel, your period is usually normal and will start on the expected day; however, sometimes it may start a few days earlier or later. If your period starts 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 more Levonorgestrel Aurovitas than you should

Although no serious harmful effects have been reported after taking several tablets at once, you may experience nausea, vomiting, or vaginal bleeding. You should consult your doctor, pharmacist, nurse, or family planning clinic 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, stating 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, this medicine may cause adverse effects, although not everyone experiences them.

The possible adverse effects are described below according to their frequency:

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

• Nausea.
• You may have irregular bleeding until your next menstrual period.
• You may have pain in the lower abdomen.
• Tiredness.
• Headache.

Common adverse 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 earlier or later than normal. 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.

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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Levonorgestrel Aurovitas

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levonorgestrel Aurovitas

• The active substance is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.
• The other components are microcrystalline cellulose, monohydrate lactose, poloxamer 188, sodium croscarmellose, and magnesium stearate.

Appearance of the product and contents of the pack

Each pack contains a complete treatment consisting of one white, round tablet, approximately 6 mm in diameter, marked 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

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Levonorgestrel Aurovitas 1.5 mg tablet EFG

Netherlands: Etos noodanticonceptie levonorgestrel, 1.5 mg tablet

Date of the most recent review of this leaflet: September 2024

Detailed 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/.