Levonorgestrel Exeltis 1,5 mg tablet EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Levonorgestrel Exeltis 1.5 mg tablet EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Levonorgestrel Exeltis is an emergency contraceptive that can be used within 72 hours (3 days) after having unprotected sex or when the usual contraceptive method has failed.

When should emergency contraception be used?

Levonorgestrel Exeltis contains a synthetic substance analogous to a hormone called levonorgestrel. It prevents approximately 84% of expected pregnancies when taken within 72 hours after unprotected sex. It will not prevent pregnancy every time, and it is more effective the sooner it is taken after unprotected intercourse. It is best to take it within 12 hours, and delaying intake up to the third day reduces its effectiveness.

Levonorgestrel Exeltis is believed to work by:

• Preventing the ovaries from releasing an egg.
• Preventing a sperm from fertilizing an egg that may have been released.

Levonorgestrel Exeltis can only prevent pregnancy if taken within 72 hours after unprotected sex. It will not work if you are already pregnant. If you have unprotected sex after taking this medicine, it will not prevent pregnancy from occurring.

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

2. What you need to know before taking Levonorgestrel Exeltis

Do not take Levonorgestrel Exeltis:

• 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 Exeltis.

Inform your doctor before taking Levonorgestrel Exeltis if you are in any of the following situations, as emergency contraception may not be suitable for you:

• You are pregnant or think you might be pregnant; this medicine will not work if you are already pregnant.

You may be pregnant if:

• Your period is more than 5 days late or you have experienced unusual bleeding around the time your next period was expected.
• You had unprotected sex more than 72 hours ago and since your last period.

You should also inform your doctor if:

• You have a small intestine disorder (such as Crohn's disease) that affects how you digest food.
• You have severe liver problems.
• You have previously had an ectopic pregnancy (when the fertilized egg implants outside the uterus).
• You have previously had inflammation of the fallopian tubes (salpingitis).

A previous ectopic pregnancy or prior fallopian tube infection increases the risk of another ectopic pregnancy.

Your doctor may decide that this medicine is not suitable for you, or that another type of emergency contraception would be more appropriate.

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.

Taking Levonorgestrel Exeltis with other medicines

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

Some medicines may prevent Levonorgestrel Exeltis from working effectively. If you have taken any of the following medicines within the last 4 weeks, Levonorgestrel Exeltis may be less suitable 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, a double dose of Levonorgestrel Exeltis 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, rifabutin).
• A treatment for HIV infection (ritonavir, efavirenz).
• A medicine for fungal infections (griseofulvin).
• Herbal remedies containing St. John's wort (Hypericum perforatum).

Consult your doctor or pharmacist if you need further information about the correct dosage for you.

Contact your doctor as soon as possible after taking the tablets to discuss reliable methods of regular contraception to prevent pregnancy (see also section 3 “How to take Levonorgestrel Exeltis” for more information).

Levonorgestrel Exeltis may also affect how other medicines work.

• A medicine called cyclosporine (used to suppress the immune system).

If you are concerned about sexually transmitted infections

This medicine will not protect you against sexually transmitted infections, as only the use of a condom can do so. Seek advice from your doctor, nurse, family planning clinic, or pharmacist if you have concerns in this regard.

How often you can use Levonorgestrel Exeltis

Levonorgestrel should only be used in emergency situations and not as a regular contraceptive method. If this medicine is used more than once during the same menstrual cycle (period), it will be less effective and more likely to disrupt your menstrual cycle.

Levonorgestrel is not as effective as other conventional 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

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Do not take this medicine if you are already pregnant. If you become pregnant after taking this medicine, it is important that you see your doctor. There are no data indicating that levonorgestrel causes harm to the developing fetus. However, your doctor may want to rule out an ectopic pregnancy (when the fetus develops outside the uterus). This is especially important if you experience severe abdominal pain after taking levonorgestrel or if you have previously had an ectopic pregnancy, fallopian tube surgery, or pelvic inflammatory disease.

Breastfeeding

Women who are breastfeeding can use levonorgestrel, but should take the following precautions.

Small amounts of the active ingredient may pass into breast milk. This is not considered harmful to the baby. However, as a precaution, you may take the tablet immediately after breastfeeding and then use a breast pump to express and discard the milk for the next 6 hours after taking levonorgestrel. This way, you can reduce the amount of active ingredient the baby might receive through breast milk.

Fertility

Levonorgestrel may cause changes in menstruation that can sometimes lead to earlier or delayed ovulation, thereby altering the timing of fertility. Fertility is expected to return rapidly after treatment with this medicine, so you should continue or start using regular contraceptive methods as soon as possible after using levonorgestrel.

Driving and using machines

Levonorgestrel tablets are unlikely to affect your ability to drive or operate machinery. However, if you feel tired or dizzy, do not drive or operate machinery.

Levonorgestrel Exeltis contains lactose

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.

3. How to take Levonorgestrel Exeltis

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If you are unsure, please consult your doctor or pharmacist again.

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 unprotected intercourse. It can only prevent pregnancy if taken within 72 hours after unprotected sex.

You may take Levonorgestrel Exeltis at any time during your menstrual cycle, except if you are already pregnant or think you may be pregnant. Do not chew the tablet; it must be swallowed whole with water. Do not delay taking the tablet. This medicine works best the sooner it is taken after unprotected sex.

If you are taking any of the medicines that may reduce the effectiveness of levonorgestrel (see section "Use of other medicines and Levonorgestrel Exeltis") or if you have taken any of these medicines within the past 4 weeks, levonorgestrel 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 levonorgestrel (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 a second episode of unprotected sex after using levonorgestrel (even if it occurs during the same menstrual cycle), the tablet will not provide contraceptive protection, and there will again be a risk of 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 body 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.

You are advised to consult a healthcare professional if you have concerns about any issues related to emergency contraception.

What to do if you vomit

If you vomit within three hours of taking the tablet, you should take another tablet. You should contact your pharmacist, doctor, nurse, or family planning center to obtain a replacement tablet.

After taking Levonorgestrel Exeltis

After taking levonorgestrel, if you wish to have sex and are not using oral contraception, you must use condoms or a diaphragm with spermicide until your next menstrual period. This medicine will not work if you have unprotected sex again before your next period.

After taking this medicine, it is recommended that you schedule an appointment with your doctor approximately three weeks later to ensure that levonorgestrel has worked. If your period is delayed by more than 5 days, or if it 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 see your doctor.

Your doctor may also inform you about longer-term contraceptive methods that are more effective in preventing pregnancy.

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

Your next period after taking Levonorgestrel Exeltis

After using levonorgestrel, your period will usually be normal and start on the expected day; however, it may occur a few days earlier or later. If your period starts more than 5 days later than expected, if you have unusual bleeding at that time, or if you think you may be pregnant, you should take a pregnancy test to check whether you are pregnant.

If you take more Levonorgestrel Exeltis than you should

Although no serious harmful effects have been reported after taking too many tablets at once, you may experience nausea (feeling sick), vomiting, or vaginal bleeding. Seek advice from your pharmacist, doctor, nurse, or family planning center, especially if you have vomited, as the tablet may not have worked properly.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• Nausea.
• Lower abdominal pain.
• Tiredness (fatigue).
• Headache.
• Irregular bleeding until your next period.

Common (may affect up to 1 in 10 people):

• Vomiting. If you vomit, see the section "What to do if you vomit" (see section 3).
• Diarrhea.
• Dizziness.
• Breast tenderness.
• Your period may be different. Most women will have a normal period at the expected time, but sometimes it may come earlier or later. 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.

Very rare (may affect up to 1 in 10,000 people):

• Skin rash.
• Hives (urticaria).
• Itching (pruritus).
• Facial swelling (facial edema).
• Hip pain (pelvic pain).
• Painful periods.

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 via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levonorgestrel Exeltis

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

Do not use this medicine after the expiry date stated on the cardboard package, following CAD. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levonorgestrel Exeltis

• The active substance is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.
• The other components are povidone K-25, monohydrate lactose (see section 2, "Levonorgestrel Exeltis contains lactose"), corn starch, anhydrous colloidal silica, and magnesium stearate.

Appearance of the medicine and contents of the pack

The medicine is a round, white or almost white, uncoated, flat tablet, marked with "145" on one side and plain on the other.

Levonorgestrel Exeltis is available in blister packs containing 1 tablet.

Marketing Authorization Holder

Exeltis Healthcare S.L.

Avenida de Miralcampo, 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares.

(Guadalajara), Spain.

Manufacturer

Mcdermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road

Dublin 13, Ireland

or

Mylan Hungary Kft

Mylan utca, 1 H-2900 Komarom, Hungary

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000,

Malta

Date of the most recent revision of this leaflet: February 2019

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/