LEVONORGESTREL EXELTIS 1.5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Levonorgestrel Exeltis 1,5 mgtablet EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

When should emergency contraception be used?

Levonorgestrel Exeltis contains a synthetic substance similar 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 is more effective if taken as soon as possible after unprotected sex. It is best to take it within 12 hours after unprotected sex, and not to delay taking it until the third day.

It is believed that Levonorgestrel Exeltis works 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 does not work if you are already pregnant. If you have unprotected sex after taking this medication, it will not prevent you from becoming pregnant.

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

2. What you need to know before taking Levonorgestrel Exeltis

Do not take Levonorgestrel Exeltis:

• 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 taking Levonorgestrel Exeltis.

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

• You are pregnant or think you may be pregnant; this medication 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 on the expected date of your next period.
• You have had unprotected sex more than 72 hours ago, and since your last period.

You should also inform your doctor if:

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

A previous ectopic pregnancy and a previous infection of the fallopian tubes increase the risk of a new ectopic pregnancy.

It is likely that your doctor will decide that this medication is not suitable for you, or that another type of emergency contraception would be better.

Psychiatric disorders:

Some women who use hormonal contraceptives like levonorgestrel have reported depression or a depressed mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for further medical advice as soon as possible.

Taking Levonorgestrel Exeltis with other medications

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

Some medications may prevent Levonorgestrel Exeltis from working effectively. If you have used any of the following medications in the last 4 weeks, Levonorgestrel Exeltis may be less suitable for you. Your doctor may prescribe another 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 Levonorgestrel Exeltis:

• Barbiturates and other medications for treating epilepsy (e.g., primidone, phenytoin, and carbamazepine).
• Medications for treating tuberculosis (e.g., rifampicin, rifabutin).
• A treatment for HIV infection (ritonavir, efavirenz).
• A medication 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 dose for you.

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

Levonorgestrel Exeltis may also affect the proper functioning of other medications.

• A medication called cyclosporin (to suppress the immune system).

If you are concerned about sexually transmitted diseases

This medication will not protect you from sexually transmitted diseases, as only the use of condoms can do so. Ask your doctor, nurse, family planning clinic, or pharmacist for advice if you are concerned about this.

How often can you use Levonorgestrel Exeltis

You should only use levonorgestrel in emergency situations and not as a regular contraceptive method. If this medication is used more than once in the same menstrual cycle (period), it will be less reliable 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 inform you about long-term contraceptive methods that are more effective in preventing pregnancy.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medication.

Pregnancy

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

Breastfeeding

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

Small amounts of the active ingredient may pass into breast milk. It is not believed to be harmful to the baby. However, as a precaution, you can take the tablet immediately after breastfeeding and then use a breast pump for the next 6 hours to discard the milk. This will reduce the amount of active ingredient that the baby may take with the breast milk.

Fertility

Levonorgestrel increases the possibility of changes in menstruation that can sometimes lead to advancing or delaying the date of ovulation, modifying fertility accordingly. After treatment with this medication, a rapid return to fertility is expected, and you should continue with your usual contraceptive methods or start them as soon as possible after using levonorgestrel.

Driving and using machines

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

Levonorgestrel Exeltis contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

3. How to take Levonorgestrel Exeltis

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, 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 unprotected sex. Do not delay taking the tablet. The medication works better the sooner it is taken after unprotected sex.It can only prevent pregnancy if taken within 72 hours after unprotected sex.

You can 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; swallow it whole with water. Do not delay taking the tablet. This medication works better the sooner it is taken after unprotected sex.

If you are using one of the medications that may prevent levonorgestrel from working correctly (see section "Using other medications and Levonorgestrel Exeltis") or if you have used one of these medications in 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 (IUD). If this is not an option for you or if you cannot see your doctor quickly, you can 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 pill, you can continue taking it as usual.

If you have unprotected sex again after using levonorgestrel (even if it is during the same menstrual cycle), the tablet will not have its contraceptive effect, and you will be at risk of pregnancy again.

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 not conclusive. Therefore, levonorgestrel 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.

What to do if you vomit

If you vomit within 3 hours of taking the tablet, you should take another one. You should contact your pharmacist, doctor, nurse, or family planning clinic to obtain another tablet.

After taking Levonorgestrel Exeltis

After taking levonorgestrel, if you want to have sex and are not using the pill, you should use condoms or a diaphragm with spermicide until your next menstrual period. This medication will not work if you have unprotected sex again before your next period.

After taking this medication, it is recommended that you make an appointment with your doctor approximately 3 weeks later to ensure that levonorgestrel has worked. 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 important that you see your doctor.

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

If you continue to use regular hormonal contraception, such as the pill, and do not have bleeding during your pill-free period, you should 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 will start on the expected date; however, it may sometimes occur a few days earlier or later. If your period is more than 5 days late or you have unusual bleeding at the expected time of your next period or if you think you may be pregnant, you should check if you are pregnant with a pregnancy test.

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 feel nauseous (feel like vomiting), vomit, or experience vaginal bleeding. Ask your pharmacist, doctor, nurse, or family planning clinic for advice, especially if you have vomited, as the tablet may not have worked properly.

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

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.

4. Possible side effects

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

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

• Feeling sick (nausea).
• Pain in the lower abdomen.
• 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 on the expected date, but it may sometimes be earlier or later. If your period is more than 5 days late 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).
• Pelvic pain.
• Painful periods.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's online system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Levonorgestrel Exeltis

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

Do not use this medication after the expiration date stated on the carton, after the EXP date. 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. Return any unused medication to your pharmacist, who will dispose of it in an environmentally friendly way. This will help protect the environment.

6. Contents of the pack and further information

Composition of Levonorgestrel Exeltis

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

Appearance of the product and pack contents

The medication is presented in the form of a round, white or almost white, uncoated tablet, flat, and marked with "145" on one side and smooth 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 last revision of this package leaflet:February 2019

Detailed and up-to-date information on this medication can be found on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/