Package Insert: Patient Information

Levonorgestrel Exeltis 1,5 mgfilm-coated tablet

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

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

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 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 taken within 12 hours to delay taking it until the third day.

It is believed that Levonorgestrel Exeltis acts:

• 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 having unprotected sex. It does not work if already pregnant. If having unprotected sex after taking this medication, it will not prevent pregnancy.

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

Do not take Levonorgestrel Exeltis:

• If you are allergic to levonorgestrel or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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; this medication will not work if you are already pregnant.

You may be pregnant if:

• Your period has been delayed by more than 5 days or you have experienced unusual bleeding on the date of your next expected period.
• You have had unprotected sex in the last 72 hours, and since your last period.

You should also inform your doctor if:

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

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

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

Mental health disorders:

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

Taking Levonorgestrel Exeltis with other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including over-the-counter medications or herbal medications.

Some medications may prevent Levonorgestrel Exeltis from working effectively. If you have used any of the medications listed below in the last 4 weeks, Levonorgestrel Exeltis may be less suitable for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), such as 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 Levonorgestrel Exeltis:

• Barbiturates and other medications for epilepsy (e.g., primidone, phenytoin, and carbamazepine).
• Medications for 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 with your doctor or pharmacist if you need additional information on the correct dosage for you.

Consult your doctoras soon as possible after taking the tablets, so they can inform you about reliable methods of regular contraception and prevent 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 cyclosporine (to suppress the immune system).

If you are concerned about sexually transmitted diseases

This medication will not protect you against sexually transmitted diseases, as only the use of a condom can do so. Ask your doctor, nurse, family planning center, or pharmacist for recommendations if you are concerned about this.

How often you can 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 may alter your menstrual cycle.

Levonorgestrel is not as effective as other conventional contraceptive methods. Your doctor, nurse, or family planning center can inform you about long-term contraceptive methods that are more effective in preventing pregnancy.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

Do not take this medication if you are already pregnant. If you become pregnant after taking this medication, it is essential to see your doctor. There is no evidence that levonorgestrel causes harm to the developing fetus in the uterus. However, your doctor may want to check if the pregnancy is ectopic (when the fetus develops outside the uterus), especially if you experience severe abdominal pain after taking levonorgestrel or 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.

It is possible that 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 feeding your baby and then use a breast pump for the next 6 hours after taking levonorgestrel to discard that milk. This way, you can reduce the amount of active ingredient that your baby may take with the breast milk.

Fertility

Levonorgestrel increases the likelihood of menstrual irregularities that may lead to advancing or delaying ovulation, thereby altering the date of fertility. After treatment with this medication, it is expected that fertility will return quickly, and therefore, you should continue with your regular contraceptive methods or start them as soon as possible after using levonorgestrel.

Driving and operating machinery

The levonorgestrel tablet is 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 medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, 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 medication works best as soon as possible after having unprotected sex.It can only prevent pregnancy if taken within 72 hours after having unprotected sex.

You can take Levonorgestrel Exeltis at any time of the 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 medication works best as soon as possible after having unprotected sex.

If you are using one of the medications that can prevent levonorgestrel from working correctly (see section “Use of 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), 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 levonorgestrel (i.e., 2 tablets taken at the same time).

If you are already using a regular contraceptive method, such as the oral contraceptive pill, you can continue taking it with the same regularity.

If you have a second unprotected sex after using levonorgestrel (also if it occurs during the same menstrual cycle), the tablet will not exert its contraceptive effect and there will be a risk of pregnancy again.

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

What to do if you vomit

If you vomit within the next three hours after taking the tablet, you must take another one. You should contact your pharmacist, doctor, nurse, or family planning center to obtain another tablet.

After taking Levonorgestrel Exeltis

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

It is recommended to 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 is abnormally light or heavy, you should contact your doctor as soon as possible. If you become pregnant after taking this medication, it is essential to see your doctor.

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

If you continue using regular hormonal contraception, such as the contraceptive pill, and do not have bleeding during your pill-free period, 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 usual day; however, it may start a few days earlier or later. If your period starts more than 5 days later than expected, if you have abnormal bleeding at that time, or if you think you may be pregnant, you should check if you are pregnant using a pregnancy test.

What to do if you take more Levonorgestrel Exeltis than you should

Although no serious adverse effects have been reported after taking too many tablets at the same time, you may feel nausea (urge to vomit), have vomiting, or experience vaginal bleeding. Consult your pharmacist, doctor, nurse, or family planning center, especially if you have vomited, as the tablet may not have worked correctly.

If you have any other 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.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

• Nausea (urge to vomit).
• Lower abdominal pain.
• Fatigue (tiredness).
• Headache.
• Irregular bleeding until your next period.

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

• Vomiting. If you have vomiting, 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 sometimes it may be early or late. 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 (edema facial).
• Lower back pain (pelvic pain).
• Painful periods.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse 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 carton packaging, after CAD. The expiration date is the last day of the month indicated.

No requires special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levonorgestrel Exeltis

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

Appearance of the product and contents of the packaging

The medicine is presented in the form of a round, white or off-white, uncoated, flat tablet marked with "145” on one face 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.

Responsible for manufacturing

Mcdermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road

Dublin 13, Ireland

Mylan Hungary Kft

Mylan utca, 1 H-2900 Komarom, Hungary

Last review date of this leaflet:February 2019

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