LEVONORGESTREL ADALVO 1.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Levonorgestrel Adalvo 1.5mg tablet EFG

levonorgestrel

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

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• 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 Adalvo and what is it used for
2. What you need to know before taking Levonorgestrel Adalvo
3. How to take Levonorgestrel Adalvo
4. Possible side effects
5. Storage of Levonorgestrel Adalvo
6. Contents of the pack and further information

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

Levonorgestrel Adalvo is an emergency contraceptive that can be used within 72 hours (3 days) after unprotected sex or if your regular contraceptive method has failed.

This includes the following cases:

• No contraceptive method was used during sex.
• The contraceptive method was not used correctly, for example, the condom was torn, slipped, or used incorrectly; if the vaginal diaphragm or cervical cap was dislodged, punctured, broken, or removed too early; or in the case of failed coitus interruptus (e.g., sperm was ejaculated into the vagina or external genitalia).

This medicine contains a synthetic hormone called levonorgestrel. It prevents about 84% of unwanted pregnancies when taken within 72 hours after unprotected sex. It will not always protect against pregnancy every time you take it, and it is more effective if taken as soon as possible after unprotected sex. It is best to take it within the first 12 hours, rather than delaying until the third day.

It is believed that Levonorgestrel works by:

• Preventing the ovaries from releasing an egg.
• Preventing sperm from fertilizing any egg that has already been released.

This medicine 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 using Levonorgestrel (even during the same menstrual cycle), the medicine will not have a contraceptive effect, and there is a risk of pregnancy.

The use of Levonorgestrel is not indicated before the first menstrual period (menarche).

2. What you need to know before taking Levonorgestrel Adalvo

Do not take Levonorgestrel Adalvo

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

Warnings and precautions

Consult your doctor before taking Levonorgestrel if you are in any of the situations described below, as the emergency contraceptive may not be suitable for you. Your doctor may prescribe another emergency contraceptive method.

• If you are pregnant or think you may be pregnant. This medicine does not work if you are already pregnant. If you are already pregnant, Levonorgestrel will not interrupt the pregnancy, so this medicine is not an "abortion pill".

You may already be pregnant if:

• Your period is more than 5 days late or you have had unusual bleeding when your next period is due.
• You have had unprotected sex more than 72 hours ago and since your last period.

The use of this medicine is not recommended if:

• You have a disease in the small intestine (such as Crohn's disease) that inhibits the absorption of the medicine.
• You have severe liver problems.
• You have a history of ectopic pregnancy (a pregnancy in which the baby develops outside the uterus).
• You have a history of a disease called salpingitis (inflammation of the fallopian tubes).

A previous ectopic pregnancy or a previous infection of the fallopian tubes increases the risk of another ectopic pregnancy.

All women should take emergency contraception as soon as possible after unprotected sex. There are some data suggesting that levonorgestrel (the active ingredient of this medicine) may be less effective with increasing body weight or body mass index (BMI), but these data were limited and not conclusive. Therefore, Levonorgestrel remains recommended for all women, regardless of their weight or BMI.

If you are concerned about any issues related to emergency contraception, talk to your doctor or another healthcare professional.

Children and adolescents

The use of this medicine is not indicated before the first menstrual period (menarche).

If you are concerned about sexually transmitted diseases

If you did not use a condom (or if it broke or slipped) during sex, you may have acquired a sexually transmitted disease or HIV.

This medicine does not protect you from sexually transmitted diseases, as only the use of condoms can do. Consult your doctor, nurse, family planning center, or pharmacist if you are concerned about this.

Other medicines and Levonorgestrel Adalvo

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

Some medicines may prevent Levonorgestrel from working effectively. If you have used any of the medicines listed below in the last 4 weeks, this medicine 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.

• 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 used to treat fungal infections (griseofulvin).
• Herbal products containing St. John's Wort (Hypericum perforatum).

If you need more information about the correct dose for you, consult your doctor or pharmacist.

Consult your doctor as soon as possible after taking the tablets to inform you about reliable contraceptive methods for regular use and to avoid pregnancy (see also section 3 for more information).

Levonorgestrel may also affect the proper functioning of other medicines:

• A medicine called ciclosporin (which suppresses the immune system).

How often can Levonorgestrel Adalvo be used

You should only use Levonorgestrel in emergency situations and never as a regular contraceptive method. If you use this medicine more than once during the same menstrual cycle, its effectiveness is reduced, and your menstrual cycle (period) may be disrupted.

Levonorgestrel does not work as well as conventional contraceptive methods. Your doctor, nurse, or family planning center can advise you on long-term contraceptive methods that are more effective in preventing pregnancy.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not take this medicine if you are already pregnant. If you become pregnant despite taking this medicine, it is essential to consult your doctor. There are no data to suggest that levonorgestrel can harm the embryo if used as advised. However, your doctor may want to confirm that your pregnancy is not ectopic (when the embryo implants outside the uterus). This is especially important if you experience severe abdominal pain after taking this medicine or if you have had an ectopic pregnancy, surgery on the fallopian tubes, or pelvic inflammatory disease.

Breastfeeding

Levonorgestrel is excreted in breast milk. Therefore, it is recommended to take the tablet immediately after breastfeeding and avoid breastfeeding for at least 8 hours after administration of levonorgestrel. Then, express milk with a breast pump during the 8 hours following tablet intake. This way, you will take your tablet well before the next feeding and reduce the amount of active ingredient that your child may ingest with breast milk.

Fertility

This medicine increases the likelihood of menstrual disturbances, which can sometimes advance or delay the date of ovulation, changing the date of fertility. Although there are no long-term fertility data after treatment with levonorgestrel, it is expected that fertility will return quickly, and you should continue or start regular contraceptives as soon as possible after using Levonorgestrel.

Driving and using machines

Levonorgestrel Adalvo contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Levonorgestrel Adalvo

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, 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 unprotected sex. Do not delay taking the tablet. The tablet works best when taken as soon as possible after unprotected sex. It can only prevent pregnancy if taken within 72 hours after unprotected sex.

• This medicine can be taken at any time during the menstrual cycle, except if you are already pregnant or think you may be pregnant. Do not crush or chew the tablet. Swallow the tablet whole with water.

• If you are using one of the medicines that can prevent Levonorgestrel from working correctly (see the previous section "Other medicines and Levonorgestrel Adalvo") or if you have used one of these medicines in the last 4 weeks, this medicine 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 together 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 during the same menstrual cycle), the medicine will not have a contraceptive effect, and there is a risk of pregnancy.

If you are concerned about any issues related to emergency contraception, talk to your doctor or another healthcare professional.

What to do if you feel sick (vomit)

If you feel sick and vomit within 3 hours of taking the tablet, you should take another tablet immediately.

After taking Levonorgestrel Adalvo

After taking this medicine, if you want to have sex and are not using the pill, you should use a condom or a diaphragm with spermicide until your next period. This is because Levonorgestrel will not work if you have unprotected sex again before your next period.

After taking this medicine, it is recommended that you make an appointment with your doctor about three weeks later to confirm that you are not pregnant. If your period is more than 5 days late or is unusually light or heavy, you should consult your doctor as soon as possible. If you become pregnant despite taking this medicine, it is essential to consult your doctor.

Your doctor will also advise you on long-term contraceptive methods that are more effective in preventing pregnancy.

If you are using hormonal contraceptives regularly, such as the pill, and do not have bleeding when expected, consult your doctor to confirm that you are not pregnant.

How your next period will be after taking Levonorgestrel Adalvo

After taking this medicine, your period will be normal and will start on the expected date. However, in some cases, it may start a few days earlier or later than expected. If your period is more than 5 days late or you experience any unusual bleeding, you should take a pregnancy test to rule out pregnancy.

If you take more Levonorgestrel Adalvo than you should

Although no serious harmful effects have been reported after taking several tablets at once, you may feel dizzy, nauseous, or experience vaginal bleeding. Consult your pharmacist, doctor, nurse, or family planning center for advice, especially if you have vomited, as the medicine may not have worked correctly.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Feeling sick (nausea)
• You may experience irregular bleeding until your next period
• You may have lower abdominal pain
• Fatigue
• Headache

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

• Vomiting (emesis). If you feel sick, read the section What to do if you feel sick (vomit).
• Your period may be different. Many women have their period normally and on the expected date, but others may have their period earlier or later than usual. You may also experience irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light or heavy, you should consult your doctor as soon as possible.

• You may have breast tenderness, diarrhea, or dizziness after taking this medicine.

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

• Rash, urticaria, itching, swelling of the face, pelvic pain, painful menstruation, abdominal pain.

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 Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levonorgestrel Adalvo

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

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

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the empty cartons and unused medicines in the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of cartons and medicines you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Levonorgestrel Adalvo

The active ingredient is levonorgestrel. Each tablet contains 1.5 milligrams of levonorgestrel.

The other components are potato starch, corn starch, anhydrous colloidal silica (E-551), magnesium stearate (E-470b), talc (E-553b), and lactose monohydrate.

Product Appearance and Packaging Content

Levonorgestrel Adalvo 1.5 mg tablet is a round, white to off-white tablet, with beveled edges, flat faces, marked with the inscription «J06» on one face and the other face is smooth.

Levonorgestrel Adalvo is available in a transparent PVC/Aluminum blister pack containing one tablet. The blister pack is packaged in a folding box.

Marketing Authorization Holder

Adalvo Limited

Malta Life Science Park,

Building 1, Level 4

Sir Temi Zammit Buildings,

San Gwann, SGN 3000, Malta

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

Date of the Last Revision of this Leaflet:10/2023

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es