Label: information for the user

Levosert 0.02mg every 24hours intrauterine system of release

levonorgestrel

Read this label carefully before starting to use this medication, as it contains important information for you.

-Keep this label, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What is Levosert and how it is used

2.What you need to know before starting to use Levosert

3.How to use Levosert

4.Possible adverse effects

5.Storage of Levosert

6.Contents of the package and additional information

Levosert is an intrauterine delivery system (IUD) for insertion into the uterus, where it slowly releases the hormone levonorgestrel.

It is used for:

Contraception

This medication is an effective long-term, non-permanent (reversible) contraceptive method.

This medication prevents pregnancy by thinning the lining of the uterus (endometrium), making the normal mucus of the cervical opening thicker, so that sperm cannot pass through to fertilize the egg, and by preventing ovulation in some women. Additionally, the presence of the T-shaped body causes local effects on the lining of the uterus.

The systemshould be removed after 8 years of use when used as a contraceptive.

Treatment of heavy menstrual bleeding

This medication is also useful for reducing menstrual blood flow, so you can use it if you suffer from heavy menstrual bleeding. This is known as menorrhagia. The hormone in this medication acts by thinning the lining of your uterus so that there is less bleeding each month.

The system should be removed or replaced after 8 years of use, or earlier if heavy menstrual bleeding reappears or becomes bothersome.

Children and adolescents

This medication is not indicated for use before the first menstrual period (menarche).

Before Levosert is placed, your doctor or nurse will perform some tests to ensure that Levosert is suitable for use. This will include a pelvic examination and may also include other examinations, such as a breast examination, if your doctor or nurse considers it appropriate.

Genital infections must be successfully treated before Levosert can be placed.

If you have epilepsy, inform your doctor or nurse before Levosert is placed because, although it is rare, a seizure may occur during insertion. Some women may feel dizzy after the procedure. This is normal and your doctor or nurse will tell you to rest for a while.

Not all women can use Levosert.

Do not use Levosert if:

-you are pregnant or suspect you may be pregnant;

-you have or have had pelvic inflammatory disease;

-you have unusual or unpleasant vaginal discharge, or vaginal itching, as this may indicate an infection;

-you have or have had uterine inflammation after a birth;

-you have or have had infection in the uterus after a birth or after an abortion in the last 3 months;

-you have or have had inflammation of the cervix;

-you have or have had an abnormal Pap smear (changes in the cervix);

-you have or have had liver problems;

-you have a liver tumor;

-you have a uterine anomaly, including uterine fibroids, especially those that distort the uterine cavity;

-you have an abnormal vaginal bleeding pattern;

-you have a condition that makes you susceptible to infections. A doctor will have told you if you have this type of condition;

-you have or have had hormone-dependent cancer, such as breast cancer;

-you have or have had or suspect the presence of any type of cancer, including blood cancer (leukemia), uterine and cervical cancer, unless you are in remission;

-you have or have had trophoblastic disease. A doctor will have told you if you have this type of disease;

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

Warnings and precautions

Before this medication is placed, your doctor or nurse will perform some tests to ensure that this medication is suitable for you. This will include a pelvic examination and may also include other examinations, such as a breast examination, if your doctor or nurse considers it appropriate.

Genital infections must be successfully treated before this medication can be placed.

If you have epilepsy, inform your doctor or nurse before this medication is placed because, although it is rare, a seizure may occur during insertion. Some women may feel dizzy after the procedure. This is normal and your doctor or nurse will tell you to rest for a while.

This medication may not be suitable for all women.

Levosert, like other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease (e.g., chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis). You will need to use condoms to protect yourself from these diseases.

Talk to your doctor before using Levosert if:

-you have or develop migraines, dizziness, blurred vision, severe headaches, or if you have headaches more frequently than before;

-you have jaundice (yellowing of the skin or eyes);

-you are diabetic (high blood sugar), have high blood pressure, or abnormal lipid blood levels;

-you have had cancer that affects the blood (including leukemia) that is now in remission

-you are under long-term steroid treatment;

-you have had a history of ectopic pregnancy (development of the fetus outside the uterus) or ovarian cysts;

-you have had or have severe arterial disease, such as a heart attack or stroke, or if you have any heart problems;

-you have a history of blood clots (thrombosis);

-you are taking other medications, as some medications may prevent Levosert from working correctly;

-you have irregular bleeding;

-you have seizures (epilepsy).

If you have or have had any of the conditions listed above, your doctor will decide if you can use Levosert.

You should also inform your doctor if any of these conditions occur for the first time while you have Levosert.

You should see a doctor or nurse as soon as possible if you experience painful swelling in the leg, sudden chest pain, or difficulty breathing, as these may be signs of a blood clot. It is essential that all blood clots are treated immediately.

Expulsion

The uterine contractions during menstruation may sometimes push the IUD out of its place or expel it.It is more likely to happen if you are overweight at the time of IUD insertion or if you have a history of heavy menstruation. If the IUD is expelled, it may not work properly and the risk of pregnancy increases. If the IUD is expelled, you are no longer protected against pregnancy.

The possible symptoms of expulsion are pain and abnormal bleeding, but Levosert can also be expelled without being noticed. Since Levosert reduces menstrual flow, an increase in it may indicate expulsion.

It is recommended that you check the strings with your finger, for example, while showering. See also section 3 “How to use Levosert - How can I know if Levosert is properly placed?” If you present signs indicating expulsion or were unable to feel the strings, you should use an additional contraceptive method (such as condoms), and consult with your healthcare professional.

Psychiatric disorders

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

Levosert and smoking

It is recommended that women quit smoking. Smoking increases the risk of developing heart attack, stroke, or blood clots.

Use of tampons or menstrual cups

It is recommended to use sanitary pads. If tampons or menstrual cups are used, you should change them carefully not to pull on the Levosert strings.

Use of Levosert with other medications

The effect of hormonal contraceptives like Levosert may be reduced by medications that increase the amount of enzymes produced by the liver. Inform your doctor if you are taking:

-phenobarbital, phenytoin, or carbamazepine (to treat epilepsy);

-griseofulvin (an antifungal);

-rifampicin or rifabutin (antibiotics);

-nevirapine or efavirenz (for HIV).

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. Levosert should not be used simultaneously with another hormonal contraceptive.

Pregnancy, breastfeeding, and fertility

Do not use Levosert during pregnancy or if you suspect you may be pregnant.

Can I get pregnant while using Levosert?

It is very rare for a woman to become pregnant while having Levosert placed.

Not having a period does not necessarily mean you are pregnant. Some women may not have periods while using the system.

If you have not had a period for 6 weeks, consider taking a pregnancy test. If it is negative, there is no need to take further tests, unless you have other symptoms of pregnancy, such as nausea, fatigue, or breast tenderness.

If you become pregnant with the device in place, contact your doctor as soon as possible to rule out an ectopic pregnancy (development of the fetus outside the uterus) and have Levosert removed to reduce the risk of a spontaneous abortion.

And if I want to have a baby?

If you want to have a baby, ask your doctor to remove Levosert. Your normal fertility level will return very quickly once the system is removed.

Can I breastfeed while using Levosert?

Small amounts of the hormone in Levosert are found in breast milk. It is not expected to pose any risk to the baby. You can continue breastfeeding while using this medication.

Driving and operating machines

No known effects on the ability to drive and operate machines.

Levosert contains barium sulfate.

The T-shaped body of Levosert contains barium sulfate, so it may be visible in X-rays.

Only a doctor or nurse with specific training can insert the system (see special instructions for insertion in the packaging).

The healthcare professional will explain the placement procedure and any associated risks. You will be examined by your doctor or nurse before the insertion of Levosert. If you have any doubts about its use, consult them.

The device must be inserted either during menstruation or within seven days of the start of menstruation. If you already have the device and it's time to replace it with a new one, you don't need to wait for your period.

If you have just given birth, you must wait at least six weeks before Levosert is placed. Levosert can sometimes be placed immediately after a miscarriage, as long as there are no genital infections.

How quickly does Levosert work?

Birth control

You are protected against pregnancy from the moment the system is placed.

Heavy menstrual bleeding

Levosert usually achieves a significant reduction in menstrual blood loss within 3 to 6 months of treatment.

How will Levosert affect my periods?

Many women experience spotting (a small amount of bleeding) in the first 3-6 months after the system is placed. Others may have prolonged or heavy bleeding. However, you may experience increased bleeding, usually in the first 2 to 3 months, before a reduction in blood loss is achieved. In general, you are more likely to have fewer days of bleeding each month and may even stop having your period. This is due to the effect of the hormone (levonorgestrel) on the uterine lining. If a significant reduction in blood loss is not achieved within 3 to 6 months, other treatments should be considered.

If you have had Levosert in place for a prolonged period and then start experiencing bleeding problems, contact your doctor or healthcare professional for advice.

How often should I have the system checked?

The system should be checked generally 6 weeks after placement, again at 12 months, and then once a year until it is removed.

How can I know if the system is in place?

After each menstrual period, you can look for the two thin threads attached to the lower end of the system. Your doctor will teach you how to do this.

Do not pullon the threads, as this could accidentally remove the system. If you cannot find the threads, contact your doctor or nurse as soon as possible and avoid sexual intercourse or use a barrier method of contraception (such as condoms) until then. The threads may simply have entered the uterus or cervical canal. If your doctor or nurse still cannot find the threads, they may have broken, or Levosert may have come out on its own, or in rare cases, it may have perforated the uterine wall (uterine perforation, see section 4).

You should also see a doctor if you can feel the lower end of the device itself, or if you or your partner experience pain or discomfort during sexual intercourse.

What happens if the system comes out on its own?

If the system comes out completely or partially, you may not be protected against pregnancy. It is rare, but possible, for this to happen without you realizing it during menstruation. An unusual increase in the amount of bleeding during menstruation may be a sign that this has happened. Inform your doctor or healthcare professional if you experience unexpected changes in your bleeding pattern.

If you stop using Levosert

Your doctor can remove the system at any time. The removal is very simple. Unless you plan to insert a new system or an intrauterine device immediately, it is essential to use another form of contraception in the week leading up to removal. Sexual intercourse during this week could lead to pregnancy once Levosert is removed.

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

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

With Levosert, side effects are more frequent during the first months after the system has been placed and decrease over time.

If you experience any of the following severe side effects, please contact your doctor or nurse immediately:

• Intense pain or fever that develops shortly after insertionmay indicate a serious infection that should be treated immediately. In rare cases, a severe infection (sepsis) may occur.
• Intense pain and continuous bleedingas this may be a sign of uterine wall damage or perforation. Perforation is rare, but it occurs more frequently during Levosert insertion, although it may not be detected until some time later. If Levosert has become lodged outside the uterine cavity, it is not effective in preventing pregnancy and should be removed as soon as possible; in very rare cases, this may require surgery. The risk of perforation is low, but it increases in women who are breastfeeding or have had a baby within 36 weeks before insertion and may increase in women with a fixed retroverted uterus. If you suspect you have suffered a perforation, seek immediate medical attention and remind them that you have Levosert inserted, especially if it was not the person who inserted it.

Possible signs and symptoms of perforation may include:

• Intense pain (like menstrual cramps) or more pain than expected
• Heavy bleeding (after insertion)
• Pain or bleeding that continues for more than a few weeks
• Changes in menstrual cycles
• Pain during sex
• If you can no longer feel the Levosert strings (see “How can I know if the system is in place?” in Section 3).

• Lower abdominal pain, especially if you also have a fever or have had unexpected bleeding or spotting,as this may be a sign of ectopic pregnancy (fetal development outside the uterus). The absolute risk of ectopic pregnancy in Levosert users is low. However, when a woman becomes pregnant with Levosert in place, the risk of ectopic pregnancy increases.

• Lower abdominal pain or experiencing painful or difficult sexmay be a sign of ovarian cysts or pelvic inflammatory disease. This is important as pelvic infections can reduce your chances of getting pregnant and increase the risk of ectopic pregnancy.

Other side effects

Most common(may affect more than 1 in 10 women) may include:

-absence of menstruation, light or infrequent (see "How will Levosert One affect my menstruation?" in Section 3.

-vaginal bleeding, including spotting

-vaginal or external genital infections caused by fungi or bacteria;

-acne;

Frequent(may affect up to 1 in 10 women) may include:

-depression, nervousness, or other mood changes;

-reduced sex drive;

-headaches;

-migraines;

-dizziness;

-nausea;

-abdominal discomfort;

-back pain;

-nausea;

-abdominal bloating;

-vomiting;

-menstrual cramps;

-increased vaginal discharge;

-breast tenderness and pain;

-painful sex;

-uterine cramps;

-Levosert becoming dislodged;

-weight gain.

Rare(may affect up to 1 in 1,000 women) may include:

-skin rash, itching,

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Conserve in the original packaging. Keep the pouch in the outer box to protect it from light. Do not open the Levosert packaging. Only your doctor or healthcare professional can do this.

Keep this medication out of sight and reach of children.

Do not use this system after the expiration date that appears on the label and on the outer packaging after “CAD:”. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Composition of Levosert

Levosert contains 52 mg of levonorgestrel, the active principle. The hormone is contained within a substance called polydimethylsiloxane. This substance is surrounded by a membrane that is also made of polydimethylsiloxane.

Appearance of the product and contents of the package

Levosert consists of a small T-shaped body made of a plastic called polyethylene. This structure provides a device for releasing the hormone gradually into the uterus.

There are two fine threads, made of polypropylene and copper phthalocyanine blue, attached to the lower end of the frame. These threads will allow for easy removal and will enable you and your doctor to check that the device is in place.

Package sizes:

1 intrauterine release system with applicator device.

5 intrauterine release systems with applicator device.

Multipack: five packages of one intrauterine release system with an applicator device.

Only some package sizes may be commercially available.

Each package contains one Levosert intrauterine release system.

Marketing Authorization Holder

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

Manufacturer

Odyssea Pharma SA

Rue du Travail 16

4460 Grâce Hollogne

Belgium

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Gedeon Richter Ibérica S.A.

Sabino Arana, 28 4º 2ª

08028 Barcelona

Spain

+34 93 2034300

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last review date of this leaflet:May 2024

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for healthcare professionals

See the instructions for use and handling included in the package.

_____________________________________________________________________________

Instructions for use and handling

Levosert 0,02 mg every 24 hours intrauterine release system

levonorgestrel

This information is intended solely for healthcare professionals

Prescriber checklist

Make the following questions before prescribing/inserting Levosert:

Have you checked that the patient's needs meet the indications for contraception or heavy menstrual bleeding and the duration of use, up to eight years?

Have you completed the patient's card included in the package and given it to the patient as a reminder (any insertion of more than eight years' duration must be reported as unauthorized use in the technical file)?

Read the following instructions for use carefully, as there may be some differences in the type of applicator device compared to other IUDs you have used previously:

Conditions of use

1. In fertile women, the intrauterine release system (IUS) is inserted within seven days of the start of menstruation. It can be replaced by a new system at any time in the cycle.
2. It is strongly recommended that the IUS be inserted only by doctors/healthcare professionals who have received adequate training and have read these instructions carefully before inserting Levosert.
3. The device is supplied in a sterile package that should not be opened until it is necessary for its insertion. The exposed product must be handled with aseptic precautions. Do not use if the inner package is damaged or open.
4. Determine the position (anteversion, retroversion) and size of the uterus by a gynecological examination. Exclude pregnancy and contraindications.
5. Place a speculum, use an appropriate antisepsis solution to clean the vagina and cervix.
6. Use cervical dilators if uterine cervix stenosis has been diagnosed. Do not apply force to overcome resistance. If cervical dilation is required, consider the use of analgesics and/or a paracervical block.
7. Grasp the cervix with a tenaculum forceps and apply a gentle traction to straighten the cervical canal and uterine cavity.
8. Determine the uterine depth by hysteroscopy. If the uterine depth is <5.5 cm, interrupt the procedure.

Description

Preparation for insertion

The insertion of Levosert has been completed.

Important information to consider during or after insertion:

• If you suspect that the IUS is not in the correct position:

• Check the insertion with an ultrasound or other suitable radiological test.
• If you suspect that the insertion is incorrect, remove the IUS. Do not reinsert the same IUS after removing it.

IMPORTANT!

In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, perform a physical examination and an ultrasound immediately to rule out uterine or cervical perforation. A physical examination alone (including checking the threads) may not be sufficient to exclude a partial perforation. If necessary, remove the system and insert a new sterile system.

Report any cases of uterine perforation or insertion difficulties to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

How to remove Levosert

The IUS is removed by gently pulling on the threads with a forceps.The use of excessive force or sharp instruments during removal may cause the system to break.If the threads are not visible and the IUS is in the uterine cavity, it can be removed using narrow tenaculum forceps or an intrauterine thread retriever. This may require cervical dilation.

If pregnancy is not desired, removal should be performed during menstruation in fertile women, provided it appears to be a menstrual cycle. If the system is removed in the middle of the cycle and the woman has had sexual intercourse in the previous week, she is at risk of pregnancy.To ensure continued contraception, a new system should be inserted immediately or an alternative contraceptive method initiated..

After removing the IUS, the system should be examined to check that it is intactand has been completely removed. During difficult removals, isolated cases have been reported where the hormone cylinder has slid over the horizontal arms, completely hiding them inside the T-shaped body. This situation does not require any further intervention once it has been confirmed that the IUS is complete. The protuberances of the horizontal arms normally prevent the complete separation of the cylinder from the T-shaped body.