LEVOSERT 0.02 mg EVERY 24 HOURS INTRAUTERINE RELEASE SYSTEM

Introduction

Package Leaflet: Information for the User

Levosert 0.02mg every 24hours intrauterine release system

levonorgestrel

Read the entire package leaflet carefully before starting to use 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.
• 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 Levosert and what is it used for
2. What you need to know before starting to use Levosert
3. How to use Levosert
4. Possible side effects
5. Storage of Levosert
6. Package contents and additional information

1. What is Levosert and what is it used for

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

It is used for:

Contraception

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

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

The system must 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 (periods). This is called 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 sooner if heavy or bothersome menstrual bleeding returns.

Children and adolescents

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

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

Do not use Levosert:

• if you are pregnant or think you may be pregnant;
• if you have or have had pelvic inflammatory disease;
• if you have an unusual or unpleasant vaginal discharge, or vaginal itching, as this may indicate an infection;
• if you have or have had inflammation of the uterine lining after childbirth;
• if you have or have had a uterine infection after childbirth or abortion in the last 3 months;
• if you have or have had cervical inflammation;
• if you have or have had an abnormal Pap test (changes in the cervix);
• if you have or have had liver problems;
• if you have a liver tumor;
• if you have a uterine anomaly, including uterine fibroids, especially those that distort the uterine cavity; have an abnormal vaginal bleeding pattern;
• if you have a condition that makes you susceptible to infections. A doctor will have told you if you have this type of condition;
• if you have or have had hormone-dependent cancer, such as breast cancer;
• if you have or have had or suspect the existence of any type of cancer, including blood cancer (leukemia), uterine, and cervical cancer, unless you are in remission;
• if you have or have had trophoblastic disease. A doctor will have told you if you have this type of disease;
• if you are allergic to levonorgestrel or any of the other components of this medication (listed in section 6).

Warnings and precautions

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

Genital infections will need to be successfully treated before this medication can be inserted.

If you have epilepsy, inform your doctor or nurse before the insertion of this medication, as it can rarely cause a seizure 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 other sexually transmitted diseases (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, worse-than-usual headaches, or if you have headaches more frequently than before;
• if you have yellowing of the skin or whites of the eyes (jaundice);
• if you are diabetic (high blood sugar levels), have high blood pressure, or abnormal blood lipid levels;
• if you have had blood cancer (including leukemia) that is now in remission
• if you are undergoing long-term steroid treatment;
• if you have had an ectopic pregnancy (fetal development outside the uterus) or a history of ovarian cysts;
• if you have had a severe arterial disease, such as a heart attack or stroke, or if you have any heart problems;
• if you have a history of blood clots (thrombosis);
• if you are taking other medications, as certain medications can prevent Levosert from working properly;
• if you have irregular bleeding;
• if you have seizures (epilepsy).

If you have or have had any of the above conditions, 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 inserted.

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 can be signs of a blood clot. It is essential that any blood clot is treated immediately.

Expulsion

Uterine muscle contractions during menstruation can sometimes push the IUS out of place or expel it. This is more likely to happen if you are overweight at the time of IUS insertion or if you have a history of heavy menstrual periods. If the IUS is displaced, it may not work properly, and the risk of pregnancy increases. If the IUS is expelled, you are no longer protected against pregnancy.

Possible symptoms of expulsion are pain and abnormal bleeding, but Levosert can also be expelled without you realizing it. Because Levosert reduces menstrual flow, an increase in flow may indicate expulsion.

It is recommended that you check the threads with your finger, for example, while showering. See also section 3 "How to use Levosert - How can I tell if Levosert is in place?". If you experience signs that indicate expulsion or are unable to feel the threads, you should use an additional contraceptive method (such as condoms) and consult 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 can lead to suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Levosert and smoking

Women are advised to stop smoking. Smoking increases the risk of developing a heart attack, stroke, or blood clots.

Use of tampons or menstrual cups

The use of pads is recommended. If you use tampons or menstrual cups, you should change them carefully to avoid pulling on the Levosert threads.

Using Levosert with other medications

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

• phenobarbital, phenytoin, or carbamazepine (for epilepsy);
• griseofulvin (an antifungal);
• rifampicin or rifabutin (antibiotics);
• nevirapine or efavirenz (for HIV).

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

Pregnancy, breastfeeding, and fertility

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

Can I get pregnant while using Levosert?

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

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 for further testing, 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 (fetal development outside the uterus) and to have Levosert removed to reduce the risk of a miscarriage. However, if Levosert is left in place during pregnancy, it not only increases the risk of miscarriage but also the risk of preterm birth. If Levosert cannot be removed, talk to your healthcare professional about the benefits and risks of continuing the pregnancy. If the pregnancy continues, you will be closely monitored during your pregnancy, and you should contact your doctor immediately if you experience stomach cramps, stomach pain, or fever.

Levosert contains a hormone called levonorgestrel, and there have been isolated cases of genital effects in babies if they are exposed to levonorgestrel intrauterine devices while in the uterus.

What 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 Levosert hormone are found in breast milk. No risk is expected for the newborn. You can continue breastfeeding during the use of this medication.

Driving and using machines

There are no known effects on the ability to drive and use machines.

Levosert contains barium sulfate.

The T-shaped body of Levosert contains barium sulfate, so it can be seen on X-rays.

3. How to use Levosert

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

The professional will explain the insertion procedure and any risks associated with its use. Afterwards, you will be examined by your doctor or nurse before the insertion of Levosert. If you have any questions about its use, you can consult with them.

Starting to use Levosert

• Before inserting Levosert, it is necessary to ensure that you are not pregnant.
• You should have Levosert inserted within 7 days of the start of your menstruation. When Levosert is inserted during these days, it acts immediately and will prevent you from getting pregnant.
• If you cannot have Levosert inserted within 7 days of the start of your menstruation or if your menstrual period arrives at unpredictable times, Levosert can be inserted on any other day. In this case, you should not have had unprotected sex since your last menstrual period, and you should have a negative pregnancy test before insertion. Additionally, Levosert may not prevent pregnancy reliably from the start. Therefore, you should use a barrier contraceptive method (such as condoms) or abstain from vaginal sex for the first 7 days after the insertion of Levosert.
• Levosert is not suitable for use as an emergency contraceptive (postcoital contraceptive).

Starting to use Levosert after childbirth

• Levosert can be inserted after childbirth once the uterus has returned to its normal size, but not before 6 weeks after childbirth (see section 4 "Possible side effects - Perforation").
• Also, see "Starting to use Levosert" above to learn more about what you need to know about the time of insertion.

Starting to use Levosert after an abortion

Levosert can be inserted immediately after an abortion, if the pregnancy was less than 3 months long and there are no genital infections. In this case, Levosert will work immediately.

Replacing Levosert

Levosert can be replaced with a new Levosert at any time during your menstrual cycle. In this case, Levosert will work immediately.

Switching from another contraceptive method (such as combined hormonal contraceptives, implant)

• Levosert can be inserted immediately if there is reasonable certainty that you are not pregnant.
• If it has been more than 7 days since the start of your menstrual bleeding, you should abstain from vaginal sex or use additional contraceptive protection for the next 7 days.

Insertion of Levosert

The examination performed by your healthcare professional before insertion may include:

• a cervical cytology test (Pap smear);
• a breast examination;
• other tests, for example for infections, including sexually transmitted diseases, pregnancy test, as necessary. Your healthcare professional will also perform a gynecological examination to determine the position and size of the uterus.

After the gynecological examination

• An instrument called a speculum is inserted into the vagina, and the cervix may be cleaned with an antiseptic solution. Then, Levosert is inserted into the uterus using a thin, flexible plastic tube (the insertion tube). Local anesthesia may be applied to the cervix before insertion.
• Some women feel dizzy or faint during or after the insertion or removal of Levosert.
• You may experience some pain and bleeding during or immediately after the insertion.

After the insertion of Levosert, you should receive a patient reminder card from your doctor for follow-up appointments. Bring this card with you to each scheduled appointment.

How quickly does Levosert work?

Contraception

If Levosert is inserted into your uterus during your menstrual period or within 7 days after the start of your period, or if you have a device and it's time to replace it with a new one, or if you have just had an abortion, you are protected against pregnancy from the moment the system is inserted.

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 blood loss) in the first 3-6 months after the insertion of the system. Others will have prolonged or heavy bleeding. However, you may experience an increase in 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 inserted for a prolonged period and then start experiencing bleeding problems, contact your doctor or healthcare professional for advice.

How often should I have my system checked?

You should check your Levosert 4 to 6 weeks after insertion, and then regularly, at least once a year until its removal. Your doctor will determine how often and what types of checks are required in your particular case. Bring the patient reminder card you received from your doctor to each scheduled appointment. Also, you should contact your doctor if you experience any of the symptoms described in section 2 "Warnings and precautions".

How can I tell if the system is in place?

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

Do not pullon the threads, as you could accidentally pull it out. If you cannot find the threads, contact your doctor or nurse as soon as possible and avoid sex or use a barrier contraceptive method (such as condoms) until then. The threads may have simply 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 go to the doctor if you can touch the lower end of the device itself, or if you or your partner experience pain or discomfort during sex.

What happens if the system comes out by itself?

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

Removal of Levosert

Levosert should be removed or replaced after 8 years of use, or earlier if heavy or bothersome menstrual bleeding returns.

Your doctor can easily remove the system at any time, after which it is possible to become pregnant. Some women feel dizzy or faint during or after the removal of Levosert. You may experience some pain and bleeding during the removal of Levosert.

Continuation of contraception after removal

If you do not want to become pregnant, Levosert should not be removed after the seventh day of the menstrual cycle (menstrual period) unless you use other contraceptive methods (e.g., condoms) for at least 7 days before the removal of the IUD.

If you have irregular periods or do not have periods, you should use a barrier contraceptive method for 7 days before removal.

Also, a new Levosert can be inserted immediately after removal, in which case no additional protection is needed. If you do not want to continue with the same method, ask your doctor about other reliable contraceptive methods.

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

4. Possible side effects

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

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

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

• Severe pain or fever that develops soon after insertionmay indicate that you have a serious infection that should be treated immediately. In rare cases, a very serious infection (sepsis) can occur.
• Severe pain and continued bleedingas this may be a sign of damage or perforation of the uterine wall. Perforation is rare, but it can occur, especially during the insertion of Levosert, 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 breastfeeding women or women who have had a baby up to 36 weeks before insertion and may increase in women with a fixed retroverted uterus. If you suspect that you may have suffered a perforation, seek medical attention immediately 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:

• severe pain (like menstrual cramps) or more pain than expected
• heavy bleeding (after insertion)
• pain or bleeding that continues for more than a few weeks
• sudden changes in periods
• pain during sex
• if you can no longer feel the Levosert threads (see "How can I tell if the system is in place?" in section 3).

• Pelvic pain, especially if you also have a fever or have had a missed period or have unexpected bleeding,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 likelihood of ectopic pregnancy increases.

• Pelvic pain or you experience difficult or painful sexas this may be a sign of ovarian cysts or pelvic inflammatory disease. This is important because pelvic infections can reduce your chances of having a baby and can increase the risk of ectopic pregnancy.

Other side effects

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

• absence of menstruation, light or infrequent (see "How will Levosert affect my periods?" in section 3.
• vaginal bleeding, including spotting.
• vaginal or genital infections (caused by fungi or bacteria);
• acne;

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

• depression, nervousness, or other mood changes;
• reduced sex drive;
• headache;
• migraine;
• feeling of fainting (presyncope);
• dizziness;
• back pain;
• abdominal discomfort;
• nausea;
• bloating;
• vomiting;
• painful periods;
• increased vaginal discharge;
• tender or painful breasts;
• painful sex;
• uterine spasm;
• Levosert coming out of place;
• weight gain.

Uncommon(may affect up to 1 in 100 women) may include:

• fainting;
• eczema;
• cervicitis (inflammation of the cervix);
• swelling or inflammation in the legs or ankles;
• increased hair growth on the face and body;
• hair loss;
• itching of the skin (pruritus);
• skin discoloration or increased skin pigmentation, especially on the face (chloasma).

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

• skin rash, itching,

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levosert

Store in the original packaging. Keep the bag in the outer box to protect it from light. Keep the container tightly closed. Only your doctor or healthcare professional can open it.

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

Do not use this system after the expiration date stated on the label and on the outer packaging after "EXP:". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Levosert

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

Product Appearance and Container Contents

Levosert consists of a small T-shaped body made of a plastic called polyethylene. This structure provides a device for gradual release of the hormone in the uterus.

There are two thin 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 allow you and your doctor to check that the device is in place.

The Levosert SLI with the insertion device is individually packaged in a peelable pouch made of two layers: a thermoformed pouch (polyester) with a peelable lid.

Each container contains one or five Levosert in a pouch or peelable pouches, which are individually packaged in one or five individual boxes with the patient information leaflet and the patient reminder card.

Container sizes:

1 intrauterine release system with an insertion device.

5 intrauterine release systems with an insertion device.

Multipack: five containers of an intrauterine release system with an insertion device.

Only some container sizes may be marketed.

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

You can request more information about this medicinal product by contacting 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 medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this leafletJuly 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals

Consult the instructions for use and handling included in the container.

_____________________________________________________________________________

Instructions for Use and Handling

Levosert 0.02 mg every 24 hours intrauterine release system

levonorgestrel

This information is intended only for healthcare professionals

Checklist for the Prescribing Professional

Ask yourself the following questions before prescribing/inserting Levosert:

• Have I 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 I completed the patient card included in the container and given it to the patient as a reminder? (any insertion for more than eight years of duration must be reported as unauthorized use)

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

Insertion Instructions

It must be inserted by a healthcare professional using an aseptic technique.

It is recommended that Levosert should only be inserted by healthcare professionals who are experienced in the placement of intrauterine release systems (IUS) and/or who have received sufficient training on the insertion procedure of Levosert and have read these instructions carefully before inserting Levosert.

Levosert is supplied in a sterile container that should not be opened until it is necessary for insertion. Do not re-sterilize. For single use. The exposed product should be handled with aseptic precautions. If the seal of the sterile container is broken, the product should be discarded (see disposal instructions in section 6.6). Do not use if the inner container is damaged or open. Do not insert after the expiration date indicated on the box and on the blister after CAD. The expiration date is the last day of the month indicated.

To determine the time of insertion, refer to section 4.2 of the summary of product characteristics.

Levosert includes a patient reminder card in the container. Complete the patient reminder card and give it to the patient after insertion.

Preparation for Insertion

• Examine the patient to rule out contraindications for the insertion of Levosert (see sections 4.3 and 4.4 under Medical Examination).
• Insert a speculum, visualize the cervix, and then perform a thorough cleaning of the cervix and vagina with a suitable antiseptic solution.
• The healthcare professional may have the assistance of auxiliary personnel if necessary.
• Hold the anterior lip of the cervix with a tenaculum or other forceps to stabilize the uterus. If the uterus is in retroversion, it may be more appropriate to hold the posterior lip of the cervix. A gentle traction can be applied with the forceps to straighten the cervical canal. The forceps should remain in place and a gentle traction should be maintained on the cervix throughout the insertion procedure.
• Insert a uterine sound through the cervical canal to the fundus to measure the depth. If the uterine depth is <5.5 cm, interrupt the procedure. Confirm the direction of the uterine cavity and rule out any evidence of intrauterine anomalies (e.g., septum, submucous myomas) or a previously inserted intrauterine contraceptive that has not been removed. If difficulty is encountered, consider cervical dilation. If cervical dilation is required, consider the use of analgesics and/or a paracervical block.

Description

Preparation for Insertion

Figure 2 Figure 3

The insertion of Levosert is complete.

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 incorrect insertion is suspected, remove the IUS. Do not reinsert the same IUS after removal.

IMPORTANT!

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

After insertion, women should be re-examined after 4 to 6 weeks to check the threads and ensure that the device is in the correct position. Report any cases of uterine perforation or insertion difficulties through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

Removal/Replacement

The IUS is removed by gently pulling on the threads with forceps. The use of excessive force or sharp instruments during removal can cause the system to break.

If the threads are not visible and it is discovered that the system is in the uterine cavity on ultrasound examination, it can be removed using narrow forceps. This may require cervical dilation or surgical intervention.

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