Levosert 0.02 mg/24 hours intrauterine system

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levosert 0.02 mg per 24 hours intrauterine delivery system

levonorgestrel

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Levosert is and what it is used for
2. What you need to know before using Levosert
3. How to use Levosert
4. Possible side effects
5. How to store Levosert
6. Contents of the pack and other information

1. What Levosert is and what it is used for

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

It is used for:

Contraception

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

This medicine prevents pregnancy by thinning the lining of the womb (uterus), thickening the normal mucus at the opening of the uterus (cervical canal), thereby preventing sperm from passing through to fertilize the egg, and by preventing the release of eggs (ovulation) in some women. In addition, the presence of the T-shaped device causes local effects on the uterine lining.

The system must be removed after 8 years of use when used for contraception.

Treatment of heavy menstrual bleeding

This medicine is also useful for reducing menstrual blood flow and may be used if you suffer from heavy menstrual bleeding (periods). This condition is called menorrhagia. The hormone in this medicine works by thinning the lining of your uterus so that there is less bleeding each month.

The system must be removed or replaced after 8 years of use, or earlier if heavy or bothersome menstrual bleeding recurs.

Children and adolescents

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

2. What you need to know before using Levosert

Do not use Levosert:

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

Warnings and precautions

Before this medicine is inserted, your doctor or nurse will perform certain tests to ensure that this medicine 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 medicine can be inserted.

If you have epilepsy, inform your doctor or nurse before insertion, as although rare, a seizure may occur during the procedure. Some women may feel faint after the procedure. This is normal, and your doctor or nurse will advise you to rest for a while.

This medicine may not be suitable for all women.

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

Talk to your doctor before using Levosert:

• if you have or develop migraine, dizziness, blurred vision, unusually severe headaches, or if you get headaches more frequently than before;
• if you have yellowing of the skin or whites of the eyes (jaundice);
• if you have diabetes (high blood sugar), high blood pressure, or abnormal blood lipid levels;
• if you have had cancer affecting the blood (including leukemia) that is currently in remission;
• if you are undergoing long-term corticosteroid treatment;
• if you have ever had an ectopic pregnancy (pregnancy outside the uterus) or a history of ovarian cysts;
• if you have had or have a serious arterial disease, such as 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 medicines, as certain medicines may reduce the effectiveness of Levosert;
• if you have irregular bleeding;
• if you have seizures (epilepsy).

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

You should also inform your doctor if any of these conditions develop for the first time while Levosert is in place.

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

Expulsion

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

Possible symptoms of expulsion include pain and abnormal bleeding, but Levosert may also be expelled without your awareness. Because Levosert reduces menstrual flow, an increase in bleeding 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 correctly placed?”. If you notice signs suggesting expulsion or are unable to feel the threads, you should use an additional contraceptive method (such as condoms) and consult your healthcare provider.

Psychiatric disorders

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

Levosert and smoking

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

Use of tampons or menstrual cups

The use of sanitary pads is recommended. If tampons or menstrual cups are used, they should be changed carefully to avoid pulling on the threads of Levosert.

Using Levosert with other medicines

The effectiveness of hormonal contraceptives such as Levosert may be reduced by medicines that increase the production of liver enzymes. Inform your doctor if you are taking:

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

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines. 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 become pregnant while using Levosert?

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

The absence of 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 the test is negative, no further testing is needed 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 (pregnancy outside the uterus) and to have Levosert removed to reduce the risk of miscarriage. However, if Levosert cannot be removed, discuss with your healthcare provider the benefits and risks of continuing the pregnancy. If the pregnancy continues, you will be closely monitored, and you should contact your doctor immediately if you experience abdominal cramps, stomach pain, or fever.

Levosert contains a hormone called levonorgestrel, and there have been isolated reports of genital effects in babies exposed to levonorgestrel-containing intrauterine devices while in the womb.

What if I want to have a baby?

If you wish to become pregnant, ask your doctor to remove Levosert. Your normal fertility will return very quickly after removal.

Can I breastfeed while using Levosert?

Very small amounts of the hormone from Levosert are present in breast milk. No risk is expected for the newborn. You may continue breastfeeding during use of this medicine.

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 specially trained doctor or nurse may insert the system (see the special instructions for insertion in the package).

The healthcare professional will explain the insertion procedure and any risks associated with its use. You will be examined by your doctor or nurse before Levosert is inserted. If you have any questions about its use, you may discuss them with your healthcare provider.

Starting to use Levosert

• Before inserting Levosert, it is necessary to ensure that you are not pregnant.
• Levosert should be inserted within 7 days of the start of your menstrual period. When Levosert is inserted during this time, it acts immediately and will prevent pregnancy.
• If you cannot have Levosert inserted within 7 days of the start of your period, or if your menstrual periods occur at unpredictable times, Levosert may be inserted on any other day. In this case, you must not have had unprotected sexual intercourse since your last menstrual period, and you must have a negative pregnancy test before insertion. In addition, Levosert may not reliably prevent pregnancy immediately. Therefore, you must use a barrier contraceptive method (such as condoms) or abstain from vaginal intercourse for the first 7 days after insertion of Levosert.
• Levosert is not suitable for use as emergency contraception (post-coital contraception).

Starting to use Levosert after childbirth

• Levosert may be inserted after childbirth once the uterus has returned to its normal size, but not earlier than 6 weeks after delivery (see section 4 “Possible side effects – Perforation”).
• See also “Starting to use Levosert” above for further information on the timing of insertion.

Starting to use Levosert after an abortion

Levosert may be inserted immediately after an abortion if the pregnancy was less than 3 months in duration, provided there are no genital infections. In this case, Levosert will act immediately.

Replacing Levosert

Levosert may be replaced by a new Levosert at any time during your menstrual cycle. In this case, Levosert will act immediately.

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

• Levosert may be inserted immediately if there is reasonable certainty that you are not pregnant.
• If more than 7 days have passed since the start of your menstrual bleeding, you must abstain from vaginal intercourse 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 infections, and a pregnancy test, as needed. Your healthcare professional will also perform a gynecological examination to determine the position and size of the uterus.

After the gynecological examination

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

After Levosert is inserted, you should receive a patient reminder card from your doctor for follow-up appointments. Keep this card with you for every scheduled appointment.

How quickly does Levosert work?

Contraception

If Levosert is inserted into your uterus either during your menstrual period or within 7 days of the start of your period, or if you have a device and it is 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 (light bleeding) during the first 3–6 months after insertion of the system. Others may have prolonged or heavy bleeding. However, you may experience increased bleeding, usually during the first 2 to 3 months, before a reduction in blood loss is achieved. In general, you are likely to have fewer bleeding days each month and may even stop having periods altogether. This is due to the effect of the hormone (levonorgestrel) on the lining of the uterus. If a significant reduction in blood loss is not achieved within 3 to 6 months, alternative treatments should be considered.

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

How often should I have my system checked?

You should have your Levosert checked 4 to 6 weeks after insertion, and then regularly, at least once a year until it is removed. Your doctor will determine how often and what types of checks are needed in your particular case. Bring the patient reminder card you received from your doctor to every scheduled appointment. In addition, 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 may check for the two thin threads attached to the lower end of the system. Your doctor will show you how to do this.

Do not pull on the threads, as this could accidentally dislodge the device. If you cannot feel the threads, contact your doctor or nurse as soon as possible and avoid sexual intercourse or use a barrier contraceptive method (such as condoms) in the meantime. The threads may simply have retracted into the uterus or cervical canal. If your doctor or nurse still cannot locate the threads, they may have broken, or Levosert may have been expelled spontaneously, or in rare cases, it may have perforated the uterine wall (uterine perforation, see section 4).

You should also see your doctor if you can feel the lower end of the device itself, or if you or your partner feel 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. This is rare but possible, and may occur without your knowledge during your menstrual period. An unusually heavy menstrual flow may be a sign that this has occurred. Inform your doctor or healthcare professional if you experience unexpected changes in your bleeding pattern.

Removal of Levosert

Levosert must 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 pregnancy may occur. Some women feel dizzy or faint during or after removal of Levosert. You may experience some pain and bleeding during removal.

Continuation of contraception after removal

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

If you have irregular periods or no periods at all, you should use a barrier contraceptive method for 7 days before removal.

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

If you have further questions about using this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

With Levosert, adverse effects are more common during the first few months after insertion of the system and tend to decrease over time.

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

• Severe pain or fever occurring shortly after insertion, as this may indicate a serious infection that should be treated immediately. In rare cases, a very serious infection (sepsis) may occur.
• Severe pain and ongoing bleeding, as this may be a sign of damage or tear in the uterine wall (perforation). Perforation is uncommon but occurs more frequently during insertion of Levosert, although it may not be detected until some time later. If Levosert has migrated outside the uterine cavity, it will not be effective in preventing pregnancy and should be removed as soon as possible; in very rare cases, surgical intervention may be required. The risk of perforation is low, but it is increased in breastfeeding women or women who have given birth within 36 weeks prior to insertion, and may also be increased in women with a fixed retroverted uterus (retroversion and fixation). If you suspect you may have experienced perforation, seek immediate medical attention and inform the healthcare provider that you have Levosert inserted, especially if it was not the person who inserted it who is now evaluating you.

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 beyond a few weeks

• sudden changes in menstrual periods

• pain during sexual intercourse

• if you can no longer feel the Levosert threads (see “How can I tell if the system is in place?” in section 3).

• Lower abdominal pain, especially if accompanied by fever, missed period, or unexpected bleeding, as this may be a sign of ectopic pregnancy (fetus developing 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.

• Lower abdominal pain or experiencing difficult or painful sexual intercourse, as this may be a sign of ovarian cysts or pelvic inflammatory disease. This is important because pelvic infections may reduce your chances of becoming pregnant and may increase the risk of ectopic pregnancy.

Other adverse effects

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

• absence of menstruation, light or infrequent periods (see "How will Levosert One affect your periods?" in section 3)
• vaginal bleeding, including spotting
• vaginal or external genital (vulva) 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 faint (presyncope)
• dizziness
• back pain
• abdominal discomfort
• nausea
• bloated abdomen
• vomiting
• painful periods
• increased vaginal discharge
• tender and painful breasts
• painful sexual intercourse
• uterine spasm
• expulsion of Levosert from its position
• weight gain

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

• fainting
• eczema
• inflammation of the cervix (cervicitis)
• swelling or inflammation in legs or ankles
• increased growth of facial and body hair
• hair loss
• skin itching (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 adverse effects

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

5. Storage of Levosert

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

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levosert

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

Nature of the product and contents of the pack

Levosert consists of a small T-shaped body made of a plastic called polyethylene. This structure provides a device for the gradual release of the hormone 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 allow for easy removal and enable you and your doctor to check that the device is in place.

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

Each pack contains one or five Levosert in peelable pouch or pouches, individually packed in one or five individual boxes with the package leaflet and patient reminder card.

Pack sizes:

1 intrauterine delivery system with applicator.

5 intrauterine delivery systems with applicators.

Multipack: five packs of one intrauterine delivery system with one applicator.

Only certain pack 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 further 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 European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Germany, Austria, Cyprus, Malta, Norway, Sweden	Levosert
Denmark	Levosert Two
Croatia	Levosert 20 micrograms/24 hours intrauterine system
Spain	Levosert 0.02 mg every 24 hours intrauterine release system
Ireland	Levosert 52 mg Intrauterine Delivery System
Iceland	Levosert 20 micrograms/24 hours intrauterine device
Italy	Benilexa
United Kingdom	Benilexa Two Handed
Slovenia	Levosert 20 micrograms/24 hours intrauterine delivery system

Date of the most recent review of this leaflet July 2024

Up-to-date detailed information on this medicine is available on the website of the Spanish Agency for Medicinal and Health Products (AEMPS): http://www.aemps.gob.es/

This information is intended for healthcare professionals only

Please consult the instructions for use and handling included in the packaging.

_____________________________________________________________________________

Instructions for use and handling

Levosert 0.02 mg per 24 hours intrauterine delivery system

levonorgestrel

This information is intended for healthcare professionals only

Checklist for the prescribing professional

Ask yourself the following questions before prescribing/inserting Levosert:

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

• Have I completed the patient card included in the packaging and provided it to the patient as a reminder? (Any insertion beyond eight years must be reported as unauthorized use)

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

Insertion instructions

Must be inserted by a healthcare professional using an aseptic technique.

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

Levosert is supplied in a sterile package that must not be opened until required for insertion. Do not re-sterilize. For single use only. The exposed product must be handled using aseptic precautions. If the sterile package seal is broken, the product must be discarded (see disposal instructions in section 6.6). Do not use if the inner package is damaged or open. Do not insert after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the stated month.

For information on the timing of insertion, refer to section 4.2 of the Summary of Product Characteristics.

Levosert includes a patient reminder card inside the packaging. Complete the patient reminder card and give it to the patient after insertion.

Preparation for insertion

• Examine the patient to rule out contraindications for Levosert insertion (see sections 4.3 and 4.4 under Medical examination).
• Insert a speculum, visualize the cervix, and then thoroughly clean the cervix and vagina with an appropriate antiseptic solution.
• The healthcare professional may be assisted by auxiliary staff if deemed necessary.
• Grasp the anterior lip of the cervix with tenaculum forceps or other suitable forceps to stabilize the uterus. If the uterus is in retroversion, grasping the posterior lip of the cervix may be more appropriate. Apply gentle traction with the forceps to straighten the cervical canal. The forceps should remain in place, and gentle traction on the cervix should be maintained throughout the insertion procedure.
• Insert a sound through the cervical canal to the uterine fundus to measure uterine depth. If uterine depth is < 5.5 cm, discontinue the procedure. Confirm uterine cavity direction and exclude evidence of intrauterine abnormalities (e.g., septum, submucosal fibroids) or a previously inserted intrauterine contraceptive device not yet removed. If difficulty is encountered, consider cervical dilation. If cervical dilation is required, consider using analgesics and/or a paracervical block.

Description

Figure 1

Preparation for insertion

Figure 2 Figure 3

Figure 4		Insert the plunger and SLI into the insertion tube Partially open the blister (about one-third from the bottom) and insert the plunger into the insertion tube. Release the threads of the marker. Pull the thread to insert the SLI into the tube. The arms of the SLI must lie in a horizontal plane, parallel to the flat side of the marker.
Figure 5	Position the lower edge of the marker at the measured depth value Align the lower edge of the blue marker with the depth measurement obtained by hysteroscopy. The flat sides of the marker must always remain parallel to the arms. This ensures the arms will open properly within the uterine cavity.
Insertion Figure 6	Adjust the position of the SLI in the insertion tube Firmly hold the plunger while pulling the thread and move the tube to adjust the position of the SLI. The lateral arm protrusions should be opposed and positioned slightly above the upper end of the insertion tube (see enlarged image 1), and the distal edge of the tube should align with the first notch of the plunger (see enlarged image 2). If the tube is not aligned with the first plunger notch, pull the thread more firmly.
Figure 7	Insert the device into the cervical canal until the blue marker contacts the cervix Remove the entire device from the blister, firmly holding the plunger and insertion tube together in the correctly adjusted position. Insert the device into the cervical canal until the blue marker is in contact with the cervix.
Figure 8	Release the intrauterine system arms Hold the plunger steady, release the thread, and pull the insertion tube downward until its lower end reaches the second notch on the plunger.
Figure 9	Push the device against the uterine fundus To position the SLI within the uterine cavity, simultaneously push the insertion tube and plunger until the blue marker is again in contact with the cervix. Levosert will then be correctly placed within the uterine cavity.
Figure 10	Transfer the SLI from the tube to the uterine cavity Without moving the plunger, pull the insertion tube downward until it reaches the plunger's ring. A slight resistance indicates passage over the plunger's thickened section. Nevertheless, continue pulling the tube downward until it reaches the plunger's ring. The SLI will then be completely released from the insertion tube.
	Sequentially remove the applicator components and trim the threads Sequentially remove first the plunger, then the insertion tube. Cut the threads to approximately 3 cm from the cervix.

Levosert insertion has been completed.

Important information to consider during or after insertion:

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

• Confirm placement with an ultrasound or other appropriate radiological examination.

• If incorrect placement is suspected, remove the IUS. Do not reinsert the same IUS after removal.

IMPORTANT!

In case of difficult insertion and/or severe pain or bleeding during or after insertion, a physical examination and immediate ultrasound should be performed to rule out perforation of the uterine body or cervix. Physical examination alone (including checking the threads) 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 4 to 6 weeks later to check the threads and confirm that the device is in the correct position. Report any case of uterine perforation or insertion difficulties through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

Removal/replacement

The IUS is removed by gently pulling the threads with forceps. Excessive force or sharp instruments during removal may cause breakage of the system.

If the threads are not visible and the system is found to be within the uterine cavity on ultrasound examination, removal can be performed using narrow forceps. This may require cervical dilation or surgical intervention.

After IUS removal, the system should be examined to confirm it is intact and completely removed. In isolated cases during difficult removals, the hormone cylinder has been reported to slide over the horizontal arms, completely concealing them within the cylinder. This situation does not require any further intervention once it has been confirmed that the IUS is complete. The protrusions on the horizontal arms normally prevent complete separation of the cylinder from the T-shaped body.