Levosert One 0.02 mg/24 hours intrauterine delivery system

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

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

Leaflet Contents

1. What Levosert One is and what it is used for

2. What you need to know before using Levosert One

3. How to use Levosert One

4. Possible side effects

5. How to store Levosert One

6. Contents of the pack and other information

1. What Levosert One is and what it is used for

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

It is used for:

Contraception

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

This medicine prevents pregnancy by thinning the lining of the womb (endometrium), 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 produces local effects on the lining of the uterus.

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

Treatment of heavy menstrual bleeding

This medicine is also useful in 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, resulting in less bleeding each month.

The system should 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 bleeding (menarche).

2. What you need to know before using Levosert One

Do not use Levosert One

• 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 uterine lining after childbirth;
• if you have or have had a uterine infection after childbirth or after an abortion within the last 3 months;
• if you have or have had inflammation of the cervix (the 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;
• if you have an abnormal pattern of vaginal bleeding;
• if you have a condition that makes you prone 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 in remission;
• if you have or have had trophoblastic disease. A doctor will have informed you if you have such a condition;
• if you are allergic to levonorgestrel or to 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 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 insertion. 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.

Like other hormonal contraceptives, this medicine does not protect against HIV infection (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 One:

• if you have or develop migraine, dizziness, blurred vision, headaches worse than usual, or if you have headaches more frequently than before;
• if you develop 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 blood cancer (including leukemia) that is now in remission;
• if you are undergoing long-term steroid 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;
• if you have a history of blood clots (thrombosis);
• if you are taking other medicines, as certain medicines may reduce the effectiveness of this medicine;
• 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 this medicine.

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

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 important that any blood clot is treated immediately.

Expulsion

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

Possible symptoms of expulsion include pain and abnormal bleeding, but Levosert One may also be expelled without you noticing. Because Levosert One reduces menstrual flow, an increase in bleeding may indicate expulsion.

It is advisable to check the threads with your finger, for example, when showering. See also section 3 “How to use Levosert One – How can I tell if Levosert One 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 professional.

Psychiatric disorders:

Some women using hormonal contraceptives such as this medicine 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 further medical advice as soon as possible.

This medicine and smoking

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

Use of tampons and 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 removal threads of Levosert One.

Other medicines and Levosert One

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

• phenobarbital, phenytoin, or carbamazepine (for treating 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 medicine. This medicine should not be used at the same time as another hormonal contraceptive.

Pregnancy, breastfeeding, and fertility

You must not use this medicine during pregnancy or if you suspect you may be pregnant.

Can I become pregnant while using this medicine?

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

The absence of a period does not necessarily mean you are pregnant. Some women may not have periods while using this system.

If you have not had a period for 6 weeks, consider taking a pregnancy test. If the test 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 (pregnancy outside the uterus), and to have the device removed to reduce the risk of miscarriage. However, if Levosert One remains in place during pregnancy, not only does the risk of miscarriage increase, but also the risk of preterm birth. If Levosert One cannot be removed, discuss with your healthcare professional 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 One 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 uterus.

What if I want to have a baby?

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

Can I breastfeed while using this medicine?

Very small amounts of the hormone from this medicine 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 or use machines.

Levosert One contains barium sulfate

The T-shaped structure of this medicine contains barium sulfate, which makes it visible on X-rays.

3. How to use Levosert One

Only a 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 this medicine is inserted. If you have any questions about its use, discuss them with your healthcare provider.

Starting to use Levosert One

• Before inserting Levosert One, it is necessary to ensure that you are not pregnant.
• Levosert One should be inserted within 7 days of the start of your menstrual period. When Levosert One is inserted during this time, it acts immediately and will prevent pregnancy.
• If you cannot have Levosert One inserted within 7 days of the start of your menstrual period, or if your menstrual cycle occurs at unpredictable times, Levosert One may be inserted on any other day. In this case, you must not have had unprotected sex since your last menstrual period, and you must have a negative pregnancy test before insertion. Additionally, Levosert One 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 One.
• Levosert One is not suitable for use as emergency contraception (postcoital contraception).

Starting to use Levosert One after childbirth

• Levosert One 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 One” above for further information on the timing of insertion.

Starting to use Levosert One after an abortion

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

Replacing Levosert One

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

Switching from another contraceptive method (e.g., combined hormonal contraceptives, implant)

• Levosert One 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 One

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

• a cervical cytology test (Papanicolaou smear);
• a breast examination;
• other tests, for example for infections, including sexually transmitted infections, and a pregnancy test, as needed. Your healthcare provider 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 One 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 Levosert One insertion or removal.
• You may experience some pain and bleeding during or immediately after insertion.

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

How quickly does Levosert One work?

Contraception

If Levosert One is inserted into your uterus either during your menstrual period or within 7 days of the start of your period, or if you already 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

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

How will Levosert One 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 occurs. Generally, you are more 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 this medicine inserted for a long time and then start experiencing bleeding problems, contact your doctor or healthcare provider for advice.

How often should I have my system checked?

You should have your Levosert One checked 4 to 6 weeks after insertion, and then regularly, at least once a year until removal. 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. Additionally, 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 check for the two fine 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 you 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 have retracted into the uterus or cervical canal. If your doctor or nurse still cannot locate the threads, they may have broken, the device 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 experience pain or discomfort during sexual intercourse.

If the system is completely or partially expelled, you may not be protected against pregnancy. This is rare but possible, and you may not notice it during your menstrual period. An unusual increase in menstrual flow may be a sign that this has occurred. Inform your doctor or healthcare provider if you experience unexpected changes in your bleeding pattern.

Removal of Levosert One

Levosert One must be removed or replaced after 8 years of use, or earlier if heavy or bothersome bleeding recurs.

Your doctor can easily remove the system at any time, after which pregnancy may occur. Some women may feel dizzy or faint during or after removal of Levosert One. You may experience some pain and bleeding during removal.

Continuation of contraception after removal

If you do not wish to become pregnant, Levosert One 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.

Alternatively, a new Levosert One 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 can cause adverse effects, although not everyone experiences them.

With this medicine, 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 developing shortly after insertion 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 injury or tear in the uterine wall (perforation). Perforation is uncommon, but occurs more frequently during insertion of this medicine, although it may not be detected until some time later. If this medicine has moved outside the uterine cavity, it is not 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 increases 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 with fixation). If you suspect you may have experienced perforation, seek immediate medical attention and remind the healthcare provider that you have this medicine inserted, especially if it was not the person who inserted it.

Possible signs and symptoms of perforation may include:

• severe pain (similar to menstrual cramps) or more pain than expected

• heavy bleeding (after insertion)

• pain or bleeding that continues beyond a few weeks

• sudden changes in periods

• pain during sexual intercourse

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

• Pain in the lower abdomen, especially if accompanied by fever, a 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 users of this medicine is low. However, when a woman becomes pregnant with this medicine in place, the likelihood of ectopic pregnancy increases.

• Pain in the lower abdomen or experiencing painful or difficult 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 and 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
• malaise (nausea)
• bloated abdomen
• vomiting
• painful periods
• increased vaginal discharge
• tender and painful breasts
• uterine cramping
• expulsion of this medicine from its place
• 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 facial and body hair growth
• 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 adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levosert One

This medicine does not require special storage conditions.

Keep in the original packaging and maintain the blister sealed in 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 medicine after the expiry date stated on the label and on the box after “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 packaging at the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levosert One

The active substance is levonorgestrel.

Levosert One contains 52 mg of levonorgestrel contained in a substance called polydimethylsiloxane, surrounded by a membrane also made of polydimethylsiloxane.

Appearance of the product and contents of the pack

• Levosert One consists of a T-shaped body made of a plastic called polyethylene. This structure contains a hormone reservoir that enables gradual release into the uterus.
• There are two fine threads made of polypropylene and copper phthalocyanine blue attached to the lower end of this structure. These threads allow for easy removal of the device and enable you and your doctor to check that the device is in place.

The Levosert One intrauterine delivery system, together with the applicator device, is individually packaged in a thermoformed plastic blister with a peelable lid inside a cardboard box. The sterile blister is packed inside a box containing the package leaflet and the patient reminder card.

Pack sizes:

1 intrauterine delivery system with applicator device.

Multipack containing 5 packs, each with one intrauterine delivery system and one applicator device.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

Manufacturer

Odyssea Pharma S.A.

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 medicine 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Austria Levosert One

Cyprus Levosert One

Germany Levosert One

Denmark Levosert One

Spain Levosert One 0.02 mg per 24 hours intrauterine delivery system

Ireland Levosert SHI

Iceland Levosertone

Italy Benilexa

Malta Levosert One

Norway Levosert Single-Handed Inserter

Sweden Levosert Single-Handed Inserter

Slovenia Levosert SHI

United Kingdom Benilexa One Handed

Date of the most recent review of this leaflet: June 2024

Other sources of information

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

_________________________________________________________________________________

This information is intended for healthcare professionals only:

Instructions for use and handling

Checklist for the prescribing physician

Ask yourself the following questions before prescribing/inserting this medicine:

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

• Have I completed the patient card included in the package and given it to the patient as a reminder? (Any use beyond eight years must be reported as off-label use.)

Please 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 One 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 insertion procedure for Levosert One and have carefully read these instructions prior to insertion.

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

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

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

Preparation for insertion

• Examine the patient to rule out contraindications for insertion of Levosert One (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 use auxiliary staff if deemed necessary.
• Grasp the anterior lip of the cervix with tenaculum forceps or other forceps to stabilize the uterus. If the uterus is in retroversion, grasping the posterior lip of the cervix may be more appropriate. Light traction may be applied 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 uterine sound through the cervical canal to the fundus to measure uterine depth. If uterine depth is < 5.5 cm, discontinue the procedure. Confirm the direction of the uterine cavity and exclude any 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 the use of analgesics and/or a paracervical block.

Description

Figure 1a: Intrauterine Delivery System (IUS) Levosert One

Figure 1b: IUS with Levosert One inserter

Figure 2: Insertion sliders

Preparation for insertion

Step 1: Open the sterile package of Levosert One

• Remove the sealed blister containing the device from the box.
• Inspect the sealed blister and do not use the product if the packaging, inserter, or IUS is damaged.
• Place the blister on a flat surface with the peelable lid facing upwards.
• Remove the peelable lid.

Step 2: Remove the inserter from the blister (Figure 3)

Figure 3

Step 3: Fully slide the sliders forward to load the IUS (Figure 4)

Figure 4

Step 4: Load the IUS into the inserter

• Ensure that the arms of the IUS are horizontal (aligned with the horizontal plane of the handle and marker); adjust the rotation of the IUS as needed using the sterile flat surface of the blister.
• While maintaining forward pressure on the blue slider, gently pull the threads backward to load the IUS into the insertion tube. Ensure uniform tension is applied to both threads while pulling. Pull the threads upward or downward to secure the threads in the groove at the base of the handle (Figure 5); securing the threads in the groove prevents the IUS from slipping out of the top of the insertion tube. Once the threads are secured in the groove, release them.

Figure 5: Securing the threads in the groove

• After loading the IUS, continue to maintain forward pressure on the BLUE slider to keep the IUS in the correct position.
• When correctly loaded, the IUS is completely inside the insertion tube, with the arm tips forming a semi-spherical dome at the top of the tube (Figure 6, image 1).

Figure 6: Position of the IUS in the insertion tube

Image 1

Image 2

Step 5: Adjust the marker (Figure 7)

Figure 7

Step 6: Insertion of the IUS into the uterus (Figure 8)

Figure 8

Step 7: Release and open the arms of the IUS

Figure 9

Figure 10: Move the device toward the uterine fundus

Step 8: Release the IUS and complete the procedure

Figure 11: Release of the IUS from the insertion tube

Figure 12: Green indicator visible and threads released from the groove

Figure 13: Cut the threads to approximately 3 cm from the cervical os

Levosert One insertion has been completed.

Important information to consider during or after insertion:

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

• Check the placement using 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 the 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 of 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 after 4 to 6 weeks to check the threads and confirm that the device is in the correct position. Report any cases 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 the system to break.

If the threads are not visible and the system is found to be within the uterine cavity on ultrasound examination, removal may 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 has been completely removed. During difficult removals, isolated cases have been reported in which the hormone cylinder has slipped 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.