Label: Information for the User

Levosert One0.02 mg every 24 hours intrauterine delivery system

levonorgestrel

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

• Keep this label, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctor or pharmacist.
• If you experience adverse effects,consult your doctor or pharmacist, eveniftheydo not appear in this label. See section 4.

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

2.What you need to knowbeforestarting touse Levosert One

3.How to use Levosert One

4.Possible adverse effects

5Storage of Levosert One

6.Contents of the package and additional information

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

It is used for:

Contraception

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

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

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

Treatment of heavy menstrual bleeding

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

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

Children and adolescents

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

No use Levosert One if

-you are pregnant or suspect you may be pregnant;

-you have or have had pelvic inflammatory disease;

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

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

-you have or have had uterine infection after a delivery or abortion in the last 3 months;

-you have or have had cervix inflammation;

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

-you have or have had liver problems;

-you have a liver tumor;

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

-you have an abnormal vaginal bleeding pattern;

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

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

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

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

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

Contraindications and Precautions

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

Genital infections will have to be successfully treated before this medication can be placed.

If you have epilepsy, inform your doctor or nurse before they place this medication because, although it is rare, it may cause a seizure during the procedure. Some women may feel like they are going to faint 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.

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

Consult your doctor before using Levosert One if:

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

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

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

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

-you are under long-term steroid treatment;

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

-you have had or have severe arterial disease, such as heart attack or stroke;

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

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

-you have irregular bleeding;

-you have seizures (epilepsy).

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

You should also inform your doctor if any of these conditions occur for the first time while using this medication.

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

Expulsion

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

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

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

Mental health disorders:

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

This medication and smoking

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

Use of tampons and menstrual cups

It is recommended to use sanitary pads. If tampons or menstrual cups are used, you should change them carefully to avoid pulling on the Levosert One extraction strings.

Other medications and Levosert One

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

-phenobarbital, phenytoin, or carbamazepine (for epilepsy);

-griseofulvin (an antifungal);

-rifampicin or rifabutin (antibiotics);

-nevirapine or efavirenz (for HIV).

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

Pregnancy, breastfeeding, and fertility

You should not use this medication during pregnancy or if you suspect you may be pregnant.

Can I get pregnant while using this medication?

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

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 have the device removed to reduce the risk of spontaneous abortion.

And if I want to have a baby?

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

Can I breastfeed while using this medication?

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

Driving and operating machinery

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

Levosert One contains barium sulfate

The T-shaped structure of this medication contains barium sulfate, making it visible with X-rays.

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

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

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

If you have just given birth, you must wait at least six weeks before having this medication inserted. This medication can sometimes be inserted immediately after an abortion, as long as there are no genital infections.

How quickly does Levosert One work?

Birth control

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

Heavy menstrual bleeding

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

If you have had this medication inserted for a long time and then start experiencing bleeding problems, contact your doctor or healthcare professional for advice.

How often should I have the system checked?

It is usually recommended to have the system checked 6 weeks after insertion, again at 12 months, and then once a year until it is removed.

How can I know if the system is in place?

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

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

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

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

If you stop using Levosert One

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

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

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

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

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

• Severe pain or fever that develops shortly after insertionmay indicate a severe infection that should be treated immediately. In rare cases, a very severe infection (sepsis) may occur.
• Severe pain and continuous bleedingas this may be a sign of damage or perforation of the uterine wall (perforation). Perforation is rare, but it occurs more frequently during the insertion of this medicine, although it may not be detected until some time later. If this medicine has been lodged outside the uterine cavity, it is not effective in preventing pregnancy and should be removed as soon as possible; in very rare cases, this may require surgery. The risk of perforation is low, but it increases in women who are breastfeeding or who have had a baby up to 36 weeks before insertion and may increase in women with a fixed uterus tilted backward (retroverted and fixed uterus). If you suspect you may have suffered a perforation, seek immediate medical attention and remind them 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 (like menstrual cramps) or more pain than expected
• Heavy bleeding (after insertion)
• Pain or bleeding that continues for more than a few weeks
• Changes in menstrual periods
• Pain during sex
• • If you can no longer feel the threads of this medicine (see section 3 “How to use Levosert “How can I know if the system is in place?”).

• Abdominal pain, especially if you also have a fever or have had an unexpected bleeding,as this may be a sign of ectopic pregnancy (fetal development outside the uterus). The absolute risk of ectopic pregnancy in users ofthis medicineis low. However, when a woman becomes pregnant withthis medicineinside, the probability of ectopic pregnancy increases.
• Abdominal pain or experiencing difficult or painful sexas it may be a sign of ovarian cysts or pelvic inflammatory disease. This is important as pelvic infections can reduce your chances of having a baby and 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 One affect my menstruation?" in section 3.

-vaginal bleeding including spotting.

-vaginal and genital infections (vulva) 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;

-swollen abdomen;

-vomiting;

-menstrual cramps;

-increased vaginal discharge;

-breast tenderness and pain;

-uterine cramps;

-This medicine comes out of place;

-weight gain.

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

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist, even if they arepossibleside effects that do not appear in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store in the original packaging.

This medication does not require special storage conditions.

Keep the blister sealed in the outer box to protect it from light.

Do not open the packaging of this medication. Only your doctor or healthcare professional should do so.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe label and on the boxafter “CAD”. The expiration date is the last day of the month indicated.

Medications should not be thrown away through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Levosert One

The active principle is levonorgestrel.

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

Appearance of the product and contents of the package

-Levosert Oneis formed by a T-shaped body made of a plastic called polyethylene. This structure carries a hormone reservoir that allows it to be released gradually in the uterus.

-There are two fine threads, made of polypropylene and copper phthalocyanine blue, attached to the lower end of this structure. These threads will allow the device to be easily removed and for you and your doctor to check that the device is in place.

The SLI Levosert One, together with the applicator device, are presented individually in a thermoformed plastic blister (PETG) with a removable cover (TYVEK-polyethylene) inside a cardboard box.

Package sizes:

1 intrauterine release system with applicator device.

Multipack with 5 packages with an intrauterine release system with an applicator device.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

Responsible for Manufacturing

Odyssea PharmaS.A.

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 medication 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 medication is authorized in the member states of the European Economic Area with the following names:

AustriaLevosert One

CyprusLevosert One

GermanyLevosert One

DenmarkLevosert One

Spain Levosert One 0.02 mg every 24 hours intrauterine release system

IrelandLevosert SHI

IcelandLevosertone

ItalyBenilexa

MaltaLevosert One

NorwayLevosert Single-Handed Inserter

SwedenLevosert Single-Handed Inserter

SloveniaLevosert SHI

United KingdomBenilexa One Handed

Last review date of thisleaflet:May 2024

Other sources of information

The detailed information about this medication is available on the website of the {Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

_________________________________________________________________________________

This information is intended solely for healthcare professionals:

Instructions for use and handling

Prescription checklist for the prescribing doctor

Make the following questions before prescribing/inserting this medication:

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

Have you completed the patient's card included in the package and given it to the patient as a reminder?

Conditions of use

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

Description

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

Figure1b:IUS with Levosert One inserter

Figure 2: Insertion guides

Preparation for insertion

Step 1: Open the sterile package of Levosert One

• Remove the sealed blister from the box that contains the device.
• Inspect the sealed blister and do not use the product if the packaging, inserter, or IUS are damaged.
• Place the sealed blister on a flat surface with the removable cover facing upwards.
• Remove the removable cover.

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

Figure 3

Step 3: Slide the insertion guides completely forward to load the IUS (figure 4)

Figure 4

Step 4: Load the IUSin the inserter

• Make sure the arms of the IUS are horizontal (aligned with the horizontal plane of the handle and the marker); adjust the rotation of the IUS as needed using the flat, sterile surface of the blister.
• Maintaining theforward pressureon the blue slider, pull the threadsbackwardsto load the IUS into the insertion tube. Make sure a uniform tension is applied to both threads when pulling. Pull the threads upwards or downwards tolock the threadsin the notch at the base of the handle (figure 5); the threads must be locked in the notch to prevent the IUS from coming out of the top of the insertion tube. Once the threads are locked in the notch, stop holding them.

Figure 5: Locking the threads in the notch

• Once the IUS is loaded, continue to maintain the 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 tips of the arms forming a semispherical cup 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: Insert 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 towards the uterine fundus

Step 8: Release the IUS and complete the procedure

Figure 11: Release the IUS from the insertion tube

Figure 12: Visible green indicator and threads released from the notch

Figure 13: Cut the threads 3 cm from the cervix

The insertion of this medication has been completed.

Important information to consider during or after insertion:

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

IMPORTANT!

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

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

How to remove this medication

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

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

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