Kyleena 19.5 mg intrauterine system

Patient Information Leaflet

Introduction

Patient Information Leaflet

Kyleena 19.5 mg intrauterine system

levonorgestrel

Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor/healthcare professional.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor/healthcare professional, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Kyleena is and what it is used for

Kyleena is a hormone-releasing intrauterine system (IUS) in the shape of a T, also known as a hormonal intrauterine device. It is a contraceptive method that prevents pregnancy for up to 5 years. The IUS contains a hormone called levonorgestrel.

Figure 1: Intrauterine delivery system

How it works

A doctor/healthcare professional will insert it into your uterus. Once inserted, it continuously releases a small amount of the hormone.

Kyleena prevents sperm and egg from meeting and thus prevents pregnancy. It works in the following ways:

• thickens the cervical mucus, which prevents sperm from passing through.
• keeps the lining of the uterus (endometrium) thin.

Figure 2: Kyleena in the uterus

2. What you need to know before using Kyleena

Important information to consider Your doctor/healthcare professional must ensure that this contraceptive is suitable for you. For this reason, they will first ask you some questions about your health. Only then will they prescribe it to you. As a contraceptive, Kyleena prevents pregnancies. However, no contraceptive method is 100% effective. Each year, approximately 2-3 out of 1,000 women using it will become pregnant. The IUD does not protect against HIV infection or any other sexually transmitted diseases. The IUD is not an emergency contraceptive, such as the "morning-after" pill. Women who have had unprotected sex shortly before IUD insertion may become pregnant.

DO NOT use Kyleena if:

• you are pregnant (see the section “Pregnancy, breastfeeding and fertility” below);
• you have an infection in the uterus, fallopian tubes or ovaries (pelvic inflammatory disease), or if you have had this condition several times in the past;
• you have a disease that makes you more prone to pelvic infections. For example: sexually transmitted infections or diseases that reduce the body’s ability to fight infections, such as advanced stages of HIV;
• you have an infection in the vagina or cervix;
• you have given birth or had a miscarriage (spontaneous or induced) within the last 3 months and subsequently developed a uterine infection;
• your most recent Pap smear test results were abnormal;
• you have or your doctor/healthcare professional suspects you may have cancer of the uterus or cervix;
• you have a tumour that requires progestogens to grow – e.g. breast cancer;
• you have vaginal bleeding of unknown cause;
• your uterus or cervix has an abnormal shape – e.g. due to non-cancerous growths in the uterus (uterine fibroids);
• you have liver disease or a liver tumour;
• you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Do not use Kyleena if any of the above apply to you. If you are unsure, speak with your doctor/healthcare professional.

Warnings and precautions

Talk to your doctor before starting to use Kyleena if you:

• have diabetes. You generally will not need to change your diabetes medication while using the IUS, but your doctor/healthcare professional may need to check this;
• have epilepsy. A seizure may occur during insertion or removal of the IUS;
• have previously had an ectopic pregnancy (pregnancy outside the uterus);
• have migraines that cause vision problems (e.g. sudden loss of vision in one eye) or other neurological symptoms (migraine with aura), or if you have severe headaches of unknown origin;
• have jaundice (yellowing of the skin, nails or whites of the eyes);
• have high blood pressure;
• have ever had a stroke or heart attack.

If any of the above apply to you (or you are unsure), speak with your doctor/healthcare professional before Kyleena is inserted.

While using Kyleena, speak to your doctor/healthcare professional immediately if you:

• have signs of pregnancy or a positive pregnancy test result (see the section “Pregnancy, breastfeeding and fertility” below);
• have signs of pregnancy along with pain, vaginal bleeding or dizziness. This may indicate an ectopic pregnancy (see section 4, “Ectopic pregnancy”);
• have abdominal pain, fever, unusual vaginal discharge or pain during sexual intercourse. This may indicate a pelvic infection and you should receive prompt treatment (see section 4, “Pelvic infection”);
• have pain during sexual intercourse, as you may have a small fluid-filled sac (cyst) on the ovary (see section 4, “Ovarian cyst”);
• have severe pain, very heavy bleeding or can no longer feel the IUS threads. This may indicate perforation (see section 4, “Perforation”).

Speak to your doctor/healthcare professional immediately if you experience any of the above symptoms.

Also, speak to your doctor/healthcare professional about Kyleena if you:

• experience a migraine or severe headache for the first time;
• notice your skin, nails or whites of the eyes turning yellow. These are signs of jaundice;
• notice an increase in blood pressure;
• have had a stroke or heart attack.

Your doctor/healthcare professional will decide whether it is still safe for you to continue using Kyleena.

Signs that Kyleena may not be in place

Some signs that the IUS may not be in place include:

• inability to feel the threads with your finger in the vagina (see section 3, “How to check yourself that Kyleena is in place”);
• feeling the lower plastic part (or your partner feels it) (see section 3, “How to check yourself that Kyleena is in place”);
• sudden changes in your menstrual pattern (e.g. you stopped having periods while using the IUS and suddenly start again).

These signs may mean that Kyleena has been expelled (see section 4, “If Kyleena comes out”) or that you have a perforation (see section 4, “Perforation”).

If you notice any of these signs indicating that Kyleena is not in place, speak to your doctor/healthcare professional immediately. You should not have sexual intercourse unless you use a condom or diaphragm until your doctor/healthcare professional confirms that the IUS is still in place.

It is possible that your partner may feel the threads during sexual intercourse. This does not mean that the IUS is out of place. However, if your partner finds the threads uncomfortable, there are things your doctor/healthcare professional can do to help.

Menstrual hygiene products

If you have your period, sanitary pads are recommended. If you use tampons or a menstrual cup, you should change them carefully, otherwise you might accidentally pull on the threads. If you think you may have moved the IUS from its position (see the list above for possible signs), you should not have sexual intercourse unless you use a condom or diaphragm until you see your doctor/healthcare professional.

Breast cancer

Women who take oral contraceptives have a slightly increased risk of breast cancer. This risk returns to the baseline level appropriate for age 10 years after stopping the pill.

Some scientific studies have suggested a slightly increased risk of breast cancer with the use of levonorgestrel-releasing IUDs such as Kyleena, while other studies have not shown an increased risk. Talk to your doctor if you have any concerns.

Mental health problems

Some women using hormonal contraceptives, including Kyleena, experience depression or depressed mood. See section 4, “Mental health problems” for more information.

Children and adolescents

Girls who have not yet started menstruating should not use Kyleena.

Other medicines and Kyleena

Tell your doctor/healthcare professional if you are taking, have recently taken or might need to take any other medicines.

Pregnancy, breastfeeding and fertility

Pregnancy

Kyleena must not be inserted if you are pregnant.

If you stop having periods while using Kyleena

Some women do not have periods while using it. If you no longer have periods, this is likely due to the IUS. You can find more information about this in section 4, “Irregular or infrequent bleeding”.

Have you missed your period for 6 weeks? Then you can take a pregnancy test. If the test shows you are not pregnant, there is no need to repeat the test.

If you notice symptoms of pregnancy

If you experience signs of pregnancy, such as missed periods, nausea or tender or painful breasts, you should:

1. take a pregnancy test;
2. contact your doctor/healthcare professional for an examination.

If you become pregnant

If you become pregnant with Kyleena in place, contact your doctor/healthcare professional immediately to have it removed.

There is a risk of miscarriage during removal. However, if you continue to use it during pregnancy, you have a higher risk of:

• miscarriage;
• premature birth.

Talk to your doctor/healthcare professional about the benefits and risks of continuing the pregnancy while using the IUS. Your doctor/healthcare professional will monitor you closely. You must contact your doctor/healthcare professional immediately if you experience:

• cramping;
• abdominal pain;
• fever.

Kyleena contains a hormone called levonorgestrel. Ask your doctor/healthcare professional about the possible effects this hormone may have on the unborn baby. Isolated cases of effects on the genitalia of female babies exposed to levonorgestrel-releasing intrauterine devices in utero have been reported.

Ectopic pregnancy

The risk of becoming pregnant while using Kyleena is very low. However, if you do become pregnant while using it, you have a higher risk that the fertilised egg will not be in the uterus but in the fallopian tube or abdominal cavity (ectopic pregnancy). An ectopic pregnancy is a serious condition requiring immediate medical attention. After an ectopic pregnancy, it may be more difficult to become pregnant again. See section 4, “Ectopic pregnancy”.

Breastfeeding

You may use Kyleena during breastfeeding. A small amount of the hormone may pass into breast milk. However, it is unlikely to affect the quantity or quality of breast milk or the growth and development of the infant.

Fertility

If you wish to become pregnant, contact your doctor/healthcare professional to have Kyleena removed.

Fertility is not affected after removal.

Driving and using machines

Kyleena has no known influence on the ability to drive and use machines.

3. How to use Kyleena

Starting to use Kyleena

• Before insertion, you must ensure that you are not pregnant.
• It must be inserted within 7 days from the start of your menstrual period. When inserted during this time, it becomes effective immediately and will prevent pregnancy from the moment of insertion.
• If it cannot be inserted within 7 days from the start of your period, or if your period is irregular, it may be inserted on any other day. In this case, you must not have had unprotected sexual intercourse since your last period and must have a negative pregnancy test before insertion. Additionally, it may not reliably prevent pregnancy immediately after insertion. Therefore, you must use a barrier contraceptive method (such as a condom) or abstain from vaginal intercourse for the first 7 days following insertion.
• Kyleena is not an emergency contraceptive, such as the "morning-after pill."

Starting to use Kyleena after childbirth

• It may be inserted after childbirth once the uterus has returned to its normal size, and not earlier than 6 weeks after delivery (see section 4, subsection "Perforation").
• See also "Starting to use Kyleena" above for additional information on timing of insertion.

Starting to use Kyleena after an abortion

• It may be inserted immediately after an abortion if the pregnancy lasted less than 3 months, provided there are no genital infections. The system becomes effective immediately upon insertion.

Replacing a currently used Kyleena with a new one

• It may be replaced at any time during your menstrual cycle with a new device. It becomes effective immediately upon insertion.

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

• Kyleena may be inserted immediately if it can be confirmed that you are not pregnant.
• If more than 7 days have passed since the start of menstrual bleeding, you must abstain from vaginal intercourse or use additional contraceptive protection for the following 7 days.

What happens when Kyleena is inserted?

Examination before insertion

Sometimes, your doctor/healthcare professional may want to carry out certain examinations before insertion, including:

• a vaginal smear test (Pap smear)
• a breast examination
• other tests (e.g. for sexually transmitted infections), if necessary.

Insertion of Kyleena

First, your doctor/healthcare professional will check the size of your uterus and its exact position in the abdomen (pelvic examination).

The doctor/healthcare professional will insert an instrument called a speculum into the vagina and clean the cervix with an antiseptic solution. Sometimes, the healthcare professional will apply local anaesthetic to the cervix and then insert the IUS into the uterus using a narrow, flexible plastic tube (insertion tube).

Insertion may sometimes be uncomfortable. Some women experience dizziness or fainting. You may also experience pain and some vaginal bleeding. This is not unusual.

After insertion, your doctor/healthcare professional will give you a card: the patient reminder card. On this card, you can record the date of your next check-up. Keep this card and bring it to every appointment.

Follow-up after insertion

A healthcare professional must check your IUS 4–6 weeks after insertion. Your doctor/healthcare professional will determine how often you need to return for follow-up checks. You should return for check-ups at least once a year. Always bring your patient reminder card to each visit.

How to check yourself that Kyleena is in place

You can check by gently inserting a finger into your vagina. You should feel the threads at the top of the vagina, near the cervix. The cervix is the entrance to the uterus. Note: Do not pull on the threads, as you may accidentally dislodge the IUS.

If you cannot feel the threads, you should ask your doctor/healthcare professional to check whether the IUS is still in place. You should not have sexual intercourse unless you use a condom or diaphragm until you have seen your doctor/healthcare professional.

If you or your partner feel the lower plastic part of Kyleena, it is not in the correct position. Contact your doctor/healthcare professional immediately. You should not have sexual intercourse until you have seen your doctor/healthcare professional, unless you use a condom or diaphragm.

Removal of Kyleena

The IUS is effective for up to 5 years. It must be removed after 5 years, although it can also be removed earlier. A healthcare professional will remove it for you. Once removed, your fertility will return.

Removal may be slightly uncomfortable. Some women experience dizziness or fainting during or immediately after removal. You may also experience some pain and vaginal bleeding. This is not unusual.

Continuation of contraception after removal

If you do not wish to become pregnant after removal of Kyleena, you should know that:

• It is best to have it removed within 7 days after the start of your period. If it is removed at any other time in your menstrual cycle, you must use a condom or diaphragm during sexual intercourse in the 7 days before removal.
• If you have irregular periods or no periods, you must use a condom or diaphragm during sexual intercourse in the 7 days before removal. Irregular periods mean that the number of days between monthly cycles is not always the same.
• You may have a new IUS inserted immediately after removal, in which case no additional contraception is needed. If you do not wish to continue with this contraceptive method, consult your doctor/healthcare professional about other reliable contraceptive methods.

4. Possible adverse effects

Like all medicines, Kyleena can cause adverse effects, although not everyone experiences them.

Serious adverse effects

Serious adverse effects may occur, so you should contact your doctor/healthcare professional immediately if you experience any of the following:

• Stomach pain, fever, unusual vaginal discharge or abnormal vaginal bleeding, or pain during sexual intercourse. These may be signs of an infection in the uterus, fallopian tubes, or ovaries (see section “Pelvic infection” below).
• Severe pain similar to menstrual cramps, more pain than expected, or very heavy vaginal bleeding after insertion. Or pain or bleeding lasting longer than a few weeks, sudden changes in menstrual pattern, pain during sexual intercourse, or inability to feel the IUS threads. These may be signs of perforation (see section “Perforation” below).
• Missed period, followed by persistent vaginal bleeding or severe or persistent lower abdominal pain. These may be signs of an ectopic pregnancy (see section “Ectopic pregnancy” below).
• Mood changes and depressive symptoms (see section “Mental health problems” below).
• Allergic reaction such as rash, hives, or swelling of the tongue, lips, face, or throat. Such reactions are very rare.

If you think any of the above apply to you, speak with your doctor/healthcare professional immediately.

Other adverse effects

Below is a list of other possible adverse effects you may experience. The more frequently occurring adverse effects are listed at the top of this list, and those occurring less frequently are listed toward the bottom.

Very common adverse effects: may affect more than 1 in 10 people

• headache

• abdominal or pelvic pain

• pimples (acne) or oily skin

• menstrual changes, for example:

• bleeding more or less than usual

• bleeding or spotting between periods

• irregular or infrequent periods

• absence of periods

More information on this can be found in the section “Irregular or infrequent periods” below

• small fluid-filled sac in the ovary (ovarian cyst). More information on this can be found in the section “Ovarian cyst” below
• inflammation of the labia and vagina (vulvovaginitis)

Common adverse effects: may affect up to 1 in 10 people

• decreased sex drive
• migraine
• dizziness
• nausea
• hair loss
• pain during menstruation
• breast pain or tenderness
• spontaneous expulsion of the IUS (complete or partial). More information on this can be found in the section “If Kyleena comes out” below
• vaginal discharge
• weight gain

Uncommon adverse effects: may affect up to 1 in 100 people

• increased body hair

Description of selected possible adverse effects:

Ectopic pregnancy

The signs of an ectopic pregnancy include:

• absence of menstruation, but later experiencing persistent vaginal bleeding
• severe or persistent pain in the lower abdomen
• typical signs of pregnancy such as nausea or tender or sore breasts, along with vaginal bleeding and dizziness
• a positive pregnancy test

You should contact your doctor/healthcare professional immediately if you experience any of these symptoms.

The risk of becoming pregnant while using Kyleena is very low. However, if you do become pregnant while using it, there is an increased risk that the fertilized egg will not be in the uterus but instead in the fallopian tube or abdominal cavity (ectopic pregnancy). Approximately 2 out of every 1000 women who use Kyleena for one year will experience an ectopic pregnancy. This type of pregnancy is a serious condition requiring immediate medical attention. Surgery may be necessary.

Some women are more likely to experience an ectopic pregnancy, including those who:

• have had a previous ectopic pregnancy
• have undergone surgery on the fallopian tubes
• have had a pelvic infection

Irregular or infrequent bleeding

Your menstrual periods may change due to the IUS. For example:

• You may experience spotting (light bleeding) between periods.
• Your periods may become less regular, meaning the number of days between menstrual cycles may vary.
• Your periods may become shorter or longer.
• You may lose more or less blood than usual during your period.
• You may stop having periods altogether.

These changes often occur only during the first few months after insertion. For example:

• Bleeding or spotting between periods is more common during the first 3 to 6 months.
• Some women may initially experience heavier-than-usual periods.

Over time, you may gradually lose less blood each month and have shorter periods. Eventually, some women may stop having periods altogether.

If you no longer have periods, this is usually normal. In most cases, this does not mean you are pregnant or entering menopause. Here's why: normally, the lining of the uterus thickens each month in preparation for pregnancy and then thins again during menstruation. Kyleena reduces the thickening of the uterine lining, which may completely stop menstruation. Your own hormone levels typically remain normal.

Your periods usually return to normal after Kyleena is removed. If they do not, contact your doctor/healthcare professional.

Pelvic infection

Kyleena is free from bacteria, viruses, and fungi (sterile), as is the inserter. Nevertheless, you may still develop a pelvic infection during or within the first 3 weeks after insertion. This may affect the lining of the uterus, fallopian tubes, or ovaries. This may occur in up to 1 out of every 10 women.

Symptoms may include:

• abdominal pain
• fever
• unusual vaginal discharge
• pain during sexual intercourse

Your risk of pelvic infection may be higher if:

• you have a sexually transmitted infection (STI)
• you or your partner have multiple sexual partners
• you have previously had a pelvic infection

If you develop a pelvic infection, it is important to see your doctor/healthcare professional immediately. A pelvic infection may lead to:

• fertility problems, meaning you may have more difficulty becoming pregnant in the future
• an ectopic pregnancy (pregnancy outside the uterus) if you become pregnant
• a serious infection or sepsis (blood infection). This is very rare but could occur shortly after insertion. Sepsis means you are severely ill due to infection. If left untreated, it can be life-threatening.

Kyleena must be removed if the pelvic infection:

• recurs several times
• is severe
• does not resolve with treatment

If Kyleena comes out

Kyleena may be expelled or fall out of place due to uterine muscle contractions during menstruation. This may affect up to 1 out of every 10 women, especially if:

• you are overweight at the time of insertion
• you previously had heavy periods

If the IUS is displaced or expelled, it may no longer work properly. Your risk of becoming pregnant increases. If it comes out, you are no longer protected against pregnancy.

If the IUS is out of place or expelled, you may feel pain or experience vaginal bleeding that is different from your usual pattern. It may also come out without you noticing.

Kyleena normally reduces the amount of blood lost during your period.

The longer you use it, the less blood you will lose during your period. This means that if you suddenly start having heavier bleeding during your periods, the IUS may have been expelled. See section 3, “How to check on your own that Kyleena is in place,” to learn how to check whether the IUS is correctly positioned and what to do if you suspect it is no longer in place.

Perforation

It is possible for Kyleena to become embedded in the uterine wall or pass through it. This is called perforation. Perforation usually occurs at the time of insertion. Perforation does not always cause pain, so it may only be noticed later. If it is no longer in place due to perforation, it is no longer effective against pregnancy. In this case, a doctor/healthcare professional must remove it as soon as possible. Sometimes, a surgical procedure is necessary.

Perforation affects up to 1 in 1,000 people. The risk of perforation is higher (up to 1 in 100 people) if:

• you are breastfeeding at the time of insertion
• you have given birth within the 9 months prior to insertion

You may experience perforation if:

• you have severe pain similar to menstrual pain or more pain than expected
• you have heavy vaginal bleeding after insertion
• you have pain or bleeding lasting longer than a few weeks
• you have sudden changes in your menstrual pattern
• you have pain during sexual intercourse
• you can no longer feel the threads

If you think you may have experienced perforation, contact a doctor/healthcare professional immediately. Remember to inform them that you have an IUS in place, especially if they were not the person who inserted it.

Ovarian cyst

Sometimes a small fluid-filled sac can form in the ovary. This sac is known as an ovarian cyst.

Signs of an ovarian cyst may include:

• pelvic pain
• pain or discomfort during sexual intercourse

An ovarian cyst usually disappears on its own. However, it may require medical treatment or, more rarely, surgical intervention. If you think you may have an ovarian cyst, contact your doctor/healthcare professional.

Mental health problems

Some women using hormonal contraceptives, including Kyleena, experience depression or depressive mood.

Depression can be serious and, in some cases, may lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor/healthcare professional as soon as possible. Depression and depressive mood may affect up to 1 in 100 users.

Reporting of adverse reactions

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

5. Storage of Kyleena

No special storage conditions are required.

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

Do not open the blister (plastic packaging containing the IUS). Only your doctor or a healthcare professional should do so.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Kyleena

The active substance is levonorgestrel. The intrauterine delivery system contains 19.5 mg of levonorgestrel.

The other components are:

• polydimethylsiloxane elastomer
• anhydrous colloidal silica
• polyethylene
• barium sulfate
• polypropylene
• copper phthalocyanine
• silver

Appearance of Kyleena and contents of the pack

Intrauterine delivery system (IUS) for uterine use. It is T-shaped and white. The vertical part is a small reservoir containing the hormone levonorgestrel. Two blue threads are attached to a loop at the lower end, which allows a healthcare professional to remove the IUS. There is also a silver ring located near the horizontal arms. This ring can be seen by your doctor during ultrasound examination.

Pack sizes:

• 1 x 1 intrauterine delivery system
• 5 x 1 intrauterine delivery system

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder

Bayer Hispania, S.L.
Av. Baix Llobregat 3-5
08970 Sant Joan Despí (Barcelona)
Spain

Manufacturer

Bayer Oy
Pansiontie 47
20210 Turku
Finland

This medicinal product is authorised in the European Economic Area member states under the following names:

• Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden: Kyleena

Date of the most recent review of this leaflet: November 2025

Other sources of information

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet, packaging, and patient reminder card. You can also access this information at the following internet address: https://cima.aemps.es/info/81418

[Inclusion at national level of the QR code linking to the summary of product characteristics]

This information is intended for healthcare professionals only:

INSERTION INSTRUCTIONS

Kyleena 19.5 mg intrauterine delivery system
levonorgestrel
For insertion by a physician/healthcare professional using an aseptic technique.

Kyleena is supplied in a sterile pack within an inserter that allows one-handed handling. The pack must not be opened until immediately before insertion. Do not re-sterilize. This product is for single use only. Do not use if the blister is damaged or open. Do not insert after the expiry date stated on the carton and blister after EXP.

Disposal of unused medicine or waste material must be carried out in accordance with local regulations.

The IUS is supplied with a patient reminder card inside the pack. Complete the patient reminder card and give it to the patient after insertion.

Preparation for insertion

• Examine the patient to rule out contraindications to insertion (see Summary of Product Characteristics, section 4.3 and section 4.4, subsection “Examination/medical consultation”).
• Insert a speculum, visualize the cervix, and then thoroughly clean the cervix and vagina with an appropriate antiseptic solution.
• Use an assistant if necessary.
• Grasp the anterior lip of the cervix with a tenaculum or other forceps to stabilize the uterus. If the uterus is retroverted, grasping the posterior lip of the cervix may be more appropriate. Gentle traction with the forceps may be applied to straighten the cervical canal. The forceps should remain in place, and gentle counter-traction should be applied to the cervix throughout the insertion procedure.
• Insert a uterine sound through the cervical canal to the uterine fundus to measure uterine depth, confirm uterine direction, and rule out any intrauterine abnormalities (e.g., septum, submucosal fibroids) or the presence of a previously inserted intrauterine contraceptive device not yet removed. If difficulties are encountered, consider cervical dilation. If cervical dilation is required, consider using analgesics and/or a paracervical block.

Insertion

1. First, fully open the sterile pack (Figure 1). Then use an aseptic technique and sterile gloves.

Push the slider forward in the direction of the arrow until fully advanced to load Kyleena into the insertion tube (Figure 2).

Figure 2

IMPORTANT! Do not pull the slider downward, as this may prematurely release Kyleena. Once released, it cannot be reloaded.

Holding the slider at the end of its travel, position the upper edge of the flange at the length of the uterine cavity as measured by the sound (Figure 3).		Figure 3
Holding the slider at the end of its travel, insert the inserter through the cervical canal until the flange is approximately 1.5–2.0 cm from the cervix (Figure 4).	1.5 – 2.0 cm	Figure 4

IMPORTANT! Do not force the inserter. Dilate the cervical canal if necessary.

Holding the inserter firmly, pull the slider to the mark to open the horizontal arms of Kyleena (Figure 5). Wait 5–10 seconds for the horizontal arms to fully open.		Figure 5
Gently advance the inserter toward the uterine fundus until the flange reaches the cervix. Kyleena is now positioned at the fundus (Figure 6).		Figure 6
While keeping the inserter in place, release Kyleena by pulling the slider downward (Figure 7). With the slider fully lowered, carefully remove the inserter by pulling it out. Trim the threads so that 2–3 cm remain visible outside the cervix.		Figure 7
IMPORTANT! If incorrect positioning of the system is suspected, confirm its location (e.g., by ultrasound). Remove the system if it is not correctly placed within the uterine cavity. A removed system must not be reinserted.

Removal/replacement

For removal/replacement, refer to the Kyleena Summary of Product Characteristics.

Remove by pulling the threads with forceps (Figure 8). A new SLI may be inserted immediately after removal. After removal, the system should be examined to ensure it is intact and has been completely removed.		Figure 8
National inclusion of the QR code linking to the Summary of Product Characteristics The Kyleena Summary of Product Characteristics is available at the following internet address: https://cima.aemps.es/info/81418