Label: information for the user

Kyleena 19.5mg intrauterine system

levonorgestrel

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• This medication has been prescribed only to you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

1. What Kyleena is and how it is used

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

3. How to use Kyleena

4. Possible adverse effects

5. Storage of Kyleena

6. Contents of the package and additional information

Kyleena is used for birth control (contraception) with a duration of up to five years.

Kyleena is an intrauterine system (IUS) in the shape of a T that, after being placed inside the uterus, slowly releases a small amount of the hormone levonorgestrel.

Kyleena works by reducing the monthly growth of the uterine lining and thickening the cervical mucus. These actions prevent sperm and the egg from coming into contact and thus prevent the fertilization of an egg by sperm.

DO NOT use Kyleena

• if you are pregnant (see section “Pregnancy, breastfeeding, and fertility”).

-if you currently have pelvic inflammatory disease (PID; infection of the female reproductive organs) or have had this condition several times in the past.

-if you have conditions associated with a higher propensity for pelvic infections.

-if you have a lower genital tract infection (a vaginal or cervical infection).

-if you have had a uterine infection after giving birth or after a spontaneous or induced abortion within the last 3 months.

- if you currently have abnormal cells on the cervix.

-if you have or suspect you have cervical or uterine cancer.

-if you have tumors that are sensitive to progestogenic hormones to grow, e.g. breast cancer.

-if you have unknown uterine bleeding.

-if you have a uterine or cervical anomaly, including fibroids that deform the uterine cavity.

-if you have liver disease or active liver cancer.

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

Warnings and Precautions

Consult your doctor before starting to use Kyleena:

• if you have diabetes. Generally, there is no need to modify your antidiabetic medication while using Kyleena, but your doctor may need to check it
• if you have epilepsy. A seizure may occur during placement or removal
• if you have had a past ectopic or extrauterine pregnancy (pregnancy outside the uterus).

Also, talk to your doctor if you experience any of the following situations before using Kyleena or if any of them appear for the first time while using Kyleena:

-migraine, with visual disturbances or other symptoms that may be signs of transient cerebral ischemia (temporary obstruction of blood supply to the brain)

-exceptionally intense headache

-jaundice (yellowing of the skin, white of the eyes, and/or nails)

-marked increase in blood pressure

-severe arterial diseases such as stroke or heart attack.

The following signs and symptoms may indicate that you may have an ectopic pregnancy and you should consult your doctor immediately (see also section “Pregnancy, breastfeeding, and fertility”):

• sus periods have stopped and then start having persistent bleeding or pain
• you have intense or persistent pain in the lower abdomen
• you have normal pregnancy signs, but also have bleeding and feel dizzy
• you have a positive pregnancy test

Contact your doctor immediately if any of the following situations occur (see also section 4):

• severe pain (such as menstrual cramps) or heavy bleeding after placement or if you experience pain/bleeding that lasts for more than a few weeks. This may be a sign of infection, perforation, or that Kyleena is not in its correct position.
• you no longer feel the threads in your vagina. This may be a sign of expulsion or perforation. You can check by carefully inserting a finger into your vagina and feeling the threads at the end of your vagina, near the cervix. Do not pull on the threads, as you may accidentally remove Kyleena. Use a barrier method (such as condoms) until your doctor has checked that the IUD is still in its correct position.
• you or your partner can feel the lower part of Kyleena. Avoid sex until your doctor has checked that the IUD is still in its correct position.
• your partner notices the extraction threads during sex.
• you think you may be pregnant.
• you experience persistent abdominal pain, fever, or abnormal vaginal discharge, which may be a sign of infection. Infections must be treated immediately.
• you experience pain or discomfort during sex, which may be a sign of infection, ovarian cyst, or that Kyleena is not in its correct position.
• you experience sudden changes in your menstrual periods (e.g. if you have a light or absent menstrual period and then start experiencing persistent bleeding or pain, or if you start bleeding heavily), which may be a sign that Kyleena is not in its correct position or has been expelled.

It is recommended to use sanitary pads. If you use tampons or menstrual cups, change them carefully to avoid pulling on the Kyleena threads. If you think you may have moved Kyleena out of position (see the list above for possible signs), avoid sex or use a barrier method (such as condoms), and contact your doctor.

Mental Health Disorders

Some women who use hormonal contraceptives like Kyleena 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.

Children and Adolescents

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

Other Medications and Kyleena

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Pregnancy, Breastfeeding, and Fertility

Pregnancy

Kyleena should not be used during pregnancy.

Some women may stop having their period while using Kyleena. Not having a period is not necessarily a sign of pregnancy. If you do not have a period and have other symptoms of pregnancy, you should see your doctor for an examination and pregnancy test.

If you have not had a period for 6 weeks and are concerned, consider taking a pregnancy test. If it is negative, there is no need to take another test unless you have other signs of pregnancy.

If you become pregnant with Kyleena in place, you should see your healthcare provider immediately to remove Kyleena. Removal may cause a miscarriage. However, if Kyleena is left in place during pregnancy, there is a greater risk of miscarriage and premature birth. If Kyleena cannot be removed, consult with your healthcare provider about the benefits and risks of continuing the pregnancy. If the pregnancy continues, you will be closely monitored during it and should contact your healthcare provider immediately if you experience stomach cramps, stomach pain, or fever.

Kyleena contains a hormone called levonorgestrel, and there have been isolated cases of effects on the genitals of female babies if they are exposed to levonorgestrel-containing IUDs while in the uterus.

If you want to become pregnant, you should contact your doctor to have Kyleena removed.

Ectopic Pregnancy (Pregnancy outside the Uterus)

It is rare to become pregnant while using Kyleena. However, if you become pregnant while using Kyleena, there is an increased risk of ectopic pregnancy. Women who have had a previous ectopic pregnancy, tubal surgery, or pelvic infection are at higher risk of ectopic pregnancy. Ectopic pregnancy is a serious condition that requires immediate medical attention (see section 2, “Warnings and Precautions” for signs and symptoms) and may affect future fertility.

Breastfeeding

You can use Kyleena during breastfeeding. Levonorgestrel (the active ingredient in Kyleena) has been identified in small amounts in the breast milk of lactating women. However, no negative effects on the baby's growth and development or on the quantity or quality of breast milk have been observed.

Fertility

Your normal fertility level will return after removing Kyleena.

Driving and Operating Machines

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

Starting to use Kyleena

• You must be sure you are not pregnant before inserting Kyleena.
• Kyleena must be inserted within 7 days of the start of your period. When inserted during those days, Kyleena will work from the time of insertion and prevent pregnancy.
• If you cannot insert Kyleena within 7 days of the start of your period or if your period is not regular, then Kyleena can be inserted on any other day. In this case, you must not have had sexual intercourse without contraception since your last menstrual period, and you must have a negative pregnancy test before insertion. Additionally, Kyleena may not prevent pregnancy reliably from the time of insertion. Therefore, you must use a barrier contraceptive method (such as a condom) or abstain from vaginal sexual intercourse in the following 7 days after the insertion of Kyleena.
• Kyleena is not indicated for use as emergency contraception (postcoital contraception).

Starting to use Kyleena after giving birth

• Kyleena can be inserted after giving birth after the uterus has recovered to its normal size, and not before 6 weeks after delivery (see section 4 “Possible adverse effects – Perforation”).
• See also “Starting to use Kyleena” above to know what else you need to know for the time of insertion.

Starting to use Kyleena after an abortion

Kyleena can be inserted immediately after an abortion if the pregnancy has lasted less than 3 months, provided there are no genital infections. Kyleena will work from the time of insertion.

Replacing Kyleena

Kyleena can be replaced at any time during your menstrual cycle with a new Kyleena. Kyleena will work from the time of insertion.

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

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

Insertion of Kyleena

Pre-insertion checks by your doctor may include:

• a cervical cytology test (Papanicolaou test)
• breast examination
• other tests, p.eg. to exclude infections, including sexually transmitted diseases, pregnancy test, if necessary.Your doctor will also perform a gynecological examination to determine the position and size of the uterus.

After a gynecological examination:

• a device called a speculum is introduced into the vagina, and the cervix can be cleaned with an antiseptic solution. Kyleena is then placed in the uterus using a thin and flexible plastic tube (the insertion tube). Local anesthesia may be applied to the cervix before insertion.
• some women may experience dizziness or fainting during insertion or after inserting or removing Kyleena.
• you may experience some pain and bleeding during insertion or shortly after.

After Kyleena is inserted, your doctor must provide you with a reminder card for the patient for follow-up visits.Bring this card to each visit.

Follow-up visit:

You should have Kyleena checked 4-6 weeks after its insertion, and subsequently at regular intervals, at least once a year. Your doctor will determine the frequency and type of reviews that are adapted to your individual case.Bring the reminder card for the patient that your doctor has provided to each visit.

Removal of Kyleena

Kyleena must be removed at the latest by the end of the fifth year of use.

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

Continuing contraception after removal

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

If you have irregular periods (menstruation) or absence of periods, you must use a barrier contraceptive method for 7 days before removal.

You can also insert a new Kyleena immediately after removal, in which case no additional protection is needed. If you do not want to continue with the same contraceptive method, ask your doctor for advice on other reliable contraceptive methods.

Like all medications, Kyleena may cause side effects, although not everyone will experience them.

Contact your doctor immediately if you notice any of the following symptoms:

• allergic reactions, including hives, itchy skin (urticaria), and angioedema (characterized by sudden swelling of the eyes, mouth, and throat, for example).

Also, see section 2 to know when to contact your doctor immediately.

The following is a list of possible side effects based on their frequency:

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

• headache
• abdominal/pelvic pain
• acne/oily skin
• changes in menstrual cycle, including increased or decreased menstrual bleeding, spotting, infrequent periods, and absence of bleeding (see also the next section on irregular and infrequent bleeding)
• ovarian cyst (see also the next section on ovarian cysts)
• vulvovaginitis (inflammation of external genital organs and vagina)

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

• depressed mood/depression
• decreased libido
• migraine
• dizziness
• nausea (gag reflex)
• hair loss
• upper genital tract infection
• dysmenorrhea (painful menstruation)
• mammary pain/discomfort
• expulsion of the device (complete and partial); (see next section on expulsion)
• genital discharge
• weight gain

Rare side effects:may affect up to 1 in 100 people

• excessive body hair
• uterine perforation (see also the next section on perforation)

Description of possible side effects selected:

Irregular or infrequent bleeding

Kyleena may affect your menstrual cycle. You may experience changes in your periods, including spotting, irregular periods, longer or shorter periods, heavier or lighter bleeding, or absence of bleeding.

You may experience bleeding and spotting between periods, especially during the first 3-6 months. Sometimes bleeding is more abundant than usual at first.

Generally, you may experience a gradual reduction in the amount and number of bleeding days each month.Some women may eventually find that their periods stop completely.

You may not experience the monthly thickening of the uterine lining due to the hormone effect, and therefore, there may be nothing to come out or shed in the form of a menstrual period.This does not necessarily mean that you have reached menopause or are pregnant.Your own hormone levels usually remain normal.

When the system is removed, your period should return to normal soon.

Pelvic infection

The Kyleena inserter and Kyleena itself are sterile. Despite this, there is a higher risk of pelvic infection (infections of the uterine lining or fallopian tubes) at the time of placement and during the first 3 weeks after placement.

Pelvic infections in SLI users are usually related to the presence of sexually transmitted diseases. The risk of infection increases if you or your partner have multiple sexual partners or if you have had a previous pelvic inflammatory disease (PID).

Pelvic infections should be treated immediately.

Pelvic infections like PID can have serious consequences and may affect fertility and increase the risk of a future ectopic pregnancy (pregnancy outside the uterus). In extremely rare cases, a severe or septicemia (very severe infection that can be fatal) may occur shortly after insertion.

Kyleena should be removed if you experience recurrent PID or if an infection is severe or does not respond to treatment.

Expulsion

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

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

We recommend that you check the strings with your finger, for example, while showering. See also section 2, "Warnings and precautions" to know how to check if Kyleena is in place. If you experience signs indicating expulsion or cannot feel the strings, you should use an additional contraceptive method (such as condoms), and consult your healthcare provider.

Perforation

During Kyleena placement, the uterine wall may be penetrated or perforated, although perforation may not be detected until later. If Kyleena is lodged outside the uterine cavity, it is not effective in preventing pregnancy and should be removed as soon as possible. You may need surgical intervention to remove Kyleena.

The risk of perforation increases in women who are breastfeeding, as well as in women who have given birth up to 36 weeks before insertion and may increase in women with a fixed and tilted uterus (retroverted and fixed uterus).If you suspect that you may have suffered a perforation, seek medical attention quickly and remind them that you have Kyleena inserted, especially if it was not the person who inserted it.

Ovarian cyst

Since the contraceptive effect of Kyleena is mainly due to its local effect on the uterus, ovulation (release of the egg) usually continues while using Kyleena. Sometimes an ovarian cyst may form.

Most cases have no symptoms.

An ovarian cyst may require medical attention, or more rarely, surgical intervention, but it usually resolves on its own.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

No special storage conditions are required.

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

Do not open the blister pack. Only your doctor or nurse should do this.

Do not use this medication after the expiration date that appears on the case and on the blister pack after “CAD”. The expiration date is the last day of the month indicated.

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

Composition of Kyleena

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

The other components are:

- Polidimetilsiloxano elastomer

- Colloidal anhydrous silica

- Polyethylene

- Barium sulfate

- Polypropylene

- Copper phthalocyanine

- Silver

Appearance of the product and contents of the package

Kyleena is an intrauterine delivery system (IUD) in the shape of a T. The white vertical arm of the T-shaped body carries a drug reservoir containing levonorgestrel. There are two blue extraction threads attached to a handle at the lower end of the vertical arm. Additionally, the vertical axis has a silver ring located near the horizontal arms, which is visible by ultrasound examination.

Package size:

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

Only some package sizes may be marketed.

Marketing Authorization 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 authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) 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

Last review date of this leaflet:May 2024

Other sources of information

You can access detailed and updated information about this medicinal product by scanning the QR code included in the leaflet, packaging, and patient reminder card with your smartphone. You can also access the same information on the following internet address:https://cima.aemps.es/info/81418

The following information is intended only for healthcare professionals:

INSERTION INSTRUCTIONS

Kyleena 19.5 mg intrauterine delivery system

levonorgestrel

For insertion by a healthcare professional using an aseptic technique.

Kyleena is supplied in a sterile package within an inserter that allows for single-handed manipulation. The package should not be opened until necessary for insertion. Do not re-sterilize. This presentation is for single use only. Do not use if the blister is damaged or open. Do not insert after the expiration date appearing on the case and the blister after “CAD”.

The disposal of unused medicinal product or waste material will be carried out in accordance with local regulations.

Kyleena is provided with a patient reminder card within the package. Complete the card and give it to the patient after insertion.

Preparation for insertion

- Examine the patient to rule out contraindications for Kyleena insertion (see Technical Dossier, section 4.3 and section 4.4 under Medical examination/exploration).

- Insert a speculum, visualize the uterine cervix, and then meticulously clean the uterine cervix and vagina with an appropriate antisepsis solution.

- Assist with a second person if necessary.

- Hold the anterior lip of the uterine cervix with a tenaculum or other forceps to stabilize the uterus. If the uterus is retroverted, it may be more appropriate to hold the posterior lip of the uterine cervix. A gentle traction may be applied with the forceps to straighten the cervical canal. The forceps should remain in place and a gentle traction should be applied to the uterine cervix throughout the insertion procedure.

- Introduce a uterine sound through the cervical canal to the uterine fundus to measure the depth and confirm the direction of the uterine cavity and to rule out any possibility of intrauterine anomalies (e.g., septum, submucosal fibroids) or the presence of a previously inserted intrauterine device that has not been removed. If difficulties are encountered, consider cervical dilation. If cervical dilation is necessary, assess the use of analgesics and/or a paracervical block.

Insertion

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

IMPORTANT!Do not pull the slider down because this may release Kyleena prematurely. Once released, Kyleena cannot be reloaded.

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

Removal/Replacement

For removal/replacement, see the Technical Dossier of Kyleena.