Kyleena

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Kyleena
19.5 mg, intrauterine system
Levonorgestrelum
Please read this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of the leaflet:

1. What Kyleena is and what it is used for
2. Important information 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 T-shaped intrauterine system, also known as a hormonal intrauterine device. It prevents pregnancy for up to five years and is a contraceptive method. Kyleena contains a hormone called levonorgestrel.
Figure 1: Kyleena intrauterine system

How Kyleena works
Your doctor will insert Kyleena into the uterus. After insertion, a small amount of hormone is continuously released.
Kyleena prevents sperm from meeting the egg, thereby preventing pregnancy. It works in the following ways:

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

Figure 2: Kyleena in the uterus

2. Important information before using Kyleena

Important information about Kyleena
Your doctor must ensure that this contraceptive method is suitable for you. Therefore, they will first ask several questions about your health. Only then will you be able to obtain a prescription.
Kyleena is a contraceptive and prevents pregnancy. However, no contraceptive method is 100% effective. Each year, approximately 2 to 3 out of 1,000 women using Kyleena become pregnant.
This system does not protect against HIV infection or other sexually transmitted infections (STIs).
This system is not emergency contraception, such as the "morning-after pill." Women who have had unprotected intercourse shortly before insertion may become pregnant.

When NOT to use Kyleena:

• if you are pregnant (see section below "Pregnancy, breastfeeding and fertility"),
• if you have an infection of the uterus, fallopian tubes, or ovaries (pelvic inflammatory disease), or if you have had repeated episodes of such infections in the past,
• if you have a condition that increases the risk of pelvic infections, such as sexually transmitted infections or conditions that weaken the body's ability to fight infections, for example advanced stages of HIV infection,
• if you have a vaginal or cervical infection,
• if you have given birth, had an abortion, or miscarried within the last three months and subsequently developed a uterine infection,
• if your most recent cervical smear test (cervical screening) results were abnormal,
• if you have or are suspected to have cancer of the uterus or cervix,
• if you have a tumour that grows under the influence of progestogens, such as breast cancer,
• if you have unexplained vaginal bleeding,
• if your cervix or uterus does not have a normal shape, for example due to non-cancerous uterine conditions (fibroids),
• if you have liver disease or a liver tumour,
• if 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 situations apply to you. If in doubt, speak to your doctor.
Warnings and precautions
Tell your doctor before using Kyleena if:

• you have diabetes. Generally, no changes to diabetes medication will be needed while using Kyleena, but your doctor may need to monitor your condition,
• you have epilepsy – seizures (epileptic fits) may occur during insertion or removal of Kyleena,
• you have previously had an ectopic pregnancy (pregnancy outside the uterus),
• you have migraines that cause visual disturbances – such as sudden loss of vision in one eye – or other neurological symptoms (migraine with aura), or other severe headaches of unknown origin,
• you have jaundice (skin, nails, and whites of the eyes turn yellow),
• you have high blood pressure,
• you have ever had a stroke or heart attack.

If any of these apply to you (or if you are unsure), you should speak to your doctor before Kyleena is inserted.
Tell your doctor immediately if, while using Kyleena:

• you experience symptoms of pregnancy or have a positive pregnancy test – see section below "Pregnancy, breastfeeding and fertility".
• you experience symptoms of pregnancy along with abdominal pain, vaginal bleeding, or dizziness. This may indicate an ectopic pregnancy – see section 4, subsection "Ectopic pregnancy".
• you develop abdominal pain, fever, unusual vaginal discharge, or pain during intercourse – this may indicate an infection requiring prompt treatment. See section 4, subsection "Pelvic infection".
• you experience pain during intercourse – you may have a small fluid-filled sac (cyst) in the ovary. See section 4, subsection "Ovarian cyst".
• you experience severe pain, very heavy bleeding, or can no longer feel the Kyleena threads in your vagina – this may indicate perforation. See section 4, subsection "Perforation".

If any of the above symptoms occur, contact your doctor immediately.
You should also speak to your doctor about Kyleena if:

• you develop migraine or severe headache for the first time,
• you notice that your skin, nails, or whites of the eyes have turned yellow – signs of jaundice,
• you notice an increase in blood pressure,
• you have a stroke or heart attack.

Your doctor will decide whether it is still safe for you to continue using Kyleena.
Be aware of signs indicating that Kyleena may not be in the correct position
Signs that Kyleena may not be correctly positioned include:

• you can no longer feel the Kyleena threads with your fingers in the vagina – see section 3, subsection "How to check on your own that Kyleena is in the correct position".
• you or your partner can feel the lower plastic end of the Kyleena frame – see section 3, subsection "How to check on your own that Kyleena is in the correct position".
• you experience sudden changes in your menstrual pattern. For example: your periods stopped after Kyleena insertion, and then suddenly returned.

These symptoms may indicate that Kyleena has been expelled – see section 4, subsection "Expulsion of Kyleena". Alternatively, they may indicate perforation – see section 4, subsection "Perforation".
If you notice any of these signs that Kyleena may not be in the correct position, you should contact your doctor immediately. Avoid sexual intercourse unless using a condom or diaphragm until your doctor confirms the device is still correctly positioned.
Your partner may feel the Kyleena threads during intercourse. This does not necessarily mean the device is out of position. However, if your partner feels uncomfortable, there are ways your doctor can help.

Menstrual hygiene products
During your period, it is recommended to use sanitary pads. If using tampons or menstrual cups, change them carefully to avoid accidentally pulling on the Kyleena threads. If you suspect the device has been displaced (see list of possible signs above), avoid sexual intercourse until you see your doctor, unless using a condom or diaphragm.

Breast cancer
Women using combined oral contraceptives have a slightly increased risk of developing breast cancer. This risk returns to normal within 10 years after stopping the pill.
Some scientific studies suggest a slightly increased risk of breast cancer with the use of levonorgestrel-releasing intrauterine systems such as Kyleena, while other studies do not show an increased risk. If you have any concerns, consult your doctor.

Mental health problems
Some women using hormonal contraceptives, including Kyleena, may experience depression or low mood. For more information, see section 4, subsection "Mental health problems".

Children and adolescents
Girls who have not yet started menstruating should not use Kyleena.

Kyleena and other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.

Pregnancy, breastfeeding and fertility
Pregnancy
Kyleena must not be inserted during pregnancy.
Absence of menstrual bleeding while using Kyleena
Some women may stop having periods while using Kyleena. If your periods stop, this is likely due to Kyleena. For more information, see section 4, subsection "Irregular or infrequent menstrual bleeding".
If your period has not occurred for 6 weeks, you may take a pregnancy test. If the test shows you are not pregnant, there is no need to repeat it.
If you experience symptoms of pregnancy
If you experience symptoms such as missed period, nausea, or tender breasts:

1. take a pregnancy test,
2. contact your doctor for an examination.

If you become pregnant while using Kyleena
If you become pregnant while using Kyleena, contact your doctor immediately. Your doctor will decide whether Kyleena should be removed.
Removing Kyleena carries a risk of miscarriage. However, leaving Kyleena in place during pregnancy may increase the risk of:

• miscarriage,
• premature delivery.

Discuss the benefits and risks of continuing the pregnancy with Kyleena in place with your doctor. Your doctor will monitor you closely. Contact your doctor immediately if you experience:

• abdominal cramps,
• abdominal pain,
• fever.

Kyleena contains a hormone called levonorgestrel. Ask your doctor about any potential effects this hormone may have on the developing baby. Very few cases have been reported of levonorgestrel affecting the genital organs of female fetuses in the uterus.

Ectopic pregnancy
The risk of becoming pregnant while using Kyleena is very low. However, if pregnancy does occur while using Kyleena, there is an increased risk that the fertilized egg (embryo) will implant outside the uterus, such as in the fallopian tube or abdominal cavity (ectopic pregnancy).
This type of pregnancy is a serious condition requiring immediate medical intervention. After an ectopic pregnancy, it may be more difficult to become pregnant again. See section 4, subsection "Ectopic pregnancy".

Breastfeeding
You may use Kyleena while breastfeeding. A small amount of hormone passes into breast milk. However, Kyleena does not affect the quality or quantity of breast milk or the growth and development of the breastfed infant.

Fertility
If you wish to become pregnant, contact your doctor to have Kyleena removed.
Kyleena does not affect fertility after removal.

Driving and using machines
Kyleena has no known effect on the ability to drive or operate machinery.

3. How to use Kyleena

Starting to use Kyleena

• Before inserting Kyleena, it must be confirmed that the woman is not pregnant.

• Kyleena should be inserted within 7 days of the start of menstrual bleeding. If inserted within this time frame, the system will be effective immediately and will prevent pregnancy.

• If Kyleena cannot be inserted within 7 days of the onset of menstrual bleeding, or if menstruation occurs at unpredictable times, the system may be inserted on any day. In such a case, unprotected sexual intercourse must be avoided since the last menstrual period, and a negative pregnancy test must be obtained prior to insertion. Additionally, Kyleena may not provide reliable contraceptive protection immediately. Therefore, a barrier method of contraception (e.g., condoms) should be used, or sexual intercourse should be avoided, for the first 7 days after insertion.

• Kyleena is not an emergency contraceptive, such as the "day after" pill.

Starting to use Kyleena after childbirth

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

Starting to use Kyleena after miscarriage

Kyleena may be inserted immediately after a miscarriage if the pregnancy lasted less than 3 months, provided there are no genital tract infections; it will then be effective immediately.

Inserting a new Kyleena when replacing an existing system

The system may be replaced with a new one on any day of the menstrual cycle and will be effective immediately.

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

• Kyleena may be inserted immediately if it is reasonably certain that the woman is not pregnant.
• If more than 7 days have passed since the start of menstrual bleeding, abstinence or additional contraceptive protection should be used for the next 7 days.

What happens during the insertion of Kyleena?

Pre-insertion examination

Prior to inserting Kyleena, the doctor may perform certain examinations, for example:

• cervical smear (cytology),
• breast examination,
• other tests if necessary, for example for sexually transmitted infections.

Insertion of Kyleena

First, the doctor will examine the size and exact position of the uterus in the pelvic cavity (pelvic examination).
The doctor will insert a speculum into the vagina and clean the cervix with an antiseptic solution. Sometimes the doctor will use local anaesthesia of the cervix. Then the doctor will insert Kyleena into the uterus through a thin, flexible, plastic tube (applicator).
Insertion of Kyleena may sometimes cause discomfort. Some women may experience dizziness or fainting. Pain or slight vaginal bleeding may also occur. This is not unusual.
After the insertion is completed, the doctor will give the woman a patient reminder card. This card can be used to record dates of future Kyleena check-ups. The card should be brought to every medical visit.

Follow-up after insertion

Kyleena should be checked by a doctor 4–6 weeks after insertion.
The doctor will decide how often follow-up visits should occur. Kyleena should be checked at least once a year. The patient reminder card should be brought to every visit.

How to check on your own that Kyleena is in the correct position

This can be checked by gently inserting a finger into the vagina. The threads should be felt at the end of the vagina near the cervix. The cervix is the entrance to the uterus.
Caution: Do not pull on the threads, as this may accidentally remove Kyleena.

If the threads cannot be felt, the doctor must check whether Kyleena is still in the correct position. Sexual intercourse should be avoided unless a condom or contraceptive cap is used, until the doctor's visit.

If the woman or her partner feels the lower plastic end of the Kyleena frame, Kyleena is not in the correct position. Medical advice should be sought immediately. Sexual intercourse should be avoided until the doctor's visit, unless a condom or contraceptive cap is used.

Removal of Kyleena

Kyleena is effective for up to 5 years. It should be removed after 5 years, but may also be removed at any time before then. The doctor will remove the system. After removal, pregnancy may occur.

Removal of Kyleena may be uncomfortable. Some women may experience dizziness or fainting during or immediately after removal. Slight pain or vaginal bleeding may also occur. This is not unusual.

Continuation of contraception after removal of the system

If the woman does not wish to become pregnant after removal of Kyleena, it should be noted that:

• It is best to remove Kyleena within 7 days of the start of the menstrual cycle. If removed at any other time than during menstruation, a condom or contraceptive cap must be used during intercourse for 7 days prior to removal.
• If the woman has irregular or no menstrual periods, a condom or contraceptive cap must be used during intercourse for 7 days prior to removal. Irregular menstruation means that the number of days between cycles is not always the same.
• A new Kyleena may also be inserted immediately after removal of the previous one. In this case, additional contraception is not necessary. If the woman does not wish to continue with the same method, she should consult her doctor for advice on other reliable contraceptive methods.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Serious adverse reactions
There are certain serious adverse reactions, meaning that if any of these occur, you should
contact your doctor immediately:

• abdominal pain, fever, unusual vaginal discharge or abnormal vaginal bleeding, or pain during sexual intercourse – this could be an infection of the uterus, fallopian tubes or ovaries – see below "Pelvic infections".
• severe pain, similar to menstrual pain, more pain than expected, or very heavy vaginal bleeding after insertion of the system. If you experience pain or bleeding lasting longer than a few weeks, sudden changes in your menstrual cycle, pain during sexual intercourse, or if the threads of the system are no longer detectable, these may be symptoms of perforation – see below "Perforation".
• periods have stopped, but vaginal bleeding continues, or there is severe or persistent lower abdominal pain – these may be symptoms of ectopic pregnancy – see below "Ectopic pregnancy".
• mood changes and symptoms of depression – see below "Mental health problems".
• allergic reaction – such as skin rash, hives or swelling of the tongue, lips, face or throat. This type of reaction is very rare.

If a woman thinks any of the above points apply to her, she should contact her doctor immediately.
Other adverse reactions
Below are other adverse reactions that may occur. The most common adverse reactions are listed at the top of the list, and the rarest ones at the bottom.
Very common adverse reactions: occur in more than 1 in 10 women

• headache
• abdominal or pelvic pain
• acne or oily skin
• changes in menstruation, for example:
  - heavier or lighter bleeding than usual
  - bleeding or light spotting (spotting) without a period
  - irregular or infrequent periods
  - absence of periods altogether
  More information on this can be found in the section "Irregular or infrequent menstrual bleeding" below.
• small fluid-filled sac on the ovary (ovarian cyst). More information on this can be found in the section "Ovarian cyst" below.
• inflammation of the vulva and vagina

Common adverse reactions: occur in less than 1 in 10 women

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

Uncommon adverse reactions: occur in less than 1 in 100 women

• increased body hair

Description of selected possible adverse reactions:
Ectopic pregnancy
Symptoms of ectopic pregnancy include:

• periods have stopped, but vaginal bleeding reappears and does not stop,
• severe or persistent pain in the lower abdomen,
• normal pregnancy symptoms such as nausea or tender breasts, but also vaginal bleeding and dizziness,
• positive pregnancy test.

You should contact your doctor immediately if you experience any of these symptoms.
The risk of becoming pregnant while using Kyleena is very low. However, if a woman does become pregnant while using Kyleena, there is an increased risk that the fertilized egg (embryo) will implant outside the uterus, such as in the fallopian tube or abdominal cavity (ectopic pregnancy).
Approximately 2 out of 1000 women using Kyleena for one year will experience an ectopic pregnancy. This type of pregnancy is a serious condition requiring immediate medical intervention. Surgery may be necessary.
Some women are at higher risk of ectopic pregnancy. These include women who:

• have previously had an ectopic pregnancy,
• have had surgery on the fallopian tubes,
• have had a pelvic infection.

Irregular or infrequent menstrual bleeding
It is likely that your periods will change due to the use of Kyleena. For example:

• You may experience light bleeding between periods. This type of bleeding is called spotting.
• Your periods may become less regular. In this case, the number of days between cycles may not always be the same.
• Periods may become shorter or longer.
• Bleeding may be lighter or heavier than usual.
• Periods may stop altogether.

Sometimes these changes occur only during the first few months after insertion. For example:

• Bleeding between periods or spotting is most common during the first 3 to 6 months.
• In some women, periods may initially be heavier than usual.

Gradually, bleeding may become lighter each month, and periods may become shorter. Eventually, some women may stop having periods altogether.
No periods? This is usually normal. In most cases, it does not mean the woman is pregnant or going through menopause. Here's why: normally, the lining of the uterus thickens each month in preparation for pregnancy, and then becomes thin again due to menstruation. Kyleena reduces the thickening of the uterine lining. This may lead to the cessation of periods. Hormone levels usually remain normal.
Normal periods usually return after removal of Kyleena. If this does not happen, contact your doctor.
Pelvic infection
Kyleena does not contain bacteria, viruses or fungi (it is sterile). This also applies to the applicator.
However, a pelvic infection may still occur during or within the first 3 weeks after insertion of Kyleena. This may affect the lining of the uterus, fallopian tubes or ovaries. This may affect fewer than 1 in 10 women.
Symptoms may include:

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

The risk of pelvic infection is higher if:

• the woman has a sexually transmitted infection,
• the woman or her partner has multiple sexual partners,
• the woman has had a pelvic infection in the past.

If a pelvic infection occurs, it is important to contact your doctor immediately. A pelvic infection may lead to:

• fertility problems in the future. This may make it more difficult to become pregnant,
• ectopic pregnancy if pregnancy occurs,
• severe infection or sepsis. This is very rare and occurs shortly after insertion of Kyleena. Sepsis means a life-threatening illness due to infection. Sepsis can be fatal if not treated.

Kyleena must be removed if a pelvic infection:

• occurs repeatedly,
• is very severe,
• does not resolve despite treatment.

Expulsion of Kyleena
Kyleena may be displaced or expelled. This is caused by uterine muscle contractions during menstruation. This may occur in fewer than 1 in 10 women, especially if:

• the woman is overweight at the time of insertion,
• she has previously had heavy periods.

If Kyleena is out of place, it may no longer work properly. The risk of pregnancy is then higher. If it is expelled, it will no longer prevent pregnancy.
If Kyleena is out of place or expelled, a woman may experience pain or vaginal bleeding that differs from normal. It is also possible that Kyleena is expelled and the woman does not notice.
Kyleena usually reduces the amount of blood lost during menstruation. The longer a woman uses it, the less blood she loses during her period. This means that if a woman suddenly starts losing more blood during her period, Kyleena may have been expelled.
Information on how to check whether Kyleena is in the correct position and what to do if you suspect it is not, can be found in section 3 "How to check on your own that Kyleena is in the correct position".
Perforation
It may happen that Kyleena is pushed into or through the uterine wall. This is called perforation. Perforation usually occurs during insertion of Kyleena.
Perforation does not always cause pain, so it may not be noticed immediately. If the system is no longer in the correct position due to perforation, it will not prevent pregnancy. The doctor must then remove it as quickly as possible. Sometimes surgery is necessary.
Perforation occurs in fewer than 1 in 1000 women. The risk of perforation is higher (in fewer than 1 in 100 women) if:

• the woman is breastfeeding at the time of insertion of Kyleena,
• the woman has given birth within the last 9 months before insertion of Kyleena.

Perforation may have occurred if:

• there is severe pain, similar to menstrual pain or more severe than expected,
• very heavy vaginal bleeding occurs after insertion,
• pain or bleeding lasts longer than a few weeks,
• sudden changes in the menstrual cycle occur,
• pain during sexual intercourse occurs,
• the threads of Kyleena are no longer detectable.

If a woman suspects perforation, she should contact her doctor immediately. She should inform the doctor about Kyleena, especially if it is not the person who inserted the system.
Ovarian cyst
Sometimes, while using Kyleena, a small fluid-filled "pouch" may appear on the ovary. This pouch is called an ovarian cyst.
Symptoms of an ovarian cyst may include:

• pelvic pain,
• pain or discomfort during sexual intercourse.

An ovarian cyst usually resolves on its own. However, it may require medical treatment. In rare cases, surgery may be necessary. If a woman suspects she may have an ovarian cyst, she should contact her doctor.
Mental health problems
Some women using hormonal contraceptives, including Kyleena, may experience depression or low mood.
Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible. Depression and low mood may occur in fewer than 1 in 100 women using Kyleena.
Reporting adverse reactions
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, consult your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Kyleena

No special storage instructions are required.
The medicine should be stored in a place inaccessible and out of sight of children.
Do not open the blister (the plastic container in which the Kyleena medicine is contained). Only a doctor or nurse may do this.
The system must not be inserted after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.

6. Contents of the package and other information

What Kyleena contains
The active substance is levonorgestrel. The intrauterine system contains 19.5 mg of levonorgestrel.
Other ingredients are:
elastomer polydimethylsiloxane
elastomer polydimethylsiloxane (containing 30-40wt% anhydrous colloidal silica)
silver
Body in the shape of a T: polyethylene (containing 20-24% barium sulfate)
Threads: polypropylene, copper phthalocyanine
What Kyleena looks like and contents of the pack
Kyleena is a hormonal intrauterine system (an intrauterine therapeutic system). It is T-shaped and white in colour. On the vertical stem there is a small hormone reservoir containing levonorgestrel. Attached to the loop at the bottom of the system are two blue threads, which allow the physician to remove Kyleena when necessary. A silver ring located near the horizontal arms of Kyleena is visible to the physician during ultrasound examination.
Pack size:
1x1 intrauterine therapeutic system.
For further information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Spain, country of export:
Bayer Hispania, S.L., Av. Baix Llobregat 3-5, 08970 Sant Joan Despí (Barcelona), Spain
Manufacturer:
Bayer Oy, Pansiontie 47, 20210 Turku, Finland
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish Marketing Authorisation number, country of export: 713563.0
Parallel Import Licence number: 41/21
This medicinal product is authorised in the European Economic Area countries 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