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Patient Info Service - information for patients

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1. What is Kyleena and what is it used for?

Kyleena is used to prevent pregnancy (contraception) for up to five years.

Kyleena is a T-shaped intrauterine drug delivery system (IUS) that slowly releases a small amount of the hormone levonorgestrel once it is placed in the uterus.

Kyleena works by reducing the monthly growth of the uterine lining and making the cervical mucus thicker. These effects prevent the sperm and egg from coming into contact with each other and the egg from being fertilized by the sperm.

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

General information

Before you can be given Kyleena, your doctor will ask you a few questions about your personal medical history.

This leaflet describes several situations when Kyleena should be removed or when Kyleena may not be reliable. In such situations, you should either not have sex or use a condom or other barrier method.

Like other hormonal contraceptives, Kyleena does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Kyleena is not intended for emergency contraception (contraception after intercourse).

Do NOT use Kyleena

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

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

  • if you have diseases that make you more prone to inflammation of the pelvis (pelvic infection).

  • if you have an inflammation of the lower genital tract (an infection of the vagina or cervix).

  • if you have had uterine inflammation after having a baby, an abortion or a miscarriage in the last 3 months.

  • if you currently have abnormal changes in cells in the area of ​​the cervix (cervix).

  • if you have or are suspected of having a malignant disease (cancer) of the cervix or uterus.

  • if you have tumors the growth of which is sensitive to sex hormones (progestins) e.g. B. breast cancer.

  • if you have unexplained vaginal bleeding.

  • if you have a malformation of the cervix or uterus, including benign muscle growths (fibroids) that cause the uterine cavity to deform.

  • if you have acute liver disease or a liver tumor.

  • if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Talk to your doctor before using Kyleena if you

  • Have diabetes. In general, it is not necessary to change your diabetes medication while using Kyleena, but your doctor may need to check this.

  • have epilepsy. A fit (seizure) may occur during insertion or removal.

  • have previously had an ectopic or extrauterine (outside of the uterus) pregnancy.

Also, talk to your doctor if you have any of the following conditions before using Kyleena, or if they happen for the first time while using Kyleena:

  • Migraines with visual disturbances or other symptoms that may indicate a temporary interruption in the blood supply to the brain (transient cerebral ischemia)

  • exceptionally severe headache

  • Jaundice (yellowing of the skin, whites of the eyes and / or nails)

  • significant increase in blood pressure

  • severe arterial disease such as stroke or heart attack.

The following signs and symptoms may indicate an extrauterine pregnancy, which is why you should contact your doctor immediately (see also section “Pregnancy, breastfeeding and fertility”):

  • Your menstrual period has stopped and you have persistent bleeding or pain.

  • You have severe or persistent abdominal pain.

  • You have normal signs of pregnancy, but you also have bleeding and feel dizzy.

  • A pregnancy test you have taken is positive.

Contact your doctor immediately if you experience the following symptoms (see section 4):

  • severe pain (such as menstrual cramps) or bleeding after inserting or if you have pain / bleeding that lasts for more than a few weeks. This can e.g. For example, it could be a sign of inflammation, a perforation in the wall of the uterus, or an indication that the Kyleena is not in the correct position.

  • if you can no longer feel the threads in your vagina. This can be an indication of expulsion or perforation. Gently insert a finger into your vagina and feel the sutures at the end of your vagina near the opening of the cervix (cervix). Do not pull the strings as you may accidentally pull Kyleena out. Avoid sexual intercourse or use a barrier method of contraception (such as condoms) until your doctor has checked that the IUS is still in the correct position.

  • if you or your partner can feel the bottom of Kyleena. Avoid intercourse until your doctor has checked that the IUS is still in the correct position.

  • if your partner feels the withdrawal threads during intercourse

  • if you think you might be pregnant

  • if you have persistent abdominal pain, fever or unusual discharge from the vagina, these may be signs of inflammation. Inflammation must be treated immediately.

  • if you experience pain or discomfort during intercourse; For example, it could be a sign of inflammation, an ovarian cyst, or an indication that the Kyleena is not in the correct position.

  • if you have sudden changes in your menstrual periods (for example, if you have little or no menstrual bleeding and then have persistent bleeding, pain, or start bleeding profusely). For example, it could be an indication that Kyleena is not in the correct position or has been expelled.

The use of sanitary napkins is recommended. If you use tampons or menstrual cups, be sure to change them carefully so as not to pull the threads on Kyleena.

Psychiatric illnesses:
Some women using hormonal contraceptives such as Kyleena report having depression or a depressed mood. Depression can be serious and occasionally lead to thoughts of suicide. If you experience mood swings and symptoms of depression, seek medical advice from your doctor as soon as possible.

Children and adolescents

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

Other medicines and Kyleena

Tell your doctor if you are taking, have recently taken, or may take any other medicines.

Pregnancy, breastfeeding and fertility

pregnancy

Kyleena must not be used during pregnancy.

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

If you haven't had a menstrual period in six weeks and are concerned, consider taking a pregnancy test. If it is negative, you don't need to do another test unless you have other signs of pregnancy.

If you become pregnant with the Kyleena in place, contact your doctor immediately to have the Kyleena removed. There is a risk of spontaneous miscarriage if Kyleena is removed during pregnancy.

Leaving Kyleena in place while pregnant increases the risk of miscarriage, inflammation, or premature labor. Talk to your doctor about the risks of continuing your pregnancy.

If you are trying to get pregnant you should contact your health care professional so that the Kyleena can be removed.

Pregnancy outside the womb

(Extrauterine pregnancy)

It is unusual to get pregnant while using Kyleena. However, if you become pregnant while using Kyleena, the risk of getting pregnant outside the uterus (extrauterine or ectopic pregnancy) is increased. Women who have had an extrauterine pregnancy, fallopian tube surgery, or pelvic inflammation are at higher risk for such pregnancy. Extrauterine pregnancy is a serious condition and requires immediate medical attention (see Section 2, “Warnings and Precautions” for signs and symptoms) and can affect your later fertility.

Breastfeeding

You can use Kyleena while breastfeeding. Levonorgestrel (the active substance in Kyleena) has been found in small amounts in the breast milk of breastfeeding women. However, no adverse effects on the growth and development of the infant or the amount or quality of breast milk were observed.

Fertility

After Kyleena is removed, your fertility will return to its normal level.

Driving and using machines

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

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3. How to use Kyleena

Insert from Kyleena

Kyleena can either be inserted:

  • within 7 days of the start of your menstrual bleeding (your monthly period),

  • Immediately after a miscarriage or an abortion in the first trimester of pregnancy, provided there is no genital infection,

  • after giving birth, but only after the uterus has returned to its normal size, and not earlier than 6 weeks after delivery (see also section 4. “Possible side effects? - perforation”).

Your doctor's pre-placement examination may include:

  • a smear of the cervix (Papanicolaou smear),

  • a breast exam,

  • other tests as required, e.g. B. for infections including sexually transmitted diseases. Your doctor will also do a pelvic exam to determine the location and size of your uterus.

After the gynecological examination, the following happens:

  • An instrument called a speculum is inserted into your vagina and the cervix can be cleaned with an antiseptic solution. Then Kyleena is inserted into the uterus with a thin, flexible plastic tube (insert tube). The cervix can be anesthetized locally before insertion.

  • Some women may feel dizzy or passed out upon or after the insertion or removal of Kyleena.

  • You may experience pain and bleeding during or shortly after placement.

After Kyleena is inserted, you should receive a patient reminder card for follow-up examinations from your health care professional. Bring this reminder card with you to every doctor's appointment.

Follow-up examination:

You should have your Kyleena checked 4-6 weeks after it is inserted and then regularly, at least once a year. Your doctor will decide how often and how you need follow-up exams. If you have received a patient reminder card, please bring it with you to every doctor's appointment.

Removal of Kyleena

Kyleena should be removed no later than the end of the fifth year of use.

Kyleena can be easily removed by your doctor at any time, after which pregnancy is possible. Some women feel dizzy or pass out during or after the Kyleena is removed. You may experience pain and bleeding while having kyleena removed.

If pregnancy is not desired, Kyleena should not be removed after the seventh day of the menstrual cycle (monthly periods) unless you are using other contraceptive methods (e.g. condoms) for at least seven days prior to the removal of the IUS.

If you have irregular or no menses, you should use a barrier method of contraception for at least 7 days prior to removal.

A new Kyleena can also be inserted immediately after removal. In this case, no additional protection is required.

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4. What side effects are possible?

Like all medicines, this medicine can have side effects, although not everybody gets them.

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

  • allergic reactions including skin rash, nettle rash (urticaria) and sudden swelling of e.g. B. eyes, mouth, or throat (angioedema)

    See section 2 “What you need to know before you use Kyleena”.

The following is a list of possible side effects, sorted by frequency:

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

  • a headache

  • Abdominal pain / pelvic pain

  • Acne / oily skin

  • Changes in menstrual bleeding, including heavier and weaker menstrual bleeding, spotting, infrequent menstrual bleeding and no bleeding (see also the following section on irregular and infrequent bleeding)

  • Ovarian cyst (see also the following section on ovarian cysts)

  • Inflammation of the external genital organs and vagina (vulvovaginitis)

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

  • Depressed moods / depression

  • Decrease in libido

  • migraine

  • dizziness

  • nausea

  • Hair loss

  • Infection (inflammation) of the upper genital tract

  • painful menstrual bleeding

  • Chest pain / discomfort

  • Expulsion of the IUS (full and partial) - (see the section below on expulsion)

  • Genital discharge

  • Weight gain

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

  • Excessive body hair

  • Puncture (perforation) of the uterus (see also the following section on perforation)

Description of selected possible side effects:

Irregular or rare bleeding

Kyleena is likely to affect your menstrual cycle. It may change your menstrual bleeding so that you have spotting (a small amount of blood), irregular, shorter or longer periods, less or heavier bleeding, or no bleeding at all.

You may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months. Sometimes the bleeding is heavier than usual at first.

Overall, it is likely that the amount and number of bleeding days will gradually decrease each month. Some women may find that their periods stop altogether.

The monthly thickening of the uterine lining may not occur due to the action of hormones, so there is nothing that can be rejected as menstrual bleeding. So this does not necessarily mean that you are going through menopause or that you are pregnant. Your own hormone levels usually stay normal.

After removing the system, your menstrual period should return to normal soon.

Inflammation of the small pelvis

The Kyleena Delivery System and Kyleena itself are sterile.Nevertheless, the risk of inflammation (infection) of the pelvis (inflammation in the lining of the uterus or fallopian tubes) is increased at the time of placement and in the first 3 weeks afterwards.

Pelvic inflammation is often associated with existing sexually transmitted diseases in IUS users. The risk of inflammation is increased if you or your partner have more than one sex partner, or if you have had pelvic inflammatory disease (PID) in the past.

Inflammation of the small pelvis needs immediate treatment.

Inflammation of the small pelvis (such as pelvic inflammatory disease, PID) can be serious, affecting fertility and increasing the risk of a future extrauterine (outside of the uterus) pregnancy. Very rarely, a serious infection or sepsis (very serious general infection that can be fatal) can occur in close connection with the insert.

If the inflammation is repeated or if inflammation is severe or unresponsive to treatment, Kyleena must be removed.

expulsion

The muscle contractions of the uterus during menstruation can sometimes cause the IUS to slip or be expelled. It's rare, but possible, for Kyleena to slip out during your menstrual period without you noticing.

It is also possible that Kyleena will be partially expelled from the uterus, i.e. H. it's out of place but not fully expelled (you and your partner may notice this during intercourse). If Kyleena has been expelled, in whole or in part, you are not protected from pregnancy.

Perforation

Penetration of the uterine wall or perforation of the uterine wall may occur when the Kyleena is inserted, although the penetration may not be noticed until later. If Kyleena is outside the uterine cavity, it will not be effective in preventing pregnancy and will need to be removed as soon as possible. Surgery may be needed to remove Kyleena.

The risk of a puncture is increased in women who are breastfeeding and in women up to 36 weeks after giving birth and may be increased in women in whom the uterus is fixed and tilted backwards (fixed retroverted uterus). If you suspect a perforation has occurred, see a doctor immediately and inform the doctor that you are a Kyleena carrier, especially if it is not the doctor who performed the insertion.

Ovarian cyst

Because Kyleena's contraceptive action is mainly based on its local action in the uterus, ovulation (ovulation) will generally continue to occur while you are using Kyleena. Sometimes an ovarian cyst can develop. In most cases this does not cause any discomfort.

An ovarian cyst may have to be treated by a doctor or, in rarer cases, surgically; it usually resolves on its own.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: http://www.bfarm.de. By reporting side effects you can help provide more information on the safety of this medicine.

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5. How to store Kyleena

This medicinal product does not require special storage conditions.

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

Do not open the blister pack. The pack should only be opened by your doctor or nurse.

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

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6. Contents of the pack and other information

What Kyleena Contains

  • The Active ingredient is: Levonorgestrel. The intrauterine drug delivery system contains 19.5 mg levonorgestrel.

  • The other ingredients are:

    • Polydimethylsiloxane, cross-linked

    • Polydimethylsiloxane, cross-linked (contains 30-40% highly dispersed silicon dioxide)

    • Polyethylene (contains 20-24% barium sulfate)

    • Polypropylene (contains ≤ 0.5% Ciaftalan copper)

    • silver

What Kyleena looks like and contents of the pack

Kyleena is a T-shaped intrauterine drug delivery system (IUS). The vertical arm of the white T-body contains a drug reservoir containing levonorgestrel. Two blue retrieval threads are attached to the loop at the bottom of the vertical arm. In addition, the vertical shaft contains a silver ring near the horizontal arms that can be seen during an ultrasound scan.

Pack size

  • 1 x 1 intrauterine drug delivery system.

  • 5 x 1 intrauterine drug delivery system (multipack).

Pharmaceutic entrepreneur

Jenapharm GmbH & Co. KG

Otto-Schott-Strasse 15

07745 Jena

Tel .: 03641 - 87 97 444

Fax: 03641 - 87 97 49 444

Email: [email protected]

Manufacturer

Bayer Oy

Pansiontie 47

20210 Turku

Finland

This medicinal product is authorized in the member states of the European Economic Area (EEA) under the following names

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

This leaflet was last revised in May 2020.

Other sources of information

Detailed information about this medicine is available by scanning the QR code (contained in the package insert, outer carton and reminder card) with a smartphone. You can find the same information on the following URL: [www.pi.bayer.com/kyleena/de].

QR code for instructions for use