19.5 mg, intrauterine insert
levonorgestrel

What Kyleena is and what it is used for

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

Kyleena is a T-shaped uterine insert that after insertion into the uterus slowly releases a small amount of the hormone et levonorgestrel.

Kyleena works by reducing the monthly growth of the uterine lining and by thickening the secretions in the cervix. These measures prevent sperm and egg from coming into contact with each other and thus prevent the egg from being fertilized by sperm.

What you need to know before using Kyleena

General notes

Before you can start using your Kyleena, qualified healthcare professionals will ask some questions about your medical history.
This leaflet describes several situations where Kyleena should be taken out or when Kyleena’s reliability may be impaired. In such situations, you should either refrain from having intercourse or using a condom or any other barrier method.
Like other hormonal contraceptives, Kyleena does not protect against HIV ( AIDS ) or other sexually transmitted diseases.
Kyleena is not suitable for use as an emergency contraceptive (postcoital contraceptive).

DO NOT use Kyleena if you:

  • is pregnant (see section for “Pregnancy, breast-feeding and fertility”)
  • have pelvic inflammatory disease ( infection of the female reproductive organs) or have previously had this disease repeatedly
  • have increased susceptibility to infection in your pelvis
  • have an infection in the lower genitals e.g. an infection of the vagina or cervix (cervix)
  • have had an infection in the womb after childbirth, abortion or miscarriage in the last three months
  • have cell changes in the cervix
  • have cancer or suspected cancer of the cervix or uterus
  • have tumors that are sensitive to progestogen hormones to grow, e.g. breast cancer
  • have unexplained bleeding from the uterus
  • a malformation of the cervix or uterus including uterine fibroids (muscle fibroids) this affects the uterine cavity
  • have an ongoing liver disease or liver tumor
  • is allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to a qualified healthcare professional before using Kyleena if you:

  • have diabetes . It is not usually necessary to change your diabetes treatment when using Kyleena, but this may need to be checked by a qualified healthcare professional.
  • have epilepsy . A seizure may occur during insertion or withdrawal
  • previously had an ectopic pregnancy (ectopic pregnancy, ectopic pregnancy).

Also, talk to a qualified healthcare professional if you have any of the following conditions or if any of the following conditions occur for the first time when using Kyleena:

  • migraine , with visual disturbances or other symptoms that may be signs of transient cerebral ischemia (temporary blockage of the blood supply to the brain)
  • very severe headache
  • jaundice (skin, whites of the eyes and / or nails turn yellow)
  • sharp rise in blood pressure
  • severe vascular disease such as stroke or heart attack.

The following signs and symptoms may indicate that you have an ectopic pregnancy and should contact a qualified healthcare professional immediately (see also the section on “Pregnancy, breast-feeding and fertility”):

  • your period has stopped and you then have a persistent bleeding or pain
  • you have severe or persistent pain in the lower abdomen
  • you have normal pregnancy symptoms, but you also have bleeding and dizziness
  • you have a positive pregnancy test.

Contact a qualified healthcare professional immediately if any of the following occur (see also section 4):

  • you experience severe pain (such as menstrual cramps) or heavy bleeding after insertion or if you have pain / bleeding that continues for more than a few weeks. This could be a sign of infection , perforation or that Kyleena is not in the correct position
  • you no longer feel the threads in the vagina. This may be a sign of ejection or perforation. You can check if the threads are in place by gently inserting a finger into the vagina and feeling the threads in the back of the vagina near the opening to the uterus (cervix). Do not pull on the threads as you may accidentally pull out Kyleena. Use a barrier method as a contraceptive (eg condom) until the qualified healthcare professional has checked that the insert is still in the correct position
  • you or your partner can feel the lower part of Kyleena. Avoid intercourse until qualified healthcare professionals have checked that the insert is still in the correct position
  • your partner knows the excerpts during intercourse
  • you think you may be pregnant
  • you have persistent abdominal pain, fever or abnormal discharge from the vagina, which may be a sign of infection . Infection must be treated immediately.
  • you feel pain or discomfort during intercourse, which can be a sign of infection , ovarian cyst or that Kyleena is not in the right position
  • you get sudden changes in your bleeding pattern (eg if you normally have little or no menstrual bleeding and you instead start to have persistent bleeding or pain, or start bleeding heavily), which may be a sign that Kyleena is not in the right position or has been rejected.

The use of sanitary napkins is recommended. If tampons or menstrual cups are used, you should change them carefully so that you do not pull on Kyleena’s threads. If you think you have pulled Kyleena out of position (see the list above with possible signs), avoid intercourse or use a barrier method as a contraceptive (such as a condom) and contact a qualified healthcare professional.

Mental disorders

Some women who use hormonal contraceptives, including Kyleena, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.

Children and young people

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

Other drugs and Kyleena

Tell your healthcare provider if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Kyleena must not be used during pregnancy.

Some women do not menstruate when they use Kyleena. It does not have to mean that you are pregnant if you do not get your period. If you do not get your period and have other signs of pregnancy, you should consult a qualified healthcare professional for an examination, and do a pregnancy test.

If you have not had a period of 6 weeks and are worried, then consider doing a pregnancy test. If the test is negative, there is no need to do a new test, unless you have other signs of pregnancy.

If you become pregnant with Kyleena on the spot, you should immediately consult a qualified healthcare professional to remove Kyleena. Taking out Kyleena can cause a miscarriage. However, leaving Kyleena in place during pregnancy not only increases the risk of miscarriage but also the risk of premature birth. If Kyleena cannot be taken, talk to a qualified healthcare professional about the benefits and risks of continuing your pregnancy, and the effects the hormone may have on your baby’s development.

If you would like to become pregnant, you should contact a qualified healthcare professional to have Kyleena removed.

Ectopic pregnancy (ectopic pregnancy)

It is uncommon to get pregnant while using Kyleena. If you become pregnant while using Kyleena, your risk of developing ectopic pregnancy (ectopic pregnancy or ectopic pregnancy) increases. Women who have previously had an ectopic pregnancy operated on the fallopian tubes or had a genital infection are at greater risk of getting an 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.

Breast-feeding

Kyleena can be used during breastfeeding. Levonorgestrel (the active substance in Kyleena) has been identified in small amounts in breast milk in breastfeeding women. However, no negative effects have been seen on the baby’s growth and development, or on the amount or quality of breast milk.

Fertility

Your fertility level will return to normal after Kyleena is removed.

Driving and using machines

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

How to use Kyleena

Deposit by Kyleena

Kyleena can either be inserted:

  • within 7 days after starting menstrual bleeding
  • immediately after an abortion in the first trimester, if genital infections can be ruled out
  • when the uterus has returned to its normal size after delivery, and not earlier than 6 weeks after delivery (see section 4 “Possible side effects – Perforation”).

Examination of qualified healthcare professionals before deployment may include:

  • cell sampling
  • examination of the breasts
  • other tests, e.g. for infection , including sexually transmitted diseases. Qualified healthcare professionals will also perform a gynecological examination to determine the location and size of the uterus.

After a gynecological examination:

  • An instrument called a speculum is inserted into the vagina, and the cervix can be wiped with a bactericidal solution. Kyleena is then inserted into the uterus using a thin, flexible plastic tube (insertion tube). Local anesthesia can be applied to the cervix before insertion.
  • some women experience dizziness or fainting during insertion or after Kyleena has been inserted or removed.
  • you may experience some pain and bleeding during or shortly after insertion.

After Kyleena is inserted, you will receive a patient card from your doctor/midwife for future examinations. Bring this card for all return visits.

Follow-up examination:

Kyleena should be checked 4-6 weeks after deposit, and thereafter regularly, at least once a year. Your doctor/midwife will decide how often and what type of check-ups are required in your case.

Bring the patient card that you received from your doctor/midwife for all return visits.

Selection of Kyleena

Kyleena should be taken by the end of the fifth year of use at the latest.

Kyleena can be easily removed by a qualified healthcare professional at any time and it is then possible for you to become pregnant. Some women experience dizziness or fainting during or after Kyleena is removed. You may experience some pain and bleeding during the withdrawal.

If you want to avoid pregnancy, Kyleena should not be taken after the seventh day of the menstrual cycle (monthly period) unless another contraceptive is used (eg a condom) for at least 7 days before removal.

If you have irregular menstruation (menstruation) or no menstruation, you should use a barrier method as a contraceptive for 7 days before withdrawal.

A new Kyleena can also be inserted immediately after the old one is removed. In such cases, no additional protection is required.

Possible side effects

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

Contact a qualified healthcare professional immediately if you notice any of the following symptoms:

  • allergic reactions including rash, hives ( urticaria ) and angioedema (characterized by sudden swelling of eg eyes, mouth, throat)

See also section 2 for information on when to contact qualified healthcare professionals immediately.

Below is a list of possible side effects according to how common they are:

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

  • headache
  • abdominal and pelvic pain
  • acne / fat hy
  • changes in the bleeding pattern such as increased or decreased menstrual bleeding, spotting, prolonged interval between bleedings or no bleeding at all (see also next section on irregular and long-term bleeding)
  • ovarian cysts (see also next section on ovarian cysts)
  • inflammation of the external genitalia or vagina (vulvovaginitis)

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

  • depression
  • decreased sex drive
  • migraine
  • dizziness
  • feeling sick (nausea)
  • hair loss
  • infection of the genitals
  • painful menstruation
  • chest pain / discomfort
  • ejection of the post (in whole or in part) – (see next section on ejection)
  • relocations
  • weight gain

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

  • strong body hair
  • perforation of the uterus (see also the next section on perforation / damage to the uterine wall)

Description of selected possible side effects:

Irregular bleeding and bleeding at long intervals

Kyleena is likely to affect your menstrual cycle. Menstruation can be changed so that you get spotting, irregular, shorter or longer menstrual cycle, reduced or increased bleeding, or no bleeding at all.

You may experience bleeding and splashing between periods, especially during the first 3-6 months. Sometimes the bleeding is greater than usual in the beginning.

You will probably have a gradual decrease in the amount of blood and the number of bleeding days each month. For some women, menstruation eventually disappears completely.

As a result of the effect of the hormone, the monthly thickening of the uterine lining may not occur, and therefore there is nothing that can come out or be expelled through a menstrual period. This does not necessarily mean that you have reached menopause or are pregnant. Your hormone levels usually remain normal.

Once the post is removed, your period should soon return to normal.

Pelvic infections or abdominal infections

Both Kyleena and its depositors are sterile. Despite this, there is an increased risk of pelvic infection / genital infection ( infection of the uterine lining or fallopian tubes) at the time of insertion and during the first 3 weeks after insertion.

Pelvic infection / genital infection in users of uterine inserts is often related to the presence of sexually transmitted diseases. The risk of infection increases if you or your partner has several sexual partners or if you have previously had a pelvic inflammatory disease.

Pelvic infections / genital infections must be treated as soon as possible.

Pelvic infections / genital infections such as Pelvic inflammatory disease can have serious consequences and can affect fertility and increase the risk of a future ectopic pregnancy (ectopic pregnancy). In extremely rare cases, severe infection or sepsis may occur shortly after insertion (very serious infection, which can be fatal).

Kyleena must be taken if you get the recurrent pelvic inflammatory disease, if an infection is severe or if treatment does not help.

Ejection

Muscle contractions in the uterus during menstruation can sometimes displace the insert or repel it completely. This is more likely to occur if you are overweight at the time of insertion or if you have had heavy periods in the past. If the insert is shifted, it may not work as intended and therefore the risk of pregnancy is higher. If the post is rejected, you are no longer protected against pregnancy.

Possible signs of expulsion are pain and abnormal bleeding, but Kyleena can also be expelled without you noticing. Because Kyleena usually decreases the amount of menstruation over time, and increased menstrual bleeding may be a sign that Kyleena has been expelled. See section 2 “Warnings and Precautions” for information on how to check if Kyleena is in place and what to do if you suspect that Kyleena is no longer in place.

Perforation / Damage to the uterine wall

Damage to the uterine wall can occur when inserting Kyleena. An injury is sometimes not discovered until after a while. If Kyleena gets stuck outside the uterine cavity, it does not effectively protect against pregnancy and must be removed as soon as possible. You may need surgery to remove Kyleena.

The risk of damage to the uterine wall is increased in breastfeeding women and in women where the insertion is made up to 36 weeks after delivery, and may be increased in women where the uterus is fixed and bent backward (retro-reflected uterus). If you suspect you have an injury to the uterine wall, contact a qualified healthcare professional immediately for advice and remind them that you have a Kyleena inserted, especially if it is not the same person who inserted it.

Cysts on the ovaries

Because the preventive effect of Kyleena is mainly due to its local effect in the womb, ovulation (ovulation) usually continues when you use Kyleena. Sometimes a cyst can form on the ovary. In most cases, it gives no symptoms.

A cyst on the ovary can sometimes require medical attention, or more rarely surgery, but usually disappears by itself.

How to store Kyleena

This medicine does not require any special storage instructions.

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

Do not open the blister. Only qualified healthcare professionals should do this.

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

Contents of the pack and other information

Content declaration

The active substance is levonorgestrel. The intrauterine insert contains 19.5 mg of levonorgestrel.

Other ingredients are:

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

What the medicine looks like and contents of the pack

Kyleena is a T-shaped intrauterine post. The vertical arm of the white T-body has a medicine container that contains levonorgestrel. Two blue removal threads are attached to the loop on the lower part of the vertical arm. In addition, the vertical arm contains a silver ring that sits close to the horizontal arms, and it is visible on an ultrasound examination.

Pack size:

  • 1×1 intrauterine post
  • 5×1 intrauterine post

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bayer AB

Box 606

169 26 Solna

Sweden

Manufacturer

Bayer Oy

Passionate 47

20210 Turku

Finland

This medicinal product is authorized under the European Economic Area under the name:

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

Muhammad Nadeem

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