Avibela 20 micrograms

• AVIBELA contains levonorgestrel and is a hormone-releasing system placed in your uterus by your healthcare provider to prevent pregnancy for up to 6 years

• AVIBELA can also be used to treat heavy menstrual bleeding (heavy periods)

• AVIBELA contains 52 mg of levonorgestrel, which is released slowly over 6 years

• AVIBELA can be removed by your healthcare provider at any time

• AVIBELA can be used whether or not you have given birth to a child.

AVIBELA should not be inserted :

• if you are hypersensitive (allergic) to levonorgestrel or any of the other ingredients of AVIBELA (see section 6)
• if you are pregnant or suspect you are pregnant
• if you have an infection of your genitals
• if you have an infection of your female reproductive organs called pelvic inflammatory disease (PID) or you have any sexually transmitted disease (STDs) including the clap (bacterial infection also called gonorrhoea)
• if you have a painful disorder of the female reproductive organs called endometriosis, where the tissue which normally lines your uterus, grows outside your uterus, after giving birth
• if you had an abortion in the last three months, which was infected
• if you have inflammation of the cervix (the lower narrow end of the uterus that opens into the vagina) which includes symptoms like bleeding between menstrual periods, pain during sex or any abnormal vaginal discharge
• if you have inflammation of the vagina, which include symptoms like discharge, itching and pain in the vaginal area
• if you have abnormal growth of cells on the surface of your cervix or type of cervical cancer called neoplasm (as diagnosed by your doctor)
• if you have cancer of the uterus (womb)
• if you have a certain type of cancer which are hormone-sensitive, including breast cancer
• if you have abnormal bleeding from your womb, which have not been diagnosed
• if you have any abnormality of the uterus (womb) which can affect the insertion and/or holding of the intra-uterine device (IUD)
• if you have severe liver disease or liver cancer
• if you have another IUD which has not been removed
• if you have an illness that increases your likelihood to get infections
• if you have acute blood cancers, like leukaemia, unless you are in remission
• if you had recent abnormal cell growth in tissue that forms in the uterus (womb) while pregnancy hormone levels remain high.

Warnings and precautions

Tell your doctor or healthcare professional before insertion of the IUD if you:

• had a heart attack
• had a stroke
• were born with heart disease or have problems with your heart valves
• have problems with blood clotting or take medicine to reduce clotting
• have high blood pressure
• recently had a baby or if you are breastfeeding
• have severe migraine headaches or partial loss of vision associated with migraine headaches
• have severe or frequent headaches
• have AIDS, HIV, or any other sexually transmitted infection.

AVIBELA is inserted by your healthcare provider. First, your healthcare provider will examine your pelvis to find the exact position of your uterus. Your healthcare provider will then clean your vagina and cervix with an antiseptic solution and slide a plastic tube containing AVIBELA through the cervix into your uterus. Your healthcare provider will then remove the plastic tube and leave AVIBELA in your uterus. Your healthcare provider will trim the threads to the right length.

You may experience pain, bleeding, or dizziness during and after placement. If your symptoms do not pass within 30 minutes after placement, AVIBELA may not have been placed correctly. Your healthcare provider will examine you to see if AVIBELA needs to be removed or replaced.

How soon after placement of AVIBELA should I return to my healthcare provider?

Call your healthcare provider if you have any questions or concerns. Otherwise, you should return to your healthcare provider for a follow-up visit 4 - 6 weeks after AVIBELA is placed to make sure that AVIBELA is in the right position.

After AVIBELA has been placed, when should I call my healthcare provider?

Call your healthcare provider if you have any concerns about AVIBELA. Be sure to call if you:

• think you are pregnant
• have pelvic pain or pain during sex
• have unusual vaginal discharge or genital sores
• have unexplained fever, flu-like symptoms, or chills
• might have been exposed to a sexually transmitted disease (STD)
• are concerned that AVIBELA may have been expelled (came out)
• cannot feel AVIBELA’s threads
• develop very severe or migraine headaches
• have yellowing of the skin or whites of the eyes (these may be signs of liver problems)
• had a stroke or heart attack
• or your partner(s) become(s) HIV positive
• develop blood cancer (leukaemia)
• have severe vaginal bleeding, bleeding that lasts a long time, or you miss your period.

AVIBELA is inserted by your healthcare provider. Not all side effects reported for AVIBELA are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using AVIBELA, please consult your doctor, pharmacist or other healthcare professional for advice.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• ectopic pregnancy: If you get pregnant while using AVIBELA, you might have an ectopic pregnancy. This means that the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain especially with missed periods may be a sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death
• intrauterine pregnancy risks: There are also risks if you get pregnant while using AVIBELA and the pregnancy is in the uterus. Severe infection, miscarriage, premature labour, premature delivery, and even death can occur with pregnancies that continue with an intrauterine system (IUD). Because of this, your healthcare provider may try to remove AVIBELA, even though removing it may cause a miscarriage. If AVIBELA cannot be removed, talk with your healthcare provider about the benefits and risks of continuing the pregnancy. If, after seeing your healthcare provider, you choose to continue your pregnancy, see your healthcare provider regularly. Call your healthcare provider right away if you get flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina. These may be signs of infection. It is not known if AVIBELA can cause long-term effects on the foetus if it stays in place during a pregnancy
• life-threatening infection: Life-threatening infection can occur within the first few days after AVIBELA is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after AVIBELA is placed
• pelvic inflammatory disease (PID) or endometritis: Some IUD users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. PID and endometritis are usually sexually transmitted. You have a higher chance of getting PID or endometritis if you or your partner has sex with other partners. PID or endometritis can cause serious problems such as infertility, ectopic pregnancy, or pelvic pain that does not go away. PID is usually treated with antibiotics. More serious cases of PID or endometritis may require surgery. Removal of the uterus (hysterectomy) is sometimes needed. In rare cases, infections that start as PID or endometritis can even cause death.
• Tell your healthcare provider right away if you have any of these signs of PID or endometritis: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal pain, painful sex, chills, or fever
• perforation: AVIBELA may partially go into the wall of the uterus (become embedded) or go completely through the wall of the uterus (perforate). If this occurs, AVIBELA may no longer prevent pregnancy. If perforation occurs, AVIBELA may move outside the uterus and can cause internal scarring, infection, or damage to other organs. You may need surgery to have AVIBELA removed if it is embedded, or perforation occurs.
• expulsion: AVIBELA may come out of your uterus (expulsion). Expulsion occurs in about 4 out of 100 women, most often in the first year of use. You may become pregnant if AVIBELA comes out. If you think that AVIBELA has come out, use another birth control method like condoms and spermicide or do not have sex (vaginal intercourse) until you are seen by a healthcare provider.
• cysts on the ovary: Some women using AVIBELA develop a painful cyst on the ovary. These cysts usually disappear on their own in 2 - 3 months. However, a cyst can cause pain and sometimes cysts will need surgery.
• changes in bleeding: 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. However, the bleeding usually becomes lighter than usual and may be irregular. Call your healthcare provider if the bleeding remains heavier than usual or increases after it has been light for a while.

These are all serious side effects. You may need urgent medical attention.

Frequent side effects of AVIBELA include:

• vaginal infection caused by bacteria, yeast infection of the outer part of your vagina (vulvovaginal)
• anxiety, depression, mood changes, sleeplessness, lower sex drive
• headache, migraine (a severe headache, often accompanied by nausea and sensitivity to light and sound), near fainting, dizziness, fainting
• nausea, pain/discomfort in your abdomen, bloating and swelling in the belly area, constipation, indigestion, diarrhoea, vomiting
• acne (pimples), hair loss
• back pain, pain in legs or arms
• severe and frequent menstrual cramps and pain during your period, pain during sex, breast pain/tenderness, pain/discomfort in your pelvis, spasm of your womb (uterus), discharge from your vagina, dryness/discomfort of your vagina and genital area, menstrual bleeding that lasts more than 7 days, bleeding after having sex (not related to your period), funny odour from your vagina, any vaginal/womb bleeding unrelated to your normal period, including spotting, infrequent menstrual periods, heavy menstrual bleeding
• weight gain, abnormal ovaries as detected by ultrasound
• bleeding after device has been inserted, device is expelled (ejected), pain during the procedure of inserting the device, device moved from where it was placed.

Less frequent side effects include:

• worsening of a mental disorder called bipolar disorder (episodes of mood swings, ranging from depressive lows to manic highs), feeling suicidal
• excessive hair growth of dark coarse hair in a male-like pattern, i.e. around mouth, chin, face, chest and back
• greasy hair
• infection of the connective tissue next to your womb, infection of the fallopian tubes or other parts of the female reproductive organs, menstrual cycle is shorter than 21 days
• swelling of the abdomen and swelling of the hands and feet.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children.

Store at or below 30 °C.

Store in the original package. Keep the tray in the outer carton in order to protect from light.

Do not open the AVIBELA pack. Only your healthcare provider should do this.

Do not use after the expiry date stated on the label and the outer pack after expiry date. The expiry date refers to the last day of that month.