Kyleena Levonorgestrel Intrauterine delivery system

KYLEENA is a T - shaped intrauterine system (IUS) which after placement in the womb slowly release a small amount of the hormone levonorgestrel. The mechanism of action of KYLEENA is within the womb and only small amounts of the hormone enter the blood. KYLEENA is used for prevention of pregnancy for up to 5 years. Only about 2 in 1000 women correctly using KYLEENA become pregnant in the first year. Only about 15 in a 1000 women with correctly placed KYLEENA become pregnant in 5 years.

You should not be given KYLEENA:

• If you are hypersensitive (allergic) to levonorgestrel or any of the other ingredients of KYLEENA
• If you are pregnant
• If currently have pelvic inflammatory disease (infection of the female reproduction organs) or have had this condition multiple times in the past
• If you have conditions associated with increased susceptibility to pelvic infections
• If you have a lower genital tract infection (infection in the vagina or the cervix i.e. neck of the womb) that has not been treated
• If you have infection of the womb after delivery of a baby, an infected abortion or miscarriage during the past 3 months
• If you have cell abnormalities in the cervix
• If you have cancer of the cervix or womb
• If you have tumours which depend on progestogen hormones to grow
• If you have unexplained uterine bleeding
• If you have an abnormality of the cervix or womb including fibroids that distort the cavity of the womb
• If you have an active liver disease or liver tumour.

Tell your doctor or healthcare professional before being given KYLEENA:

• If any of the following conditions exists before KYLEENA use or appears for the first time while using KYLEENA, consult a healthcare professional, who will help to decide whether or not it is appropriate to use or continue using KYLEENA:

• migraine, with visual disturbances or other symptoms, which may be signs of a transient cerebral ischaemia (temporary blockage of the blood supply to the brain)
• severe headache
• jaundice (a yellowing of the skin, whites of the eyes, and/or nails)
• blood pressure
• severe disease of arteries such as stroke or heart attack

Tell your healthcare professional if you were born with heart disease (congenital) or you have heart valve disease. If you have diabetes, there is generally no need to alter the diabetic medication while using KYLEENA, but this may need to be checked by your healthcare professional.

Your doctor will tell you how long your treatment with KYLEENA will last. Do not remove KYLEENA early because you will not be protected from falling pregnant. If you have the impression that the effects of KYLEENA is too strong or too weak, tell your doctor or pharmacist.

When should KYLEENA be inserted: You can have KYLEENA inserted within seven days from the onset of the menstrual bleeding (your monthly period). KYLEENA can also be inserted immediately after a first trimester abortion provided that there are no genital infections. KYLEENA can be inserted after giving birth only after womb has returned to its normal size after delivery and not earlier than 6 weeks after delivery (see section “Before you use KYLEENA – Perforations). KYLEENA can be replaced by a new system at any time of the cycle.

Additional information on special populations:

Children and adolescents:

The effectiveness and safety of KYLEENA have not been established in children and adolescents under the age of 18 years.

Elderly patients (65 years or older):

KYLEENA is not indicated for use in postmenopausal women.

Patients with impaired liver function:

KYLEENA must not be used in women with active liver disease and/or liver tumour. If you have a liver impairment, tell your healthcare professional (see section “Do not use KYLEENA”).

Patients with impaired kidney function:

KYLEENA has not been studied in women with kidney impairment.

How is KYLEENA inserted: After a gynaecological examination, an instrument, called a speculum, is placed into the vagina and the cervix may be cleansed with an antiseptic solution. KYLEENA is then inserted into the womb using a thin, flexible plastic tube (the insertion tube). Local anaesthesia may be applied to the cervix prior to insertion. Some women may experience pain and dizziness during or after insertion. If these do not pass within half an hour in the resting position, KYLEENA may not be correctly positioned. Your healthcare professional will examine you to see if KYLEENA needs to be removed or replaced.

KYLEENA can have side effects. Not all side effects reported for KYLEENA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using this medicine, please consult your doctor, pharmacist or other healthcare professional for advice healthcare. The following is a list of side effects that have been linked with the use of KYLEENA:

Frequent side effects:

• Headache
• Abdominal/pelvic pain
• Acne/seborrhoea (greasy skin)
• Bleeding changes including increased and decreased menstrual bleeding, spotting, infrequent periods (oligomenorrhoea) and absence of bleeding (amenorrhoea)
• Ovarian cysts
• Vulvovaginitis (inflammation of the external genital organs or vagina)
• Depressed mood/depression
• Migraine
• Nausea (feeling sick)
• Upper genital tract infection
• Painful menstruation (dysmenorrhea)
• Breast pain/discomfort
• Expulsion of KYLEENA (complete and partial)
• Genital discharge.

Less frequent side effects:

• Hirsutism (excessive body hair)
• Uterine perforation*

* The perforation risk is higher (between 1 and 10 in every 1000 patients) in women who are breastfeeding at the time of insertion and when it is inserted up to 36 weeks after delivery. Hypersensitivity including rash, urticaria (hives) and angioedema (swelling of face, lips, cheeks, tongue or throat) may occur. The removal threads may be felt by the partner during intercourse.

Store all medicines out of reach of children. Store at or below 30 °C. Do not use KYLEENA after the expiry date which is stated on the package. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.