Mirena 52 mg

MIRENA is a T shaped intrauterine delivery system (IUS) which after insertion releases the hormone levonorgestrel into the womb. The purpose of the T-body is to adjust the system to the shape of the womb. The vertical arm of the T-body carries a cylinder containing levonorgestrel. Two removal threads are tied to the loop at the lower end of the vertical arm. MIRENA is used for contraception (prevention of pregnancy), idiopathic menorrhagia (excessive menstrual bleeding) protection from endometrial hyperplasia (excessive growth of the lining of the womb) during oestrogen replacement therapy.

Your doctor will examine you and ask you about your medical history in order to decide whether you can use MIRENA. Do not use MIRENA: If you are hypersensitive (allergic) to levonorgestrel or any of the other ingredients of MIRENA. Do not use MIRENA under any of the following conditions:

• if you are pregnant or think you might be pregnant
• if you currently or recurrently have an infection of the female reproduction organs
• if you have a lower genital tract infection.
• if you have an infection of the womb after delivery.
• if you have had an infection of the womb after abortion during the past 3 months
• if you have infection of the cervix (neck of womb).
• if you have cell abnormalities in the cervix.
• if you have cancer of suspected cancer of the cervix or womb.
• if you have tumours which depend on progestogen hormone to grow.
• if you have unexplained abnormal uterine bleeding.
• if you have abnormality of the cervix or womb including fibroids if they distort the cavity of the womb
• if you have conditions associated with increased susceptibility to infections.
• if you have active liver disease or liver tumour.

Warnings and precautions

Take special care with MIRENA If any of the conditions mentioned below exists or appears for the first-time while using MIRENA, consult a specialist who may decide to continue using MIRENA or remove the system. The conditions are:

• migraine, asymmetrical visual loss or other symptoms which may be signs of a transient cerebral ischaemic (temporary blockage of the blood supply to the brain).
• exceptionally severe headache
• jaundice (a yellowing of the skin, white of the eyes and/or nails)
• marked increase in blood pressure
• severe disease of arteries such as stroke or heart attack.

MIRENA may be used with caution in women who have congenital heart disease or valvular heart disease at risk of infective inflammation of the heart muscle. If you have diabetes and you are using MIRENA your blood glucose concentration should be monitored. Irregular bleedings may mask some symptoms and signs of endometrial polyps or cancer, and in these cases diagnostic measures have to be considered. MIRENA is not the method of first choice for postmenopausal women with shrinking of the womb.

When should MIRENA be inserted You should have MIRENA inserted within seven days from the onset of the menstrual bleeding. In this case barrier methods of contraception are not needed in addition. It is possible to insert MIRENA any other time during the menstrual cycle if it is certain that you are not pregnant. Please tell your doctor if you had unprotected sexual intercourse since your last menstrual bleeding. If MIRENA is inserted - more than seven days since menstrual bleeding started, use a barrier method such as condom or diaphragm for the next seven days or do not have sexual intercourse for the next seven days. MIRENA cannot be used as an emergency contraceptive. MIRENA can also be inserted immediately after a first trimester abortion provided that there are no genital infections. MIRENA should be inserted only after the womb has returned to its normal size after delivery and not earlier than 6 weeks after delivery (see section “Before you use MIRENA – Perforations”). MIRENA can be replaced by a new system at any time of the cycle. When MIRENA is used to protect the lining of the womb during oestrogen replacement therapy, it can be inserted at any time in an amenorrhoeic woman (woman who has no monthly bleeding), or during the last days of menstruation or withdrawal bleeding. MIRENA should be inserted by a medical practitioner who is experienced in MIRENA insertion.

How is MIRENA inserted?

• Your doctor will do a normal pelvic (gynaecological) examination and find the particular position of your womb,
• an instrument called a speculum is inserted into the vagina,
• the cervix is cleansed with an antiseptic solution.
• MIRENA is then inserted into the womb via a thin, flexible plastic tube (the inserter).
• Local anaesthesia may be applied to the cervix prior to insertion, if appropriate.
• The flexible plastic tube will be withdrawn from your body leaving MIRENA in your womb.

Some women may experience pain and dizziness after insertion. If these do not pass within half an hour in the resting position, MIRENA may not be correctly positioned. An examination should be carried out and MIRENA removed if necessary. After insertion of MIRENA you may receive a patient reminder card from your doctor for follow-up examination. Bring this with you to every schedule appointment.

When should I see my doctor?

You should have your MIRENA checked 4 to 12 weeks after insertion, and thereafter regularly, at least once a year. If you received a patient reminder card from your doctor, bring this with you to every scheduled appointment. You should contact your doctor if any of the following occurs:

• You no longer feel the threads in your vagina
• You can feel the lower end of the system
• You think you may be pregnant
• You have persistent abdominal pain, fever, or unusual discharge from the vagina
• You or your partner feels pain or discomfort during sexual intercourse
• There are sudden changes in your menstrual periods (for example, if you have little or no menstrual bleeding, and then you start having persistent bleeding or pain, or you start bleeding heavily
• You have other medical problems, such as migraine headaches or intense headaches that recur, sudden problems with vision, jaundice, or high blood pressure
• You experience any of the conditions mentioned in the section “Before you use MIRENA”.

For how long can MIRENA be used?

MIRENA is effective for five years, after which it has to be removed. If you like, you may have a new MIRENA inserted when the old one is removed. What if I want to become pregnant or have MIRENA removed for another reason? The MIRENA can be easily removed at any time by your doctor, after which pregnancy is possible. Removal usually is a painless procedure. Fertility returns to normal after removal of MIRENA. If pregnancy is not desired, MIRENA should not be removed after the seventh day of the menstrual cycle (monthly periods) unless contraception is covered with other methods (e.g. condoms) for at least seven days before the removal. If you have irregular periods (menses) or no periods, you should use barrier methods of contraception for seven days before removal until your menstruation reappears. A new MIRENA can also be inserted immediately after removal, in which case no additional protection is needed.

MIRENA can have side effects. Not all side effects reported for MIRENA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MIRENA please consult your health care provider for advice. Below we list side effects when MIRENA is used for contraception (prevention of pregnancy) and idiopathic menorrhagia (excessive menstrual bleeding).

Possible side effects when MIRENA is used for protection of endometrial hyperplasia (excessive growth of the lining of the womb) during oestrogen replacement therapy were observed at a similar frequency unless specified (see footnote):

Frequent side effects

• Headache
• Abdominal/pelvic pain
• Bleeding changes including increased and decreased menstrual bleeding, spotting, oligomenorrhoea (infrequent periods) and amenorrhoea (absence of bleeding)
• Vulvovaginitis (inflammation of the external genital organs or vagina)
• Genital discharge
• Depressed mood/ depression
• Migraine
• Nausea (feeling sick)
• Acne
• Hirsutism (excessive body hair)
• Back pain
• Upper genital tract infection
• Ovarian cysts
• Dysmenorrhoea (painful menstruation)
• Breast pain
• Intrauterine contraceptive device expelled (complete or partial)

Less frequent

• Alopecia (loss of hair)
• Uterine perforation (piercing of the womb)

Unknown frequency

• Hypersensitivity (allergic reaction) including rash, urticaria (hives) and angioedema (characterised by sudden swelling of e.g. the eyes, mouth, throat.)
• Blood pressure increase

The removal threads may be felt by the partner during intercourse. If you become pregnant while using MIRENA, there is a possibility that pregnancy is outside the womb (see section “Extrauterine pregnancy”). Cases of sepsis (very severe systemic infection, which may be fatal) have been reported following intrauterine device insertions.

Keep all medicine out of the reach and sight of children. Store at or below 30 °C. Protect from moisture and direct sunlight. Do not use MIRENA 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.