MIRENA^®

Levonorgestrel-releasing intrauterine system (IUS)

What is in this leaflet

Please read this leaflet carefully and ask your doctor if you have any other questions or are not sure about anything.

What is MIRENA used for and how does it work

MIRENA is a T-shaped intrauterine system (IUS) which after insertion releases the hormone levonorgestrel into the womb. The purpose of the T-shape is to adjust the system to the shape of the womb. The vertical arm of the T-structure carries a cylinder containing hormone. Two removal threads are tied to the loop at the lower end of the vertical arm.

How does MIRENA work?

The vertical part of the "T" contains a hormone, levonorgestrel, which is similar to a hormone that you make in your body. Levonorgestrel belongs to the family of hormones called progestogens. The system releases levonorgestrel into your body at a constant rate, but in very small amounts (20 micrograms per 24 hours). MIRENA prevents pregnancy in 3 ways:

by controlling the monthly development of the lining of the womb, so that the lining is not thick enough for you to become pregnant;
by making the normal mucus thicker in the cervical canal (opening to the womb), so the sperm cannot enter the womb to fertilise the egg;
by affecting the movement of the sperm inside the womb, preventing fertilisation.

What is MIRENA used for?

MIRENA may be used for contraception (prevention of pregnancy) and for treatment of menorrhagia (excessive menstrual bleeding).

How effective is MIRENA?

In contraceptive effectiveness, MIRENA is comparable with female sterilisation. It is as effective as today's most effective copper intrauterine devices (IUDs) or oral contraceptives ("the Pill"). Studies (clinical trials) found that there were about two pregnancies per year for every 1,000 women using MIRENA.

In the treatment of excessive menstrual bleeding, MIRENA causes a strong reduction of menstrual bleeding within 3 months of insertion. Some users have no periods at all.

Before you use MIRENA

When should MIRENA not be used?

The MIRENA system should not be used if you have any of the following conditions:

Known or suspected pregnancy

Current or recurrent pelvic inflammatory disease

Lower genital tract infection

Infection of the womb after delivery

Infection of the womb after abortion during the past 3 months

Infection of the cervix (neck of the womb)

Cell abnormalities in the cervix

Cancer or suspected cancer of the cervix or womb

Undiagnosed abnormal bleeding out of your vagina

Abnormality of the cervix or womb including fibroids if they distort the cavity of the womb

Conditions associated with increased susceptibility to infections

Active liver disease or liver tumour

Hypersensitivity to the constituents of MIRENA.

What else you should know

MIRENA is not the method of first choice for young women who have never been pregnant.

Infections

The insertion tube helps to prevent MIRENA from contamination with micro-organisms during the insertion, and the MIRENA inserter has been designed to minimise the risk of infections. Despite this, there is an increased risk of pelvic infection immediately and during the first month after insertion. Pelvic infections in IUS or IUD users are often related to sexually transmitted diseases. The risk of infection is increased if the woman or her partner has several sexual partners. Pelvic infections must be treated promptly. Pelvic infections may impair fertility and increase the risk of ectopic pregnancy (pregnancy outside the womb) in the future. MIRENA must be removed if there are recurrent pelvic infections or if an acute infection does not respond to treatment within a few days.

Consult a doctor without delay if you have persistent lower abdominal pain, fever, pain in conjunction with sexual intercourse or abnormal bleeding.

Expulsion

The muscular contractions of the womb during menstruation may sometimes push the IUS out of place or expel it. Possible symptoms are pain and abnormal bleeding. If the IUS is displaced, the effectiveness is reduced. It is recommended that you check for the threads with your finger, for example while having a shower. If you have signs which indicate that MIRENA may have been expelled or if you cannot feel the threads, you should avoid intercourse or use another contraceptive, and consult your doctor. As MIRENA decreases menstrual flow, an increase of menstrual flow may indicate that expulsion has occurred.

Perforation

In very rare cases, most often during insertion, MIRENA may penetrate or perforate the wall of the womb. An IUS which has become lodged outside the cavity of the womb is not effective and must be removed as soon as possible.

Ectopic pregnancy

It is very rare to become pregnant while using MIRENA. If you become pregnant while using MIRENA, it is possible that you could carry the foetus outside of your womb (an ectopic pregnancy). An ectopic pregnancy is a serious condition which calls for immediate medical attention. If the following symptoms occur, you should see your doctor immediately:

your menstrual periods cease and then you start having persistent bleeding or pain;
you have vague or very bad pain in your lower abdomen;
you have normal signs of pregnancy, but you also have bleeding and feel dizzy.

Faintness

Some women feel dizzy after MIRENA is inserted. This is a normal physical response. Your doctor will tell you to rest for a while after you have had MIRENA inserted.

Enlarged ovarian follicles

As the contraceptive effect of MIRENA is mainly due to its local effect, ovulatory cycles with follicular rupture usually occur in women of fertile age. Sometimes degeneration of the follicle is delayed and the follicle may continue to develop. Most of these enlarged follicles produce no symptoms, although some may be accompanied by pelvic pain or pain during intercourse. Enlarged follicles may require medical attention, but they usually disappear on their own.

How to use MIRENA properly

What precautions should be taken before insertion and removal?

Examination before insertion may include a Pap smear and other tests, e.g. for infections, including sexually transmitted diseases, as necessary. A gynaecological examination should be performed to determine the position and size of the womb.

If any of the following conditions exist prior to insertion of MIRENA, or if any arise for the first time or recur after insertion, MIRENA may be used with caution after specialist consultation or your doctor may consider removal of the system:

migraine or asymmetrical visual loss
exceptionally severe headache
jaundice (a yellowing of the whites of the eyes and/or nails)
marked increase in blood pressure
confirmed or suspected hormone-dependent tumours, including breast cancer
severe disease of arteries such as stroke or heart infarction.

In women using contraceptive pills containing progestogen only, some studies have indicated that there may be a slightly increased risk of venous blood clots, but the results were not very certain. However, you should see your doctor immediately if there are symptoms or signs of clots. Symptoms of venous or arterial blood clots can include: pain and/or swelling in one leg; sudden severe pain in the chest, whether or not it radiates to the left arm; sudden breathlessness; sudden onset of coughing; any unusual, severe or prolonged headache; sudden partial or complete loss of vision; double vision; slurred speech or speech difficulties; vertigo; collapse with or without focal seizure; weakness or very marked numbness suddenly affecting one side or one part of the body; motor disturbances; severe stomach ache. Symptoms or signs indicating blood clots in the vessels of your eye are: unexplained partial or complete loss of vision, double vision, or any other unexplained disturbances of your eyesight.

Extensive varicose veins and superficial thrombophlebitis (inflammation of a vein with clot formation) may also be associated with venous blood clotting.

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. Antibiotic preventative medication should be administered to these patients when inserting or removing MIRENA.

In diabetic users of MIRENA, the blood glucose concentration should be monitored.

When should MIRENA be inserted?

You can have MIRENA inserted within 7 days of the onset of menstrual bleeding. The IUS can also be inserted immediately after abortion provided that there are no genital infections. The IUS should not be inserted earlier than 6 weeks after delivery.

MIRENA can be replaced by a new system at any time of the cycle.

MIRENA should not be used as emergency contraception (after unprotected intercourse).

How is MIRENA inserted?

After a gynaecological examination, an instrument called a speculum is inserted into the vagina and the cervix is cleansed with an antiseptic solution. The IUS is then inserted into the womb via a thin, flexible plastic tube. You can feel the insertion, but it should not cause much pain.

After insertion, some women may experience pain and dizziness. If this persists after half an hour of resting, the IUS may not be correctly positioned. Your doctor should carry out an examination and, if necessary, remove the IUS.

What if I want to become pregnant or have MIRENA removed for another reason?

MIRENA can be easily removed at any time by your doctor, after which pregnancy is possible. Removal is usually a painless procedure. Fertility returns to normal after removal of MIRENA. You may become pregnant during the first menstrual cycle after MIRENA is removed.

If pregnancy is not desired, MIRENA should not be removed after the fifth day of the menstrual cycle unless other contraceptive methods (e.g. condoms) are used for at least 5 days before the removal. If you have had no menstrual periods while using MIRENA, you should start another method of contraception, e.g. barrier methods or the contraceptive pill 5 days before MIRENA removal. A new MIRENA can also be inserted immediately after removal, in which case no additional contraceptive protection is needed.

How long should I wait to have sexual intercourse after the insertion?

To give your body a rest, it is best to wait about 24 hours after having MIRENA inserted before having sexual intercourse. However, as soon as it is inserted, MIRENA will prevent pregnancy.

Overdosage

Not applicable

When using MIRENA

Do I need to have MIRENA checked regularly?

You should have your MIRENA checked twice during the first year, usually 4 - 12 weeks after insertion and again 12 months after insertion. After the first year, you should have your MIRENA checked once a year unless your doctor decides otherwise.

For how long can MIRENA be used?

MIRENA offers protection against pregnancy for 5 years, after which the IUS has to be removed. If you wish, you may have a new MIRENA inserted when the old one is removed.

What happens if MIRENA comes out by itself?

It is rare but possible for MIRENA to come out during your menstrual period without you noticing. An unusual increase in the amount of bleeding during your period could mean that your MIRENA has come out through your vagina. It is also possible for part of MIRENA to come out of your womb (you and your partner may notice this during sexual intercourse). If MIRENA comes out completely or partially, you will not be protected from pregnancy.

How can I tell whether MIRENA is in place?

You can check yourself if the threads are in place after your period. Gently put a finger into your vagina after your period and feel for the threads at the end of your vagina near the opening of your womb (cervix).

Do not pull the threads because you may accidentally pull out MIRENA. If you cannot feel the threads, contact your doctor.

Can MIRENA affect my menstrual periods?

MIRENA does affect your menstrual cycle. It can change your menstrual periods so that you have spotting (a small amount of blood loss), shorter of longer periods, lighter or heavier bleeding, or no bleeding at all.

Many women have frequent spotting or light bleeding in addition to their periods for the first 3 - 6 months after they have MIRENA inserted. Some women may have heavy or prolonged bleeding during this time. Please inform your doctor, especially if such symptoms persist.

Overall, you are likely to have a gradual reduction in the number of bleeding days and in the amount of blood lost each month. Some women eventually find that periods stop altogether. As the amount of menstrual bleeding is usually reduced with the use of MIRENA, most women experience an increase in their blood haemoglobin value.

When the system is removed, periods return to normal.

Is it abnormal to have no periods?

Not when you are using MIRENA. If you find that you do not have periods, it is because of the effect of the hormone on the lining of the womb. The monthly thickening of the lining does not happen. Therefore there is nothing to come away as a period. It does not necessarily mean that you have reached menopause or are pregnant. Your own hormone levels remain normal. Not having periods can be an advantage for a woman's health.

Can MIRENA cause pain or discomfort?

After insertion, some women may experience pain and dizziness. If this persists after half an hour of resting, the IUS may not be correctly positioned. An examination should be carried out by your doctor and the IUS removed if necessary.

In the first few weeks after insertion, some women feel pain (like menstrual cramps). You should return to your doctor or clinic if you have severe pain or if the pain continues for more than 3 weeks after you have had MIRENA inserted.

When should I see my doctor?

You should have your IUS checked 4 - 12 weeks after it is fitted, again at 12 months, and then once a year until it is removed. MIRENA can stay in place for 5 years before it must be removed.

You should also see your doctor if:

you can no longer feel the MIRENA threads
you can feel the lower end of the system
you think you may be pregnant
you have persistent abdominal pain
you have a 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 (e.g. little or no menstrual bleeding followed by heavy or persistent bleeding or pain)
you have other medical problems, such as migraine, exceptionally severe headache, sudden problems with vision, jaundice (a yellowing of the whites of the eyes and/or nails), or high blood pressure
you have a skin problem which you think might be an allergic reaction to MIRENA.

Can I become pregnant while using MIRENA?

It is very rare for a woman to become pregnant with MIRENA in place. But if MIRENA comes out (is expelled), you are no longer protected and must use another form of contraception until you see your doctor.

Some women may not have their periods while using MIRENA. Not having a period is not necessarily a sign of pregnancy. If you have not had a period for 6 weeks and are concerned, then consider having a pregnancy test. If this is negative, there is no need to carry out another test unless you have other signs of pregnancy, e.g. sickness, tiredness or breast tenderness.

If you become pregnant with MIRENA in place, you should have MIRENA removed as soon as possible. If you leave MIRENA in place during pregnancy, the risk of having a miscarriage, infection or preterm labour will be increased. You might also consider having an abortion. The hormone in MIRENA is released into the womb. This means that the foetus is exposed to a relatively high concentration of hormone locally, although the amount of the hormone received through the blood and placenta is little. The effect of such an amount of hormone on the foetus is not known at present, because it is very rare for women to become pregnant with MIRENA in place. To date there is no evidence of birth defects caused by MIRENA in cases where pregnancy has continued to term with MIRENA in place.

Can I breast-feed while using MIRENA?

Yes, you can. Levonorgestrel has been identified in small quantities in the breast milk of nursing women. There appears to be no adverse effect on infant growth or development when using any progestogen-only contraceptive method after 6 weeks after delivery. Progestogen-only methods do not appear to affect the quantity or quality of breast milk.

Will MIRENA interfere with sexual intercourse?

Neither you nor your partner should feel the IUS during intercourse. If you do, intercourse should be avoided until your doctor has checked that the IUS is still in the correct position.

Should I tell my doctor if I am taking any other medications?

You should tell your doctor if you are taking any medicines for a long time (for example, epilepsy medication) or any drugs which induce liver enzymes (for example, primidone, barbiturates, phenytoin, carbamazepine, rifampicin, oxcarbazepine or griseofulvin).

Can tampons be used?

Use of sanitary pads is recommended. If tampons are used, you should change them with care so as not to pull the threads of MIRENA.

Side effects

Serious side effects

Pregnancy in the case of method failure may be ectopic. This requires immediate medical attention (see symptoms listed in the section "What else you should know" ) . Pelvic inflammatory disease, which may be serious, can occur during the use of the IUS. Enlarged ovarian follicles may require medical attention. MIRENA may pierce the wall of the womb.

Other possible side effects

It is perfectly normal for you to experience changes in menstrual bleeding patterns during the use of MIRENA. The changes may include spotting, shorter or longer menstrual periods, irregular bleeding, prolonged interval of bleedings or no bleeding at all, heavy flow and menstrual pain.

Ovarian cysts have been detected in 12% of women during the use of MIRENA (see the information on enlarged ovarian follicles under "What else you should know" ).

The following side effects have been reported by 1 - 10% of women using MIRENA: abdominal, pelvic or back pain; acne, water retention, weight gain breast tension, headache, mood lability, nervousness, depressive mood, vaginal discharge or inflammation of the cervical canal.

Less than 1% of women have reported genital infections, reduced sexual desire, hair loss, excessive body hair or itching.

Less than 0.1% of women have reported migraine, skin rash, urticaria, eczema or abdominal bloating.

These side effects are more common during the first months after MIRENA insertion and usually subside during prolonged use.

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