INFORMATION FOR CONSUMERS

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Consumer Medicine Information

MIRENA^®

Levonorgestrel 20 mcg/24 hours

What is in this leaflet

Please read this leaflet carefully before starting treatment with MIRENA. It will advise you about how to use MIRENA properly and when to tell your doctor about health-related conditions. If you have any questions or need more advice, ask your doctor, professional health care provider or pharmacist.

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 the hormone levonorgestrel. Two removal threads are tied to the loop at the lower end of the vertical arm.

How does MIRENA work?

Contraceptive implants such as MIRENA are among the most effective reversible methods of contraception known. However, no contraceptive is 100 percent effective. In effect, MIRENA is comparable with female sterilization. Pregnancy rates are low and when used for the treatment of excessive menstrual bleeding MIRENA causes a strong reduction of menstrual bleeding after three months. Some users have no periods at all.

The vertical part of the "T" contains a hormone, levonorgestrel, which is similar to one of the hormones that you make in your body. Levonorgestrel belongs to the family of hormones called progestogens. MIRENA exerts a strong progestogen effect within the uterus or womb and produces an anti-proliferative effect on the womb lining. The system also 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 fertilize the egg;
• by affecting the movement of the sperm inside the womb, preventing fertilization.

What is MIRENA used for?

MIRENA is used to prevent pregnancy. MIRENA is also indicated for use in cases of menorrhagia (excessive menstrual bleeding) and for protection from excessive growth of the lining of the womb during short-term estrogen replacement therapy.

How effective is MIRENA?

In contraceptive effectiveness, MIRENA is comparable to female sterilization. It is as effective as today's most effective copper uterine 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 of unknown cause, MIRENA greatly reduces menstrual bleeding after three months. Some users have no periods at all.

Before you use MIRENA

You must not use MIRENA if:

• you are allergic to levonorgestrel (the hormone released from MIRENA) or any of the ingredients in MIRENA implants
• you are pregnant or think you might be pregnant
• you have current or recurrent pelvic inflammatory disease (inflammation of the female reproduction organs)
• you have a lower genital tract infection
• you have an infection of the womb after delivery
• you have an infection of the womb after abortion during the past 3 months
• you have an infection of the cervix (neck of the womb)
• you have cell abnormalities in the cervix
• you have a cancer or suspected cancer of the cervix or the womb
• you have tumors which depend on progestogen hormones to grow
• you have undiagnosed abnormal bleeding out of your vagina
• you have an abnormality of the cervix or womb including fibroids if they distort the cavity of the womb
• you have conditions associated with increased susceptibility to infections
• you have active liver disease or liver tumor

What else should you know

MIRENA is not the method of first choice for young women who have never been pregnant, nor for postmenopausal women with shrinking of the womb.

MIRENA should not be used as an emergency (post-coital) contraceptive.

When MIRENA is used together with estrogen-containing preparations it is important to review the product information for these products. Current evidence indicates that estrogen replacement therapy should only be used short-term and the need for therapy should be frequently reviewed. In most circumstances, the risk of long-term estrogen replacement therapy outweighs the benefits.

If you are planning to use MIRENA and have, or someone in you family has had, certain diseases, you should discuss the use of MIRENA thoroughly with your doctor.

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

In women using contraceptive pills containing progestogen only, some recent studies indicated that there may be a slightly increased risk in venous blood clots, but the results were not very certain. However, you should see your doctor, immediately, if you have symptoms or signs of clots. Symptoms of venous or arterial blood clots can include: pain and/or swelling in a 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, prolonged headache; sudden partial or complete loss of vision; double vision; slurred speech or speech difficulties (aphasia), 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.

It is still under discussion whether varicose veins and superficial thrombophlebitis (inflammation of a vein with clot formation) are 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 preventive medication should be administered to these patients when inserting or removing MIRENA.

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

Infections

The insertion tube helps to prevent MIRENA from contamination with micro-organisms during the insertion, and the MIRENA inserter has been designed to minimize the risk of infections. Despite this, there is an increased risk of pelvic infection immediately and during the first month after the insertion. Pelvic infections in IUS (Intra Uterine System) 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 infection may impair fertility and increase the risk of extrauterine pregnancy (pregnancy outside the womb) in the future. MIRENA must be removed if there are recurrent pelvic infections or infections of the lining of the womb or if an acute infection is severe or 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 indicative of an expulsion or you cannot feel the threads, you should avoid intercourse or use another contraceptive, and consult your doctor. As MIRENA decreases menstrual flow, increase of menstrual flow may be indicative of an expulsion.

Perforation

In 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. The risk of perforation is increased if MIRENA is inserted shortly after delivery (see the section "When and how to use MIRENA"), in lactating women, or in women with the uterus fixed and leaning backwards

Ectopic pregnancy

It is very rare to become pregnant while using MIRENA. If you become pregnant while using MIRENA, the risk that you could carry the fetus outside of your womb (an ectopic pregnancy) is relatively increased. Women who have already had an ectopic pregnancy, surgery of the tubes from the ovaries to the womb or a pelvic infection carry a higher risk. An ectopic pregnancy is a serious condition which calls for immediate medical attention. The following symptoms could mean that you may have an ectopic pregnancy and 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 (cells that surround a maturing egg in the ovary)

Since 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 development of the follicle may continue. Most of these follicles give no symptoms, although some may be accompanied by pelvic pain or pain during intercourse. These enlarged follicles may require medical attention, but they usually disappear on their own.

MIRENA does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

MIRENA and other medicines

Medicines that decrease the effectiveness of MIRENA in preventing pregnancy include: medicines which induce liver enzymes such as primidone, barbiturates, phenytoin, carbamazepine, rifampicin, rifabutin, nevirapine, oxcarbazepine and griseofulvin. If you take medicines that decrease the effectiveness of MIRENA, you may need to take additional contraceptive precautions. Discuss this matter with your doctor.

Even if you are taking any such medicine, you may still be able to use MIRENA. You may need to use another method of contraception while you are taking the other medicine and for 28 days afterwards.

You should tell your doctor if you are taking any medicines over a long period of time (e.g. epilepsy medication).

MIRENA and Breast-feeding

If you are breast-feeding and want to use MIRENA, you should discuss this with your doctor. Small amounts of levonorgestrel (the hormone in MIRENA) will be excreted in breast milk. Studies have not shown any significant effects on the growth or development of breast-fed babies from the sixth week after childbirth. MIRENA does not appear to affect the quality or quantity of breast milk.

MIRENA and Pregnancy

It is very rare that you may become pregnant with MIRENA in place. In the case that MIRENA is expelled, you are no longer protected and must use another form of contraception until you see your doctor.

You may have no periods while using MIRENA. This does not necessarily mean you are pregnant. If you do not have your period for six weeks and have other symptoms of pregnancy (for example nausea, tiredness, breast tenderness) you should see your doctor for an examination to determine whether you are pregnant or not.

If you become pregnant with MIRENA in place, it must be removed as soon as possible. If left in MIRENA may increase the risk of having a miscarriage, infection or preterm labor.

The hormone in MIRENA is released into the womb. This means that the fetus is exposed to a relatively high concentration of hormone locally, although the amount of the hormone received through the blood to the placenta is small. The effect of such an amount of hormone on the fetus cannot be ruled out, but to-date, there is no evidence of birth defects caused by MIRENA in cases where pregnancy has continued to term with MIRENA in place.

MIRENA and the ability to drive

There is no observed effect of MIRENA on the ability to drive and use machines. However, heavy lifting should be avoided in the first few days after insertion of MIRENA.

Important information about some of the ingredients of MIRENA

The T-frame of MIRENA contains barium sulfate which makes it visible in X-ray examination.

How to use MIRENA properly

When and how to use MIRENA

You can have MIRENA inserted within seven days from the onset of menstrual bleeding. Insertion outside this time (e.g. if you don't have a regular menstrual cycle) can only occur if effective contraception has been used for the seven days before insertion and will need to be continued for seven days following insertion. The IUS can also be inserted immediately after 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. MIRENA can be replaced by a new system at any time of the cycle.

MIRENA is not suitable for use as an emergency contraceptive (used after unprotected intercourse).

When MIRENA is used to protect the lining of the womb during estrogen replacement therapy, it can be inserted at any time in an amenorrheic woman (a woman who has no monthly bleeding), or during the last days of menstruation or withdrawal bleeding.

MIRENA should be inserted by a physician/health care professional who is experienced in MIRENA insertion.

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

You should see your doctor if:

• 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 feel pain or discomfort during sexual intercourse
• You have 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

Insertion of MIRENA

After a gynecological 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.

Some women may experience pain and dizziness after insertion. If these do not pass within half an hour in the resting position, the IUS may not be correctly positioned. An examination should be carried out and the IUS removed if necessary.

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

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.

What if I want to become pregnant

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.

Can I become pregnant after stopping use of MIRENA?

You may become pregnant during the first menstrual cycle after MIRENA is removed as it will no longer interfere with your normal fertility.

MIRENA can be removed during the first seven days of your menstrual cycle without requiring extra contraceptive precautions before removal. However after MIRENA is removed you will no longer be protected and an alternative method of contraception will be needed.

If MIRENA is to be removed after the seventh day of the menstrual cycle, and pregnancy is not desired, it is important to use another method of contraception (e.g. condoms) for at least seven days before its removal. Be sure to tell your doctor if you have had unprotected intercourse during the week before you have MIRENA removed.

When you have no menstrual bleeding, you should use a barrier method of contraception for seven days before removal.

A new MIRENA can also be inserted immediately after removal, in which case no additional protection is needed.

How long should I wait to have sexual intercourse after 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.

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.

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 if 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 or 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 hemoglobin value. When the system is removed, periods return to normal.

If you find that you do not have periods with MIRENA 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.

In fact not having periods can be a great advantage for a woman's health.

Special circumstances

Additional contraceptive precautions are only required when situations arise that may reduce the efficacy and reliability of MIRENA such as: implants that have been in place for over 5 years, implants inserted after the 7^th day of menstrual bleeding or certain medicines.

Overdosage

There has been no experience of overdose with MIRENA.

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.

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 feel 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 skin, 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
• you experience any of the conditions mentioned in the section called "Before you use 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 (see the section called "Extra contraceptive precautions") 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 fetus is exposed to a relatively high concentration of hormone locally, although the amount of the hormone received through the blood and placenta is minimal. The effect of such an amount of hormone on the fetus 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, however you should discuss this with your doctor first. 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 medicines 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.

Tell your doctor if:

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

• Migraine or one-sided visual loss or other symptoms which may be a sign of a temporary blockage of the blood supply to the brain (transient cerebral ischemia)
• 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 tumors, including breast cancer
• Severe disease of the arteries such as stroke or heart attack

Adverse effects

Serious side effects

If a pregnancy occurs in the case of method failure, the risk that it may be ectopic (located outside the womb) is increased. 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. In addition, cases of breast cancer have been reported (frequency unknown).

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 bleeding or no bleeding at all, heavy flow and menstrual pain.

Ovarian cysts have been detected in 12% of women during the use of MIRENA.

Allergic skin reactions may be due to the IUS.

In addition, the following undesirable effects that may be associated with MIRENA have been reported. These side effects have been listed by the parts of the body that they may affect and how common they are.

The following definitions apply when the words "common", "uncommon" and "rare" appear in this leaflet relating to adverse effects:

"very common" means more than 1 in every 10 patients may experience these.
"common" means between 1 and 10 in every 100 patients may experience these.
"uncommon" means between 1 and 10 in every 1,000 patients may experience these.
"rare" means between 1 and 10 in every 10,000 patients may experience these.

Nervous System and Psychiatric Disorders
Common	- headache - depression - nervousness - decreased libido
Uncommon	- migraine - altered mood
Digestive System
Common	-abdominal pain - nausea (feeling sick)
Uncommon	- abdominal bloating
Skin and Subcutaneous Disorders
Common	- acne
Uncommon	- excessive body hair (hirsuitism) - hair loss - severe itching (pruritis) - inflammation of the skin (eczema)
Rare	- rash - hives (urticaria)
Musculoskeletal, Connective Tissue and Bone Disorders
Common	- back pain
Reproductive System Disorders
Very Common	- uterine or vaginal bleeding including spotting, infrequent periods (oligomenorrhea), and absence of bleeding (amenorrhea) - benign ovarian cysts (see the section called "Enlarged ovarian follicles")
Common	- pelvic pain - painful menstruation (dysmenorrhea) - vaginal discharge - inflammation of the external genital organs or vagina (vulvovaginitis) - breast tenderness - breast pain - expulsion of MIRENA
Uncommon	- pelvic inflammatory disease (infection of the female upper genital tract, the female structures above the neck of the womb) - inflammation of the lining of the womb (endometritis) - inflammation of the neck of the womb (cervicitis/Papanicalaou smear normal, class II)
Rare	- perforation of the womb
Investigations
Common	- weight gain
General Disorders
Uncommon	- swelling (edema)

Similar side effects have been reported when MIRENA has been used for hormone replacement therapy in combination with estrogen preparations.

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

If you are concerned about any of these side effects or notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Storage

Do not use after the expiry date stated on the package.

Store all medicines properly and keep them out of reach of children.

Further information

MIRENA contains:

active substances (per implant)

levonorgestrel (52 mg)

other substances

polydimethylsiloxane elastomer, silica (colloidal anhydrous), polyethylene, barium sulphate, iron oxide

If you have any further questions please consult your doctor or pharmacist.

Sponsor

Bayer New Zealand Limited
3 Argus Place
Hillcrest
North Shore
AUCKLAND 0627

Free phone: 0800 233 988

www.femalelife.co.nz

This leaflet was last revised on 29^th May 2007