Mirena

Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.

If you have any doubts or queries about your medication, please contact your doctor or pharmacist.

Mirena

(Levonorgestrel Intrauterine System)

About this booklet

Please read this booklet carefully before you decide to have Mirena fitted.

It provides you with some useful information about Mirena. The information in this booklet applies only to Mirena. If you have any questions or are not sure about anything, please ask your doctor, nurse or clinic.

What is Mirena?

It consists of a small T-shaped frame made from a plastic called polyethylene. This carries 52 milligrams of levonorgestrel, a hormone used in many contraceptive pills and hormone replacement therapy (HRT) preparations. The hormone is contained within a substance called polydimethylsiloxane. This is surrounded by a membrane (skin) also made of polydimethylsiloxane.

The T-shaped frame also contains barium sulphate so that it can be seen on X-rays.

This structure provides a system for releasing the hormone gradually into the uterus (womb).

There are two fine threads, made of iron oxide and polyethylene, attached to the bottom of the frame. These allow easy removal and allow you or your doctor to check that the system is in place.

Each pack contains one Mirena.

Product Licence Holder:

Bayer plc

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

United Kingdom

PL Number:

PL 00010/0547

Mirena is manufactured by:

Bayer Schering Pharma Oy

Pansiontie 47

FIN-20101 Turku

Finland

What is the system for?

Contraception and menorrhagia:

Mirena is an effective, long-term and reversible method of contraception.

Mirena is also useful for reducing menstrual blood flow, so it can be used if you suffer from heavy menstrual bleeding (periods). This is called menorrhagia.

Mirena is placed inside the uterus (womb) where it slowly releases the hormone levonorgestrel over a period of 5 years or until it is removed.

Protection of the lining of your uterus (womb) during the menopause:

You may also use Mirena if you are going through the menopause. The menopause is a gradual process, which usually takes place between the ages of about 45 and 55. Although the menopause is natural, it often causes distressing symptoms such as hot flushes and night sweats. These symptoms are due to the gradual loss of the female sex hormones (oestrogen and progestogen) produced by the ovaries. Mirena contains one of the hormones (a progestogen) that are lost during the menopause.

Oestrogens can be used to relieve the menopausal symptoms. However, taking oestrogens alone increases the risk of abnormal growth or cancer of the lining of the womb. Taking a progestogen, such as the levonorgestrel in Mirena, with the oestrogen, lowers the risk.

Not so much is known about how well Mirena protects the lining of the womb after 4 years of use in women taking oestrogen. Your doctor will therefore remove your Mirena after 4 years. Your doctor will be able to advise you further.

How does the system work?

As a contraceptive, the hormone in Mirena prevents pregnancy by:

• controlling the monthly development of the womb lining so that it is not thick enough for you to become pregnant


• making the normal mucus in the cervical canal (opening to the womb) thicker, so that the sperm cannot get through to fertilise the egg


• preventing ovulation (the release of eggs) in some women


• there are also local effects on the lining of the womb caused by the presence of the T-shaped frame.

In treating menorrhagia, the hormone in Mirena reduces menstrual bleeding by:

• controlling the monthly development of the womb lining, making it thinner, so that there is less bleeding every month.

The hormone in Mirena helps you through the menopause by:

• replacing the hormone (progestogen) that your body no longer makes


• protecting the lining of your womb from abnormal growth or cancer

Will Mirena suit you?

Before you have Mirena fitted, your doctor may carry out some tests to make sure that Mirena is suitable for you to use.

Not all women should use Mirena. Tell your doctor:

• if you are pregnant, suspect that you are pregnant or are breast feeding


• if you have an unusual vaginal bleeding pattern


• if you have an abnormal womb or fibroids


• if you have an unusual or unpleasant vaginal discharge, or vaginal itching


• if you have or have had pelvic inflammatory disease


• if you have or have had inflammation of the lining of your womb following delivery of your baby


• if you have or have had an infection of the womb after delivery or after abortion during the past 3 months


• if you have or have had inflammation of the cervix (neck of your womb)


• if you have or have had an abnormal smear test (changes in the cervix)


• if you have had a stroke, heart attack or any heart problems


• if you have or have had liver problems


• if you have any condition which makes you susceptible to infections. A doctor will have told you if you have this


• if you have or have had any type of cancer, suspected cancer or leukaemia


• if you have or have had trophoblastic disease. A doctor will have told you if you have this


• if you are sensitive to the hormone levonorgestrel or to any of the ingredients in Mirena


• if you are diabetic, have high blood pressure or abnormal blood lipid levels


• if you have fits (epilepsy)


• if you have a history of blood clots (thrombosis)


• if you are on long-term steroid therapy


• if you are taking any other medicines as some medicines may stop Mirena from working properly


• if you have or develop migraine, dizziness, blurred vision, unusually bad headaches or if you have headaches more often than before


• if you have ever had an ectopic pregnancy or a history of ovarian cysts.

You may still be able to use Mirena if you have or have had some of these conditions. Your doctor or clinic will advise you.

You must also tell your doctor if any of these conditions occur for the first time whilst you have the Mirena in place.

If you get:

• painful swelling in your leg


• sudden chest pain


• difficulty breathing

• See a doctor as soon as possible as these may be signs of a blood clot.

It is advisable to give up smoking.

When Mirena is fitted for contraception:

What if I want a baby?

If you want a baby, ask your doctor to remove Mirena. Your usual level of fertility will return very quickly after the system is removed.

Can I breast feed while using Mirena?

Very small amounts of the hormone in Mirena are found in breast milk but the levels are lower than with any other hormonal contraceptive method. If you want to breast feed your baby, you should discuss this with your doctor.

Can I become pregnant whilst using Mirena?

It is very rare for women to become pregnant with Mirena in place.

Missing a period may not mean that you are pregnant. Some women may not have periods whilst using the system.

If you have not had a period for 6 weeks 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.

However, if you become pregnant with the system in place you should have it removed as soon as possible. You might want to consider having an abortion. Your doctor or clinic will advise you.

How and when is Mirena fitted?

Only a doctor or specially trained nurse can fit the system.

They will:

• give you a pelvic examination to find the position and size of your womb


• place a speculum (an instrument to help the doctor see the cervix) into your vagina


• clean your vagina and cervix


• place a thin flexible tube containing the system into your vagina and then through the cervix into the womb. (At this point you might feel a little discomfort)


• withdraw the tube leaving the system in place


• trim the threads to a suitable length for easy removal.

When Mirena is fitted for contraception or menorrhagia:

The system should be inserted either during your period or within seven days from the beginning of your period. If you already have the system and it is time to replace it with a new one, you do not need to wait until your period. If you have just had a baby, you should wait at least 6 weeks before having Mirena fitted. Mirena can sometimes be fitted immediately after you have had an abortion, provided that you have no genital infections.

When Mirena is fitted to protect the lining of your womb during the menopause:

If you no longer have periods then Mirena can be inserted at any time. If you still have periods, Mirena should be inserted during the last days of bleeding.

If you have epilepsy, tell the doctor or nurse fitting the Mirena because, although rare, a seizure (fit) can occur during insertion. Some women might feel faint after the system is fitted. This is normal and your doctor will tell you to rest for a while. In very rare cases during fitting, part or all of the system could penetrate the wall of the womb. If this happens the system is removed.

How quickly should Mirena work?

Contraception:

You are protected from pregnancy as soon as the system is fitted.

Menorrhagia:

Mirena usually achieves a significant reduction in menstrual blood loss in 3 to 6 months of treatment.

Protection of the lining of your womb during the menopause:

The hormone in Mirena will begin to protect the lining of your womb as soon as it is fitted.

How often should I have the system checked?

You should have the system checked usually 6 weeks after it is fitted, again at 12 months and then once a year until it is removed.

What happens if the system comes out by itself?

If the system comes out either completely or partially you may not be protected against pregnancy.

It is rare but possible for this to happen without you noticing during your menstrual period. An unusual increase in the amount of bleeding during your period might be a sign that this has happened. Tell your doctor or clinic if there are any unexpected changes in your bleeding pattern.

How can I tell whether the system is in place?

After each menstrual period, you can feel for the two thin threads attached to the lower end of the system. Your doctor will show you how to do this.

Do not pull the threads because you may accidentally pull it out. If you cannot feel the threads, go to your doctor.

You should also go to your doctor if you can feel the lower end of the system itself or you or your partner feel pain or discomfort during sexual intercourse.

Can I change my mind?

Your doctor can remove the system at any time. The removal is very easy. Unless you plan to have a new system or an intra-uterine device fitted immediately, it is important to use another form of contraception in the week leading up to the removal. Intercourse during this week could lead to pregnancy after Mirena is removed.

How will Mirena affect my periods?

Mirena will affect your menstrual cycle. You might experience spotting, shorter or longer periods, painful periods, lighter periods or no periods at all.

If you have had Mirena fitted for contraception:

Many women have spotting (a small amount of blood loss) for the first 3-6 months after the system is fitted. Others will have prolonged or heavy bleeding. You may have an increase in bleeding however, usually in the first 2 to 3 months, before a reduction in blood loss is achieved. Overall you are likely to have fewer days bleeding in each month and you might eventually have no periods at all. This is due to the effect of the hormone (levonorgestrel) on the lining of the womb.

If you have had Mirena fitted for menorrhagia:

Mirena usually achieves a significant reduction in menstrual blood loss in 3 to 6 months of treatment. You may have an increase in bleeding however, usually in the first 2 to 3 months, before a reduction in blood loss is achieved. If a significant reduction in blood loss is not achieved after 3 to 6 months, alternative treatments should be considered.

If you have had Mirena fitted to protect the lining of your womb during the menopause:

You may have some spotting and irregular bleeding during the first few months after Mirena is fitted. Over time, this bleeding will become less and you might eventually have no periods at all.

If you have had Mirena fitted for quite a long time and then start to have bleeding problems, contact your doctor or clinic for advice.

There is a calendar on the last page of this patient information booklet. Your doctor may ask you to fill this in to check your pattern of bleeding. If you are asked to do so, mark the date of insertion with an “X” in the appropriate date square. Mark days of spotting with “o” and bleeding with “•”.

What about side-effects?

Taking any medicine carries some risk of side effects. With Mirena these are most common during the first months after the system is fitted and decrease as time goes on. The most common side effects (more than one in 10 women) are menstrual changes and ovarian cysts (fluid-filled sacs in the ovary). Other possible side-effects reported by women who use Mirena are listed below. We have divided these side effects into groups, depending on how common the reactions were.

Common (more than one in 100 women but less than one in 10) side effects can include:

• bloating or swelling of your legs or ankles;



• weight gain;



• depression, nervousness or other mood changes;



• headache;



• abdominal, pelvic or back pain;



• feeling sick (nausea);



• spots (acne);



• painful periods;



• increased vaginal discharge;



• inflammation of the neck of the womb (cervicitis);



• tender, painful breasts; or



• the Mirena coming out by itself.

Uncommon (more than one in 1000 women but less than one in 100) side effects can include:

• genital infections that may cause: vaginal itching; pain on passing urine; or lower abdominal (tummy) pain from inflammation of the womb, ovaries or Fallopian tubes;



• increased growth of hair on the face and body;



• hair loss; or



• itchy skin (pruritus).

Rare (less than one in 1000 women) side effects can include:

• reduced sex drive;



• migraine;



• bloated abdomen;



• rashes, itching, eczema; or



• the wall of the womb torn when the Mirena is fitted.

Ovarian cysts and pelvic inflammatory disease have been reported so tell your doctor if you have lower abdominal pain or if you experience painful or difficult sex. This is important as pelvic infections can reduce your chances of having a baby and can increase the risk of ectopic pregnancy (development of a fertilised egg outside the womb.

Ectopic pregnancy is possible with Mirena but highly unlikely. The risk of this happening is lower than for women using no contraception or a copper intrauterine device.

You should tell your doctor if you have lower abdominal (tummy) pain especially if you also have a fever or have missed a period or have unexpected bleeding. This might be a sign of ectopic pregnancy.

If you think you are reacting badly to Mirena or are having any other problems, please tell your doctor or clinic.

Storage

Do not open the Mirena pack. Only your doctor or clinic should do this. The system should not be used after the date printed on the pack.

This booklet was revised May 2008.