Mirena is a T-shaped intrauterine delivery system (VMS), which is then placed in the uterus releases the hormone levonorgestrel. T-shape is chosen in order to adapt the system to the shape of the uterus






What is Mirena and what it is used
Mirena is a T-shaped intrauterine delivery system ( VMS ) , which is then placed in the uterus releases the hormone levonorgestrel . T -shape is chosen in order to adapt the system to the shape of the uterus. The vertical arm of the T-shaped system carries a tank containing the drug substance levonorgestrel . Two mobile strands are attached to the loop at the lower end of the vertical arm .

Mirena is used for:
Contraception (prevention of pregnancy ) ;
Idiopathic menorrhagia ( excessive menstrual bleeding) ;
Prevention of endometrial hyperplasia (excessive growth of the inner layer of the uterus ) during estrogen replacement therapy .

2 . What you should know before using Mirena
General remarks
Before you start using Mirena , your doctor will ask you some questions about your health and that of your close relatives .
About 2 of 1000 women using Mirena properly , get pregnant during the first year .
About 7 out of 1000 women using Mirena properly , get pregnant within five years.
In this sheet are described in several situations where Mirena must be removed, or where the reliability of Mirena can be smaller. In these situations, or must abstain from sex or you should take extra non-hormonal contraceptive measures , eg . to use a condom or other barrier method . Do not use rhythm or temperature method. These methods may prove to be unreliable , as amended Mirena typical monthly changes in body temperature and mucus in the cervix .
Mirena and other hormonal contraceptives , does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Do not use Mirena under the following conditions :
if you are pregnant or think you may be pregnant ;
if you have or have ever had a disease of the pelvic organs ( infection of the female genitals ) ;
if you have an infection of the lower genital tract ;
if you have an infection of the uterus after birth;
if you had an infection of the uterus after a miscarriage in the past three months;
if you have an infection of the cervix ( cervical cancer ) ;
if you have a cell dysplasia of the cervix ;
If you have cancer or suspected cancer, uterine or cervical cancer ;
if you have tumors whose growth depends on progestagen hormones ;
if you have undiagnosed vaginal bleeding ;
if you have abnormalities of the uterus or cervix , including fibroids if they distort the uterine cavity;
if you have a condition associated with increased susceptibility to infections ;
if you have severe active liver disease or liver cancer ;
if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in Section 6) .
Warnings and Precautions
Consult a specialist who can decide whether to continue using Mirena or system to be removed, or if there is a first time experience any of the following conditions :
migraine , asymmetrical visual loss or other symptoms that may show transient cerebral ischemia (temporary blockage of blood flow to the brain) ;
extremely severe headache ;
jaundice ( yellowing of the skin, whites of the eyes and / or nails ) ;
significant increases in blood pressure ;
severe disease of the arteries as cerebral infarction or myocardial infarction.
Mirena should be used with caution in women with congenital heart disease or valvular disease of an infectious inflammation of the heart muscle. In these women, it is necessary to apply antibiotic prophylaxis prior to insertion or removal of Mirena .
In diabetics using Mirena requires monitoring the blood glucose concentration .
Irregular bleeding may mask some symptoms and signs of endometrial polyps or cancer , in which case you need to take diagnostic measures.
Mirena is not a method of first choice for young women who have never been pregnant , and postmenopausal women with a reversal of the uterus.
Due to limited data from a test reading in Mirena preventing endometrial hyperplasia (excessive growth of the inner layer of the uterus ) in estrogen replacement therapy , the risk of breast cancer with the use of Mirena for this indication can be any confirmed nor rejected.

Medical examination / consultation
Review before placing the Mirena may include PAP smear , breast exam and other tests , eg . infections , including sexually transmitted diseases , as appropriate. Should be performed gynecological examination to determine the size and position of the uterus.
Mirena is not suitable for postcoital contraception ( use after intercourse ) .

Pelvic infections in women using intrauterine devices (CPA ) , often associated with sexually transmitted infections. The risk of infection is increased when the woman or her partner have more than one sexual partner. Infections in the pelvic area should be promptly treated. Infections in the pelvic area may reduce fertility and increase the risk of ectopic pregnancy (pregnancy outside the uterus ) in the future.
In extremely rare cases , shortly after placing the Navy may occur severe infection or sepsis ( very severe infection that can be fatal ) .
Mirena should be removed, if there is a recurrent infection , or pelvic infection of the lining of the uterus , or if the acute infection was severe and was not affected by treatment in a few days.
Immediately consult a doctor if you have persistent pain in the lower abdomen, fever, pain during intercourse or abnormal bleeding . Severe pain or temperature, occurring shortly after putting the system may mean that you have a serious infection that should be treated immediately.

Muscle contractions of the uterus during menstruation can sometimes displaced or discarded intrauterine system ( VMS ) . Possible symptoms are pain and abnormal bleeding . If the Navy shifted , efficiency may be reduced . If the Navy be discarded , you are no longer protected from pregnancy . It is advisable to check the threads with your finger , for example during bathing. If you have signs showing the disposal system , or you can not grope the threads , you should avoid sexual intercourse or use another contraceptive and consult your doctor. Since Mirena decreases menstrual bleeding, strengthening it may be an indicator for disposal.

In rare cases , most often during insertion , Mirena can penetrate or break through the wall of the uterus , which may reduce the protection against pregnancy. BMC , which is located outside the cavity of the uterus is ineffective and must be removed as quickly as possible . The risk of perforation may be increased if Mirena is placed shortly after birth (see section 3 . When should be placed Mirena ) in lactating women or women with flat and inverted uterus back (to red).

ectopic pregnancy
Very rare are the cases of pregnancy with Mirena inserted . However, if you become pregnant while you are peaceful, risk to the fetus is located outside the uterus ( ectopic pregnancy ) is relatively increased . About 1 in 1,000 women using Mirena properly , pregnant tubal year. Women who have already had an ectopic pregnancy surgery on the fallopian tubes or pelvic infection are at higher risk of ectopic pregnancy. An ectopic pregnancy is a serious condition that requires immediate medical attention .
The following symptoms may indicate that you have an ectopic pregnancy, you should immediately consult your doctor :
Your menstrual cycles have stopped and then get continuous bleeding or pain;
You stupid or very severe pain in the lower abdomen ;
You normal symptoms of pregnancy , but also have bleeding and feel dizzy.
Some women feel dizzy after insertion of Mirena . This is a normal physiological response . Your doctor will advise you to rest a while after insertion of Mirena .

Enlarged ovarian follicles ( cells surrounding the egg ripening in the ovary )
Since the contraceptive effect of Mirena is mainly due to a local action , in fertile women is normally displayed ovulatory cycles with follicular rupture . Sometimes the reversal of the follicle is delayed and maturation of the follicle may continue . Most of these follicles produce no symptoms , but some may be accompanied by pelvic pain or pain during intercourse . Enlarged follicles may require monitoring by the physician but usually disappear spontaneously.

Additional information on special populations
Children and adolescents
Mirena is used in women of childbearing age. There was no relevant indication for use of Mirena before menarche ( first menstrual bleeding ) .

Elderly women (aged 65 or more)
Mirena has not been studied in women over 65.

Women with hepatic impairment
Mirena should not be used in women with hepatic impairment ( see section 2, " Do not use Mirena ').

Women with renal impairment
Mirena has not been studied in women with renal impairment.

Other medicines and Mirena
Tell your doctor if you are taking , have recently taken or might take any medicines, including medicines obtained without a prescription.
The metabolism of levonorgestrel may be increased by concomitant use of other drugs such as antiepileptics ( phenobarbital , phenytoin , carbamazepine ) and antibiotics ( rifampicin , rifabutin , nevirapine , efavirenz ) . Since the mechanism of action of Mirena is mainly local , they are not expected to have a significant impact on the efficacy of Mirena .

Pregnancy, lactation and fertility
Mirena should not be used during an existing or suspected pregnancy .
Very rarely is the occurrence of pregnancy in Mirena inserted . But if Mirena be discarded , you are no longer protected and you must use another form of contraception until you meet with your doctor.
Some women may not have a monthly cycle while using Mirena . The lack of a monthly cycle is not necessarily a sign of pregnancy occurs. If you cycle and you have other pregnancy symptoms (eg nausea , fatigue, breast tenderness ) should go to your doctor to review and make a pregnancy test.
If you become pregnant while using Mirena , the system should be removed as quickly as possible . If you leave Mirena in the uterus during pregnancy , the risk of miscarriage , premature delivery or infection will increase. The hormone in Mirena is released into the uterine cavity. This means that the fetus is exposed to relatively high concentrations of the hormone locally , although the amount of hormone produced by the placenta , and blood , is small. The effect of this hormone on the quantity of the fruit should be kept in mind .

Mirena can be used during breastfeeding . Levonorgestrel has been identified in small amounts in the milk of lactating women ( about 0.1 % of the dose levonorgestrel goes into the child during breastfeeding) . No deleterious effects on growth or development of the infant when used Mirena six weeks after birth . Self- treatment with progestogens appear to affect the quantity or quality of breast milk.
Ask your doctor or pharmacist before taking any medicine if you are pregnant or breastfeeding.

Driving and using machines
No effects are known .

Mirena contains barium sulphate
T- shaped frame of Mirena contains barium sulfate , which makes it visible on X-ray .

3 . How to use Mirena
What is the effectiveness of Mirena ?
Contraception , Mirena is effective and most effective modern copper intrauterine delivery systems . The failure rate of Mirena is approximately 0.1% per year. This frequency can be increased in the event of disposal or perforation (see section " Medical examination / consultation ').
In the treatment of idiopathic excessive menstrual bleeding Mirena resulted in a significant reduction of blood loss during menstruation after the first three months. In some women, menstruation ceases all .

When should be placed Mirena ?
Mirena can be inserted within seven days of the menstrual period. Navy can be inserted and immediately after an abortion within the first trimester if no genital infections. Navy should be placed only after the uterus has recovered to normal after birth and no earlier than six weeks after birth . Mirena can be replaced with a new system at any point in the cycle .
If the Mirena is used to protect the lining of the uterus during estrogen replacement therapy , it can be placed at any time, in women with amenorrhea ( women with no withdrawal bleeding ) or in the last days of menstruation or withdrawal bleeding .
Mirena must be made by the physician / health care professional with experience in the placement of Mirena .

How is Mirena ?
After the pelvic examination , vaginal place an instrument called a speculum , the cervix is cleaned with an antiseptic solution. Intrauterine system (CPA ) is inserted into the uterus through a thin, flexible plastic tube ( applicator ) . It may be a local anesthetic of the cervix prior to insertion , as appropriate .

Some women may experience pain and dizziness after insertion . In case in the prone position of the woman are not switched to a half hour after the application, the CPA can not be positioned correctly . Should be conducted gynecological examination and if necessary the Navy should be removed .

When should I consult a doctor ?
Your intrauterine system ( VMS ) should be checked 4-12 weeks after insertion and then regularly at least once a year. Also, you should consult with your doctor if you get any of the following conditions :
If you no longer can feel the threads in the vagina ;
If you feel the bottom of the system;
If you think you may be pregnant ;
If you have persistent abdominal pain , fever or abnormal vaginal discharge ;
If you or your partner feel pain or discomfort during sexual intercourse ;
If sudden changes in your menstrual cycle ( for example, if your period is scarce or completely ceases , then get continuous bleeding or pain or heavy bleeding begins ) ;
If you have other health problems such as migraine headaches or recurrent very severe headache , sudden vision problems , jaundice or high blood pressure;
If you suffer from any of the conditions listed in section 2, " What you should know before using Mirena ."
For how long can I use Mirena ?
Mirena is effective five years after which the Navy must be removed . If you want when removed it can be replaced.

What do I do if I want to get pregnant or Mirena can be removed for another reason ?
Your doctor may remove the Navy anytime soon then pregnancy can occur . Usually, removal is a painless procedure . Fertility is restored after removal of Mirena .
In the event that no pregnancy is desired , Mirena should be removed after the seventh day of the menstrual cycle , unless contraception is provided by other means (e.g., rubber ) of at least seven days prior to removal . In case that the woman has no menstruation , it must use barrier contraception seven days before the removal of the system, until menstruation occurs again . Mirena may be replaced with a new one immediately after the removal of the previous one, which does not require additional contraceptive protection .

Can I get pregnant after stop using Mirena ?
Yes. Once removed, Mirena no longer hinder your normal fertility. You can still get pregnant during the first menstrual cycle after removal of Mirena .

Can Mirena to affect my menstrual cycle ?
Mirena affect your menstrual cycle. It can change your menstrual cycle , so you have spotting (light bleeding ) , longer or shorter period , scarce or abundant menstruation or no menstruation.
Many women during the first 3-6 months after insertion of Mirena often seen spotting or light bleeding between normal menstruation. Some women may have prolonged bleeding profusely or during that period. Please tell your doctor , especially if these symptoms persist.
Usually a gradual decrease in the number of days during which there is bleeding, and the amount lost each month blood. In some women, menstruation ceases all . As the amount of blood lost is usually reduced with the use of Mirena , most women increases hemoglobin in the blood.
When the system is removed , normal menstruation refundable.

Is it normal to not have her period ?
Yes, when using Mirena . If you miss your period when you are peaceful, this is due to the effects of hormones on the uterine lining . Monthly thickening of the mucosa does not occur . Therefore, there is nothing that can be discarded as menstruation. This does not mean that you have entered menopause , or you are pregnant. Levels of your own hormones remain normal .
In fact , the absence of menstruation can be a great advantage to a woman's health .

How do I know if I'm pregnant ?
Pregnancy is unlikely in women with Mirena , even if your period is missing.
If you have not had a period for six weeks, and you are concerned , do your pregnancy test. If it is negative, it is not necessary to do a second , unless there are other symptoms of pregnancy such as nausea , fatigue, or breast tenderness .

Can the Mirena cause pain or discomfort ?
Some women feel pain ( like cramps during the menstrual cycle) in the first few weeks after insertion of Mirena . You should return to your doctor or clinic if the pain is severe or if it lasts more than three weeks after insertion of Mirena .

Will have an impact on sexual contacts Mirena ?
Neither you nor your sexual partner should feel the Navy during sexual contact. Otherwise, refrain from sexual activity until your doctor does not check whether the Navy is positioned correctly.

What is the recommended time to avoid sexual intercourse after insertion of the helix ?
To give rest to your body, it is best to wait about 24 hours after the system before you have sex . However, as soon as placed , Mirena begins to protect you from pregnancy .

Can I use tampons ?
The use of sanitary napkins . If you use tampons, their replacement should be done very carefully so as not to pull the threads of Mirena .

What happens if Mirena disposed spontaneously ?
It is possible though rare Mirena be shed during the menstrual period, without you noticing. An abnormal increase in the amount of menstrual blood can mean that Mirena was expelled through the vagina . It is also possible to partially Mirena has come out of the womb ( you and your partner may notice during sex) . If Mirena is discharged in whole or in part, you are no longer protected from pregnancy .

How can I be sure that Mirena is in place ?
You alone can check whether after menstruation threads are in place . Gently insert your finger into the vagina and felt the threads in the bottom , near the mouth of the womb ( cervix ) .

Do not pull the threads , because you may accidentally download Mirena out . If you are unable to feel the threads , ask your doctor.

4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
Below is a list of possible side effects when Mirena is used for contraception (prevention of pregnancy ) and idiopathic menorrhagia ( excessive menstrual bleeding) .
Possible side effects when Mirena is used to protect the endometrium from hyperplasia (excessive growth of the endometrium ) during estrogen replacement therapy have been reported with similar frequency , unless otherwise stated in the footnotes.

Very common: 10 or more out of 100 women are likely to develop such a reaction :
headache ;
Abdominal pain / pelvic pain ;
Changes in bleeding , including increasing and decreasing menstrual bleeding , spotting , oligomenorrhea ( rare menstruation ) and amenorrhea (absence of bleeding) ;
Vaginitis (inflammation of the vulva or vagina ) ;
Vaginal discharge .
Common : Between 1 and 10 in every 100 women are likely to develop such a reaction :
Depressed mood / depression ;
Nausea (feeling sick) ;
acne ;
Hirsutism ( excessive hair growth ) ;
Back pain ;
Infections of the upper genital tract
Ovarian cysts ;
Dysmenorrhea ( painful menstruation ) ;
Chest pain ;
Disposal of intrauterine contraceptive device (fully and partially ) .
Uncommon : between 1 and 10 in every 1000 women are likely to develop such a reaction :
Alopecia (hair loss) .
Rare : between 1 and 10 in every 10,000 women are likely to develop such a reaction :
Perforation of the uterus.
Not known ( data can not be estimated ):
Hypersensitivity ( allergic) reactions , including rash , urticaria ( hives) and angioedema (characterized by sudden swelling as eyes, mouth, throat) ;
Increase in blood pressure.
Description of selected possible side effects:
Threads for removal can be felt by the partner during sexual intercourse.
If you become pregnant while you are having Mirena is able to be an ectopic pregnancy ( see section 2. Ectopic pregnancy ) .
The risk of perforation is increased in lactating women.
Cases of sepsis ( very severe systemic infection that can be fatal ) after inserting the Navy .
There is no known risk of breast cancer when used with Mirena protection indication of endometrial hyperplasia (excessive growth of the endometrium ) during estrogen replacement therapy . Cases of breast cancer ( not known ) .

Following possible adverse reactions were reported in association with procedures or removal of Mirena :
Pain during the procedure , bleeding during the procedure , vasovagal reaction with dizziness or syncope ( fainting ) upon insertion . The procedure can cause a fit (seizure ) in an epileptic woman.

If you get any side effects , tell your doctor. This includes all listed in this leaflet .

5 . How to store Mirena
Keep out of reach of children. No special storage conditions.
Do not use this medicine after the expiry date stated on the carton after " EXP " . The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . Package Contents and more information
What does Mirena
The active substance is levonorgestrel 52 mg.
The other ingredients are polydimethylsiloxane elastomer , silica colloidal anhydrous , polyethylene , barium sulfate , iron oxide .

Mirena looks like and contents of pack
Pack sizes: 1 sterile intrauterine delivery system for intrauterine administration.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bayer Oy , Finland .

Bayer Oy , Finland .

Date of last revision of package : 12/2011 .

The following information is intended for healthcare professionals only :
Medical examination / consultation
Before placing the woman should be informed of the effectiveness , risks and side effects of Mirena . Must be performed a physical examination , including pelvic examination , breast exam and Pap test . Should exclude pregnancy and sexually transmitted diseases and genital infections should heal completely. You need to determine the location of the uterus and the size of the uterine cavity. Fundus location of Mirena is essential to ensure uniform exposure of the endometrium to a progestagen to prevent expulsion and maximize efficacy. Therefore, instructions for placement must be carefully observed. Insertion and removal may be associated with some pain and bleeding. The procedure can cause fainting as an expression of vasovagal reaction or a seizure in epileptics .
Because irregular bleeding / spotting is common during the first months of therapy is recommended to exclude endometrial pathology before insertion of Mirena .
If women continue to use Mirena inserted earlier for contraception endometrial abnormality should be excluded if the bleeding occurs after initiation of estrogen replacement therapy.
If bleeding occur after prolonged therapy must also take appropriate diagnostic measures.

Oligo / amenorrhea
In women of childbearing potential , oligomenorrhea and amenorrhea develops gradually in 57 % and 16 % of women , respectively . Possibility of pregnancy should be considered if menstruation does not occur within six weeks after the beginning of the previous period.
Mirena When used in conjunction with estrogen replacement therapy , in most women amenorrhea occurs gradually during the first year of treatment .

Disposal System
Partial expulsion may decrease the effectiveness of Mirena . Mirena shear must be removed . New system can be placed immediately.

missing threads
If review ends of the strands to help remove Mirena , can be seen in the neck , you should first rule out pregnancy. The fibers may be drawn into the uterus or cervix and out again in the next period. When exclude the presence of pregnancy , the position of the fibers can be detected by probing gently with a suitable tool . If they can not be detected , this means that the system may have been discarded . Specifying the relative position of the system can be applied ultrasound . In the event that it can not take place or is unsuccessful , can not be applied to an x-ray localization of Mirena .

Ovarian cysts
Since the contraceptive effect of Mirena is mainly local in fertile women usually appear ovulatory cycles with follicular rupture . Sometimes atresia of the follicle is delayed and folliculogenesis may continue . Ovarian cysts have been reported as adverse reactions in approximately 7% of women using Mirena . Most of these cysts are asymptomatic but may be accompanied by pelvic pain and dyspareunia .
In most cases, ovarian cysts disappear spontaneously under observation for two to three months. If this does not happen is continued ultrasound monitoring and other diagnostic / therapeutic measures . In rare cases, a surgical intervention.

Insertion and removal / replacement
Putting after birth should be delayed until complete involution of the uterus , but not earlier than six weeks after birth. If involution is delayed, you should consider waiting until 12 weeks after birth. In case of difficulty in placing and / or unusual pain or bleeding during or after installation, should immediately carry out a physical and ultrasound examination to exclude perforation.
Mirena is removed by gently pulling on the threads with forceps. If the fibers are not visible , and the system is in the uterine cavity , the removal can be carried out using a narrow holder. This may require dilation of the cervix or any other surgical intervention.
If no pregnancy is desired , the removal must be performed during menstruation in women of fertile age , provided that there is a menstrual cycle . If the system is removed in the middle of the cycle and the woman had intercourse within one week , there is a risk of pregnancy , unless it is fitted with a new system, immediately after removal of the previous one.
After removal of Mirena should be checked the integrity of the IUS . In difficult removal were reported single cases where hormonal cylinder is horizontal slide over his shoulders and hides them together inside the cylinder . This situation does not require further intervention , once having established the integrity of the IUS . Protruding ends of the horizontal arms usually prevent complete removal of the cylinder from the T-shaped body .

Instructions for use and handling
Mirena is supplied in a sterile package , which must be opened up prior to installation . The open system is to be treated aseptically. If the integrity of the sterile packaging is damaged , the system must be discarded.

Removal of Mirena or probing of the uterus may cause miscarriage. If the system can not be removed and the woman wishes to continue the pregnancy , she should be warned about the risks and possible consequences of preterm birth for the child. The pace of such pregnancies should be monitored carefully. It is necessary to exclude an ectopic pregnancy . The woman should be instructed to report any symptoms that suggest complications of pregnancy, such as spastic abdominal pain with fever .
Because of the intrauterine location and local hormonal action must be taken into account the possible occurrence of virilizing effects on the fetus .



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