Mirena (Levonorgestrel) IUD Birth Control System

Please read this INSTRUCTIONS carefully before using this medicine, as it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is MIRENA® and what is it used for? 2. Cautions before using MIRENA® 3. How to use MIRENA®? 4. What are the possible side effects? 5. MIRENA® storage

headers are included.

1. What is MIRENA® and what is it used for?

• MIRENA® is an intrauterine system. It contains 52 mg of active substance (levonorgestrel).

• Levonorgestrel, the active ingredient of MIRENA®, is a hormone from the progestogen group.

• MIRENA® is available as 1 sterile intrauterine system.

• MIRENA® is used to prevent pregnancy and to prevent thickening of the uterine lining during estrogen treatment for increased menstrual bleeding without a specific cause.

• MIRENA® is a T-shaped intrauterine system that secretes levonorgestrel hormone into the uterus after insertion. The reason for the T-shape is to fit the system to the shape of the uterus. The vertical arm of the T-body carries a drug store containing levonorgestrel.

2. Cautions before using MIRENA ® DO NOT use MIRENA® if:

• If you are pregnant or have a suspicion of pregnancy,

• If you have an infection of your internal genital tract,If you have a

•lower-genital tract infection,If you have an

•internal uterine inflammation,If you

•have an infection in the last 3 months,

• If you have cervical inflammation,

• In the uterus If there are cell changes,

• If the uterus or cervix has malignant tumors,

• Progestagene-related tumor,If there are

•abnormal uterine bleeding that cannot be diagnosed,If there are

•structural defects or masses that disrupt the uterine cavity

,cases that increase the risk of infection,

• There are• Acute liver disease or liver tumor,

• If you are allergic to the ingredients of,

MIRENAMIRENA ® CAREFULLY:

• If there is asymmetric vision loss or other symptoms indicating migraine, temporary cerebral ischemia,

• Unusual severe headache,

• Jaundice,If there is

•significant tension,If you

•have severe vascular disease such as stroke or heart attack,

• Pain in the leg swelling; sudden severe chest pain that does not spread / spread to the left arm; sudden breathlessness; the onset of sudden cough; unusual, severe, prolonged headache; sudden partial or complete vision loss; double vision; speech distortion or aphasia (speech difficulties), vertigo; collapse with / without focal seizure; very pronounced drowsiness or weakness that suddenly affects a part or part of the body; motor disorders; If there are signs of vascular congestion, such as severe stomach pain,If there are signs of congestion in the

•eyes vessels (vision loss, double vision),If

•there is valvular heart disease with congenital heart disease or infectious inflammation risk of the heart muscle,

• If you have diabetes.

Irregular hemorrhages, endometrial polyps, or some signs and signs of cancer may be stored, and diagnostic measures should be considered.

MIRENA® is not the first choice for post-menopausal women who have never been pregnant or are pregnant.

Before using MIRENA®, make sure that there are no pregnancy and sexually transmitted diseases. If there are, genital infections should be treated completely.

There may be some pain and bleeding during application and removal. In rare cases, it may cause fainting or seizure in epileptic patients.

Control examinations should be performed 4-12 weeks after the procedure, then once a year, or at intervals recommended by your doctor.

It is not appropriate to use MIRENA® as the next day protection method after sexual intercourse.

In women using MIRENA®, irregular bleeding / spotting may be common in the first months, and in 20% there is a decrease in menstrual bleeding and / or complete discontinuation. If the menstruation does not occur within 6 weeks following the beginning of the previous menstruation, the possibility of pregnancy should be considered. In cases where menstruation is completely discontinued, repeated pregnancy tests are not required if there are no other symptoms of pregnancy.

MIRENA® should be removed in the event of a sudden, severe infection, in the event of recurrence of genital infections or failure to respond to treatment within a few days.

In some cases, MIRENA® may move or be completely dislodged. However, the system may leave the uterine cavity without notice unless it causes loss of protection. Partial displacement may reduce its effectiveness and should be removed. A new one can be fitted if desired. Since MIRENA® decreases the amount of bleeding under normal conditions, an increase in the amount of bleeding may indicate the displacement of the system.

The rupture or perforation of the uterine body or cervix by an intrauterine device is rarely seen and usually occurs during insertion; this may reduce the effectiveness of MIRENA®. In such a case, the system must be removed.

The risk of absolute ectopic pregnancy is low in MIRENA® users. However, if a woman becomes pregnant while wearing MIRENA®, the possibility of an ectopic pregnancy increases relatively.

If control threads do not show withdrawal threads in the cervix, the possibility of pregnancy should be ruled out. Yarns may have escaped into the uterus or cervical canal and may appear again in the next menstrual period. Where the yarns cannot be found, the possibility of MIRENA® being slipped or dropped must be taken into consideration.

In some women using MIRENA®, cysts may be seen in the ovaries in the first months. They usually disappear spontaneously within two to three months. In cases where this does not occur, it is recommended that the condition be monitored by ultrasound or other diagnostic measures are taken.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Using MIRENA® with food and drink MIRENA® has no known interaction with food and beverages.

Pregnancy Consult your doctor or pharmacist before using the medicine. MIRENA® should not be used during pregnancy. If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding Consult your doctor or pharmacist before using the medicine. Approximately 0.1% of the levonorgestrel dose is transferred to the baby during lactation. However, the dose released from a MIRENA® in the uterine cavity is unlikely to pose a risk to the baby. No harmful effects on the growth or development of a baby have been found in cases where MIRENA® has been used from the sixth week postnatal to breastfeeding women. It has not been shown that only contraceptive methods involving progestagen affect the amount and quality of breast milk. In women using MIRENA® during breastfeeding, intermittent bleeding has been reported.

Vehicle and machine use MIRENA® has no known influence on the ability to drive and use machines.

Important information about some of the ingredients in MIRENA ® MIRENA ® contains barium sulfate, which can be seen on the X-ray machine.

Use with MIRENA® in combination with other medicines. Some blood tests may be appropriate:

• Phenobarbital, phenytoin, carbamazepine used in sara disease

• Rifampicin used as antibiotic, rifabutinNevirapine

•used in the treatment of viral infectionsEfavirenz

•used in the treatment of HIV please inform your doctor or pharmacist about these.

3. How to use MIRENA® Instructions for appropriate use and dose / frequency of administration: Your doctor will determine the dosage of your medicine and apply it to you, depending on your disease. MIRENA® is effective for 5 years after application and the system must then be removed. You can install a new MIRENA® if you want to remove the old one.

MIRENA® may be worn within seven days of the onset of menstrual bleeding. MIRENA® can also be worn immediately after the first trimester abortion, provided there is no genital infection. MIRENA® should be worn when the uterus returns to its normal size, not before 6 weeks after birth. MIRENA® can be replaced by a new system at any time. When MIRENA® estrogen is used to protect the uterine wall during replacement therapy, the unvaccinated woman (a woman without a monthly bleeding) can be worn at any time or during the last days of menstruation or during withdrawal bleeding.

Method and method of application: MIRENA® is placed in the uterine cavity.

It is recommended that MIRENA® be worn only by physicians / health professionals who are experienced in the application and / or are sufficiently trained for the application. Some women may feel pain and dizziness immediately after it is inserted. If they do not pass within the rest position within half an hour, the system may not be installed properly. An inspection should be carried out and the system removed if necessary. Some women may feel pain (such as menstrual cramps) in the first few weeks after MIRENA® is inserted. If pain persists for more than three weeks after MIRENA® has been inserted, or if you have serious pain, you should consult your doctor or clinic. Neither you nor your partner should feel the MIRENA® during sexual intercourse. If you feel it, you should avoid contact until your doctor checks that MIRENA® is in the correct position. For your comfort, it is best to wait 24 hours after having MIRENA® inserted to engage in sexual intercourse. However, MIRENA® will begin to prevent pregnancy immediately after it has been inserted.

Different age groups: Use in elderly: MIRENA® has not been tested in women over 65 years of age.

Specific Use Cases: Renal insufficiency: MIRENA® has not been tested in women with renal failure. Liver failure: MIRENA® should not be used in acute liver disease and liver tumors.

Talk to your doctor or pharmacist if you have an impression that MIRENA® is too strong or too weak.

If you have used more MIRENA® than you should: Talk to a doctor or pharmacist if you have used more than MIRENA®.

If you forget to use MIRENA®: Do not take double doses to compensate for forgotten doses.

MIRENA® does not prevent fertility after MIRENA® is discontinued. You may become pregnant after MIRENA® removal.

If you have any further questions regarding the use of this medicine, ask your doctor.

4. What are the possible side effects? Like all medicines, side effects may occur in people who are sensitive to the substances contained in the content of MIRENA®.

If you notice any of the following, tell your doctor or contact your nearest hospital emergency department:

• infection of internal genital organs (your woman is a side effect that can be detected during your birth examination)

• inflammation of the uterine lining (a side that can be identified during your birthday examined your woman enabled)

• cervical inflammation (your woman is a side effect that can be detected during your birth examination)

•

rupture of the uterus (is a side effect can be determined woman during your birth examination)

These are all serious side effects. Emergency medical intervention may be required.

If you notice any of the following, tell your doctor:

• Depressive mood

• Irritability

• Emotional changes

• Decreased sexual desire

• Headache

• Migraine

• Abdominal pain

• Abdominal swelling

• Nausea

• Pimples

• Hair lossHair loss

•

• Back pain

• Lower abdominal pain

Menstrual pain•

vaginal discharge•

•infection of the external genitalia

•breast tenderness

• breast pain

•Edema

• Weight gain

•

Itching

redness•

•Hives

• eczema

•

not be thrown out

mırena®'nthe effects of these serious side. Please inform your doctor or pharmacist if you experience any side effects not mentioned in these instructions.

5. Storage of MIRENA® Keep MIRENA® in a place where the child cannot see, reach, and pack.

Store MIRENA® at room temperature, away from sunlight and humidity, below 30oC.

Use in accordance with expiration dates. Do not use MIRENA ® after the expiration date. Do not use MIRENA ® if you notice any defects in the product and / or its packaging.

License holder: Bayer Türk Kimya San. Ltd. Sti. Fatih Sultan Mehmet Mah. Balkan Cad. No.53 34770 Ümraniye - Istanbul

Manufacturer: Bayer OY, Turku / Finland

This instructions for use is approved on 01/10/2009.

THE FOLLOWING INFORMATION IS FOR THE HEALTH PERSONNEL WHO WILL

IMPROVE THIS ENVIRONMENT Placement and subtraction / substitution In women of childbearing age, MIRENA® should be placed in the uterine cavity within the first seven days of the menstruation. MIRENA® can be replaced with a new system on any day of the cycle. The system can be applied immediately following first trimester abortions.

For postpartum applications, the uterus should be expected to complete complete involution, and this should not be before the sixth week postpartum. If involution is largely delayed, it is appropriate to wait until postpartum 12 weeks. Physical and ultrasonographic examination should be performed immediately in order to avoid the possibility of perforation in the event of difficulty in placement of the system and / or in case of abnormal pain or bleeding during or after insertion.

If Estrogen is to be used for endometrial protection during replacement therapy, MIRENA® can be worn to an amenorrheic woman at any time, or in the last days of menstruation or withdrawal bleeding.

It is recommended that MIRENA® be worn only by physicians / health professionals who are experienced in the application and / or are sufficiently trained for the application.

With the help of a forceps, MIRENA® is removed by gently pulling out its threads. If the yarns cannot be seen and the system is within the uterine cavity, it can be removed with the help of a thin tenaculum. This method may require dilatation of the cervical canal.

The system should be removed after 5 years. If the user wants to use the same method, a new intrauterine system can be placed at the same time.

If pregnancy is not desirable, MIRENA® should be removed during menstruation if a cycle is found in fertile women. If the system is removed at the middle of the cycle and the woman has had an intercourse within the last week, there is a risk of pregnancy unless a new system is removed following removal.

After MIRENA is removed, the integrity of the system must be checked. In case of difficulties in removing the system, it was reported that the hormone cylinder slid over horizontal arms in rare cases and they were stored in the cylinder. In this case, further intervention is not necessary if the integrity of the IUD is confirmed. The knuckle portions of the horizontal arms generally prevent the cylinder from detaching from the T-body.

The operating and operating instructions are provided in a sterile package that must not be opened until MIRENA® is installed. Opened product should be used according to aseptic conditions. If the packaging of the sterile package is damaged, the product must be discarded.