Mirena - Medsafe

1 Mirena (Mi RAY na). levonorgestrel intrauterine delivery system Consumer Medicine Information WHAT IS IN THIS There are two fine threads, The hormone in Mirena made of iron oxide and prevents pregnancy by: LEAFLET polyethylene, attached to the controlling the monthly This leaflet answers some bottom of the frame. These development of the womb common questions about allow easy removal and allow lining so that it is not thick Mirena . It does not contain all you or your doctor to check that enough for you to become the available information. It the system is in place. pregnant does not take the place of making the normal mucus in talking to your doctor or Mirena may be used as a long the cervical canal (opening to pharmacist. term and reversible method of the womb) thicker, so that contraception, for the treatment the sperm cannot get through All medicines have risks and of excessive menstrual bleeding to fertilise the egg benefits. Your doctor has (menorrhagia) or for protection preventing ovulation (the weighed the risks of you using from endometrial hyperplasia release of eggs) in some Mirena against the benefits they (excessive growth of the lining women expect it will have for you.)

2 Of the womb) during hormone there are also local effects on replacement therapy. It is the lining of the womb If you have any concerns placed inside the womb where it caused by the presence of the about using this medicine, ask slowly releases the hormone (at T-shaped frame - since your doctor or pharmacist. an initial rate of 20 micrograms Mirena is an intrauterine per 24 hours) over a period of system (IUS). Keep this leaflet. five years or until it is removed. affecting the movement of You may need to read it again. sperm inside the womb, Mirena works in the treatment preventing fertilisation. of excessive monthly bleeding WHAT Mirena IS and as protection in estrogen Mirena is not an emergency replacement therapy by slowly USED FOR releasing the progestogen contraceptive. Mirena consists of a small T- hormone levonorgestrel, within Ask your doctor if you have shaped frame made from a the womb. Levonorgestrel any questions about why this plastic called polyethylene.

3 This suppresses the response of the medicine has been prescribed carries 52 mg levonorgestrel, a cells in the lining of the womb for you. hormone used in many to estrogen making the lining of Your doctor may have contraceptive pills. The the womb insensitive to prescribed it for another reason. hormone is contained within a circulating oestradiol. This substance called stops the growth of the lining of dimethylsiloxane/methylvinylsil the womb, which results in a oxane cross linked elastomer reduction in the volume and BEFORE YOU USE. and is surrounded by a duration of menstrual bleeding. Mirena . membrane (skin) also made of This is the mechanism of action Not all women can use the same elastomer. in the treatment of excessive Mirena . All products have bleeding (menorrhagia) and for benefits and risks. If you are This structure provides a system protection against over unsure if Mirena is suitable for releasing the hormone stimulation of the lining of the for you, discuss this with your gradually into the womb womb in estrogen replacement doctor.

4 (uterus). therapy. Mirena should not be the first choice of contraception in Mirena CMI 1. young women who have not had infections of the womb after determine the position and the a baby. childbirth or after an abortion size of your womb. in the last three months When you must not use it infection or cell Your doctor may consider abnormalities in the cervix removal of the system if any of Do not use Mirena if you have (opening to the womb) the following conditions exist an allergy to: or arise for the first time. levonorgestrel, the active Do not use this medicine after Mirena should be used with ingredient in Mirena caution after specialist the expiry date printed on the consultation. any of the inactive ingredients pack. listed at the end of this leaflet. migraine with visual If it has expired or is damaged, disturbances or other return it to your pharmacist for Some of the symptoms of an symptoms which may be disposal. The expiry date is allergic reaction may include: signs of a temporary printed on the carton and on the shortness of breath blockage of blood supply to sachet after To be inserted the brain wheezing or difficulty in before ( 11 18 refers to breathing severe headaches November 2018).

5 The expiry swelling of the face, lips, jaundice (yellowing of the date refers to the last day of that tongue or other parts of the skin and eyes). month by which it should be body inserted. increase in blood pressure rash, itching or hives on the stroke or heart attack skin. Do not use this medicine if the blood clots in the legs (deep packaging is torn or shows vein thrombosis), the lungs Do not use this medicine if signs of tampering. (pulmonary embolism) or you are pregnant or suspect other parts of the body. you may be pregnant. If you are not sure whether you should start using this Tell your doctor if you have Do not give it to a child. medicine, talk to your doctor. any of the following conditions, Mirena may be Do not use Mirena if you used with caution: Before you start to use it if you were born with heart have, or have had any of the following medical conditions: Tell your doctor if you have disease (congenital) or undiagnosed vaginal allergies to any other valvular heart disease bleeding from the womb medicines, foods, diabetes, there is generally abnormal cervix or womb, or preservatives or dyes.

6 No need to alter your fibroids which distort the diabetic medication while cavity of the womb Before insertion, your doctor using Mirena but this may progestogen dependent will inform you of the benefits need to be checked by your tumours and risks of Mirena . A physical doctor examination including pelvic tumours in the cervix or examination, examination of the Pelvic infections have been womb breasts and a Pap smear should reported with the use of liver disease or liver tumour be performed. intrauterine delivery systems if you have pelvic such as Mirena . You have an inflammatory disease or have Your doctor should also rule out increased risk of pelvic had recurrent pelvic pregnancy. Any sexually infections if you have multiple inflammatory disease in the transmitted infections (STIs) sexual partners, STIs or a past (infection of the female and genital infections should be history of pelvic inflammatory reproductive organs). treated successfully before disease.

7 Pelvic infections may if you have conditions insertion. impair fertility and increase the associated with increased risk of ectopic pregnancy. risk of developing pelvic Your doctor will also need to do infections a gynaecological examination to Pain, bleeding or dizziness may lower genital tract infections occur when Mirena is placed or Mirena CMI 2. removed. If you have epilepsy, These medicines may be estrogen replacement therapy, it tell your doctor because affected by Mirena or may can be inserted at any time if seizures can occur during affect how well it works. You you do not have monthly placement or removal. may need different amounts of bleeding or else during the last your medicines, or you may days of menstruation or If you have not told your need to take different withdrawal bleeding. You may doctor about any of the above, medicines. feel faint after the system is tell them before you start inserted. This is normal and using Mirena .

8 Your doctor and pharmacist your doctor will tell you to rest have more information on for a while. Taking other medicines medicines to be careful with or avoid while taking this Tell your doctor or medicine. WHILE USING. pharmacist if you are taking any other medicines, Mirena . including any that you get HOW TO USE The current recommendation is without a prescription from to wait about 24 hours after your pharmacy, supermarket Mirena having Mirena inserted before or health food shop. Follow all directions given to having sexual intercourse. you by your doctor or Some medicines and Mirena pharmacist carefully. You may feel faint after Mirena may interfere with each other. They may differ from the is placed. This is normal and These include: information contained in this your doctor will tell you to rest medicines to treat high leaflet. for a while. In rare cases, part or blood pressure, chest pain all of the system could penetrate and/or irregular heartbeats If you do not understand the the wall of the womb.

9 If this such as verapamil, diltiazem instructions given, ask your happens, Mirena needs to be medicines used to treat doctor or pharmacist for help. removed. epilepsy such as phenytoin, barbituates, primidone, How to use it You should have Mirena carbamazepine, felbamate, checked usually 4-12 weeks topiramate, oxcarbazepine Mirena is inserted and removed after it is placed and then once a rifampicin or rifabutin for by a professional, experienced year until it is removed. It can the treatment of in the use of IUSs. stay in place for five years. tuberculosis macrolide antibiotics ( When to use it Your doctor can remove the clarithromycin, system at any time and removal The system should be inserted erythromycin) is usually easy. Mirena should within seven days from the herbal medicines containing beginning of your period. If you be removed before the seventh St John's Wort day of the menstrual cycle already have the system and it is medicines used to treat time to replace it with a new unless another form of HIV/AIDS such as contraception is used in the one, you do not need to wait for efavirenz or nevirapine week leading up to the removal.

10 Your period. some medicines used to Intercourse during this week treat Hepatitis C Virus could lead to pregnancy after Mirena can be inserted (HCV) such as boceprevir, Mirena is removed. immediately after a first telaprevir trimester abortion. It should not medicines used to treat Mirena does not protect against be used until the womb has fungal infections such as HIV infection (AIDS) and other returned to normal size after ketoconazole, itraconazole, STIs. Additional methods giving birth and no earlier than voriconazole, fluconazole, should be used ( condoms) to six weeks after delivery. griseofulvin prevent transmission of STIs. grapefruit juice When Mirena is used to protect the lining of the womb during Mirena CMI 3. The removal threads may be felt of blood loss. Some women condition that requires by the partner during sexual eventually find that their immediate medical attention. intercourse. periods stop altogether. The following symptoms Expulsion If you are using Mirena with could mean that you may If the system comes out either estrogen replacement therapy, a have an ectopic pregnancy partially or completely you may non-bleeding pattern is likely to and you should see your not be protected against develop during the first year of doctor immediately: pregnancy.