Mirena levonorgestrelreleasing intrauterine system. Mirena patient information leaflet pil by bayer plc. Nda 21225 mirena fda approved 08 june 2017 fdaapproved patient labeling patient information mirena muranah levonorgestrelreleasing intrauterine system mirena does not protect against hiv infection aids and other sexually transmitted infections stis. Some types of ius may also be used to treat heavy periods menorrhagia. The device is a tshaped plastic frame thats inserted into the uterus, where it releases a type of the hormone progestin. Patient information prescription information prescriber information please see important safety information for kyleena, mirena or skyla on third page and accompanying full prescribing information for kyleena, mirena and skyla. Oct 30, 2017 the intrauterine system ius is a very effective method of contraception.
Select choice of specialty pharmacies specialty pharmacy fax phone hours of operation q cvs specialty in the. Brand names paragard mirena, skyla, liletta, and others when does the iud start working. If you have any questions about mirena, have a conversation with your healthcare provider, who can help you decide which birth control option is best for you. Fdaapproved patient labeling patient information mirena. Kyleena is over 99% effective at preventing pregnancy for each year of use 98.
Once fitted, it works as a contraceptive for as long as you need it to, up to between three or five years, when it needs to be replaced. For additional important safety information about mirena please see page 16 of this. The bleeding profile with mirena is quite different from that of copper intrauterine devices, which frequently increase bleeding, whereas mirena decreases it figure 3. It does not take the place of talking to your doctor.
It may also be helpful if you are a partner, relative or friend of someone who is affected by pms. Use condoms or another backup method of birth control for the first 7 days after the iud is inserted to prevent pregnancy. This leaflet aims to answer your questions about having the intra uterine system ius, known as mirena, inserted. Women should expect cramping as the device comes out. On this page about mirena you will find information relating to side effects, age restrictions, food interactions, whether the medicine is available at a government subsidised price on the pharmaceutical benefits scheme pbs as well as other useful information. Please compare the leaflet preparedrevised date towards the end of the leaflet to establish if there have been any changes. Bayer plc 400 south oak way, reading, rg2 6ad telephone. Larc is very effective because it doesnt depend on you remembering to take or use contraception. Due to regulatory changes, the content of the following patient information leaflet may. Progesterone is a hormone found in other preparations, including the oral contraceptive pill. Skyla levonorgestrelreleasing intrauterine system is a hormonereleasing iud that prevents pregnancy for up to 3 years. The intrauterine device iud that releases levonorgestrel 20 mcgday mirena, referred to as lng20 has been studied in women following endometrial ablation. It is a small plastic device in the shape of a t with a hormone called levonorgestrel in its stem.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Evaluate patients 4 to 6 weeks after insertion of mirena and then yearly or more often if clinically indicated. Clinical trials of mirena excluded women with a history of ectopic pregnancy. The hormonereleasing iud mirena what is the hormonereleasing iud. How long will i be bleeding heavily after mirena coil. Your birth control choices reproductive health access. In epileptic patients, the insertion procedure may precipitate a seizure. Prior to insertion, give the patient the patient information booklet. What mirena is and what it is used for page number 2. Mirena decreases abnormally heavy menstrual blood loss. Mirena patient information leaflet pil emc pdf source. Helping you choose the method of contraception thats best.
Mirena is an intrauterine system ius affecting the movement of sperm inside the womb, preventing fertilisation. Septic abortion in patients becoming pregnant with an iud in place, septic abortionwith. The mirena ius has also been licensed more recently for. The progestin iuds start working 7 days after they are inserted. The hormonereleasing iud mirena family planning nsw. What is the difference between kyleena, liletta, skyla and mirena.
Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Your birth control choices reproductive health access project. We acknowledge receipt of your amendment dated august 23, 20, june 25, 2014, july 6, july 23, october 9, and october 19, 2015. Mirena is a thin plastic tshaped device containing levonorgestrel which is a synthetic form of the female hormone known as progesterone.
It is placed inside the uterus womb to prevent pregnancy. Evaluate patients 4 to 6 weeks after insertion of kyleena and then yearly or more often if clinically indicated. Patient information leaflets this leaflet gives you information about the hormone coil that your doctor has recommended. This information does not take the place of talking with your. If pregnancy should occur with mirena in place, mirena should be removed. After a routine mirena removal, there should be no symptoms or pain. Mirayna levonorgestrel intrauterine delivery system. Mirena is also used to treat heavy menstrual bleeding without a known reason in women who want to use a hormonal contraceptive method and have achieved menarche i. Pre and postplacement counselling mirena healthcare. Mirena was the first lngreleasing ius and has been available in the uk since 1995. Fnpnsw has taken every care to ensure that the information is accurate. Mirena is a tshaped intrauterine delivery system ius which after insertion releases the hormone levonorgestrel into the womb.
Pdf icon download leaflet view the patient leaflet in pdf format. In diabetic users of mirena, the blood glucose concentration should be monitored. Mirena 20 micrograms24 hours intrauterine delivery system levonorgestrel read all of this leaflet carefully before you start using this medicine. Mirena prescribing information this provides medical and scientific information on mirena in general. Less than 1% of users get a serious pelvic infection called pelvic inflammatory disease pid. Mirena is an intrauterine system ius containing 52 mg levonorgestrel. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. See 17 for patient counseling information and fdaapproved patient labeling revised. Information for you published in march 2018 managing premenstrual syndrome pms about this information this information is for you if you have, or think you have, premenstrual syndrome pms and want to know more about it. If you have a pelvic infection, get infections easily, or have certain cancers, dont use mirena.
An ius is a small, tshaped plastic device thats put into your womb uterus by a doctor or nurse. Mirena also treats heavy periods in women who choose intrauterine contraception. Removal or manipulation of mirena may result in pregnancy loss. For more information about accessing mirena, contact the womens healthcare whc support center. Mirena levonorgestrelreleasing intrauterine system is a hormonereleasing iud that prevents pregnancy for up to 5 years. Mirena may be used with caution in women who have congenital heart disease or valvular heart disease at risk of infective endocarditis. Gather information and consult with a physician about. It explains the benefits, risks and alternatives, as well as what you can expect when you come to hospital. National collaborating centre for womens and childrens health. Your doctor will give you this medicine in a hospital or clinic. Mirena levonorgestrelreleasing intrauterine system patients.
Please refer to the local summary of product characteristics for the information applicable in your country. If you have a pelvic infection, get infections easily, or have certain cancers, dont use skyla. Approximately 3 out of 4 patients with health insurance have coverage for. If you have any questions or are not sure about anything, please ask your doctor or nurse. This section provides information on the proper use of a number of products that contain levonorgestrel. Patient information liletta lyeletuh levonorgestrelreleasing intrauterine system read this patient information carefully before you decide if liletta is right for you. Mirena has anyone else experienced a brown discharge. It releases the hormone progestogen to stop you getting pregnant and lasts for 3 to 5 years, depending on the brand. If you have a pelvic infection, get infections easily, or have certain cancers, dont use mirena and kyleena. Mirena is over 99% effective at preventing pregnancy for up to 5 years.
Exclude pregnancy and confirm that there are no other contraindications to the use of mirena. Aug 22, 2019 the ius is an intrauterine contraceptive which releases levonorgestrel lng. It has a plastic tshaped frame with a reservoir containing 52 mg of lng and releasing 20 micrograms24 hours at the outset. Read this patient information carefully before you decide if mirena is right for you. This medicine comes with a patient information insert. If women experience severe pain, fevers or excessive bleeding after removal, they. If you have any further questions, please speak to a doctor or nurse caring for you. The information in this booklet applies only to mirena. The information in this fact sheet has been provided for educational purposes only. Please refer to the local patient information leaflet for the information applicable in your country. Antibiotic prophylaxis should be administered to these patients when inserting or removing mirena. The only hormonereleasing intrauterine device iud available in australia is called mirena. For additional information about mirena, including side effects, please see mirena safety considerations and the patient information.
Due to regulatory changes, the content of the following patient information leaflet may vary from the one found in your medicine pack. Mirena is a hormonal intrauterine device iud that can provide longterm birth control contraception. For information on coronavirus please go to our page on coronavirus. Mirena patient information this provides medical and scientific information on mirena in general. In the event of an intrauterine pregnancy with mirena, consider the following. Hormonal iud contains the hormone progestogen mirena or jaydess the iud is put in your uterus by an experienced nurse or doctor. Antibiotic preventive medication should be administered to these patients when inserting or removing mirena. Liletta, mirena, skyla and others 99% must be placed in uterus by a health care provider usually removed by a health care provider may be left in place 3 to 7 years, depending on which iud you choose no pill to take daily may improve period cramps and bleeding can be used while breastfeeding you can become pregnant right after it is removed. Your doctor may have prescribed it for another reason. For important information about kyleena, please see the full prescribing information. Mirena global website womens guide longacting contraceptive. What you need to know before you use mirena page number 3. This information does not take the place of talking with your gynecologist or other healthcare professional.
Iud information reproductive health access project. A guide for those considering birth control with mirena. Fdaapproved patient labeling patient information mirena mur. It provides you with some useful information about mirena. Ensure that the patient understands the contents of the patient information booklet and obtain the signed patient informed consent located on the last page of the patient information booklet. This prior approval supplemental new drug application provides for changes to the w. The ius is a method of longacting reversible contraception larc.
An iud is a small, tshaped object that goes inside your uterus. For important information about mirena, please see the full prescribing information. This intrauterine device iud is inserted into your uterus. The patient information leaflet included in the mirena package should be given to the patient prior to placement and they should be given the opportunity to read the information and discuss fully any questions the patient may have concerning mirena as well as other methods of contraception and therapies for heavy menstrual bleeding. Longacting reversible contraception the effective and appropriate use of longacting reversible contraception. Pharmaceutical form mirena consists of a white or almost white drug core covered with an opaque membrane, which is mounted on the vertical stem of a tbody. The intrauterine system ius is a very effective method of contraception. Mirena is a small intrauterine contraceptive made of soft, flexible plastic that is put in place by your healthcare provider during an office visit mirena is one of the most effective forms of birth control available in the united statesover 99% effective1 mirena prevents pregnancy for as long as you want, for up to 5 years. Commissioned by the national institute for health and clinic excellence, october 2005. 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. Bayer womens healthcare support specialty pharmacy.