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MIRENA is a brand name for Levonorgestrel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Contraception. Idiopathic menorrhagia. Mirena may be particularly useful in women with idiopathic menorrhagia requiring (reversible) contraception. Protection from endometrial hyperplasia during oestrogen replacement therapy.
Verbatim from this product's MHRA label. Tap a section to expand.
Mirena is inserted into the uterine cavity.
Duration of use Contraception:
Mirena is effective for 8 years for contraception and should be removed no later than 8 years after insertion.
Idiopathic menorrhagia:
Mirena is effective for 5 years in the indication idiopathic menorrhagia. Clinical data (from clinical trials conducted in women of 18 years and over) beyond 5 years of use are limited, return of symptoms may indicate reduced efficacy.
The system should be removed or replaced in case symptoms return. If symptoms have not returned after 5 years of use, continued use of the system may be considered. Remove or replace no later than 8 years after insertion.
Protection from endometrial hyperplasia during oestrogen replacement therapy:
In the indication for protection from endometrial hyperplasia during oestrogen replacement therapy, clinical data (from clinical trials conducted in women of 18 years and over) beyond 4 years of use are limited. Mirena should therefore be removed no later than 4 years after insertion.
Starting treatment Mirena is supplied within an inserter in a sterile package which should not be opened until required for insertion. The exposed product should be handled with aseptic precautions. 6 for disposal instructions). Mirena is supplied with a patient reminder card in the outer package.
Complete the patient reminder card and give it to the patient, after IUS insertion. Insertion It is strongly recommended that Mirena should only be inserted by healthcare professionals who are experienced in Mirena insertions and/or have undergone sufficient training for Mirena insertion.
Before insertion, the patient should have been carefully examined in order to detect any contraindication to IUS insertion. Exclude pregnancy before insertion. Consider the possibility of ovulation and conception before using this product.
4). • For contraception and idiopathic menorrhagia Table 1: When to insert Mirena in women of fertile age Starting Mirena - Mirena should be inserted into the uterine cavity within 7 days of the onset of menstruation. In this case Mirena provides contraceptive protection upon insertion and no back-up contraception is needed.
Undesirable effects are more common during the first months after the insertion, and subside during prolonged use. 1). 4) but has been estimated from clinical trial data to occur in 7% of users. 4). In clinical trials with Mirena that excluded breastfeeding women the frequency of perforation was "rare".
A separate study with 362 women who have used Mirena for more than 5 years showed a consistent adverse reaction profile in Years 6 through 8. 4). 4). 4). The procedure may also precipitate a seizure in patients with epilepsy. The removal threads may be felt by the partner during intercourse.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
For long-acting products like Mirena, please report information of when Mirena was inserted and removed, as applicable.
Medical Examination Before insertion, a complete personal and family medical history should be taken. Physical examination should be guided by this and by the contraindications and warnings for use. Pulse and blood pressure should be measured and a bimanual pelvic examination performed to establish the orientation of the uterus.
The patient should be re-examined six weeks after insertion and further examinations should be performed where clinically indicated and adapted to the individual woman rather than as routine procedure. Prior to insertion pregnancy should be excluded and genital infection should be successfully treated.
Women should be advised that Mirena does not protect against HIV (AIDs) and other sexually transmitted disease (please refer to the section below on pelvic infections). Women should be encouraged to attend cervical and breast screening as appropriate for their age.
For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.
The contraindications and warnings for the oestrogen component should also be considered prior to commencing the HRT regimen. 3 when Mirena is used in conjunction with an oestrogen for HRT use). - Severe or multiple risk factors for arterial disease - Thrombotic arterial or any current embolic disease - Acute venous thromboembolism In general, women using hormonal contraception should be encouraged to give up smoking.
Mirena should be used with caution in postmenopausal women with advanced uterine atrophy.
Insertion/removal warnings and precautions General Information:
As the insertion technique is different from other intrauterine devices, special emphasis should be given to training in the correct insertion technique. Instructions for insertion are in the package. Insertion and removal may be associated with some pain and bleeding.
• Known or suspected pregnancy • Confirmed or suspected hormone sensitive tumours including breast cancer • Current or recurrent pelvic inflammatory disease • Cervicitis • Current genital infection • Postpartum endometritis, infected abortion during the past three months • Conditions associated with increased susceptibility to infections • Cervical dysplasia • Uterine or cervical malignancy • Undiagnosed abnormal genital bleeding • Congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity • Liver tumour or other acute or severe liver disease • Acute malignancies affecting the blood or leukaemias except when in remission • Recent trophoblastic disease while hCG levels remain elevated • Hypersensitivity to the active substance or to any of the excipients.
Active or previous severe arterial disease, such as stroke or myocardial infarction is a contraindication when Mirena is used in conjunction with an oestrogen for HRT use.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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- If insertion within 7 days of the onset of menstruation is not possible or the woman does not experience regular menses, Mirena may be inserted at any time during the menstrual cycle provided that the healthcare professional can reliably exclude the possibility of prior conception.
However, in this case immediate contraceptive protection is not reliably ensured. Therefore, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for the next 7 days to prevent pregnancy.
Postpartum insertion In addition to the instructions above (Starting Mirena):
Postpartum insertions should be postponed until the uterus is fully involuted, however should not be performed earlier than 6 weeks after delivery. If the patient is experiencing significant post-partum bleeding and/or pain then infection or other causes should be excluded before insertion.
If involution is substantially delayed, consider waiting until 12 weeks postpartum. Insertion after first- trimester abortion Mirena can be inserted immediately after first trimester abortion. In this case no back-up contraception is needed.
Replacing Mirena Mirena can be replaced by a new system at any time in the menstrual cycle. In this case no back up contraception is needed. , combined hormonal contraceptives, implant) - Mirena can be inserted immediately if it is reasonably certain that the woman is not pregnant.
- Need for back-up contraception: If it has been more than 7 days since menstrual bleeding began, the woman should abstain from vaginal intercourse or use additional contraceptive protection for the next 7 days. • Protection from endometrial hyperplasia during oestrogen replacement therapy When used for endometrial protection during oestrogen replacement therapy, Mirena can be inserted at any time in an amenorrhoeic woman, or during the last days of menstruation or withdrawal bleeding.
Mirena provides the progestogen component of hormone therapy (HRT). Therefore in women receiving HRT, Mirena can be used in combination with oral or transdermal oestrogen preparations without additional exogenous progestogens. The product information of the oestrogen component of the HRT should be consulted prior to the use of Mirena as the important risk factors associated with HRT use should be considered, such as the risk of endometrial cancer, breast cancer and venous thromboembolisms.
4. • Mirena is supplied sterile having been sterilised with ethylene oxide. Do not resterilise. For single use only. Do not use if the inner package is damaged or open. Insert before the month and year shown on the label. • Mirena is inserted with the provided inserter (figure 1) into the uterine cavity by carefully following the insertion instructions.
Preparation for insertion • Examine the patient to establish the size and position of the uterus, in order to detect any signs of acute genital infections or other contraindications for the insertion of Mirena and to exclude pregnancy.
• Insert a speculum, visualise the cervix and then thoroughly cleanse the cervix and vagina with a suitable antiseptic solution. • Use an assistant as necessary. • Grasp the anterior lip of the cervix with a tenaculum or other forceps to stabilise the uterus.
If the uterus is retroverted, it may be more appropriate to grasp the posterior lip of the cervix. Gentle traction on the forceps can be applied to straighten the cervical canal. The forceps should […]
In case of difficult insertion and/or exceptional pain or bleeding during or after insertion, the possibility of perforation should be considered and appropriate steps should be taken, such as performing a physical examination and an ultrasound (see also ‘Perforation’).
Vaginal ultrasound examination may be considered to ascertain the correct position of the system. In case Mirena cannot be located in the uterine cavity, expulsion or complete perforation should be considered (see paragraph “perforation” below) and X-ray may be used.
Thereafter, re-examination should be performed once a year or more frequently if clinically indicated. The procedure may precipitate fainting as a vasovagal reaction, or a seizure in an epileptic patient. In the event of early signs of a vasovagal attack, insertion may need to be abandoned or the system removed.
The woman should be kept supine, the head lowered and the legs elevated to the vertical position if necessary in order to restore cerebral blood flow. A clear airway must be maintained; an airway should always be at hand. Persistent bradycardia may be controlled with intravenous atropine.
If oxygen is available it may be administered. 2). After removal of Mirena, the system should be examined to ensure that it is intact and has been completely removed.
Perforation:
Perforation or penetration of the uterine corpus or cervix by an intrauterine contraceptive may occur, most commonly during insertion, although it may not be detected until sometime later, and may decrease the effectiveness of Mirena.
In some of these cases, the device may be located outside of the uterine cavity. If perforation is suspected the system should be removed as soon as possible; surgery may be required. 6) per 1000 insertions in the copper IUD cohort. The study showed that both breastfeeding at the time of insertion and insertion up to 36 weeks after giving birth were associated with an increased risk of perforation (see Table 2).
Both risk factors were independent of the type of IUS/IUD inserted. 5) per 1000 insertions. […]