Mirena.co.uk

Mirena® 20 micrograms/24 hours intrauterine delivery group A streptococcal sepsis) can occur fol owing IUS
system (levonorgestrel) - Prescribing Information
insertion. If pelvic infection suspected bacteriological (Refer to full Summary of Product Characteristics (SmPC) examinations & monitoring is recommended, even with discrete symptoms. Start appropriate antibiotics & remove Presentation: Intrauterine system consisting of T-shaped
Mirena if symptoms do not resolve within 72hrs, if recurrent frame containing 52mg levonorgestrel. Indication(s):
endometritis or pelvic infection occurs, or if an acute infection Contraception, idiopathic menorrhagia, protection from is severe. Bleeding, pain, increased menstrual flow may endometrial hyperplasia during oestrogen replacement indicate partial/complete expulsion. Prescribers should consult
therapy. Posology & method of administration: Before
the SmPC for further guidance on perforation, infection or insertion exclude pregnancy & genital infection. Contraception, expulsion. Reduction in menorrhagia is usually achieved in 3 to idiopathic menorrhagia: Women of fertile age: insert into 6 months of treatment. If menorrhagia persists: re-examine & uterine cavity within 7 days of onset of menstruation. Delay consider alternative treatments. Exclude endometrial pathology postpartum insertions until 6 weeks after delivery. Mirena can before insertion. If bleeding irregularities develop during be inserted immediately after a first trimester termination. prolonged treatment use appropriate diagnostic measures, as Mirena is effective for 5 years; remove after 5 years use - new irregular bleeding may mask symptoms/signs of endometrial system can be inserted at the same time. Protection from polyps or cancer. Consider ectopic pregnancy if lower endometrial hyperplasia during oestrogen replacement therapy: abdominal pain occurs, especially if period is missed or if an Insert at any time in an amenorrhoeic woman or during last amenorrhoeic woman starts bleeding - higher risk of further days of menstruation or withdrawal bleeding - remove after 4 ectopic pregnancy if previous history exists. Ovarian cysts years. In women receiving HRT, Mirena can be used with were reported. Some studies suggest slightly increased risk of unopposed oestrogens. Prescribers should consult the SmPC breast cancer in women using COCs – may be of similar for full information on inserting & removing Mirena. Contra-
magnitude for progestogen-only contraception (like Mirena) but indications:
evidence is based on smaller no. of users, so is less conclusive confirmed/suspected hormone dependent tumours (incl. breast than that for COCs. Risk of breast cancer when Mirena used as cancer); (re-)current pelvic inflammatory disease (PID); progestogen component of HRT unknown. See SmPC for ful cervicitis; current genital infection; postpartum endometritis, details. Monitor blood glucose in diabetic users. Not suitable infected abortion during past 3 months; increased for use as a post-coital contraceptive. Fertility, pregnancy &
susceptibility to infections; cervical dysplasia; uterine/cervical lactation: Pregnancy: If pregnancy occurs with Mirena in situ,
malignancy; undiagnosed abnormal genital bleeding; exclude ectopic pregnancy, remove system & consider congenital/acquired uterine abnormality incl. fibroids that termination of pregnancy. Removal of Mirena or probing of distort the uterine cavity; liver tumour or other acute/severe uterus may result in spontaneous abortion. If removal liver disease; acute malignancies affecting the blood or impossible, inform woman about increased risk of leukaemias except when in remission; recent trophoblastic spontaneous abortion/premature labour. Monitor pregnancy disease with elevated hCG levels; hypersensitivity to the active closely. Teratogenicity (esp. virilisation) cannot be excluded, no substance or excipients. Active/previous severe arterial evidence of birth defects to date. Lactation: About 0.1% of the disease (e.g. stroke or MI), when used with concomitant levonorgestrel dose is transferred during breastfeeding but no
oestrogen for HRT use. Warnings & precautions: Use with known deleterious effects on infant growth/development.
caution & consider removal if the fol owing exist or occur for Uterine bleeding has been reported rarely during lactation. the first time: Migraine with aura, unusually severe or frequent Fertility: pregnancy rate at 1 year similar to those not using headache, jaundice, marked increase of blood pressure, contraception once Mirena is removed for planned pregnancy.
malignancies affecting the blood or leukaemias in remission, Undesirable effects: Very Common - uterine/vaginal bleeding
use of chronic corticosteroid therapy, history of ovarian cysts, (incl. spotting), oligomenorrhoea, amenorrhoea Common- active/previous severe arterial disease, severe/multiple risk depressed mood/depression, nervousness, decreased libido, factors for arterial disease, thrombotic arterial or any current headache, migraine, abdominal pain, nausea, acne, hirsutism, embolic disease, acute VTE. Use with caution in back pain, ovarian cysts, pelvic pain, dysmenorrhoea, vaginal postmenopausal women with advanced uterine atrophy. discharge, vulvovaginitis, breast tenderness, breast pain, IUS Insertion technique is different from other intrauterine devices expulsion, weight increase. Serious side effects - cf. (IUDs); special emphasis should be given to training in the CI/Warnings & Precautions in addition: hypersensitivity (incl. correct insertion technique. Insertion/removal may be urticaria, angioedema), PID, endometritis, cervicitis. Cases of associated with pain & bleeding & may result in fainting as a sepsis (incl. group A streptococcal sepsis) have been reported vasovagal reaction or seizure in epileptics. In cases of difficult following IUD insertion. A large post authorisation safety study insertion, exceptional pain/bleeding during or after insertion, shows an increased risk of perforation in breastfeeding exclude perforation of uterus or cervix. If perforation women. Prescribers should consult the SmPC in relation to suspected, remove system. Risk of perforation is increased in other side effects. Legal Category: POM Package Quantities
breastfeeding women & may be increased in post-partum & Basic NHS Costs: £88.00 MA Number(s): PL 00010/0547
insertions & in women with fixed retroverted uterus. The Mirena Further information available from: Bayer plc, Bayer House,
inserter has been designed to minimise the risk of infections. In Strawberry Hill, Newbury, Berkshire RG14 1JA United users of copper IUDs, the highest rate of pelvic infections Kingdom. Telephone: 01635 563000. Date of preparation:
occurs during the first month after insertion & decreases later.
Although extremely rare, severe infection or sepsis (including Mirena® is a trademark of the Bayer Group. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yel owcard. Adverse events should also be reported to Bayer plc. Tel.: 01635 563500, Fax.: 01635 563703, Email: [email protected]

Source: http://www.mirena.co.uk/site-resources/pdfs/Mirena_PI_UK.pdf