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Prescribing Information


Levosert 20 micrograms/24 hours Intrauterine Delivery System.


Please refer to the Summary of Product Characteristics (SPC) before prescribing. Presentation: intrauterine delivery system (IUS) containing 52 mg levonorgestrel. Indication(s): Contraception. Heavy menstrual bleeding; Levosert may be particularly useful in women with heavy menstrual bleeding requiring (reversible) contraception. Dosage and Administration: A gynaecological examination, including examination of the breasts and exclusion of pregnancy and infection should be performed before insertion. Cervical infection and sexually transmitted diseases should be excluded. In women of fertile age, Levosert is inserted into the uterine cavity within 7 days of the onset of menstruation. To reduce the risk of perforation, postpartum insertions should be postponed until 6 weeks after delivery. Levosert can be inserted immediately after a first trimester abortion. Levosert is effective for 3 years and should be removed after 3 years of use, if desired a new system can be inserted at the same time. Consult the SPC for full information on insertion and removal. Contraindications: Known or suspected pregnancy; current or recurrent pelvic inflammatory disease; current genital infection; postpartum endometritis; infected abortion during the past three months; cervicitis, cervical dysplasia; suspected or confirmed uterine or cervical malignancy; liver tumour or other acute or severe liver disease; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; undiagnosed abnormal genital bleeding; conditions associated with increased susceptibility to infections; active or previous severe arterial disease, such as stroke or myocardial infarction; current or suspected hormone dependent tumours such as breast cancer; hypersensitivity to the active substance or to any of the excipients; acute malignancies affecting the blood or leukaemias except when in remission; recent trophoblastic disease while hCG levels remain elevated. Warnings and Precautions: Before insertion, a complete personal and family medical history should be taken. Pulse and blood pressure should be measured and a bimanual pelvic examination performed to establish the orientation of the uterus. Re-examine six weeks after insertion and where clinically indicated. Use with caution or consider removal if any of the following conditions exist or arise for the first time during treatment: migraine with aura; unusually severe or frequent headache; jaundice; marked increase of blood pressure; malignancies affecting the blood or leukaemias in remission; use of chronic corticosteroid therapy; past history of symptomatic functional ovarian cysts; active or previous severe arterial disease, such as stroke or myocardial infarction; severe or multiple risk factors for arterial disease; thrombotic arterial or any current embolic disease; venous thromboembolism; women should be encouraged to stop smoking. Insertion/removal may be associated with pain and bleeding and may result in fainting as a vasovagal reaction or seizure in epileptics. In cases of difficult insertion, exceptionalpain /bleeding during or after insertion, exclude perforation of the uterine corpus or cervix. If perforation is suspected the system should be


removed. Risk of perforation may be increased in post- partum insertions, in lactating women and in women with a fixed retroverted uterus.If pelvic infection is suspected appropriate antibiotics should be started, if the woman experiences recurrent endometritis or pelvic infection or if an infection is severethe IUS should be removed. Symptoms of partial or complete expulsion of the IUS may include bleeding or pain. Increased menstrual flow or unexpected bleeding may be indicative of expulsion. If menorrhagia persists an assessment of the uterine cavity using ultrasound scan should be performed and endometrial biopsy considered. Irregular bleeding/ spotting may occur during the first months of therapy in pre-menopausal women and endometrial pathology should be excluded before insertion. The possibility of pregnancy should be considered if menstruation does not occur within six weeks of the onset of previous menstruation and expulsion should be excluded. In menorrhagia if significant reduction in menstrual blood loss is not achieved within 3 to 6 months alternative treatments should be considered. The possibility of ectopic pregnancy should be considered in the case of lower abdominal pain - especially in connection with missed periods or if an amenorrhoeic woman starts bleeding. Ovarian cysts have been reported, some may be accompanied by pelvic pain or dyspareunia. Some studies suggest slightly increased risk of breast cancer in women using combined oral contraceptives (COC). The risk may be of similar magnitude for progestogen only methods such as Levosert but the evidence is based on much smaller populations of users and so is less conclusive. Blood glucose concentrations should be monitored in diabetic patients. Interactions: The effects may be impaired by drugs which induce liver enzymes, including barbiturates, primidone, phenytoin, carbamazepine, griseofulvin and rifampicin. Fertility, Pregnancy & Lactation: Should not to be used during an existing or suspected pregnancy. If pregnancy occurs with Levosert in situ, ectopic pregnancy should be excluded, the system removed and termination of the pregnancy considered. Removal or probing of the uterus may result in spontaneous abortion. If removal is impossible inform women about the risks and monitor the pregnancy closely. Levonorgestrel is excreted in very small quantities in breast milk and breast feeding can be continued during use. Uterine bleeding has been reported rarely during lactation. The use of levonorgestrel IUS does not alter the course of female fertility after the removal of the IUS. Undesirable Effects: Very common: uterine/vaginal bleeding (including spotting), oligomenorrhoea, amenorrhoea and benign ovarian cysts. Common: depressive mood, nervousness, decreased libido, headache, abdominal pain, nausea, acne, back pain, pelvic pain, dysmenorrhoea, vaginal discharge, vulvovaginitis, breast tenderness, breast pain, IUS expulsion, weight increase. Serious: urticaria, oedema, pelvic inflammatory disease, endometritis, cervicitis. Consult SPC in relation to other adverse reactions. Pack Size and NHS Price: £66.00. Legal Category: POM. Further information is available from: Actavis UK Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS. Marketing Authorisation Number: PL 30306/0438. Date of PI Preparation: 31/12/2014


Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.


Adverse events should also be reported to Actavis on 01271 385257. UK/LE/0006/02-15f Date of prep: October 2015


Introducing Levosert® Effective contraception


1. Scottish Medicines Consortium – levonorgesterel (Levosert). Available at: www.scottishmedicines.org.uk (last accessed May 2015).


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