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LEVOSERT is a brand name for Levonorgestrel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Contraception. Treatment of heavy menstrual bleeding. Levosert may be particularly useful in women with heavy menstrual bleeding requiring (reversible) contraception.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Levosert is inserted into the uterine cavity and is effective for eight years in the indication contraception and has a demonstrated efficacy for 3 years for the indication heavy menstrual bleeding. Therefore, Levosert should be removed or exchanged after 8 years of use, or earlier if heavy or bothersome menstrual bleeding returns.
Insertion It is strongly recommended that Levosert should only be inserted by healthcare professionals who are experienced in IUS insertions and/or have undergone training for the Levosert insertion procedure. Before insertion, the patient should be 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 under Medical examination). Contraception and heavy menstrual bleeding Table 1. When to insert Levosert in women of fertile age Starting Levosert - Levosert should be inserted into the uterine cavity within 7 days of the onset of menstruation.
In this case Levosert provides contraceptive protection upon insertion and no back- up contraception is needed. - If insertion within 7 days of the onset of menstruation is not possible or the woman does not experience regular menses, Levosert 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 upon insertion 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 Levosert):
Postpartum insertions should be postponed until the uterus is fully involuted, however should not be performed earlier than 6 weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum. Insertion after first-trimester abortion Levosert can be inserted immediately after first trimester abortion.
In this case no back-up contraception is needed. Replacing Levosert Levosert 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) - Levosert can be inserted immediately if it is reasonably certain that the woman is not pregnant.
Undesirable effects are more common during the first months after the insertion, and subside during prolonged use. 1) and benign ovarian cysts. The frequency of benign ovarian cysts depends on the diagnostic method used, and in clinical trials enlarged follicles have been diagnosed in 12% of the subjects using a levonorgestrel IUS.
Most of the follicles are asymptomatic and disappear within three months. The table below reports adverse reactions by MedDRA system organ class (MedDRA SOCs). The frequencies are based on clinical trial data. 4). In clinical trials with levonorgestrel IUS that excluded breast-feeding women the frequency of perforation was "rare".
6). 4). 4). The procedure may also precipitate a seizure in patients with epilepsy. 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.
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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.
Prior to insertion pregnancy should be excluded and genital infection should be successfully treated. Women should be advised that Levosert does not protect against HIV (AIDS) and other sexually transmitted disease (please refer to the section below on pelvic infections).
The patient should be re-examined 4 to 6 weeks after insertion to check the threads and ensure that the device is in the correct position. Vaginal ultrasound examination may be considered to ascertain the correct position of the system.
In case Levosert 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.
Women should be encouraged to attend cervical and breast screening as appropriate for their age. Levosert is not for use as a post-coital contraceptive. Conditions under which Levosert can be used with caution Levosert may be used with caution after specialist consultation, or removal of the system should be considered, if any of the following conditions exist or arise for the first time during treatment: - Migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia - Unusually severe or unusually 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 - Acute venous thromboembolism.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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- 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. Important information to consider during or after insertion 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 physical examination and ultrasound.
After insertion, women should be re-examined after 4 to 6 weeks to check the threads and ensure that the device is in the correct position. 4). Removal/replacement Levosert is removed by gently pulling on the threads with forceps. If the threads are not visible and the system is found in the uterine cavity on ultrasound exam, it may be removed using a narrow forceps.
This may require dilatation of the cervical canal or surgical intervention. After removal of Levosert, the system should be examined to ensure it is intact. During difficult removals, single cases have been reported of the hormone cylinder sliding over the lateral arms and hiding them together inside the cylinder.
This situation does not require further intervention once completeness of the IUS has been ascertained. The knobs of the lateral arms usually prevent complete detachment of the cylinder from the T-body. Continuation of contraception after removal • If the woman wishes to continue using the same method, a new system can be inserted immediately following removal of the original system.
• If the woman does not wish to continue using the same method but pregnancy is not desired, the removal should be carried out within 7 days of the onset of menstruation, provided the woman is experiencing regular menses. If the system is removed at some other time during the cycle or the woman does not experience regular menses and the woman has had intercourse within a week, she is at a risk of pregnancy.
To ensure continuous contraception a barrier contraceptive method should be used (such as condoms) starting at least 7 days before the removal. After removal, the new contraceptive method should be started immediately (follow the instructions for use of the new contraceptive method).
Special populations Paediatric population Levosert has not been studied in patients below 16 years of age. Levosert should not be used before menarche. Elderly There is no indication for the use of Levosert in postmenopausal women. 3).
Renal impairment Levosert has not been studied in women with renal impairment. Method of administration To be inserted by a healthcare professional using aseptic technique. Levosert is supplied in a sterile pack which should not be opened until required for insertion.
Do not resterilise. For single use only. The exposed product should be handled with aseptic precautions. 6 for disposal instructions). Do not use if the inner package is damaged or open. Do not insert after the expiry date which is stated on the […]
Levosert may be used with caution in women who have congenital heart disease or valvular heart disease at risk of infective endocarditis. Irregular bleedings may mask some symptoms and signs of endometrial polyps or cancer, and in these cases diagnostic measures have to be considered.
In general, women using Levosert should be encouraged to stop smoking.
Insertion / removal warnings and precautions General information:
Insertion and removal may be associated with some pain and bleeding. In case of difficult insertion and/or exceptional pain or bleeding during or after insertion, physical examination and ultrasound should be performed immediately to exclude perforation of the uterine corpus or cervix (see also ‘Perforation’).
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.
Perforation:
Perforation of the uterine corpus or cervix may occur, most commonly during insertion, although it may not be detected until sometime later. In some cases, the device may migrate to the intra-abdominal area. This may be associated with severe pain and continued bleeding.
If perforation is suspected the system should be removed as soon as possible; surgery may be required. 1%. 6) per 1,000 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).
These risk factors were independent of the type of IUS/IUD inserted. 1; n=41,910 insertions) Breast-feeding at the time of insertion and insertion up to 36 weeks after giving birth were confirmed as risk factors also in the subgroup that were followed up for 5 years.
2), in lactating women and in women with a fixed retroverted uterus. Re-examination after insertion should follow the guidance given above under the heading "Medical examination" including the consideration to use vaginal ultrasound examination to ascertain the correct position of the system 4 to 12 weeks thereafter, which may be adapted as clinically indicated in women with risk factors for perforation.
Pelvic infection:
In users of copper intrauterine devices (IUDs), the highest rate of pelvic infections occurs during the first month after insertion and decreases later. Known risk factors for pelvic inflammatory disease are multiple sexual partners, frequent intercourse and young age.
Pelvic infection may have serious […]