If any of the conditions/risk factors mentioned as follows is present, the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before the woman decides to start with Lynestrenol (Exluton). In the event of aggravation, exacerbation or first appearance of any of these conditions, the woman should contact the physician. The physician should then decide on whether the use of Lynestrenol (Exluton) should be discontinued as follows.
The risk for breast cancer increases in general with increasing age. During the use of oral contraceptives (OCs) the risk of having breast cancer diagnosed is slightly increased. This increased risk disappears gradually within 10 years after discontinuation of OC use and is not related to the duration of use, but to the age of the woman when using the OC.
The expected number of cases diagnosed per 10,000 women who use combined OCs (up to 10 years after stopping) relative to never users over the same period have been calculated for the respective age groups and are presented in the table as follows. (See Table 1.)
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The risk in POP users is possibly of similar magnitude as that associated with combined OCs. However, for POPs the evidence is less conclusive. Compared to the risk of getting breast cancer ever in life, the increased risk associated with OCs is low. The cases of breast cancer diagnosed in OC users tend to be less advanced than in those who have not used OCs. The increased risk in OC users may be due to an earlier diagnosis, biological effects of the pill or a combination of both.
Since a biological effect of progestogens on liver cancer cannot be excluded an individual benefit/risk assessment should be made in women with liver cancer.
When acute or chronic disturbances of liver function occur, the woman should be referred to a specialist for examination and advice.
If a sustained hypertension develops during the use of Lynestrenol (Exluton), or if a significant increase in blood pressure Lynestrenol (Exluton) not adequately respond to antihypertensive therapy, the discontinuation of Lynestrenol (Exluton) should be considered.
Epidemiological investigations have associated the use of combined OCs with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). Although the clinical relevance of this finding for lynestrenol used as a contraceptive in the absence of an estrogenic component is unknown, Lynestrenol (Exluton) should be discontinued in the event of a thrombosis.
Discontinuation of Lynestrenol (Exluton) should also be considered in case of long-term immobilisation due to surgery or illness. Women with a history of thrombo-embolic disorders should be made aware of the possibility of a recurrence.
The protection with progestogen-only pills against ectopic pregnancies is not as good as with combined oral contraceptives, which has been associated with the frequent occurrence of ovulations during the use of progestogen-only pills. Additional risk factors for ectopic pregnancy include a history of ectopic pregnancy and tubal damage from infection or surgery. Should pregnancy occur in spite of the use of Lynestrenol (Exluton), the physician should exclude extra-uterine pregnancy. In addition, in case of amenorrhea or abdominal pain the possibility of an ectopic pregnancy should be included in the differential diagnosis.
Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking Lynestrenol (Exluton).
Although progestogens may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using progestogen-only pills. However, diabetic patients should be carefully observed while taking progestogen-only pills.
The following conditions have been reported both during pregnancy and during sex steroid use, but an association with the use of progestogens has not been established: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis- related hearing loss, (hereditary) angioedema.
Lynestrenol (Exluton) contains less than 50 mg lactose and therefore should not be administered to patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.