Visabelle

/ Bayer

For oral use.
The dosage of Visabelle is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. The tablet can be taken with or without food.
Tablets must be taken continuously without regard to vaginal bleeding. When a pack is finished the next one should be started without interruption.
There is no experience with Visabelle treatment >15 months in patients with endometriosis.
Treatment can be started on any day of the menstrual cycle.
Any hormonal contraception needs to be stopped prior to initiation of Visabelle. If contraception is required, non-hormonal methods of contraception should be used (e.g. barrier method).
Management of missed tablets: The efficacy of Visabelle may be reduced in the event of missed tablets, vomiting and/or diarrhea (if occuring within 3-4 hours after tablet taking). In the event of one or more missed tablets, the
woman should take one tablet only, as soon as she remembers, and should then continue the next day at her usual time. A tablet not absorbed due to vomiting or diarrhea should likewise be replaced by one tablet.
Paediatric population: Visabelle is not indicated in children prior to menarche.
The safety and efficacy of Visabelle was investigated in an uncontrolled clinical trial over 12 months in 111 adolescent women (12-<18) with clinically suspected or confirmed endometriosis.
Geriatric population: There is no relevant indication for use of Visabelle in the Geriatric population.
Patients with hepatic impairment: Visabelle is contraindicated in patients with present or past severe hepatic disease.
Patients with renal impairment: There are no data suggesting the need for a dosage adjustment in patients with renal impairment.

Treatment of endometriosis.

Should not be used in the presence of any of the conditions listed below, which are partially derived from information on other progestogen-only preparations. Should any of the conditions appear during therapy, treatment must be discontinued immediately:Known or suspected pregnancy.Lactation.Active venous thromboembolic disorder.Arterial and cardiovascular disease, present or in history (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease).Diabetes mellitus with vascular involvement.Presence or history of severe hepatic disease as long as liver function values have not returned to normal.Presence or history of liver tumors (benign or malignant).Known or suspected sex hormone-dependent malignancies.Undiagnosed vaginal bleeding.Hypersensitivity to the active substance or to any of the excipients.

Before starting treatment, pregnancy must be excluded. During treatment, patients are advised to use non-hormonal methods of contraception (e.g. barrier method) if contraception is required. Pregnancies that occur among users of progestogen-only preparations used for contraception are more likely to be ectopic than are pregnancies among users of combined oral contraceptives. Therefore, in women with a history of extrauterine pregnancy or an impairment of tube function, the use of Visabelle should be decided on only after carefully weighing the benefits against the risks. It can be assumed that special warnings and special precautions for use of other progestogen-only preparations are also valid for the use of Visabelle although not all of the warnings and precautions are based on respective findings in the clinical studies with Visabelle.Circulatory disorders: From epidemiological studies there is little evidence for an association between progestogen-only preparations and an increased risk of MI or cerebral thromboembolism. The risk of cardiovascular and cerebral events is rather related to increasing age, hypertension, and smoking. In women with hypertension the risk of stroke may be slightly enhanced by progestogen-only preparations. Some studies indicate that there may be a slightly, but not statistically significant increased risk of venous thromboembolism (deep venous thrombosis, pulmonary embolism) associated with the use of progestogen-only preparations. Generally recognized risk factors for venous thromboembolism (VTE) include a positive personal or family history (VTE in a sibling or a parent at a relatively early age), age, obesity, prolonged immobilization, major surgery or major trauma. In case of long-term immobilization it is advisable to discontinue the use of Visabelle (in the case of elective surgery at least four weeks in advance) and not to resume treatment until two weeks after complete remobilization. The increased risk of thromboembolism in the puerperium must be considered. Treatment should be stopped at once if there are symptoms of an arterial or venous thrombotic event or suspicion thereof.Tumors: A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using oral contraceptives(OCs), mainly estrogen-progestogen preparations. The excess risk gradually disappears during the course of the 10 years after cessation of combined oral contraceptives (COC) use. Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer. The risk of having breast cancer diagnosed in progestogen-only pill users is possibly of similar magnitude to that associated with COC. However, for progestogen-only preparations, the evidence is based on much smaller populations of users and so is less conclusive than that for COCs. These studies do not provide evidence for causation. The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in OC users, the biological effects of OCs or a combination of both. The breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users. In rare cases, benign liver tumors, and even more rarely, malignant liver tumors have been reported in users of hormonal substances such as the one contained in Visabelle. In isolated cases, these tumors have led to life-threatening intra-abdominal hemorrhages.Changes in bleeding pattern: Treatment affects the menstrual bleeding pattern in the majority of women. Uterine bleeding, for example in women with adenomyosis uteri or uterine leiomyomata, may be aggravated. If bleeding is heavy and continuous over time, this may lead to anemia (severe in some cases). Discontinuation of treatment should be considered in such cases.Other conditions: Patients who have a history of depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree. Visabelle generally does not appear to affect blood pressure in normotensive women. However, if a sustained clinically significant hypertension develops during treatment, it is advisable to discontinue therapy and treat the hypertension. Recurrence of cholestatic jaundice and/or pruritus which occurred first during pregnancy or previous use of sex steroids necessitates the discontinuation of treatment. Visabelle may have a slight effect on peripheral insulin resistance and glucose tolerance. Diabetic women, especially those with a history of gestational diabetes mellitus, should be carefully observed. 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 during therapy. Persistent ovarian follicles (often referred to as functional ovarian cysts) may occur during treatment. Most of these follicles are asymptomatic, although some may be accompanied by pelvic pain.
See prescribing information for full details.

Undesirable effects are more common during the first months after start of therapy, and subside with duration of treatment. The most frequently reported undesirable effects during treatment that were considered at least possibly related to therapy were headache (9.0%), breast discomfort (5.4%), depressed mood (5.1%), and acne (5.1%).
See prescribing information for full details.

See prescribing information for full details.