Evafact

Endometriosis.

1 tab daily w/o interruption, start on any day of menstrual cycle.

May be taken with or without food: Take preferably at the same time each day w/ some liqd.

Hypersensitivity. Active venous thromboembolic disorder; past or present arterial & CV disease (eg MI, CVA, ischemic heart disease); DM w/ vascular involvement; presence or history of severe hepatic disease, benign or malignant hepatic tumors; known or suspected sex hormone-dependent malignancies; undiagnosed vag bleeding.

Discontinue use if cholestatic jaundice &/or pruritus recur. Uterine bleeding w/ adenomyosis uteri or uterine leiomyomata; changes in menstrual bleeding pattern; breast cancer; osteoporosis, changes in bone mineral density; history of depression & chloasma gravidarum; HTN. Risk factors for increased risk of VTE eg, personal or family history, age, obesity, prolonged immobilization, major surgery or trauma. Diabetic women, history of gestational DM. Women w/ history of extrauterine pregnancy or tube function impairment. Perform physical & gynecological exam prior to & during treatment. Discontinue use at least 4 wk before elective surgery. Ensure adequate intake of Ca & vit D during treatment. Avoid exposure to sun or UV radiation. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; lactose-free diet. Severe hepatic impairment. May inhibit ovulation during treatment. Not to be used during pregnancy. Not recommended during lactation. Adolescents; not indicated in childn pre-menarche.

Increased wt; depressed & altered mood, sleep disorder, nervousness, loss of libido; headache, migraine; nausea, abdominal pain & distention, flatulence, vomiting; acne, alopecia; back pain; breast discomfort, ovarian cyst, hot flushes, uterine/vag bleeding including spotting; asthenic conditions, irritability.

Affected metabolism w/ CYP3A4 inducers or inhibitors. Diminished efficacy w/ substances increasing sex hormones clearance eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, St. John's wort-containing products. Increased/decreased plasma conc w/ HIV PIs, NNRTIs, HCV inhibitors. Increased plasma conc w/ CYP3A4 inhibitors eg, ketoconazole, erythromycin.

Oestrogens, Progesterones & Related Synthetic Drugs

G03DB08 - dienogest ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.

B