Endovelle

Dienogest

Endometriosis.

1 tab daily w/o any break, taken preferably at the same time each day & can be started on any day of menstrual cycle. Take throughout 28 days w/o regard to bleeding. When a pack is finished, the next one should be started w/o interruption.

May be taken with or without food.

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

Exclude pregnancy before starting treatment. Use non-hormonal method of contraception eg, barrier method during treatment if required. Women w/ history of extrauterine pregnancy or impairment of tube function, diabetes especially w/ history of gestational DM, chloasma gravidarum. May slightly enhance risk of stroke in hypertensive women. Consider increased risk of thromboembolism in puerperium. Discontinue treatment if symptoms or suspicion of arterial or venous thrombotic event are present; bleeding is heavy & continuous; depression recurs to a serious degree; clinically significant HTN develops. Persistent ovarian follicles may occur during use. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Complete medical history & physical & gynaecological exam prior to initiation or reinstitution of treatment. Patients at increased risk of osteoporosis. Childn & adolescents (menarche to 18 yr).

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

May be affected by CYP3A4 inducers or inhibitors. Reduced therapeutic effect w/ phenytoin, barbiturates, primidone, carbamazepine, rifampicin & possibly oxcarbazepine, topiramate, felbamate, griseofulvin & products containing St. John's wort. Increased or decreased plasma conc w/ HIV/HCV PIs & NNRTI. Increased plasma conc w/ azole antifungals eg, itraconazole, voriconazole, fluconazole; verapamil; macrolides eg, clarithromycin, erythromycin; diltiazem & grapefruit juice. May influence results of certain lab tests including biochemical parameters of liver, thyroid, adrenal & renal function, plasma levels of carrier proteins eg, lipid/lipoprotein fractions, parameters of carbohydrate metabolism & coagulation & fibrinolysis.

Oestrogens, Progesterones & Related Synthetic Drugs

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