Dienogest Teva

Dienogest

Endometriosis.

1 tab daily w/o any break.

May be taken with or without food.

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 (as long as liver function values have not returned to normal); liver tumours (benign or malignant). Known or suspected sex hormone-dependent malignancies. Undiagnosed vag bleeding.

Not a contraceptive. Stop any hormonal contraception prior to initiation of Dienogest Teva. Efficacy may be reduced in case of missed tab, vomiting &/or diarrhea (if occurring w/in 3-4 hr after taking tab). Uterine bleeding (eg, in women w/ adenomyosis uteri or uterine leiomyomata) may be aggravated. Changes in menstrual bleeding pattern. Risk of stroke may be slightly enhanced in women w/ HTN. Discontinue use in case of long-term immobilization (at least 4 wk in advance for elective surgery) & do not resume treatment until 2 wk after complete remobilization. Consider increased risk of thromboembolism in the puerperium. Risk of breast cancer; liver tumours. Changes in bone mineral density. Careful risk-benefit assessment before starting treatment in patients w/ increased risk of osteoporosis. Carefully observe patients w/ history of depression. Discontinue use in case of sustained clinically significant HTN. Discontinue use in case of recurrence of cholestatic jaundice &/or pruritus which occurred 1st during pregnancy or previous use of sex steroids. Carefully observe diabetic women, especially those w/ history of gestational DM. Women w/ tendency to chloasma should avoid exposure to sun or UV radiation while on treatment. Carefully weigh benefits against risks in women w/ history of extrauterine pregnancy or impairment of tube function. Persistent ovarian follicles (functional ovarian cysts) may occur during use. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Must not be administered to pregnant women. Not recommended during lactation. Not indicated in childn prior to menarche; childn <18 yr. No relevant indication in the geriatric population.

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 flushes, uterine/vag bleeding (including spotting); asthenic conditions, irritability.

Increased clearance w/ enzyme inducers eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, & possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, ketoconazole & products containing St. John's wort. Increased or decreased plasma conc w/ combinations of HIV PIs & NNRTIs (eg, ritonavir, nevirapine, efavirenz), including combinations w/ HCV inhibitors. Increased plasma conc w/ strong CYP3A4 inhibitors eg, ketoconazole; moderate inhibitors eg, erythromycin. May influence results of lab tests, including biochemical parameters of liver, thyroid, adrenal & renal function, plasma levels of (carrier) proteins (eg, corticosteroid-binding globulin & lipid/lipoprotein fractions), parameters of carbohydrate metabolism & parameters of coagulation & fibrinolysis.

Oestrogens, Progesterones & Related Synthetic Drugs

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

P₁S₁S₃