Vienomet

Endometriosis.

1 tab daily continuously w/o regard to vag bleeding. Take preferably at the same time each day. May start on any day of menstrual cycle. Start next pack w/o interruption when finished.

May be taken with or without food.

Hypersensitivity. Active venous thromboembolic disorder. Presence or history of arterial & CV disease (eg, MI, CVA, ischemic heart disease); severe hepatic disease as long as liver function values have not returned to normal; benign or malignant liver tumours. DM w/ vascular involvement. Known or suspected sex hormone-dependent malignancies. Undiagnosed vag bleeding.

Discontinue use in case of long-term immobilization & not resume until 2 wk after complete remobilization; if depression recurs to serious degree. Consider treatment discontinuation if bleeding is heavy & continuous over time leading to anemia. Stop any hormonal contraception prior to initiation of treatment; if symptoms of arterial or venous thrombotic event is suspected. W/draw use if sustained clinically significant HTN develops during treatment. Avoid sun or UV radiation exposure while on treatment in women w/ tendency to chloasma. Serious uterine bleeding; changes in bleeding pattern; circulatory disorders; changes in bone mineral density. Slightly increased risk of stroke in women w/ HTN. Functional ovarian cysts. Occasional chloasma. History of VTE; depression; extrauterine pregnancy or impairment of tube function; chloasma gravidarum; gestational DM. Patients w/ endometriosis & ongoing treatment for >15 mth; at increased risk of osteoporosis. Diabetic women. Ensure adequate intake of Ca & vit D in women of all ages. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Consider hepatic tumour in differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur. Discontinue use in case of recurrence of cholestatic jaundice &/or pruritus 1st during pregnancy or previous use of sex steroids. Ectopic pregnancies. Not to be administered to pregnant women. Not recommended during lactation. Not indicated in childn prior to menarche & geriatric patients.

Increased wt; depressed mood, sleep disorder, nervousness, loss of libido, altered mood; 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.

Increased clearance w/ phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin & St. John's wort containing-products. Decreased steady state conc & systemic exposures w/ rifampicin. Increased or decreased plasma conc w/ HIV PIs & NNRTIs including combinations w/ HCV inhibitors. Increased plasma conc w/ strong CYP3A4 inhibitors. Increased AUC_(0-24h) w/ ketoconazole & erythromycin. May influence 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, & coagulation & fibrinolysis.

Oestrogens, Progesterones & Related Synthetic Drugs

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

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