Leon Farma




Concise Prescribing Info
Dosage/Direction for Use
May be taken with or without food: Take w/o any break, 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, known or suspected sex hormone-dependent malignancies, undiagnosed vag bleeding. Presence or history of severe hepatic disease & benign or malignant liver tumours.
Special Precautions
May aggravate uterine bleeding in women w/ adenomyosis uteri or uterine leiomyomata. Discontinue in anemia; long-term immobilization; symptoms of arterial or venous thrombotic event or suspicion; when depression, cholestatic jaundice &/or pruritus recur. Changes in menstrual bleeding pattern; persistent ovarian follicles. May slightly increase risk of stroke in women w/ HTN; venous thromboembolism (DVT, pulmonary embolism), breast cancer. Increased risk of thromboembolism in the puerperium. Consider hepatic tumour in the differential diagnosis when severe abdominal pain, liver enlargement or signs of intra-abdominal hemorrhage occur. History of depression; diabetic women, especially those w/ history of gestational DM; history of extrauterine pregnancy or tube function impairment. Decrease in bone mineral density (BMD) in lumbar spine. Perform risk-benefit assessment in patients at increased risk of osteoporosis before starting treatment. Adequate intake of Ca & vit D. W/draw treatment in sustained HTN. Avoid exposure to sun or UV radiation during therapy in women w/ tendency to chloasma. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Contraindicated in present or past severe hepatic disease. Pregnancy & lactation. Childn prior to menarche.
Adverse Reactions
Increased wt; depressed mood, sleep disorder, nervousness, loss of libido; headache, migraine; nausea, abdominal pain; acne, alopecia; breast discomfort, ovarian cyst, hot flushes, uterine/vag bleeding including spotting; asthenic conditions, irritability.
Drug Interactions
Increased clearance of sex hormones w/ phenytoin, barbiturates, primidone, carbamazepine, rifampicin, & possibly oxcarbazepine, topiramate, felbamate, griseofulvin, & products containing St. John's wort (Hypericum perforatum). Decreased steady state conc & systemic exposure w/ rifampicin. Increased or decreased plasma conc of progestin w/ HIV PIs, NNRTIs & HCV inhibitors. Increased plasma conc w/ strong (eg, ketoconazole) & moderate (eg, erythromycin) CYP3A4 inhibitors.
ATC Classification
G03DB08 - dienogest ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.
Endovelle tab 2 mg
1 × 28's
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