Agencia Lei Va Hong


A. Menarini
Concise Prescribing Info
Estrogen deficiency symptoms in postmenopausal women, >1 yr after menopause. Prevention of osteoporosis in postmenopausal women at high risk of future fracture who are intolerant of, or contraindicated for other medicinal products approved for the prevention of osteoporosis.
Dosage/Direction for Use
May be taken with or without food: Take at the same time each day. Swallow whole, do not chew.
Hypersensitivity. Known, past or suspected breast cancer; known or suspected estrogen-dependent malignant tumors; undiagnosed genital bleeding; untreated endometrial hyperplasia; previous or current venous thromboembolism; known thrombophilic disorders, any history of arterial thromboembolic disease; acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal; porphyria. Pregnancy & lactation.
Special Precautions
Leiomyoma or endometriosis; risk factors for thromboembolic disorders; risk factors for estrogen-dependent tumors eg, 1st degree hereditary for breast cancer; HTN; liver disorders; DM w/ or w/o vascular involvement; cholelithiasis; migraine or severe headache; SLE; history of endometrial hyperplasia; epilepsy; asthma; otosclerosis. Risk of endometrial hyperplasia & carcinoma; breast cancer; ovarian cancer; venous thromboembolism; ischaemic stroke. Not intended for contraceptive use. Cardiac or renal dysfunction. Women w/ pre-existing hypertriglyceridemia. Galactose intolerance; Lapp lactase deficiency; glucose-galactose malabsorption. Discontinue treatment in case of jaundice/deterioration in liver function, significant change in BP, new onset of migraine-type headache.
Adverse Reactions
Lower abdominal pain; abnormal hair growth; vag discharge, endometrial wall thickening, postmenopausal haemorrhage, breast tenderness, genital pruritus, vag candidiasis, vag haemorrhage, pelvic pain, cervical dysplasia, genital discharge, vulvovaginitis; wt increase; abnormal cervical smear.
Drug Interactions
May enhance the effect of anticoagulants eg, warfarin. May interact w/ CYP3A4 substrates. Enhanced metabolism w/ CYP3A4 inducers eg, barbiturates, carbamazepine, hydrantoins, rifampicin, herbal prep containing St. John's wort.
ATC Classification
G03CX01 - tibolone ; Belongs to the class of other estrogens. Used in the treatment of menopausal symptoms.
Livial tab 2.5 mg
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