Zuellig Pharma
Concise Prescribing Info
Complaints resulting from natural or artificial menopause. Prevention of osteoporosis in postmenopausal women at high risk of future fractures intolerant of or contraindicated for other medicinal products approved for osteoporosis prevention.
Dosage/Direction for Use
May be taken with or without food: Swallow whole w/o chewing preferably at the same time each day.
Hypersensitivity. Known or suspected breast cancer; oestrogen-dependent malignant tumours; undiagnosed vag bleeding; active deep venous thrombosis, thromboembolic states; untreated endometrial hyperplasia; known thrombophilic alteration; recent or active arterial thrombolic disease; porphyria. Severe or history of hepatic disorders. Pregnancy & lactation.
Special Precautions
Discontinue use if VTE develops & in case of jaundice or hepatic function deterioration, significant BP increase, new onset of migraine-type headache. Not intended for contraceptive use. Increased risk of ischaemic stroke, breast, ovarian & endometrial cancer. Exclude endometrial malignancy prior to therapy; breakthrough bleeding & spotting. Leiomyoma or endometriosis; history of or risk factors for thromboembolic disorders & estrogen-dependent tumors; HTN; DM w/ or w/o vascular involvement; cholelithiasis; migraine or headache; SLE; history of endometrial hyperplasia; epilepsy; asthma; otosclerosis. Preexisting hypertriglyceridemia; cardiac dysfunction. Women on anticoagulant treatment. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Hepatic disorders. Renal dysfunction.
Adverse Reactions
Abdominal pain; wt gain; vag bleeding or spotting, leucorrhoea, breast tension, genital pruritus & moniliasis, vaginitis; hypertrichosis.
Drug Interactions
Enhanced effect of anticoagulants. Affected pharmacokinetics of CYP3A4 substrates eg, midazolam. Enhanced metabolism by barbiturates, carbamazepine, hydantoins & rifampicin. Induced metabolism by St. John's wort.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03CX01 - tibolone ; Belongs to the class of other estrogens. Used in the treatment of menopausal symptoms.
Tiboleen tab 2.5 mg
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