Concise Prescribing Info
Contents
16 red FC tab each containing Estradiol 1 mg. 12 white FC tab each containing Estradiol 1 mg, norethisterone acetate 1 mg
Indications/Uses
Hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women w/ at least 6 mth since last menses. Prevention of osteoporosis in postmenopausal women at high risk of future fractures.
Dosage/Direction for Use
1 red tab daily for the 1st 16 days followed by 1 white tab for the next 12 days.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Known, past or suspected breast cancer; oestrogen-dependent malignant tumours (eg, endometrial cancer); undiagnosed genital bleeding; untreated endometrial hyperplasia; previous or current venous thromboembolism (DVT, pulmonary embolism); known thrombophilic disorders (eg, protein C, protein S or antithrombin deficiency); active or previous arterial thromboembolic disease (eg, angina, MI); acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal; porphyria.
Special Precautions
Leiomyoma or endometriosis; risk factors for thromboembolic disorders; risk factors for oestrogen-dependent tumours eg, 1st degree heredity for breast cancer; HTN; liver disorders; DM w/ or w/o vascular involvement; cholelithiasis; migraine or (severe) headache; SLE; epilepsy; asthma; otosclerosis. W/draw immediately in case of jaundice or deterioration in liver function; significant increase in BP; new onset of migraine-type headache. Endometrial hyperplasia & carcinoma, breast & ovarian cancer, venous thromboembolism, CAD, ischaemic stroke, hypothyroidism, angioedema, patients w/ cardiac or renal dysfunction, women w/ pre-existing hypertriglyceridaemia, increased thyroid binding globulin, circulating corticosteroids & sex steroids, increased risk of dementia in women after the age of 65, patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not indicated during pregnancy & lactation.
Adverse Reactions
Headache; breast tenderness. Vaginal candidiasis; dizziness, insomnia, depression; increased BP, aggravated HTN; dyspepsia, abdominal pain, flatulence, nausea; rash, pruritus; vaginal haemorrhage, uterine fibroids aggravated; oedema; wt increased.
Drug Interactions
Metabolism may be increased when administered concomitantly w/ CYP450 inducers eg, anticonvulsants (phenobarb, phenytoin, carbamazepine); anti-infectives (rifampicin, rifabutin, nevirapine, efavirenz); ritonavir, telaprevir, nelfinavir; St. John's wort. Increased circulating levels w/ ketoconazole. Increased blood levels of cyclosporine.
ATC Classification
G03CA53 - estradiol, combinations ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
Presentation/Packing
Form
Novofem tab
Packing/Price
1 × 28's
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