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Syndrome (MAS) received 20 mg tamoxifen once a day for up to 12 months duration,there was an age-dependent decrease in clearance and an increase in exposure (AUC),(with values up to 50% higher in the youngest patients) compared with adults.CYPD26 polymorphismTamoxifen is metabolised mainly via CYP3A4 to N-desmethyl-tamoxifen, which isfurther metabolised by CYP2D6 to another active metabolite endoxifen. In patientswho lack the enzyme CYP2D6 endoxifen concentrations are approximately 75%lower than in patients with normal CYP2D6 activity. Administration of strongCYP2D6 inhibitors reduces endoxifen circulating levels to a similar extent.5.3 Preclinical safety dataTamoxifen was not mutagenic in a range of in vitro and in vivo mutagenicity tests.Tamoxifen was genotoxic in some in vitro and in vivo genotoxicity tests in rodents.Gonadal tumours in mice and liver tumours in rats receiving tamoxifen have beenreported in long-term studies. The clinical relevance of these findings has not beenestablished.Tamoxifen is an active substance on which extensive clinical experience has beenobtained.6 PHARMACEUTICAL PARTICULARS6.1 List of excipientsLactose monohydrateCellulose, microcrystallinePovidoneCarmellose sodiumMagnesium stearate6.2 IncompatibilitiesNone reported.6.3 Shelf life3 years.6.4 Special precautions for storageStore in the original package in order to protect from heat, light and moisture.
6.5 Nature and contents of container1. The product is packed in blister packaging (10 tablets/strip) in 20 MU hardtemper aluminium foil and white opaque 200MU PVC laminated with 60 G/M2PVC (35MU) in pack sizes of 28, 30, 42, 50, 56, 60, 84, 90, 100, 112 and 250tablets. It is subsequently packed in printed box board cartons.2. The product is also blister packed (10 tablets per strip) in aluminium foil with thedull side laminated to the plain 25MU nylon and the bright side lacquerlaminated to 60MU UPVC in pack sizes of 28, 30, 42, 50, 56, 60, 84, 90, 100,112 and 250 tablets. It is subsequently packed in printed box board cartons.Not all pack sizes may be marketed.6.6 Special precautions for disposalNone.7 MARKETING AUTHORISATION HOLDERCrescent Pharma LtdUnits 3 and 4, Quidhampton Business UnitsPolhampton LaneOvertonHampshireRG25 3EDUnited Kingdom8 MARKETING AUTHORISATION NUMBER(S)PL 20416/0226
Page 1 and 2: SUMMARY OF PRODUCT CHARACTERISTICS1
Page 3 and 4: • Hypersensitivity to the active
Page 5 and 6: Concomitant medications that inhibi
Page 7 and 8: Unless specified, the following fre
Page 9 and 10: Congenital, familial andgenetic dis
Page 11 and 12: Porphyria cutanea tarda has been ob
Page 13 and 14: to tamoxifen. The poor metaboliser
Page 15 and 16: breast cancerNon-invasivecancers77(
Page 17: No age-related effects of tamoxifen

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