Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
Tibolone
Merck Sharp & Dohme Australia Pty Ltd
Medicine Registered
XYVION ® TABLETS _tibolone 2.5 mg_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Xyvion. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Xyvion against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS INFORMATION WITH THE PACK. You may wish to read it again. WHAT XYVION IS USED FOR Xyvion tablets contain the active ingredient tibolone, which is a synthetic steroid medicine used for hormone replacement therapy (HRT). It mimics the activity of the female sex hormones in the body. Xyvion contains tibolone, a substance that has favourable effects on different tissues in the body, such as brain, vagina and bone. Xyvion is used in postmenopausal women at least 12 months since their last natural period. Xyvion is used for: RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During the menopause, the amount of oestrogen produced by a woman's body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Xyvion alleviates these symptoms after menopause. You will only be prescribed Xyvion if your symptoms seriously hinder your daily life. PREVENTION OF OSTEOPOROSIS After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor. If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can take Xyvion to prevent osteoporosis after menopause. Xyvion is not a contraceptive. Xyvion has no effect on alertness and concentration as far as is known. A doctor's prescription is required to obtain this medicine. BEFORE YOU USE XYVION _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE XYVION IF: • you are pregnant or think you may be pregnant • you are breastfeeding • you have or h Pročitajte cijeli dokument
RA 1850 CCDS 1850 12(12.0) PI ref.: D120911 v2 Page 1 of 12 PRODUCT INFORMATION XYVION NAME OF THE MEDICINE XYVION (tibolone) 2.5 mg tablets _Molecular formula C_ _21_ _H_ _28_ _O_ _2 _ _Molecular mass 312.45. _ _[CAS No. 5630-53-5] _ _ _ CHEMICAL NAME: (7α, 17α) - 17 - hydroxy-7-methyl-19-norpregn-5 (10)-en-20-yn-3-one. OTHER NAME: 17α-ethynyl-17-hydroxy-7α-methyl-5(10)-estren-3-one. PHARMACEUTICAL FORM Tablets, each containing 2.5 mg of the steroid tibolone._ _ DESCRIPTION Tibolone exists as white to almost white crystals or crystalline powder. Tibolone is related to and derived from naturally occurring steroids. It is optically pure and has the D-configuration. It is practically insoluble in water, aqueous acid or alkali at 20 0 C. LIST OF EXCIPIENTS XYVION tablets 2.5 mg contain potato starch, magnesium stearate, ascorbyl palmitate and lactose. PHARMACOLOGY PHARMACODYNAMIC PROPERTIES ATC code: G03CX01 After oral administration tibolone is rapidly metabolised into three compounds which contribute to the pharmacological effects of XYVION. Two of these metabolites (the 3 αOH and 3 βOH metabolite) have predominantly oestrogenic activity, a third metabolite (∆ 4 -isomer of tibolone) and the parent compound have predominantly progestagenic and androgenic activities. RA 1850 CCDS 1850 12(12.0) PI ref.: D120911 v2 Page 2 of 12 XYVION substitutes for the loss of oestrogen production in postmenopausal women and alleviates menopausal symptoms. XYVION prevents bone loss following menopause or ovariectomy. XYVION has various tissue-specific effects. It has oestrogenic effects on the vagina, on bone and on the thermoregulatory centres in the brain (hot flushes). Based on in vitro data, XYVION inhibits the sulphatase enzyme in cultured breast cancer cells thereby reducing the levels Pročitajte cijeli dokument