País: Regne Unit
Idioma: anglès
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Raloxifene hydrochloride
Actavis Group PTC ehf
G03XC01
Raloxifene hydrochloride
60 mg
Film-coated Tablet
Oral use
14, 28, 30, or 84 tablets
POM - Prescription Only Medicine
Pharmathen S.A., Pharmathen International S.A.
Selective Oestrogen Receptor Modulator
It is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Authorised
2015-01-19
Raloxifene 60mg tablet leaflet - UK item no: print proof no: origination date: originated by: revision date: revised by: dimensions: pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: supplier: technically app. date: min pt size: TECHNICAL APPROVAL AAAH5476 5 31.12.14 jh 08.01.15 jh Pharmathen 200 x 400 11.5 31.12.14 07.01.15 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • The full name of this medicine is Raloxifene Hydrochloride 60mg Film-coated Tablets but within the leaflet it will be referred to as Raloxifene Tablets. WHAT IS IN THIS LEAFLET 1. What Raloxifene Tablets are and what they are used for 2. What you need to know before you take Raloxifene Tablets 3. How to take Raloxifene Tablets 4. Possible side effects 5. How to store Raloxifene Tablets 6. Contents of the pack and other information 1. WHAT RALOXIFENE TABLETS ARE AND WHAT THEY ARE USED FOR Raloxifene Tablets contains the active substance raloxifene hydrochloride. Raloxifene Tablets are used to treat and prevent osteoporosis in postmenopausal women. Raloxifene Tablets reduce the risk of vertebral fractures in women with postmenopausal osteoporosis. A reduction in the risk of hip fractures has not been shown. How Raloxifene Tablets work. Raloxifene Tablets belong to a group of non- hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs). When a woman reaches t Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Raloxifene Hydrochloride Actavis 60mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base. Excipient(s) with known effect: Each tablet contains lactose monohydarate (1.5 mg). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet. Elliptically shaped (12.6 mm x 6.6 mm), white film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Raloxifene Hydrochloride is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Raloxifene or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one tablet daily by oral administration, which may be taken at any time of the day without regard to meals. Due to the nature of this disease process, Raloxifene Hydrochloride is intended for long term use. Generally calcium and vitamin D supplements are advised in women with a low dietary intake. _Elderly: _ No dose adjustment is necessary for the elderly. _Renal impairment: _ Raloxifene Hydrochloride should not be used in patients with severe renal impairment (see section 4.3). In patients with moderate and mild renal impairment, Raloxifene Hydrochloride should be used with caution. _Hepatic impairment: _ Raloxifene Hydrochloride should Llegiu el document complet