国家: 马耳他
语言: 英文
来源: Medicines Authority
CALCIUM, COLECALCIFEROL, RISEDRONATE SODIUM
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
M05BB02
CALCIUM 1000 mg COLECALCIFEROL 880 µg RISEDRONATE SODIUM 35 mg
FILM-COATED TABLET EFFERVESCENT GRANULES
CALCIUM 1000 mg COLECALCIFEROL 880 µg RISEDRONATE SODIUM 35 mg
POM
DRUGS FOR TREATMENT OF BONE DISEASES
Withdrawn
2008-02-05
LEAFL ET: PAGE 1 SAP-Nr.: 10001568 Product: IS Actonel Combi D Sachet small IE WE10 Country: Ireland Version: 8 Constructed: 20.09.2014 s+b/hp Modifi ed: 13.11.2014 s+b/khf/hp/hp/hp/hp/ hp/khf Size: 210 x 480 mm (80 x 105 mm) Fontversion: Futura Smallest font size: 9 pt Pages: 1 of 2 Colours: PMS Black ■ ● Techn. Drawing (Size, perforation, label, Placeholder for Sticker, varnish free area) ● Colours ● Pharma Code (Laetus), Placement ● Code of goods ● Version ● Braille ● Barcode (EAN, ...) APPROVED QA-LABEL CONTROL WORD BY WORD CHECKED AND APPROVED BY LOCAL REGULATORY Datum/Date: ................................................................. Unterschrift/Sign: ........................................................... ......................................... Replace SAP-No.: 10000701/ 10001434 MPMS-No.: 98911520-XXX Diecut –––––––––––– Reason for change: SANOFI -AVENTIS REMOVED, COLLOIDAL ANHYDROUS SILICA CHILDREN AND ADOLESCENTS Risedronate sodium is not recommended for use in children below 18 due to insuffi cient data on safety and effi cacy. OTHER MEDICINES AND ACTONEL PLUS CA & D ❍ _Actonel tablets_ Medicines containing one of the following lessen the effect of the Actonel tablet if taken at the same time: • calcium • magnesium • aluminium (for example some indigestion mixtures) • iron. Take these medicines at least 30 minutes after your Actonel tablet. ❑ _Calcium/vitamin D_ _3_ _ sachets_ Medicines containing calcium/vitamin D 3 are known to interfere with the following: • digitalis (used to treat heart disorders) • tetracycline antibiotics • steroids (such as cortisone) • sodium fl uoride (used to strengthen the tooth enamel) • thiazide diuretics (used to remove water from the body by increasing urine production) • cholestyramine (used to treat high blood cholesterol levels) • laxatives (such as paraffi n oil). 阅读完整的文件
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Actonel Plus Ca & D 35 mg film-coated tablets + 1000 mg / 880 IU effervescent granules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 35 mg risedronate sodium, (equivalent to 32.5 mg risedronic acid). Each sachet of effervescent granules contains 1000 mg calcium (as 2500 mg calcium carbonate) and 22 micrograms (880 IU) colecalciferol (vitamin D 3 ). Excipients with known effect: Each film-coated tablet contains 126.0 mg of lactose monohydrate (equivalent to 119.7 mg lactose). Each sachet of effervescent granules contains potassium (163 mg), sucrose (3.6 mg), soya-bean oil (0.7 mg) and sorbitol (100 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _Film-coated tablet_ Oval, light-orange, film-coated tablet with RSN on one side and 35 mg on the other. _Effervescent granules_ White effervescent granules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures (see section 5.1). Actonel Plus Ca & D is only intended for use in assessed patients for whom the amount of calcium and vitamin D 3 included is considered to provide adequate supplementation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION A weekly unit of Actonel Plus Ca & D consists of 1 Actonel 35 mg film-coated tablet and 6 calcium/vitamin D 3 sachets in a box. Posology The recommended dose in adults is 1 Actonel 35 mg tablet on the first day followed on the next day by 1 calcium/vitamin D 3 sache 阅读完整的文件