Country: Միացյալ Թագավորություն
language: անգլերեն
source: myHealthbox
alendronic acid
Internis Pharmaceuticals Ltd
M05BA04
alendronic acid
70mg
Effervescent Tablet
Oral use
Packs with 4, 12 or 24 effervescent tablets.
POM - Prescription Only Medicine
Temmler Pharma GmbH & Co. KG
Drugs affecting bone structure and mineralisation, bisphosphonates
Treatment of postmenopausal osteoporosis. Binosto 70 mg reduces the risk of vertebral and hip fractures.
Authorised
2015-09-16
P C P H EAD ER B O X APP RO VE D B Y D ATE O P ER ATOR A RT W O RK N O C R N FI X R EA SO N F SU F O R C HA N G E ISSU ED B Y D ATE M H R A/IMB SUBMISSION REQUIRED Yes C niallmcateer-lee 587379 12126 New product introduction M H R A H EA D ER B O X P RO D UCT T IT LE C FONTS USED O LO U RS U SE D C OMP O N ENT P AC K SI ZE IG CODE D IM ENS IO N S P RO O F N O. D AT E Leaflet 4's 25408601 195 x 396mm 3 30.07.2015 Process Black Keyline (Does not print) Binosto 70mg Effervescent Tablets Internis Arial Helvetica Neue LT Std P C P H EAD ER B O X APP RO VE D B Y D ATE O P ER ATOR A RT W O RK N O C R N FI X R EA SO N F SU F O R C HA N G E ISSU ED B Y D ATE M H R A/IMB SUBMISSION REQUIRED Yes C niallmcateer-lee 587379 12126 New product introduction M H R A H EA D ER B O X P RO D UCT T IT LE C FONTS USED O LO U RS U SE D C OMP O N ENT P AC K SI ZE IG CODE D IM ENS IO N S P RO O F N O. D AT E Leaflet 4's 25408601 195 x 396mm 3 30.07.2015 Process Black Keyline (Does not print) Binosto 70mg Effervescent Tablets Internis Arial Helvetica Neue LT Std READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE, BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU, EVEN IF THIS IS A REPEAT PRESCRIPTION. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharma- cist or nurse. • This medicine has been prescribed for you. 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 or nurse. This includes any possible si read_full_document
Binosto 70 mg effervescent tablets Summary of Product Characteristics Updated 16Sep2015 | Internis Pharmaceuticals Ltd 1. Name of the medicinal product Binosto 70 mg effervescent tablets 2. Qualitative and quantitative composition Each effervescent tablet contains 70 mg alendronic acid as 91.37 mg of alendronate sodium trihydrate. Excipients: each effervescent tablet contains 602.54 mg of sodium. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Effervescent Tablet White to offwhite round effervescent tablets of 25 mm diameter, flat faced with bevelled edges. After dissolution the solution has a pH of 4.8 – 5.4 4. Clinical particulars 4.1 Therapeutic indications Treatment of postmenopausal osteoporosis. Binosto 70 mg reduces the risk of vertebral and hip fractures. 4.2 Posology and method of administration Posology The recommended dose is one 70 mg effervescent tablet once weekly. Patients should be instructed that if they miss a dose of Binosto 70 mg, they should take one effervescent tablet on the morning after they remember. They should not take two effervescent tablets on the same day but should return to taking one effervescent tablet once a week, as originally scheduled on their chosen day. The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be reevaluated periodically based on the benefits and potential risks of Binosto on an individual patient basis, particularly after 5 or more years of use. _Use in the elderly:_ In clinical studies there was no age related difference in the efficacy or safety profiles of alendronate. Therefore no dosage adjustment is necessary for the elderly. _Use in renal impairment:_ No dosage adjustment is necessary for patients with read_full_document