Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Sodium alendronate trihydrate (micronised)
Lexon (UK) Ltd
M05BA; M05BA04
Sodium alendronate trihydrate (micronised)
70 milligram(s)
Effervescent tablet
Product subject to prescription which may be renewed (B)
Bisphosphonates; alendronic acid
Authorised
2018-04-27
BINOSTO ONCE WEEKLY 70 MG EFFERVESCENT TABLETS (alendronic acid) 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 pharmacist 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 of the side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: What Binosto is and what it is used for What you need to know before you take Binosto How to take Binosto Possible side effects How to store Binosto Contents of the pack and other information WHAT BINOSTO IS AND WHAT IT IS USED FOR WHAT IS BINOSTO? Alendronate, the active substance of Binosto belongs to a group of non-hormonal medicines called bisphosphonates. Binosto prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures. WHAT IS BINOSTO USED FOR? Your doctor has prescribed Binosto to treat your osteoporosis. Binosto reduces the risk of spine and hip fractures. BINOSTO IS A ONCE WEEKLY TREATMENT. WHAT IS OSTEOPOROSIS? Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman’s skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis. Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in broken bones. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, e Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Binosto Once Weekly 70 mg Effervescent Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each effervescent tablet contains 70 mg alendronic acid as 91.37mg of alendronate sodium trihydrate. Excipients: each effervescent tablet contains 602.54 of sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent Tablet _Product imported from Spain_ White to off-white round effervescent tablets of 25 mm diameter, flat faced with bevelled edges. After dissolution the solution has a pH of 4.8 – 5.4. The appearance of the product after dissolution is a clear colourless solution. 4 CLINICAL PARTICULARS As per PA0126/280/001 5 PHARMACOLOGICAL PROPERTIES As per PA0126/280/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sodium dihydrogen citrate Citric acid anhydrous Sodium hydrogen carbonate Sodium carbonate anhydrous Strawberry flavour [Maltodextrin (Maize), Arabic gum, Propylene glycol (E 1520), nature-identical flavouring substances] Acesulfame potassium Sucralose 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the market in the country of origin. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _7_ _/_ _0_ _4_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _1_ _9_ _5_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.4 SPECIAL PRECAUTIONS FOR STORA Διαβάστε το πλήρες έγγραφο