Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ALENDRONATE MONOSODIUM SALT TRIHYDRATE
ZUELLIG PHARMA SDN BHD
ALENDRONATE MONOSODIUM SALT TRIHYDRATE
12tablet Tablets; 4tablet Tablets
SWISSCO SERVICES AG
BUFFERED BINOSTO ® Alendronic Acid (70mg) Effervescent Tablets 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Buffered Binosto_ _®_ is used for 2. How _Buffered Binosto_ _®_ works 3. Before you use _Buffered Binosto_ _®_ 4. How to use _Buffered Binosto_ _®_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Buffered _ _Binosto_ _®_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 1. WHAT _BUFFERED BINOSTO_ _®_ IS USED FOR Your doctor has prescribed _Buffered _ _Binosto_ _®_ to treat your osteoporosis. _Buffered _ _Binosto_ _®_ reduces the risk of spine and hip fractures. _BUFFERED _ _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, everyday activity, such as lifting, or from minor injury that would not generally break normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘dowager’s hump’) and loss of mobility. HOW CAN OSTEOPOROSIS BE TREATED? Osteoporosis can be treated and it is never too late to begin treatment. _Buffered Binosto_ _®_ not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip. As well as your treatment with _Buffered _ _Binosto_ _®_ , your doctor may suggest you make changes t Baca dokumen lengkapnya
Read package insert carefully before use. Consult your doctor for more information. Prescription medicine only. Keep out of reach of children. 1. NAME OF THE MEDICINAL PRODUCT Buffered 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: 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. Each effervescent tablet contains 602.54 mg of sodium. 3. PHARMACEUTICAL FORM Effervescent Tablet 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 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of postmenopausal osteoporosis. Alendronate sodium (Buffered 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. Al en drona te Sodi um Buffere d Binosto ® Baca dokumen lengkapnya