البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ALENDRONATE AS SODIUM
MERCK SHARP & DOHME ISRAEL LTD
M05BA04
TABLETS
ALENDRONATE AS SODIUM 70 MG
PER OS
Required
MERCK SHARP & DOHME B.V, HOLLAND
ALENDRONIC ACID
Fosalan is indicated for the treatment of osteoporosis in postmenopausal women to prevent fractures, including those of the hip and spine (vertebral compression fractures). Treatment to increase bone mass in men with osteoporosis.
2016-08-22
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine is marketed upon physician’s prescription only FOSALAN ® ONCE-WEEKLY 70 MG TABLETS Each tablet contains: Alendronate Sodium 91.37 mg (equivalent to 70 mg free acid) For a list of inactive ingredients see section 6 "FURTHER INFORMATION?”. See also section 2.7, “IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF FOSALAN”. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • This leaflet contains concise information about FOSALAN. If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. • This medicine is not intended for children. See also section 2.8. • FOSALAN is only intended for use in women after menopause. You should not take FOSALAN if you are pregnant or think you may be pregnant, or if you are breast-feeding. 1. WHAT FOSALAN ONCE-WEEKLY 70 MG IS INTENDED FOR? FOSALAN ONCE-WEEKLY 70 MG is indicated for: • the treatment of osteoporosis in postmenopausal women, to prevent fractures. • Treatment to increase bone mass in men with osteoporosis. THERAPEUTIC GROUP:_ _bisphosphonates. It is not known how long you need to take FOSALAN for the treatment of osteoporosis. You should see your doctor regularly to determine if FOSALAN is still right for you. 2. BEFORE YOU TAKE FOSALAN 2.1 DO NOT TAKE FOSALAN IF YOU: − Are hypersensitive (allergic) to alendronate sodium or to any of the other ingredients of FOSALAN (for a list of inactive ingredients, see section 6 "FURTHER INFORMATION") − Have certain problems with your esophagus (the tube that connects your mouth with your stomach) − Cannot stand or sit upright for at least 30 minutes − Have low levels of calcium in your blood 2.2 SPECIAL WARNINGS CONCERNING USE OF FOSALAN BEFORE STARTING TREATMENT WITH FOSALAN, TELL YOUR DOCTOR IF YOU: • Have problems with اقرأ الوثيقة كاملة
FOSALAN ® ONCE-WEEKLY 70MG TABLETS (ALENDRONATE SODIUM) 1 THRERAPEUTIC INDICATIONS AND USAGE 1.1 TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN FOSALAN ® is indicated for the treatment of osteoporosis in postmenopausal women to prevent fractures, including those of the hip and spine (vertebral compression fractures). _[See Clinical Studies (14.1).] _ TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS 1.2 IMPORTANT LIMITATIONS OF USE The optimal duration of use has not been determined. The safety and effectiveness of FOSALAN for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically. 2 DOSAGE AND ADMINISTRATION 2.1 TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN The recommended dosage is: one 70 mg tablet once weekly 2.2 TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS The recommended dosage is: one 70 mg tablet once weekly 2.3 IMPORTANT ADMINISTRATION INSTRUCTIONS Instruct patients to do the following: • Take FOSALAN _at least _one-half hour before the first food, beverage, or medication of the day with plain water only _[see Patient Counseling Information (17.2)]. _Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of FOSALAN _[see Drug Interactions _ _(7.1)]. _Waiting less than 30 minutes, or taking FOSALAN with food, beverages (other than plain water) or other medications will lessen the effect of FOSALAN by decreasing its absorption into the body. • Take FOSALAN upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a FOSALAN tablet should be swallowed with a full glass of water (not less than 200 ml). Patients should not lie do اقرأ الوثيقة كاملة