Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
ALENDRONIC ACID AS ALENDRONATE SODIUM TRIHYDRATE; COLECALCIFEROL
MERCK SHARP & DOHME ISRAEL LTD
A11CC05
TABLETS
COLECALCIFEROL 140 MCG; ALENDRONIC ACID AS ALENDRONATE SODIUM TRIHYDRATE 70 MG
PER OS
Required
MERCK SHARP & DOHME CORP., USA
COLECALCIFEROL
COLECALCIFEROL
Fosavance is indicated for : - Treatment of Osteoporosis in postmenopausal women: Fosavance increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). - Treatment to increase bone mass in men with osteoporosis.
2014-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine can be sold under doctor's prescription only FOSAVANCE ® 70 MG/5600 IU TABLETS Each tablet contains: Alendronic Acid 70 mg (as alendronate sodium trihydrate) Cholecalciferol (Vitamin D 3 ) 140 microgram (5600 IU) For a list of inactive ingredients see section 6 "WHAT FOSAVANCE CONTAINS?”. See also section 2.7, “IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF FOSAVANCE”. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • This leaflet contains concise information about FOSAVANCE. 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. • FOSAVANCE is only intended for use in women after menopause. You should not take FOSAVANCE if you are pregnant or think you may be pregnant, or if you are breast-feeding. 1. WHAT IS FOSAVANCE INTENDED FOR? FOSAVANCE is indicated for: • the treatment of osteoporosis in women after menopause. FOSAVANCE helps increase bone mass and reduces the chance of having a hip or spinal fracture (break). • treatment to increase bone mass in men with osteoporosis. THERAPEUTIC GROUP: FOSAVANCE is a tablet containing the two active substances: alendronic acid, that belongs to a non-hormonal medicines class called bisphosphonates, and cholecalciferol known as vitamin D 3 . FOSAVANCE should not be used to treat vitamin D deficiency. It is not known how long you need to take FOSAVANCE for the treatment of osteoporosis. You should see your doctor regularly to determine if FOSAVANCE is still right for you. 2. BEFORE YOU TAKE FOSAVANCE 2.1 DO NOT TAKE FOSAVANCE IF YOU: Are hypersensitive (allergic) to alendronate sodium or to cholecalciferol or to any of the other ingredients of FOSAVANCE (for a list of inactive ingredients, se Citiți documentul complet
FOSAVANCE ® 70 MG/ 5600 IU TABLETS (ALENDRONATE SODIUM/CHOLECALCIFEROL) 1 THERAPEUTIC INDICATIONS AND USAGE FOSAVANCE ® 70 mg/ 5600 IU TABLETS are indicated for: 1.1 TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN For the treatment of osteoporosis, FOSAVANCE 70 MG/ 5600 IU TABLETS increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS FOSAVANCE 70 MG/ 5600 IU TABLETS is indicated for treatment to increase bone mass in men with osteoporosis _[see Clinical Studies (14.2)]_. 1.2 IMPORTANT LIMITATIONS OF USE FOSAVANCE 70 MG/ 5600 IU TABLETS alone should not be used to treat vitamin D deficiency. The optimal duration of use has not been determined. The safety and effectiveness of FOSAVANCE 70 MG/ 5600 IU TABLETS 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 alendronate/5600 IU vitamin D 3 tablet once weekly. 2.2 TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS The recommended dosage is one 70 mg alendronate/5600 IU vitamin D 3 tablet once weekly. 2.3 IMPORTANT ADMINISTRATION INSTRUCTIONS Instruct patients to do the following: • Take FOSAVANCE 70 MG/ 5600 IU TABLETS _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 alendronate _[see Drug Interactions (7.1)]_. Waiting less than 30 minutes, or taking Citiți documentul complet