Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ALENDRONATE MONOSODIUM SALT TRIHYDRATE
HOVID BERHAD
ALENDRONATE MONOSODIUM SALT TRIHYDRATE
1 x 4'stablet Tablets
HOVID BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ HOVID ALENDRONATE 70 MG TABLET Alendronate Sodium USP (70 mg) 1 WHAT IS IN THIS LEAFLET 1. What Hovid Alendronate 70 mg Tablet is used for 2. How Hovid Alendronate 70 mg Tablet works 3. Before you use Hovid Alendronate 70 mg Tablet 4. How to use Hovid Alendronate 70 mg Tablet 5. While you are using Hovid Alendronate 70 mg Tablet 6. Side effects 7. After using Hovid Alendronate 70 mg Tablet 8. Product description 9. Manufacturer 10. Product Registration Holder WHAT HOVID ALENDRONATE 70 MG TABLET IS USED FOR This medicine contains the active ingredient alendronate sodium. It is used to treat and / or prevent Post-menopausal osteoporosis, corticosteroid-induced osteoporosis and reduces the risk of vertebral and hip fractures metastases and hypercalcaemia of malignancy. HOW HOVID ALENDRONATE 70 MG TABLET WORKS Alendronate sodium belongs to a group of non-hormonal medicines called biphosphonates. This medicine slows down the removal of old bones to allow bone-forming cells enough time to build new bones. BEFORE YOU USE HOVID ALENDRONATE 70 MG TABLET _- When you must not use it _ _ _ Do not take this medicine if: you are allergic to alendronate sodium or any of the excipients, or other substances including food, preservatives or dyes you have problems with your food pipe (oesophagus) you cannot stand or sit upright for at least 30 minutes you have low level of blood calcium you are pregnant or breastfeeding. _- Before you start to use it _ _ _ Tell your doctor if: you plan to become pregnant or breastfeed you have swallowing or digestive problems such as ulcers you have kidney problems you have dental or jaw bone problems you currently smoke or used to be a smoker in the past _- Taking other medicines _ _ _ Talk to your doctor or pharmacist if you are taking any other medicines in any form including any that you buy or obtained without a prescription. Some medicines interfere with alendronate sodium. You must wait at least 30 minutes after taking Osteomax before taking Læs hele dokumentet
VIALE06-var (MY)2 ALENDRONATE 70 MG TABLET DESCRIPTION Oval, white uncoated tablet; shallow convex with ‘HD’ and break bar embossed on one face. COMPOSITION Each tablet contains Sodium Alendronate Trihydrate 91.4mg equivalent to 70 mg Alendronic Acid. ACTIONS AND PHARMACOLOGY The active ingredient of Hovid Alendronate 70 mg Tablet, alendronate sodium trihydrate, is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. Preclinical studies have shown preferential localisation of alendronate to sites of active resorption. Activity of osteoclasts is inhibited, but recruitment or attachment of osteoclasts is not affected. The bone formed during treatment with alendronate is of normal quality. Alendronate is given in the management of osteoporosis either alone or with Vitamin D. PHARMACOKINETICS ABSORPTION Alendronate is poorly absorbed after oral doses. Absorption is decreased by food, especially by products containing calcium or other polyvalent cations. Relative to an intravenous reference dose, the oral mean bioavailability of alendronate in women was 0.64% for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardised breakfast. Bioavailability was decreased similarly to an estimated 0.46% and 0.39% when alendronate was administered one hour or half an hour before a standardised breakfast. In osteoporosis studies, alendronate was effective when administered at least 30 minutes before the first food or beverage of the day. Bioavailability was negligible whether alendronate was administered with, or up to two hours after, a standardised breakfast. Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approximately 60%. In healthy subjects, oral prednisone (20 mg three times daily for five days) did not produce a clinically meaningful change in oral bioavailability of alendronate (a mean increase ranging from 20% to 44%). DISTRIBUTION The mean steady-state volume of distributi Læs hele dokumentet