Source: HPRA (Health Products Regulatory Authority)
IBANDRONATE SODIUM MONOHYDRATE
Laboratorios LICONSA, S.A.
150 Base Milligrams
Film Coated Tablet
License Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Bonefurbit 150mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg ibandronic acid (as ibandronate sodium hydrate). Excipients: Each film-coated tablet contains 88.60 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White film-coated tablets of oblong shape and scored “LC” on one side. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established. 4.2 Posology and method of administration Posology: The recommended dose is one 150 mg film-coated tablet once a month. The tablet should preferably be taken on the same date each month. Bonefurbit should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day (see section 4.5) or any other oral medicinal products or supplementation (including calcium). In case a dose is missed, patients should Read the complete document