Bondronat Tablet 50mg

DKSH SINGAPORE PTE. LTD.

DKSH SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**3.2 Dosage and Method of Administration** The recommended dose is one 50 mg film-coated tablet daily. Bondronat should be taken after an overnight fast and before the first food or drink of the day. Medications and supplements (including calcium) should similarly be avoided prior to taking Bondronat tablets. Fasting should be continued for at least 60 minutes after taking the tablet. Plain water may be taken at any time during the course of Bondronat treatment. - The tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the patient is standing or sitting in an upright position. - Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration. - Plain water is the only drink that should be taken with Bondronat. Please note that some mineral waters may have a higher concentration of calcium and therefore should not be used. - Patients should not lie down for 60 minutes after taking Bondronat. _Patients with hepatic impairment_ No dosage adjustment is expected to be necessary (see 4.2.5 Pharmacokinetics in Special Populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Patients with renal impairment_ For patients with mild renal impairment (CLcr ≥50 and <80 mL/min) no dosage adjustment is necessary. For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) a dosage adjustment to one 50 mg film-coated tablet every second day is recommended. For patients with severe renal impairment (CLcr <30 mL/min) the recommended dose is one 50 mg film-coated tablet once weekly ( _see section_ 4.2.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Elderly_ No dose adjustment is necessary. _Children_ Safety and efficacy have not been established in patients less than 18 years old.