Details

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• Active Ingredient: Ibandronic acid (as sodium monohydrate) 150 mg per tablet.

• Registration Number (MAL): MAL21036035ACRZ.

• Manufacturer: Penn Pharmaceutical Services Limited, Tredegar, Wales, United Kingdom.

• Registration Holder: DKSH Malaysia Sdn. Bhd., Petaling Jaya, Selangor, Malaysia.

Indications

• Treatment of osteoporosis in postmenopausal women at increased risk of fracture.

• Demonstrated reduction in the risk of vertebral fractures; efficacy on femoral neck fractures has not been established.

Instructions for Use

• Dosage: One 150 mg film-coated tablet once a month, preferably on the same date each month.

• Administration:

  • Take after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day.

  • Swallow the tablet whole with a full glass of plain water (180–240 ml) while sitting or standing upright.

  • Do not chew, crush, or suck the tablet.

  • Do not lie down for at least 1 hour after taking the tablet.

• Missed Dose: If a dose is missed, take one tablet the morning after it is remembered, unless the time to the next scheduled dose is within 7 days. In that case, wait until the next dose and continue the monthly schedule. Do not take two tablets within the same week