Unibon Tablet (Ibandronate Sodium Hydrate)

Adult dose

Take 1 tablet once a month, regularly on the same day each month, in the morning with plenty of water at least 1 hour before consuming food, beverages (other than water), or any other oral medications or dietary supplements (including calcium): - This medicine should be swallowed with plenty of water (180-240ml) while standing or sitting upright, and you should not lie down for 60 minutes after taking it. - Mineral water may reduce the absorption of this medicine, so take it with plain water. - To avoid esophageal ulcers, do not chew or suck the tablet. If you forget to take this medicine on your scheduled day - If 8 days or more remain until your next scheduled dose, take 1 tablet the morning after you realize you missed the dose, and thereafter take 1 tablet each month on your previously scheduled day. - If 7 days or fewer remain until your next scheduled dose, take 1 tablet on your next scheduled dose day, and thereafter continue taking 1 tablet each month on your previously scheduled day. - Do not take 2 tablets in the same week. Patients with inadequate dietary intake should supplement with calcium or vitamin D. Patients with hepatic impairment No dose adjustment is necessary. Patients with renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment whose creatinine clearance is 30mL/min or higher. Use of this medicine is not recommended in patients with creatinine clearance below 30mL/min because clinical experience is insufficient. Older adults No dose adjustment is necessary.

Child dose

18 years and under: Efficacy and safety have not been studied.

This medication should not be used in certain patients. For example, patients with allergic reactions to this drug or its components, untreated hypocalcemia, patients who cannot sit or stand upright for 60 minutes or more, patients with esophageal function abnormalities causing delayed esophageal emptying, and those with genetic issues such as lactose intolerance should not take this medication. In patients with severe renal impairment, this medication should be administered cautiously. Patients with significantly reduced kidney function need special attention. While taking this medication, side effects such as dyspepsia, nausea, abdominal pain, diarrhea, headache, myalgia, and rash may occur. Most side effects are mild to moderate and are not usually severe enough to require discontinuation of treatment. Severe esophageal-related side effects such as esophagitis, esophageal ulcers, and esophageal strictures have been rarely reported, so if you experience difficulty swallowing, pain, chest pain, or heartburn, discontinue use immediately and consult your doctor. This medication's absorption can be hindered when taken with calcium, milk, antacids, etc., so it is important to avoid eating or taking other medications for at least 1 hour after taking this medication. Serious side effects, such as osteonecrosis of the jaw, may occur rarely, so it is advisable for cancer patients or those undergoing dental treatment to have oral examinations before use. It is also advisable to avoid excessive dental treatment during use. Additionally, other rare serious side effects such as ocular inflammation, severe allergic reactions, atypical femoral fractures, etc., have been reported; if any unusual symptoms occur, inform healthcare professionals immediately. Pregnant or breastfeeding women are advised against using this medication as its safety has not been established. During treatment, strictly adhere to the specified dosage method, particularly remaining upright for 60 minutes after taking the medication to reduce esophageal irritation. Finally, the safety and efficacy of this medication have not been established in children under 18 years of age, so it should not be used in pediatric patients.

Dyspepsia, nausea, abdominal pain, diarrhea, bloating, gastroesophageal reflux disease, headache, influenza-like illness, fatigue, myalgia, arthralgia, rash, gastritis, esophagitis, muscle cramps, musculoskeletal pain, musculoskeletal stiffness, dysphagia, vomiting, esophageal ulcer, stricture, dizziness, low back pain, duodenitis, hypersensitivity reaction, angioedema, facial swelling, urticaria, uveitis, scleritis, osteonecrosis of the jaw and external auditory canal, anaphylactic reaction, shock, worsening of asthma, Stevens-Johnson syndrome, erythema multiforme, vesicular dermatitis, atypical subtrochanteric fracture, intertrochanteric femur fracture, paresthesia of the eye, weakness, pruritus

Store this medication in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

White to nearly white oblong film-coated tablet

Package unit

1 tablet (1 tablet/PTP×1)