Ibanell Tablet (Ibandronic Acid Sodium Monohydrate)

Adult dose

One tablet monthly, regularly taken on the same day each month in the morning at least 1 hour before consuming any food, drink (excluding water), or other oral medications or dietary supplements (including calcium). - This medication should be swallowed with a sufficient amount (180-240 mL) of water while standing or sitting upright, and you should not lie down for 60 minutes after taking it. - Mineral water may decrease the absorption of this medication, so it should be taken with plain water. - To avoid esophageal ulcers, do not chew or suck on it. If a patient forgets to take a dose on the scheduled date: - If more than 8 days remain until the next scheduled dose, take one tablet the next morning after recognizing the missed dose, and from then on continue to take one tablet monthly on the originally scheduled date. - If 7 days or less remain until the next scheduled dose, take one tablet on the next scheduled date and continue taking one tablet monthly on the previously scheduled dates. - Do not take two tablets in the same week. Patients with inadequate dietary intake should supplement with calcium or vitamin D. Hepatic impairment No dose adjustment necessary. Renal impairment Patients with mild or moderate renal impairment with creatinine clearance over 30 mL/min do not need dose adjustment, however, for patients with creatinine clearance below 30 mL/min, clinical experience is insufficient, and administration of this drug is not recommended. Elderly No dose adjustment necessary. Pediatric and adolescent The safety and efficacy in children under 18 years old have not been studied.

Child dose

The safety and efficacy in children under 18 years old have not been studied.

This medication should not be administered to certain patients.\nFirstly, patients who are allergic to this drug or its components should not use it.\nAdditionally, patients with low blood calcium levels must normalize their calcium levels before administering this drug.\nPatients must remain upright for at least 60 minutes after taking the medication, and it is not recommended for patients who cannot maintain this position.\nPatients with esophageal dysfunction that prevents food from passing properly should also not take this drug.\nThis medication contains lactose, so those with lactose intolerance or related genetic disorders should avoid taking it.\nPatients with severe renal failure should use this drug cautiously, and administration should be decided based on a doctor’s judgment.\nThis medication may irritate the gastrointestinal tract, potentially causing symptoms like dyspepsia, nausea, abdominal pain, and diarrhea.\nSymptoms such as headache, muscle pain, joint pain, and rash have also been reported.\nRarely, serious gastrointestinal issues like esophagitis and esophageal ulcers may occur; consult healthcare personnel immediately if these symptoms appear.\nDuring the course of taking this medication, do not take it with food or antacids, or iron supplements containing calcium, and avoid food or other medications for at least 1 hour after taking this drug.\nOsteonecrosis of the jaw, a serious side effect, may rarely occur, so it is important to consult a doctor before any dental procedures.\nThere is also a possibility of eye inflammation, so if there are any abnormal symptoms in the eyes, seek medical attention immediately.\nPregnant or breastfeeding women are advised not to use this medication due to unverified safety.\nThe elderly can use it without special dose adjustments, but its safety and efficacy have not been established for children under 18 years old.\nOverdose may lead to gastrointestinal disturbances and hypocalcemia, and in such cases, contact a medical institution immediately.\nThis medication should be kept out of reach of children, and any unused medication should be disposed of using designated methods to prevent environmental pollution.

Serious side effects

Urticaria, angioedema, facial swelling, hypersensitivity reactions, anaphylactic reactions/shock, exacerbation of asthma, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, uveitis, scleritis, episcleritis, esophageal ulcers, esophageal strictures, esophageal erosions, severe gastrointestinal adverse effects, severe swelling associated with elevated blood pressure, serious allergic reactions, severe cutaneous adverse reactions, serious skin adverse reactions, severe neurological symptoms, severe swelling or

Mild side effects

• Dyspepsia
• nausea
• abdominal pain
• diarrhea
• bloating
• gastroesophageal reflux disease
• headache
• influenza-like illness
• fatigue
• muscle pain

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is safe to store it at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication.

Appearance

White rectangular film-coated tablet

Package unit

1T/PTP