Ibandren 150 mg (Ibandronic Acid Sodium Hydrate)

Adult dose

Take 1 tablet once a month regularly on the same morning of each month, at least 1 hour before eating food, drinking beverages (other than water), or taking 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 should not be lying down for 60 minutes after taking it. - Sparkling water may reduce the absorption of this medication, so it should be taken with plain water. - Chewing or sucking should be avoided to prevent esophageal ulcers. If a patient forgets to take the dose on the scheduled day: - If there are more than 8 days remaining until the next scheduled dose, take 1 tablet the following morning after recognizing that a dose has been missed, and then continue to take 1 tablet on the previously scheduled day each month. - If there are 7 days or less remaining until the next scheduled dose, take 1 tablet on the next scheduled day and continue to take 1 tablet on the previously scheduled day each month. - Do not take 2 tablets within the same week. Patients with inadequate dietary intake should supplement with calcium or vitamin D. Patients with liver impairment No dosage adjustment is required. Patients with kidney impairment Patients with mild to moderate renal impairment (creatinine clearance greater than 30 mL/min) do not require dosage adjustment; however, the administration of this medication is not recommended for patients with clearance less than 30 mL/min due to insufficient clinical experience. Elderly No dosage adjustment is required. Children and adolescents Efficacy and safety have not been studied in children under 18 years of age.

Child dose

Administration is not recommended for children under 18 years of age as efficacy and safety have not been studied.

This medication should not be administered to certain patients. Firstly, patients who are allergic to this medication or any of its components should not use it. Additionally, untreated hypocalcemia can make taking this medication risky. Patients who cannot maintain an upright position for at least 60 minutes after taking the medication should not use it. Patients with esophageal conditions that prevent swallowing, such as esophageal strictures or achalasia, should also avoid this medication. This medication contains lactose, so patients with lactose intolerance, galactose intolerance, or certain genetic metabolic disorders should refrain from taking it. Caution is advised when administering this medication to patients with severe renal failure; careful monitoring by a doctor is required in this case. Common side effects when taking this medication may include dyspepsia, nausea, abdominal pain, diarrhea, headaches, muscle pain, joint pain, rashes, or others. Some patients may experience flu-like symptoms, such as joint pain, muscle pain, fever, chills, and fatigue, temporarily. Furthermore, gastrointestinal issues, such as esophagitis, esophageal ulcers, or esophageal strictures, may occur; therefore, if symptoms like difficulty swallowing, pain while swallowing, chest pain, or heartburn appear, immediate cessation of the medication and a consultation with a doctor is necessary. This medication may irritate the gastric mucosa, so patients with upper gastrointestinal disorders such as gastritis or duodenitis should use it with caution. Bisphosphonate medications can be associated with osteonecrosis of the jaw; thus, it is recommended to have a dental examination before any dental treatments and to avoid excessive dental treatments during the course of treatment. There have also been rare reports of inflammatory conditions of the eye, severe allergic reactions, skin conditions, and atypical fractures of the femur; thus, if any of these symptoms occur, immediate consultation with medical professionals is necessary. This medication may hinder the absorption of calcium, milk, antacids, etc.; therefore, do not take food or other medications for at least 1 hour after taking it. The safety of this medication during pregnancy or breastfeeding has not been established; it is advisable not to use it if pregnant or breastfeeding. No special dosage adjustment is required for the elderly, but safety and efficacy have not been confirmed for children under 18 years of age. In case of overdose, gastrointestinal disturbances or hypocalcemia may occur, so it is important to avoid exceeding the recommended dose. Finally, this medication should be stored out of reach of children, and unused medications should be disposed of properly to prevent environmental contamination.

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rashes with high fever, blisters, peeling skin, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory disturbances accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, lightning-like headaches, seizures, confusion, visual disturbances,

Mild side effects

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. Also, avoid storing it in extremely hot or cold places, and it is advisable to keep it at room temperature between 1°C and 30°C. Proper storage will help maintain the effectiveness of the medication.

Appearance

[For domestic] White to nearly white, oblong film-coated tablet [For export] Pink, oblong film-coated tablet

Package unit

1 tablet/PTP