Bonjenic Tablet 150 mg (Ibandronate Sodium Hydrate)

Adult dose

Take 1 tablet monthly at the same time each month in the morning, at least 1 hour prior to consuming food, beverages (excluding water), or other oral medications or dietary supplements (including calcium). This medication should be taken with a sufficient amount (180-240 mL) of water while in a standing or sitting position, and one should not lie down for 60 minutes after taking it. Mineral water may reduce the absorption of this medication, so it should be taken with plain water. To prevent esophageal ulcers, it should not be chewed or sucked. If the patient forgets to take the medication on the scheduled day: - If there are 8 days or more remaining until the next scheduled dose, take 1 tablet the following morning after acknowledging the missed dose and then continue taking 1 tablet per month on the previously scheduled dates. - If there are 7 days or less remaining until the next scheduled dose, take 1 tablet on the next scheduled dose and then continue taking 1 tablet per month on previously scheduled dates. - 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 necessary. Patients with kidney impairment Patients with mild to moderate renal impairment with creatinine clearance greater than 30 mL/min do not require dose adjustment; however, for patients with clearance less than 30 mL/min, clinical experience is insufficient to recommend using this medication. Elderly No dosage adjustment is necessary. Children and adolescents Efficacy and safety have not been studied in children under 18 years of age.

Child dose

Efficacy and safety have not been studied in children and adolescents under 18 years of age.

This medication should not be used in certain patients. For example, individuals who are allergic to this medication or its components, those with untreated hypocalcemia, those unable to sit upright or stand for more than 60 minutes, individuals with esophageal dysfunction where food does not pass easily, and those with genetic issues such as lactose intolerance or galactose intolerance should not take this medication. Caution should be exercised in patients with severe renal failure. Individuals with significantly impaired kidney function require particular attention. Some patients may experience various side effects including dyspepsia, nausea, abdominal pain, diarrhea, headache, muscle pain, joint pain, and rash while taking this medication. Most side effects are mild to moderate and may not require discontinuation of treatment. Moreover, this medication can irritate the esophagus and may cause difficulty swallowing, esophagitis, or esophageal ulcers; therefore, it is important to remain upright for at least 60 minutes after taking the medication and strictly adhere to the administration guidelines. As a bisphosphonate, there is a rare risk of osteonecrosis of the jaw, inflammation of the eyes, and severe allergic reactions; thus, patients should consult a physician immediately if any unusual symptoms occur. This medication may have reduced absorption when taken with food, milk, calcium supplements, or antacids; therefore, patients should refrain from consuming other foods or medications for at least 1 hour after taking this medication. Pregnant or nursing women are advised to avoid using this medication as its safety has not been established. Elderly patients do not require special dose adjustment; however, safety and efficacy have not been confirmed in children under 18 years of age, so it is not used in this population. In case of overdose, gastrointestinal disturbances or hypocalcemia may occur, so it is crucial to adhere strictly to the prescribed dosage; immediate medical attention is required if any problems arise. Lastly, this medication should be stored out of the reach of children, and unused medications should be disposed of properly to prevent environmental contamination.

Serious side effects

Hives, severe swelling (angioedema, facial swelling), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by coughing and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances

Mild side effects

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

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly closed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature to preserve the medication's effectiveness.

Appearance

White to almost white rectangular film-coated tablets

Package unit

1 tablet (1 tablet/PTP x 1)