Hani Banjeong 150mg (Ibandronic Acid Sodium Monohydrate)

Adult dose

Take 1 tablet once a month regularly on the same morning at least 1 hour before consuming food, drinks (excluding water), or other oral medications or dietary supplements (including calcium) with a sufficient amount of water. This medication should be swallowed while standing or sitting upright with enough water (180-240 ml), and lying down for 60 minutes after taking it is prohibited. If a dose is missed, on the day after realizing the missed dose, take 1 tablet if there are more than 8 days until the next scheduled dose, and thereafter continue to take 1 tablet on the originally scheduled monthly dose date. If it is within 7 days until the next scheduled dose, take 1 tablet on the next scheduled dose date and continue to take 1 tablet on the originally scheduled monthly doses thereafter. Do not take 2 tablets in the same week. Patients with inadequate dietary intake should supplement with calcium or vitamin D. In patients with liver impairment, dosage adjustment is not necessary. In patients with renal impairment, those with mild or moderate renal impairment and with a creatinine clearance above 30 mL/min do not require dosage adjustment; however, for patients below 30 mL/min, due to insufficient clinical experience, administration of this medication is not recommended. For elderly patients, dosage adjustment is not necessary. Efficacy and safety in children and adolescents have not been studied.

Child dose

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

This medication should not be used in certain patients. For example, it should not be administered to patients allergic to this medication or its ingredients or those with untreated hypocalcemia. Additionally, patients who cannot sit or stand upright for at least 60 minutes or those who have esophageal issues that make it difficult for food to pass should not take this medication. This medication contains lactose, so it should not be used in patients with lactose intolerance or certain genetic issues. It should be administered with caution in patients with severe renal impairment, as a physician's judgment is required. Gastrointestinal side effects may occur when taking this medication, with reports of dyspepsia, nausea, abdominal pain, diarrhea, etc. Some patients may exhibit influenza-like symptoms, muscle pain, joint pain, or rashes. Rarely, symptoms such as esophagitis, esophageal ulcers, dizziness, and low back pain may also occur, so if symptoms appear, immediate consultation with a healthcare provider is necessary. Serious adverse effects, such as eye inflammation or osteonecrosis of the jaw, have been reported rarely, so if unusual symptoms occur, seek medical attention immediately. Prior to taking this medication, hypocalcemia or bone and mineral metabolism disorders must be treated first, and it is important to ensure adequate intake of calcium and vitamin D. Be sure to follow the prescribed dosage and administration guidelines, and for at least 60 minutes after taking the medication, avoid consuming food, calcium, magnesium, iron, or other products for proper absorption of the drug. Caution is advised when taken in conjunction with non-steroidal anti-inflammatory drugs due to the risk of gastrointestinal irritation. This medication is not recommended for use in pregnant or breastfeeding women, and safety has not been established in children under 18 years old. Store the medication out of children's reach, and do not transfer it to another container. Dispose of unused medication properly to prevent environmental pollution.

Serious side effects

Urticaria, severe swelling (edema), angioedema, facial swelling, chest tightness, difficulty breathing, cold sweat, pallor (severe allergic reaction), severe cutaneous adverse reactions (severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain), jaundice (yellowing of the skin or eyes), profound generalized malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis (severe nephropathy)

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 sealed container to protect it from air or moisture. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's efficacy and safety.

Appearance

White to almost white rectangular film-coated tablet

Package unit

1 tablet (1 tablet/PTP X 1)