Ibandronate Sodium Hydrate 150 mg Tablets

Adult dose

One tablet is to be taken regularly once a month in the morning at the same time with sufficient water at least 1 hour before food, beverages (excluding water), other oral medications, or dietary supplements (including calcium). It must be swallowed with a sufficient amount (180-240 mL) of water while standing or sitting upright, and patients should not lie down for 60 minutes after taking it. It should not be chewed or sucked. In case of a missed dose: - If there are more than 8 days left until the next scheduled dosing date, the patient should take one tablet the morning after realizing the missed dose, and then continue taking one tablet at the previously scheduled dosing date each month. - If there are 7 days or less left until the next scheduled dosing date, the patient should take one tablet on the next scheduled dosing date and continue taking one tablet at the previously scheduled dosing date each month. - Two tablets should not be taken within the same week. Patients with inadequate dietary intake should supplement calcium or vitamin D.

Child dose

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

This medication should not be used in certain patients. For example, those who are allergic to this drug or its components, patients with untreated hypocalcemia, individuals who cannot remain upright or sit for more than 60 minutes, those with esophageal dysfunction that prevents food from descending properly, and individuals with genetic issues like lactose intolerance should not take this medication. In patients with severe renal failure, this drug should be administered with caution, and it is essential to consult with a doctor before use. When taking this medication, gastrointestinal discomfort, nausea, abdominal pain, and diarrhea may occur. Headache, myalgia, arthralgia, and rash have also been reported. Some patients may temporarily experience flu-like symptoms, but these are generally mild and resolve without treatment. Serious esophageal issues such as esophagitis, esophageal ulcers, and dysphagia may occur, so it is crucial to remain upright or sitting for at least 60 minutes after taking the medication, and if there is pain or discomfort while swallowing, the medication should be stopped immediately and medical advice should be sought. This medication may be hindered in its absorption when taken with calcium, milk, or antacids, so it is important not to consume food or other drugs for at least one hour after taking it. Rare side effects such as osteonecrosis of the jaw have been reported, so it is advisable to have a dental examination before starting this medication and to avoid excessive dental treatment during its use. Also, long-term use of this medication may rarely lead to atypical fractures of the femur or other bones, so if there is pain in the thigh or groin, it is important to consult a doctor. It is advisable not to take this medication during pregnancy or breastfeeding, and its safety in children under 18 has not been established. If any adverse reactions or uncomfortable symptoms occur while taking this medication, consult with healthcare professionals immediately.

Serious side effects

• Urticaria, angioedema, facial swelling → severe allergic reaction
• Esophageal ulcers or strictures, including esophagitis
• Angioedema, urticaria → severe allergic reaction
• Uveitis, scleritis, inflammation of the eye
• Anaphylactic reactions/shock → severe allergic reaction
• Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis → severe skin reactions
• Angioedema, urticaria → severe allergic reaction
• Osteonecrosis of the jaw → severe

Mild side effects

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

This medication can be sensitive to air and moisture, so it must be stored in a tightly closed container. The storage temperature should be kept between 1°C and 30°C at room temperature, which helps maintain the effectiveness of the drug for a long time.

Appearance

White rectangular film-coated tablet

Package unit

1 tablet/PTP