Ibandronate Tablets (Sodium Ibandronate Hydrate)

Adult dose

Take 1 tablet once a month regularly on the same day in the morning at least 1 hour before consuming food, beverages (excluding water), or other oral medications or dietary supplements (including calcium) with a sufficient amount of water. This medication must be swallowed with sufficient water (180-240 mL) in a standing or upright sitting position, and lying down is not allowed for 60 minutes after taking it. Mineral water may reduce the absorption of this medication.

Child dose

The safety and efficacy in pediatric patients 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 who have allergies to this medication or its components, untreated hypocalcemia, patients who cannot sit or stand upright for more than 60 minutes, and patients with esophageal issues that impede the passage of food. Additionally, this medication contains lactose and should not be used by patients with lactose intolerance or certain genetic conditions. Caution is necessary for patients with severe renal impairment. Side effects such as indigestion, nausea, abdominal pain, diarrhea, headache, muscle pain, joint pain, and rash may occur during the course of treatment. Particularly during initial administration, influenza-like symptoms may appear temporarily and are mostly mild and resolve without treatment. This medication can irritate the gastrointestinal mucosa, potentially leading to severe complications such as esophagitis, esophageal ulcers, and esophageal erosions, so the correct usage should be strictly followed. If difficulty swallowing or chest pain occurs, discontinue use immediately and consult a physician. Being a bisphosphonate, rare side effects such as osteonecrosis of the jaw or external auditory canal osteonecrosis have been reported, so a dental examination before any dental treatment is advisable, and excessive dental treatments during therapy should be avoided. Significant bone, joint, or muscle pain may occur, and rarely, atypical fractures may occur in the femur and other bones, so inform a doctor if these symptoms appear. This medication may interfere with absorption when taken with food or products containing calcium, aluminum, magnesium, or iron, so it should not be taken with such food or medications for at least 1 hour after consumption. It is safe to avoid this medication in pregnant or breastfeeding women. The safety and efficacy in children or adolescents under 18 years have not been established. Overdose may lead to gastrointestinal discomfort or hypocalcemia, so caution is needed with dosage, and do not induce vomiting; remain upright. This medication should be kept out of the reach of children, and unused drugs 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 (including anaphylaxis reactions/shock)
• Severe rash with high fever, blisters, skin peeling, mucosal pain in mouth/eyes (including Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis)
• Difficulty breathing or shortness of breath, asthma attacks, respiratory distress associated with cough + fever
• Jaundice indicated by yellowing of skin or eyes
• Sudden and intense...

Mild side effects

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

This medication should be kept in a tightly closed container to prevent air and moisture from entering. It is recommended to store at room temperature between 1 and 30 degrees Celsius.

Appearance

White to almost white oval film-coated tablets

Package unit

1 tablet/PTP