Amicabon Tablet (Sodium Ibandronate Monohydrate)

Adult dose

Take 1 tablet once a month regularly in the morning on the same day of each month at least 1 hour before consuming food, beverages (except water), or other oral medications or dietary supplements (including calcium). This medication must be swallowed while standing or sitting upright with a sufficient amount (180-240 ml) of water, and patients must not lie down for 60 minutes after taking it. If a dose is missed, take the next tablet on the prescribed day.

Child dose

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

This medication should not be used in certain patients. It should not be administered to patients with allergies to this medication or any of its components, patients with untreated hypocalcemia, patients unable to sit or stand upright for more than 60 minutes, patients with esophageal disorders, and patients with lactose intolerance or related genetic disorders. It should be used cautiously in patients with severe renal failure. This medication can irritate the gastrointestinal tract, potentially leading to symptoms such as dyspepsia, nausea, abdominal pain, and diarrhea. Additionally, symptoms such as headache, fatigue, myalgia, arthralgia, and rash have also been reported. In rare cases, serious side effects such as eye inflammation or osteonecrosis of the jaw may occur in some patients. Before taking this medication, it is important to treat hypocalcemia or bone and mineral metabolic disorders, and to ensure adequate intake of calcium and vitamin D. While taking the medication, patients must remain sitting or standing upright for at least 60 minutes and should follow the correct administration procedures to minimize esophageal irritation. Moreover, patients must avoid consuming food or products containing calcium, aluminum, magnesium, or iron within one hour of taking this medication. Caution should be observed when taking this medication alongside non-steroidal anti-inflammatory drugs due to the risk of gastrointestinal irritation. Patients at risk of osteonecrosis of the jaw should undergo dental examinations before beginning treatment and should avoid excessive dental procedures during treatment. This medication is not safe for use in pregnant or nursing women. Safety and efficacy have not been established in children under 18 years old. In case of overdose, gastrointestinal disturbances and hypocalcemia may occur, and immediate consultation with a healthcare provider is advised. Finally, this medication should be kept out of reach of children, and expired medications should be disposed of safely.

Serious side effects

Urticaria, angioedema, facial swelling, esophageal ulcers or strictures, angioedema, urticaria, uveitis, scleritis, anaphylactic reaction/shock, exacerbation of asthma, Stevens-Johnson syndrome, erythema multiforme, bullous pemphigoid, osteonecrosis of the jaw and external auditory canal, atypical subtrochanteric and femoral diaphyseal fractures, atypical fractures of the pelvis

Mild side effects

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. The recommended storage temperature is between 1 to 30 degrees Celsius.

Appearance

White to almost white, rectangular film-coated tablet

Package unit

1 tablet (1 tablet PTP x 1)