くすりのしおり

Internal
Revised: 7/2016

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
Bonviva Tablet 100mg
 Active ingredient:
Ibandronate sodium hydrate
 Dosage form:
white tablet, major axis: approx. 12.2 mm, minor axis: approx. 6.2 mm, thickness: approx. 4.5 mm
 Print on wrapping:
ボンビバ錠 100 mg

Effects of this medicine

This medicine suppresses bone resorption by osteoclasts in the bone, thereby increasing bone density and preventing bone fractures.
It is usually used to treat osteoporosis.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have disorders that delay passage through the esophagus, such as esophageal stenosis.
    If you cannot keep your body in an upright position for at least 60 minutes after taking this medicine.
    If you have hypocalcemia, swallowing difficulty (hard to swallow), esophagitis, gastritis, duodenitis, esophageal ulcer, gastric ulcer, duodenal ulcer or renal disorder.
  • If you are pregnant, possibly pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • In general, for adults, take 1 tablet (100 mg as ibandronate) at a time with a glass of water (approximately 180 mL), once a month, when you wake up (before taking breakfast). For at least 60 minutes after taking this medicine, do not lie down, and avoid eating, drinking fluids other than water (do not drink mineral water high in calcium or magnesium content) and taking other medicines. Strictly follow the instructions.
  • This medicine may cause adverse reactions in the mouth, throat or esophagus. Take this medicine after keeping your body in an upright position, and do not chew or dissolve this medicine in the mouth.
  • Do not take this medicine at bedtime or before getting out of bed.
  • If you miss a dose, do not take the medicine on the same day, but take 1 tablet the next morning. From the next dose, take the medicine once a month, counting from the day you took the missed dose. You should never take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • If you become pregnant or may have become pregnant while taking this medicine, consult with your doctor or pharmacist immediately.
  • Try to take enough calcium and vitamin D through meals, etc.
  • Abnormalities in the jaw bone may occur while taking bisphosphonates, including this medicine. Such adverse reactions have been reported often related to dental treatment such as tooth extraction, so receive adequate explanations about the following points from your doctor or pharmacist:
    - Consult with your doctor, and then receive dental checkup before taking this medicine if needed. If possible, have your dental treatment, such as tooth extraction, completed before taking this medicine.
    - Keep your mouth clean by brushing your teeth.
    - Receive dental checkup regularly.
    - When you visit a dentist, tell the dentist that you are taking this medicine.
    - Try to avoid treatments such as tooth extraction as much as possible while taking the medicine.
    - If abnormalities are identified in the teeth/jaw (such as jaw pain, loose teeth or swollen gums), visit a dentist/oral surgery specialist immediately.
  • Abnormalities in the bone of the external ear canal may occur while taking bisphosphonates. According to some cases reporting such an adverse reaction, the development of the reaction has been associated with ear infection or wound. If symptoms such as ear itch, heat sensations inside the ear, strange sensations in the ear, otorrhea and ear pain persist, visit an otolaryngologist.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include diarrhea, back pain, headache, joint pain and malaise. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, see your doctor immediately.
  • hard to swallow, pain on swallowing, fever, chest pain, abdominal pain, back pain, belching, heartburn, nausea, vomiting, vomiting of blood, bloody stool, black stool  [upper gastrointestinal disorder]
  • general malaise, light headedness, decreased consciousness, impaired mind, hot flush, facial pallor, swelling around eyes and lips, hoarseness, breathing difficulty, shortness of breath, palpitation, hives, impaired judgment [anaphylactic shock, anaphylactic reaction]
  • sore mouth, swollen mouth, redness, feeling of loose teeth, loose teeth, numbness of jaw, heavy feeling in the jaw, fever, loss of appetite [jaw bone necrosis/jaw osteomyelitis]
  • ear itch, heat sensations inside the ear, strange sensations in the ear, otorrhea, ear pain [osteonecrosis of the external ear canal]
  • pain in the thigh or inguinal region [atypical subtrochanteric and proximal femoral shaft fractures]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Store away from direct sunlight and moisture. Keep out of the reach of children and store at room temperature (1 to 30 degrees Celsius).
  • Discard the remainder. Do not store them. Ask your pharmacy or medical institution on how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.