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    IBANDRONATE SODIUM

    IBANDRONATE SODIUM ORAL (BONIVA)

    BOXED WARNING:
    Patients should talk with their healthcare professional about the benefits and risks of taking oral bisphosphonates and how long they should expect to take them. Patients should talk with their healthcare professional if they develop swallowing difficulties, chest pain, new or worsening heartburn, or have trouble or pain when swallowing. Patients should be instructed to carefully follow the directions for use of the oral bisphosphonate drug they are prescribed.

    CONTRAINDICATION:
    FDA notified healthcare professionals and patients of an update to the drug label for Reclast (zoledronic acid) regarding the risk of kidney failure.

    BEFORE USING THIS MEDICINE: Tell your doctor: TOP
    If you are PREGNANT.
    Tell your doctor if you are having any of the following conditions: TOP
    THROAT (ESOPHAGUS) PROBLEMS; KIDNEY DISEASE; PEPTIC ULCER.
    * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding.
    * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use.
    HOW MEDICINE IS ADMINISTERED? TOP
    Use this medicine exactly as directed on the label, unless instructed differently by your doctor
    * Patient should read specific "MEDICATION GUIDE" provided with this medicine before starting treatment and each time their prescription is renewed.
    * Take with water at least 60 minutes before the first food, beverage, or medication of the day.
    * DO NOT lie down for at least 60 minutes after taking dose.
    * Swallow whole, DO NOT chew or break tablets.
    * This medicine should be taken WITH a full glass of water (6-8oz).
    * Talk to your physician about weight-bearing exercises which may improve your condition.
    * Take calcium and vitamin D supplements, if dietary intake is inadequate, unless otherwise instructed by your physician.
    WARNINGS/PRECAUTIONS: TOP
    * STOP TAKING MEDICINE & GET EMERGENCY HELP IMMEDIATELY IF A HYPERSENSITIVITY OR ANAPHYLACTIC REACTION occurs: (see symptoms below):-
    * shortness of breath, fast or irregular breathing, fever, joint pain, fast pulse, lightheadedness or fainting, swelling of face, hives, & itching.
    * Safety of use during pregnancy has not been established. This medicine SHOULD NOT BE USED DURING PREGNANCY unless benefit justifies potential risk to the fetus. CALL YOUR DOCTOR.
    * Smoking or drinking alcohol may worsen your condition.
    * This medication may cause stomach or intestine bleeding and ulceration. Contact your doctor immediately if heartburn or stomach discomfort occurs.
    * SPECIAL POPULATIONS:
    * Patients with Renal Impairment: Not recommended for use in patients with severe renal impairment (Creatinine Clearance <30 ml/minute).
    ADVERSE REACTIONS: Stop taking this medicine and get emergency help IMMEDIATELY if you experience:
    Severe allergic reaction.
    Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience:
    Chest pain; Heartburn; Difficulty swallowing.
    Other Common Side Effects: TOP
    Diarrhea; Indigestion; Back pain; Headache; Memory difficulty; Dizziness; Vomiting.
    Other Common Side Effects:
    If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY.
    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
    This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients.



    Copyright © CliniDATA Source, Inc. 03/14. All rights reserved


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