Apo-Alendronate/Vitamin D3 Special Precautions

BEFORE using APO-ALENDRONATE / VITAMIN D₃, the patient should talk to the doctor or pharmacist if he/she: Has cancer, gum disease, poor oral hygiene, or diabetes; gets chemotherapy or radiotherapy; takes corticosteroids or immunosuppressive drugs; takes angiogenesis inhibitors that slow down the growth of new blood vessels and are used mostly to treat cancer (e.g. bevacizumab); is or has been a smoker; is a heavy alcohol user.
If any of the previously mentioned are applicable, have a dental check-up before starting APO-ALENDRONATE / VITAMIN D₃.
Has or has had any medical problems including known kidney disease; has or has had any dental problems; has any allergies; has any swallowing or digestive problems.
Osteonecrosis of the external auditory canal: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infection.
Warning on the possible risk of atypical thigh bone (femur) fractures; Optimal duration of use of bisphosphates for treatment and prevention of osteoporosis is uncertain.
Digestive problems: Some patients may experience digestive problems while taking APO-ALENDRONATE / VITAMIN D₃, which may be severe, including irritation or ulceration of the esophagus, which can cause chest pain, heartburn or difficulty or pain upon swallowing. These reactions may occur especially if patients do not drink the recommended amount of water with APO-ALENDRONATE / VITAMIN D₃ and/or if they lie down in less than 30 minutes or before their first food of the day.
The patient should talk to the doctor: If he/she has ear pain and/or discharge from the ear while taking APO-ALENDRONATE / VITAMIN D₃ as these could be signs of bone damage in the ear.
Effect on ability to drive or operate machinery: There have been side effects reported with APO-ALENDRONATE / VITAMIN D₃ that may affect the ability to drive or operate machinery. Individual responses to APO-ALENDRONATE / VITAMIN D₃ may vary.
Use in Pregnancy & Lactation: Do not take APO-ALENDRONATE / VITAMIN D₃ if pregnant or breast-feeding.
Use in Children: APO-ALENDRONATE / VITAMIN D₃ is not indicated for anyone under 18 years of age and should not be given to them.
Use in the Elderly: APO-ALENDRONATE / VITAMIN D₃ works equally well in, and is equally well tolerated by, patients older and younger than 65 years of age.