Effects of this medicine

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 [esophageal stenosis, achalasia (achalasia of esophagus), etc.], hypocalcemia.
• If you cannot keep your body in an upright position or stand for more than 30 minutes.

• If you are 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 (35 mg of alendronate) at a time with approximately 180 mL of water, once a week at the time of awakening in the morning. Avoid lying down, eating/drinking (except water) and taking other medicines for at least 30 minutes after taking this medicine. Strictly follow the instructions.
• Do not take this medicine with drinks other than water (including mineral water high in calcium/magnesium content), foods or other medicines.
• This medicine may cause ulcer in your mouth or throat, do not chew this medicine or dissolve it in the mouth.

• If you miss a dose, take 1 tablet in the morning after the day you notice. Take the next dose on a prespecified day of the week, and then continue your regular dosing schedule. 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

• Try to ingest enough calcium through meals, etc.
• Consult with your doctor, and receive dental checkup before starting this medicine if needed. If possible, have your dental treatment, such as tooth extraction, completed before taking this medicine.
• Maintain your oral hygiene by brushing your teeth and receive dental checkup regularly while taking this medicine.
• When you visit a dentist, tell the dentist that you are taking this medicine and try to avoid treatments such as tooth extraction as much as possible.

Possible adverse reactions to this medicine

• swallowing difficulty, pain on swallowing, vomiting of blood [esophageal/intraoral disorder, gastric/duodenal disorder]
• general malaise, loss of appetite, yellow discoloration of the skin and the white of eyes [liver dysfunction, jaundice]
• fever, redness and swelling of skin/mucosa with rash or blisters, conjunctival hyperemia [toxic epidermal necrolysis, mucocutaneous ocular syndrome]
• jaw pain, loose teeth, gum swelling [jaw bone necrosis/jaw osteomyelitis ]
• otitis externa, ear discharge (otorrhea), ear pain [osteonecrosis of the external ear canal]
• pain in the thigh or inguinal region [atypical subtrochanteric and proximal femoral shaft fractures]

Storage conditions and other information

• Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
• Discard the remainder. Do not store them. Ask your pharmacy or medical institution on how to discard the remainder.

For healthcare professional use only : Day Month Year