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 respiratory dysfunction such as chronic lung disease, asthma, bradyarrhythmia, hepatic or renal function disorder, organic brain disorder (impaired consciousness/coma, brain tumor, etc.), stomatitis/oral hemorrhage/oral mucosal defect.
  If you have history of drug dependence.

• 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, the starting dose for an episode of breakthrough pain is 50 mcg or 100 mcg of fentanyl. Place the tablet at the buccal site (above a rear molar, between the upper cheek and gum) and wait until it dissolves. The optimal dose (50 to 800 mcg) is determined through the titration in a step-by-step manner by your doctor. During the titration period, in cases where the breakthrough pain episode is not relieved with either dose of 50 to 600 mcg, you may take only one additional dose using the same dose for that episode after 30 minutes. Once the optimal dose is determined, in general, for adults, take the optimal dose for an episode of breakthrough pain. The maximum single dose is 800 mcg. You can take for 4 episodes or less of breakthrough pain a day with a 4 hours or more interval to take the next dose. Each tablet contains 800 mcg of fentanyl. Strictly follow the instructions.
• Place the tablet at the alternate sides of your mouth when administering subsequent doses. This medicine is not designed to swallow.
• When your mouth is dry, you can moisten your mouth with a small amount of water before placing the tablet.
• Do not crush, suck, chew or swallow the tablet.
• If remnants from the tablet remain after 30 minutes, you may swallow with a glass of water.
• Because this medicine has moisture absorbency, remove from blister just before use.
• Do not take the tablet which is broken or chipped off when it is removed from blister.
• The tablet removed from mouth should not be left. Dispose it safely with plenty of water. (While you are in hospital, consult with a medical staff.)

• 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 any symptom such as respiratory depression and consciousness disturbance occur, consult with your doctor or pharmacist immediately.
• The medicine may cause drowsiness and dizziness; do not drive a vehicle or operate dangerous machinery.
• Drinking alcohol intensify the effects of the medicine and may cause respiratory depression, hypotension, dizziness, thirst, sedation or coma. Avoid drinking alcohol while you are taking the medicine.
• Some foods and beverages may affect the action of the medicine. Grapefruit juice may intensify the effects of the medicine; do not drink grapefruit juice while you are taking the medicine.
• If you have stomatitis/oral hemorrhage/oral mucosal defect, the risk of adverse effects may be increased. Consult with your doctor or pharmacist.

Possible adverse reactions to this medicine

• unable to stop taking the medicine and be dependent on the subject [dependence]
• shallow and rapid respiration, breathing difficulty [respiratory depression]
• faint-consciousness, distracted mind, impaired judgment [consciousness disturbance]
• breathing difficulty, hives, twilight state [shock, anaphylaxis]
• convulsion [convulsion]

Storage conditions and other information

• Keep the medicine out of the reach of infants, children and pets. Store away from direct sunlight, heat and moisture.
• Do not open the package until you are ready to take the medicine.
• Never give this medicine to anyone else.
• Return tablets which are no longer needed to the hospital or pharmacy. Inquire your hospital or pharmacy about how to return.

For healthcare professional use only : Day Month Year