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ABSTRAL® (fentanyl) Sublingual Tablets CII, First-in-class, Sublingual, Immediate Release Opioid for Managing Breakthrough Cancer Pain, Now Available in the U.S.
Date:4/4/2011

pain after surgery, headache, migraine, or dental pain.

Do not take ABSTRAL if you are allergic to any of the ingredients in ABSTRAL.

Tell your doctor about all of your medical and mental health problems. If you have trouble breathing or lung problems such as asthma, wheezing, or shortness of breath, ABSTRAL may cause more serious breathing problems.

Do not take any medicine while using ABSTRAL until you have talked to your healthcare provider. Be very careful about taking other medicines that may make you sleepy, such as other pain medicines, anti-depressants, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers. Also, do not drink alcohol while using ABSTRAL.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABSTRAL affects you. ABSTRAL can make you sleepy. Ask your healthcare provider when it is ok to do these activities.

ABSTRAL is only available through a program called the ABSTRAL REMS program. To receive ABSTRAL, you must talk to your healthcare provider, understand the benefits and risks of ABSTRAL, agree to all of the instructions, and sign the Patient-Prescriber Agreement form.

You or a family member should call your healthcare provider or get emergency medical help right away if you:

  • Have trouble breathing
  • Have drowsiness with slowed breathing
  • Have shallow breathing (little chest movement with breathing)
  • Feel faint, very dizzy, confused, or have other unusual symptoms

These symptoms can be a sign that you have taken too much ABSTRAL or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not take any more ABSTRAL until you have talked to your healthcare provider.

ABSTRAL can cause your blood pressure to drop. This can make you feel dizzy or lightheaded if you get up too
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SOURCE ProStrakan Group plc
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