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FDA Approves Shared REMS (Risk Evaluation and Mitigation Strategy) Program for all TIRF (Transmucosal Immediate Release Fentanyl) Pain Treatments
Date:12/30/2011

lems are more likely to occur in patients with underlying breathing problems, elderly patients, or impaired or weak patients.  These problems usually occur after large initial doses in patients who are not opioid tolerant or when opioids are given with other medicines that that slow breathing.

ABSTRAL is made with the prescription medicine fentanyl.  Your healthcare provider will prescribe a starting dose of ABSTRAL that may be different than other fentanyl-containing medicines you may have been taking.  Do not switch from ABSTRAL to other medicines that contain fentanyl without talking with your healthcare provider.

ABSTRAL is a federally controlled substance (CII) because it is a strong opioid (narcotic) pain medicine that can be misused by people who abuse prescription medicines or street drugs.

Never give ABSTRAL to anyone else, even if they have the same symptoms you have.  It may harm them or cause death.

Do not take ABSTRAL for short-term pain that you would expect to go away in a few days, such as 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
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SOURCE ProStrakan, Inc.
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