May 24, 2017
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"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.

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  • Advise patients that psychiatric symptoms (paranoia, hostility, mania, depressive, suicidal) and cognitive symptoms (confusion, memory problems, speech disorder) may occur during treatment with PRIALT.
  • Caution patients against engaging in hazardous activity requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle during treatment with PRIALT.
  • Caution patients about possible combined effects with other CNS-depressant drugs. Dosage adjustments may be necessary when PRIALT is administered with such agents because of the potentially additive effects.
  • Advise patients to contact a physician if the patient experiences new or worsening muscle pain, soreness, weakness with or without darkened urine.
  • Instruct patients and their caregivers to contact a physician immediately if the patient has any of the following
    • A change in mental status (e.g., lethargy, confusion, disorientation, decreased alertness)
    • A change in mood, perception (hallucinations, including unusual tactile sensations in the oral cavity)
    • Symptoms of depression or suicidal ideation
    • Nausea, vomiting, seizures, fever, headache, and/or stiff neck, as these may be symptoms of developing meningitis
    • Decreased level of consciousness, unresponsiveness or stupor
    • New muscular symptoms (e.g., muscle cramps, myalgias)
    • Withdrawal symptoms (e.g., nausea, insomnia, flu-like symptoms) as a result of abruptly discontinuing opioid therapy
    • Development of serious skin reaction (e.g., bullous dermatitis, skin ulcers, skin exfoliation)

For use only in the Medtronic SynchroMed® II Infusion System and CADD-Micro Ambulatory Infusion Pump.

Last reviewed on RxList: 4/5/2016
This monograph has been modified to include the generic and brand name in many instances.

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