"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.
The most frequently observed reactions include lightheadedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus, and skin reactions.
Read the Synalgos DC (aspirin, caffeine, and dihydrocodeine bitartrate capsules, usp) Side Effects Center for a complete guide to possible side effects
The CNS-depressant effects of Synalgos-DC may be additive with that of other CNS depressants. See “WARNINGS.” Aspirin may enhance the effects of anticoagulants and inhibit the uricosuric effects of uricosuric agents.
Clinical studies of Synalgos-DC did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects.
In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/4/2013
Additional Synalgos DC Information
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