Kenyan Health Patient Information Leaflet
Non-opioid analgesic / antipyretic
Mild to moderate pain associated with muscle tension. Clinical selection for Paracetamol / Chlorzoxazone should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC. Class context: Non-opioid analgesic / antipyretic. Confirm site-specific dose, duration and monitoring before prescribing.
Dosing is indication-, age-, weight- and organ-function-specific for this INN. Do not use class averages for high-risk patients. Confirm the exact regimen in the current SmPC and Kenya Standard Treatment Guidelines. Typical professional workflow: (1) confirm indication, (2) check renal/hepatic function, (3) screen interactions/allergies, (4) select dose/route/duration, (5) define monitoring.
[Paracetamol] Rare at therapeutic doses. Serious: acute liver failure in overdose, rare severe skin reactions (SJS/TEN/AGEP). [Chlorzoxazone] ADVERSE REACTIONS Chlorzoxazone containing products are usually well tolerated. It is possible in rare instances that chlorzoxazone may have been associated with gastrointestinal bleeding. Drowsiness, dizziness, lightheadedness, malaise, or over-stimulation may be noted by an occasional patient. Rarely, allergic type skin rashes, petechiae, or ecchymoses may develop during treatment. Angioneurotic edema or anaphylactic reactions are extremely rare. There is no evidence that the drug will cause renal damage. Rarely, a patient may note discoloration of the urine resulting from a phenolic metabolite of chlorzoxazone. This finding is of no known clinical significance. To report SUSPECTED ADVERSE EVENTS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800- FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
Store as labelled. Keep out of reach of children.