Kenyan Health Patient Information Leaflet
Non-opioid analgesic / antipyretic
Therapeutic use is agent- and indication-specific within the class (Non-opioid analgesic / antipyretic). Use according to culture results, national guidelines (Kenya STG/EML where applicable) and the current product SmPC. Spastic Pain
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.
[Aceclofenac] Dyspepsia, nausea, fluid retention, raised BP. Serious: peptic ulcer/bleed, AKI, heart failure exacerbation, severe skin reactions, bronchospasm, hepatitis (rare). [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.