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warnings
WARNINGS Reye’s Syndrome may develop in individuals who have chicken pox, influenza, or flu symptoms. Some studies suggest possible association between the development of Reye’s Syndrome and the use of medicines containing salicylate or aspirin. Orphengesic Forte Tablets (Orphenadrine Citrate, Aspirin and Caffeine Tablets 50 mg/ 770 mg/ 60 mg) contain aspirin and therefore are not recommended for use in patients with chicken pox, influenza, or flu symptoms. Orphengesic Forte Tablets may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly. Aspirin should be used with extreme caution in the presence of peptic ulcers and coagulation abnormalities. Usage in Pregnancy Since safety of the use of this preparation in pregnancy, during lactation, or in the child-bearing age has not been established, use of the drug in such patients requires that the potential benefits of the drug be weighed against its possible hazard to the mother and child. Usage in Children The safe and effective use of this drug in children has not been established. Usage of this drug in children under 12 years of age is not recommended.
ADVERSE REACTIONS Side effects of Orphengesic Forte Tablets are those seen with aspirin and caffeine or those usually associated with mild anti-cholinergic agents. These may include tachycardia, palpitation, urinary hesitancy or retention, dry mouth, blurred vision, dilation of the pupil, increased intraocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, and rarely, urticaria and other dermatosis. Infrequently, an elderly patient may experience some degree of confusion. Mild central excitation and occasional hallucinations may be observed. These mild side effects can usually be eliminated by reduction in dosage. One case of aplastic anemia associated with the use of orphenadrine citrate, aspirin and caffeine has been reported. No causal relationship has been established. Rare G.I. hemorrhage due to aspirin content may be associated with the administration of Orphengesic Forte Tablets. Some patients may experience transient episodes of light-headedness, dizziness or syncope.