Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
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.
Orphengesic Forte Tablets may also cause exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrosis (TEN), and fixed drug eruption (FDE) ( see 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.
Like all medications, Orphengesic Forte can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: