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 In view of the small amount of atropine present (0.025 mg/tablet), such effects such as dryness of the skin and mucous membranes, flushing, hyperthermia, tachycardia and urinary retention are very unlikely to occur, except perhaps in children.
Many of the adverse effects reported during clinical investigation of MOTOFEN ® are difficult to distinguish from symptoms associated with the diarrheal syndrome.
However, the following events were reported at the stated frequencies: Gastrointestinal: Nausea, 1 in 15 patients;
vomiting, 1 in 30 patients;
dry mouth, 1 in 30 patients;
epigastric distress, 1 in 100 patients;
and constipation, 1 in 300 patients.
Central Nervous System: Dizziness and light-headedness, 1 in 20 patients;
drowsiness, 1 in 25 patients;
and headache, 1 in 40 patients;
WARNINGS MOTOFEN ® IS NOT AN INNOCUOUS DRUG AND DOSAGE RECOMMENDATIONS SHOULD BE STRICTLY ADHERED TO.
MOTOFEN ® IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE.
OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH (SEE OVERDOSAGE ).
THEREFORE, KEEP THIS MEDICATION OUT OF THE REACH OF CHILDREN.
FLUID AND ELECTROLYTE BALANCE – THE USE OF MOTOFEN® DOES NOT PRECLUDE THE ADMINISTRATION OF APPROPRIATE FLUID AND ELECTROLYTE THERAPY.
Like all medications, Motofen 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: