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; tiredness, nervousness, insomnia and confusion ranged from 1
in 200 to 1 in 600 patients.
Other less frequent reactions: Burning eyes and
blurred vision occurred in a few cases.
The following adverse reactions have been reported in
patients receiving chemically-related drugs: numbness of extremities, euphoria,
depression, sedation, anaphylaxis, angioneurotic edema, urticaria, swelling of
the gums, pruritus, toxic megacolon, paralytic ileus, pancreatitis, and
THIS MEDICATION SHOULD BE KEPT IN A CHILD-RESISTANT
CONTAINER AND OUT OF THE REACH OF CHILDREN SINCE AN OVERDOSAGE MAY RESULT IN
SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN
DAMAGE OR DEATH.
Drug Abuse And Dependence
MOTOFEN® tablets are a Schedule IV controlled substance.
Addiction to (dependence on) difenoxin hydrochloride is
theoretically possible at high dosage. Therefore, the recommended dosage should
not be exceeded. Because of the structural and pharmacological similarities of
difenoxin hydrochloride to drugs with a definite addiction potential, MOTOFEN® should
be administered with considerable caution to patients who are receiving
addicting drugs, to individuals known to be addiction prone, or to those in
whom histories suggest may increase dosage on their own initiative.