Scopolamineside effects

The following serious adverse reactions are described elsewhere in labeling:

Acute Angle Closure Glaucoma

Neuropsychiatric Adverse Reactions

Eclamptic Seizures in Pregnant Women

Gastrointestinal and Urinary Disorders

Hyperthermia

Drug Withdrawal/Post-Removal Symptoms

Blurred Vision

MRI Skin Burns Most common adverse reactions are:

Motion Sickness (>15%): dry mouth, drowsiness, blurred vision and dilation of the pupils.

PONV (≥ 3%): dry mouth, dizziness, somnolence, agitation, visual impairment, confusion, mydriasis and pharyngitis. To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Motion Sickness The most common adverse reaction (approximately two thirds) was dry mouth. Less common adverse reactions, included drowsiness (less than one sixth), blurred vision and dilation of the pupils. PONV Common adverse reactions, occurring in at least 3% of patients in PONV clinical trials are shown in Table 1. Table 1 Common Adverse Reactions* in Surgical Patients for the Prevention of PONV *occurring in at least 3% of patients and at a rate higher than placebo TRANSDERM SCŌP % (N = 461) Placebo % (N = 457) Dry mouth 29 16 Dizziness 12 7 Somnolence 8 4 Agitation 6 4 Visual Impairment 5 3 Confusion 4 3 Mydriasis 4 0 Pharyngitis 3 2

6.2 Postmarketing

Experience The following adverse reactions have been identified during post-approval use of scopolamine transdermal system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Psychiatric disorders: acute psychosis including: disorientation, hallucinations, and paranoia Nervous system disorders: amnesia, coordination abnormalities, disturbance in attention, headache, restlessness, speech disorder General disorders and administration site conditions: application site reactions (including blistering, burning, pruritus, and rash) and hyperthermia Eye disorders: amblyopia, angle closure glaucoma, dry eyes, eyelid irritation, eye pruritus Skin and subcutaneous tissue disorders: erythema, rash generalized, skin irritation Renal and urinary disorders: dysuria Ear and labyrinth disorders: vertigo