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.
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: • Acute Angle Closure Glaucoma [see Warnings and Precautions ( 5.1 )] • Neuropsychiatric Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Eclamptic Seizures in Pregnant Women [see Warnings and Precautions ( 5.3 )] • Gastrointestinal and Urinary Disorders [see Warnings and Precautions ( 5.4 )] • Drug Withdrawal/Post-Removal Symptoms [see Warnings and Precautions ( 5.5 )] • Blurred Vision [see Warnings and Precautions ( 5.6 )] • MRI Skin Burns [see Warnings and Precautions ( 5.7 )] Most common adverse reactions are: • Motion Sickness (>15%): dry mouth, drowsiness, blurred vision and dilation of the pupils.
( 6.1 ) • PONV (≥ 3%): dry mouth, dizziness, somnolence, agitation, visual impairment, confusion, mydriasis and pharyngitis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 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
Scopolamine Transdermal System % (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 *occurring in at least 3% of patients and at a rate higher than placebo 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: hallucinations, disorientation, and paranoia Nervous system disorders : headache, amnesia, coordination abnormalities, speech disorder, disturbance in attention, restlessness General disorders and administration site conditions : application site burning Eye disorders : dry eyes, eye pruritus, angle closure glaucoma, amblyopia, eyelid irritation Skin and subcutaneous tissue disorders : rash generalized, skin irritation, erythema Renal and urinary disorders : dysuria Ear and labyrinth disorders : vertigo
5 WARNINGS AND PRECAUTIONS • Acute Angle Closure Glaucoma : Monitor for increased intraocular pressure in patients with open-angle glaucoma and adjust glaucoma therapy as needed.
Discontinue if signs or symptoms of acute angle closure glaucoma develop.
( 5.1 ) • Neuropsychiatric Adverse Reactions : May cause psychiatric and cognitive effects, seizures and impair mental and/or physical abilities.
Monitor patients for new or worsening psychiatric symptoms during treatment and during concomitant treatment with other drugs that are associated with similar psychiatric effects.
( 5.2 , 7.1 ) • Eclamptic Seizures in Pregnant Women : Avoid use in patients with severe preeclampsia.
Like all medications, Scopolamine Trandermal System 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: