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Skin burns have been reported at the application site in patients wearing an aluminized transdermal system during an MRI scan. It may harm them.You can ask your pharmacist or doctor for information about scopolamine transdermal system that is written for health professionals.Inactive ingredients: peach-colored polyethylene/polyester film, polypropylene, povidone and silicone adhesive. Weigh this potential risk against the benefits before prescribing scopolamine transdermal system to patients with a history of seizures, including those receiving anti-epileptic medication or who have risk factors that can lower the seizure threshold.Scopolamine can cause drowsiness, disorientation, and confusion. Pediatric patients are particularly susceptible to the adverse reactions of scopolamine; including mydriasis, hallucinations, amblyopia and drug withdrawal syndrome.
*occurring in at least 3% of patients and at a rate higher than placeboThe following adverse reactions have been identified during post-approval use of scopolamine transdermal system. Instruct patients to seek medical attention if they experience severe symptoms.Scopolamine can cause temporary dilation of the pupils resulting in blurred vision if it comes in contact with the eyes.Advise patients to wash their hands thoroughly with soap and water and dry their hands immediately after handling the transdermal system The following serious adverse reactions are described elsewhere in labeling: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.The most common adverse reaction (approximately two thirds) was dry mouth. These symptoms can be severe and may require medical intervention.In cases of toxicity remove the scopolamine transdermal system. This information does not take the place of talking to your doctor about your medical condition or your treatment.Scopolamine transdermal system is a prescription medicine used for adults to help prevent:It is not known if scopolamine transdermal system is safe or effective in children.Before you use scopolamine transdermal system, tell your doctor about all of your medical conditions, including if you:Ask your doctor if you are not sure if your medicine is one that is listed above.Know the medicines you take. Serious symptomatic cases of overdosage involving multiple transdermal system applications and/or ingestion may be managed by initially ensuring the patient has an adequate airway and supporting respiration and circulation. If there is evidence of transdermal system ingestion, endoscopic removal of swallowed transdermal systems, or administration of activated charcoal should be considered, as indicated by the clinical situation.

Less common adverse reactions, included drowsiness (less than one sixth), blurred vision and dilation of the pupils.Common adverse reactions, occurring in at least 3% of patients in PONV clinical trials are shown in Table 1.The following adverse reactions have been identified during post-approval use of scopolamine transdermal system.

Neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported.Clinical trials of scopolamine transdermal system did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects.
In any case where there is serious overdosage or signs of evolving acute toxicity, continuous monitoring of vital signs and ECG, establishment of intravenous access, and administration of oxygen are all recommended.The signs and symptoms of overdose/toxicity due to scopolamine should be carefully distinguished from the occasionally observed syndrome of withdrawal If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Because there have been no consistent reports of adverse events in breastfed infants over decades of use, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for scopolamine transdermal system and any potential adverse effects on the breastfed child from scopolamine transdermal system or from the underlying maternal condition.Safety and effectiveness in pediatric patients have not been established.
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