the effects of transderm scōp [see warnings and precautions ( 5.2 )] . either transderm scōp or the interacting drug should be chosen, depending on the importance of the drug to the patient. if the interacting drug cannot be avoided, monitor patients for cns adverse reactions. 7.2 anticholinergic drugs concomitant use of scopolamine with other drugs having anticholinergic properties may increase the risk of cns adverse reactions [see drug interactions ( 7.1 )], intestinal obstruction and/or urinary retention. consider more frequent monitoring during treatment with transderm scōp in patients receiving anticholinergic drugs [see warnings and precautions ( 5.2 , 5.4 )] . 7.3 oral drugs absorbed in the stomach transderm scōp, as an anticholinergic, may delay gastric and upper gastrointestinal motility and, therefore, the rate of absorption of other orally administered drugs. monitor patients for modified therapeutic effect of concomitant orally administered drugs with a narrow therapeutic index. 7.4 interaction with gastric secretion test scopolamine will interfere with the gastric secretion test. discontinue transderm scōp 10 days prior to testing.

s difficulty in urination. ( 5.4 , 7.2 ) • drug withdrawal/post-removal symptoms : anticholinergic symptoms may occur 24 hours or more after removal of the transdermal system. ( 5.5 ) • blurred vision : avoid contact with the eyes. ( 2.1 , 5.6 ) • magnetic resonance imaging (mri) skin burns : remove transderm scōp prior to mri scan. ( 5.7 ) 5.1 acute angle closure glaucoma the mydriatic effect of scopolamine may cause an increase in intraocular pressure resulting in acute angle closure glaucoma. monitor intraocular pressure in patients with open angle glaucoma and adjust glaucoma therapy during transderm scōp use, as needed. advise patients to immediately remove the transdermal system and contact their healthcare provider if they experience symptoms of acute angle closure glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). 5.2 neuropsychiatric adverse reactions psychiatric adverse reactions scopolamine has been reported to exacerbate psychosis. other psychiatric reactions have also been reported, including acute toxic psychosis, agitation, speech disorder, hallucinations, paranoia, and delusions [see adverse reactions ( 6.2 )] . monitor patients for new or worsening psychiatric symptoms during treatment with transderm scōp. also, monitor patients for new or worsening psychiatric symptoms during concomitant treatment with other drugs that are associated with similar psychiatric effects [see drug interactions ( 7.1 )] . seizures seizures and seizure-like activity have been reported in patients receiving scopolamine. weigh this potential risk against the benefits before prescribing transderm scōp to patients with a history of seizures, including those receiving anti-epileptic medication or who have risk factors that can lower the seizure threshold. cognitive adverse reactions scopolamine can cause drowsiness, disorientation, and confusion. discontinue transderm scōp if signs or symptoms of cognitive impairment develop. elderly and pediatric patients may be more sensitive to the neurological and psychiatric effects of transderm scōp. consider more frequent monitoring during treatment with transderm scōp in elderly patients [see use in specific populations ( 8.5 )] . transderm scōp is not approved for use in pediatric patients [see use in specific populations ( 8.4 )] . hazardous activities transderm scōp may impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle, operating machinery or participating in underwater sports. concomitant use of other drugs that cause central nervous system (cns) adverse reactions (e.g., alcohol, sedatives, hypnotics, opiates, and anxiolytics) or have anticholinergic properties (e.g., other belladonna alkaloids, sedating antihistamines, meclizine, tricyclic antidepressants, and muscle relaxants) may increase this effect [see drug interactions ( 7.1 )] . inform patients not to operate motor vehicles or other dangerous machinery or participate in underwater sports until they are reasonably certain that transderm scōp does not affect them adversely. 5.3 eclamptic seizures in pregnant women eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous and intramuscular scopolamine [see use in specific populations ( 8.1 )] . avoid use of transderm scōp in patients with severe preeclampsia. 5.4 gastrointestinal and urinary disorders scopolamine, due to its anticholinergic properties, can decrease gastrointestinal motility and cause urinary retention. consider more frequent monitoring during treatment with transderm scōp in patients suspected of having intestinal obstruction, patients with pyloric obstruction or urinary bladder neck obstruction and patients receiving other anticholinergic drugs [see drug interactions ( 7.2 )] . discontinue transderm scōp in patients who develop difficulty in urination. 5.5 drug withdrawal/post-removal symptoms discontinuation of transderm scōp, usually after several days of use, may result in withdrawal symptoms, such as disturbances of equilibrium, dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, bradycardia and hypotension. the onset of these symptoms is generally 24 hours or more after the transdermal system has been removed. instruct patients to seek medical attention if they experience severe symptoms. 5.6 blurred vision 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 [see dosage and administration ( 2.1 )] . 5.7 magnetic resonance imaging (mri) skin burns transderm scōp contains an aluminized membrane. skin burns have been reported at the application site in patients wearing an aluminized transdermal system during an mri scan. remove transderm scōp before undergoing an mri.

each transderm scōp transdermal system is formulated to deliver in vivo approximately 1 mg of scopolamine over 3 days. • only wear one transdermal system at any time. • do not cut the transdermal system. • apply the transdermal system to the skin in the postauricular area (hairless area behind one ear). • after the transdermal system is applied on the dry skin behind the ear, wash hands thoroughly with soap and water and dry hands [see warnings and precautions ( 5.6 )] . • if the transdermal system becomes displaced, discard the transdermal system, and apply a new transdermal system on the hairless area behind the other ear. • upon removal, fold the used transdermal system in half with the sticky side together, and discard in household trash in a manner that prevents accidental contact or ingestion by children, pets or others. 2.2 recommended adult dosage motion sickness apply one transderm scōp transdermal system to the hairless area behind one ear at least 4 hours before the antiemetic effect is required – for use up to 3 days. if therapy is required for longer than 3 days, remove the first transdermal system and apply a new transderm scōp transdermal system behind the other ear. ponv for surgeries other than cesarean section : apply one transderm scōp transdermal system the evening before scheduled surgery. remove the transdermal system 24 hours following surgery.

76 or fda at 1-800-fda-1088 or www.fda.gov/safety/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: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

the effects of transderm scōp [see warnings and precautions ( 5.2 )] . either transderm scōp or the interacting drug should be chosen, depending on the importance of the drug to the patient. if the interacting drug cannot be avoided, monitor patients for cns adverse reactions. 7.2 anticholinergic drugs concomitant use of scopolamine with other drugs having anticholinergic properties may increase the risk of cns adverse reactions [see drug interactions ( 7.1 )], intestinal obstruction and/or urinary retention. consider more frequent monitoring during treatment with transderm scōp in patients receiving anticholinergic drugs [see warnings and precautions ( 5.2 , 5.4 )] . 7.3 oral drugs absorbed in the stomach transderm scōp, as an anticholinergic, may delay gastric and upper gastrointestinal motility and, therefore, the rate of absorption of other orally administered drugs. monitor patients for modified therapeutic effect of concomitant orally administered drugs with a narrow therapeutic index. 7.4 interaction with gastric secretion test scopolamine will interfere with the gastric secretion test. discontinue transderm scōp 10 days prior to testing.

ved in humans using a transdermal system. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data eclamptic seizures in published case reports, two pregnant patients with severe preeclampsia were administered intravenous and intramuscular scopolamine, respectively, and developed eclamptic seizures soon after scopolamine administration [see warnings and precautions ( 5.3 )] . animal data in animal reproduction studies, when pregnant rats and rabbits received scopolamine hydrobromide by daily intravenous injection, no adverse effects were observed in rats. an embryotoxic effect was observed in rabbits at doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by transderm scōp did not affect uterine contractions or increase the duration of labor. 8.2 lactation risk summary scopolamine is present in human milk. there are no available data on the effects of scopolamine on the breastfed infant or the effects on milk production. 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 transderm scōp and any potential adverse effects on the breastfed child from transderm scōp or from the underlying maternal condition. 8.4 pediatric use safety and effectiveness in pediatric patients have not been established. pediatric patients are particularly susceptible to the adverse reactions of scopolamine; including mydriasis, hallucinations, amblyopia and drug withdrawal syndrome. neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported. 8.5 geriatric use clinical trials of transderm scōp did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects. in other clinical experience, elderly patients had an increased risk of neurologic and psychiatric adverse reactions, such as hallucinations, confusion, dizziness and drug withdrawal syndrome [ see warnings and precautions ( 5.2 , 5.5 ) ]. consider more frequent monitoring for cns adverse reactions during treatment with transderm scōp in elderly patients [see warnings and precautions ( 5.2 )] . 8.6 renal or hepatic impairment transderm scōp has not been studied in patients with renal or hepatic impairment. consider more frequent monitoring during treatment with transderm scōp in patients with renal or hepatic impairment because of the increased risk of cns adverse reactions [see warnings and precautions ( 5.2 )].

iscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data eclamptic seizures in published case reports, two pregnant patients with severe preeclampsia were administered intravenous and intramuscular scopolamine, respectively, and developed eclamptic seizures soon after scopolamine administration [see warnings and precautions ( 5.3 )] . animal data in animal reproduction studies, when pregnant rats and rabbits received scopolamine hydrobromide by daily intravenous injection, no adverse effects were observed in rats. an embryotoxic effect was observed in rabbits at doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by transderm scōp did not affect uterine contractions or increase the duration of labor.

hin 4 hours with peak concentrations being obtained, on average, within 24 hours. the average plasma concentration produced is 87 pg/ml (0.28 nm) for free scopolamine and 354 pg/ml for total scopolamine (free + conjugates). following removal of the used transdermal system, there is some degree of continued systemic absorption of scopolamine bound in the skin layers. distribution the distribution of scopolamine is not well characterized. it crosses the placenta and the blood brain barrier and may be reversibly bound to plasma proteins. elimination metabolism and excretion scopolamine is metabolized and conjugated with less than 5% of the total dose appearing unchanged in the urine. the enzymes responsible for metabolizing scopolamine are unknown. the exact elimination pattern of scopolamine has not been determined. following transdermal system removal, plasma concentrations of scopolamine decline in a log linear fashion with an observed half-life of 9.5 hours. less than 10% of the total dose is excreted in the urine as the parent drug and metabolites over 108 hours. drug interaction studies an in vitro study using human hepatocytes examined the induction of cyp1a2 and cyp3a4 by scopolamine. scopolamine did not induce cyp1a2 and cyp3a4 isoenzymes at the concentrations up to 10 nm. in an in vitro study using human liver microsomes which evaluated the inhibition of cyp1a2, 2c8, 2c9, 2c19, 2d6 and 3a4, scopolamine did not inhibit these cytochrome p450 isoenzymes at the concentrations up to 1 micromolar. no in vivo drug-drug interaction studies have been conducted.

the exact elimination pattern of scopolamine has not been determined. following transdermal system removal, plasma concentrations of scopolamine decline in a log linear fashion with an observed half-life of 9.5 hours. less than 10% of the total dose is excreted in the urine as the parent drug and metabolites over 108 hours. drug interaction studies an in vitro study using human hepatocytes examined the induction of cyp1a2 and cyp3a4 by scopolamine. scopolamine did not induce cyp1a2 and cyp3a4 isoenzymes at the concentrations up to 10 nm. in an in vitro study using human liver microsomes which evaluated the inhibition of cyp1a2, 2c8, 2c9, 2c19, 2d6 and 3a4, scopolamine did not inhibit these cytochrome p450 isoenzymes at the concentrations up to 1 micromolar. no in vivo drug-drug interaction studies have been conducted.

derm scōp as compared to 72% of placebo-treated patients.

ith open-angle glaucoma advise patients with open-angle glaucoma to remove the transderm scōp transdermal system immediately and contact their healthcare provider if they experience symptoms of acute angle closure glaucoma, including pain and reddening of the eyes, accompanied by dilated pupils, blurred vision and/or seeing halos around lights [see warnings and precautions ( 5.1 )] . neuropsychiatric adverse reactions • advise patients that psychiatric adverse reactions may occur, especially in patients with a past psychiatric history or in those receiving other drugs also associated with psychiatric effects, and to report to their healthcare provider any new or worsening psychiatric symptoms. • advise patients to discontinue transderm scōp and contact a healthcare provider immediately if they experience a seizure. • advise patients, especially elderly patients, that cognitive impairment may occur during treatment with transderm scōp,especially in those receiving other drugs also associated with cns effects, and to report to their healthcare provider if they develop signs or symptoms of cognitive impairment such as hallucinations, confusion or dizziness. • inform patients not to operate motor vehicles or other dangerous machinery or participate in underwater sports until they are reasonably certain that transderm scōp does not affect them adversely [see warnings and precautions ( 5.2 )] . decreased gastrointestinal motility and urinary retention instruct patients to remove the transdermal system if they develop symptoms of intestinal obstruction (abdominal pain, nausea or vomiting) or any difficulties in urinating [see warnings and precautions ( 5.4 )] . drug withdrawal/post-removal symptoms inform patients that if they remove the transderm scōp transdermal system before treatment is complete, withdrawal symptoms may occur and to seek immediate medical care if they develop severe symptoms after removing transderm scōp [see warnings and precautions ( 5.5 )] . blurred vision inform patients that temporary dilation of the pupils and blurred vision may occur if transderm scōp comes in contact with the eyes. instruct patients to wash their hands thoroughly with soap and water immediately after handling the transdermal system [see dosage and administration ( 2.1 ), warnings and precautions ( 5.6 )] . mri skin burns instruct patients to remove the transderm scōp transdermal system before undergoing an mri [see warnings and precautions ( 5.7 )]. marketed by: baxter healthcare corporation deerfield, il 60015 usa manufactured by: alza corporation, vacaville, ca 95688 for gsk consumer healthcare, warren, nj 07059 for product inquiry 1 800 ana drug (1-800-262-3784) trademarks are owned by or licensed to the gsk group of companies. ©2019 gsk group of companies or its licensor

ure. what should i tell my doctor before using transderm scōp? before you use transderm scōp, tell your doctor about all of your medical conditions, including if you: • have glaucoma (increased pressure in the eye). • have a history of seizures or psychosis. • have problems with your stomach or intestines. • have trouble urinating. • are scheduled to have a gastric secretion test. • have liver or kidney problems. • are pregnant or plan to become pregnant. it is not known if transderm scōp can harm your unborn baby. • are breastfeeding or plan to breastfeed. transderm scōp can pass into your breast milk and may harm your baby. talk to your doctor about the best way to feed your baby if you use transderm scōp. tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. transderm scōp may affect the way other medicines work, and other medicines may affect how transderm scōp works. medicines that you take by mouth may not be absorbed well while you use transderm scōp. especially tell your doctor if you take: • a sedative, hypnotic, opioid or anxiolytic (medicines that make you sleepy) • an antidepressant medicine • an anticholinergic medicine, such as an allergy or cold medicine, a medicine to treat bladder or bowel spasms, certain asthma medicines, or other medicines for motion sickness ask your doctor if you are not sure if your medicine is one that is listed above. know the medicines you take. keep a list of them and show it to your doctor or pharmacist when you get a new medicine. how should i use transderm scōp? • see the detailed instructions for use for information about how to use transderm scōp at the end of this patient information leaflet. • it is important that you apply transderm scōp exactly as your doctor tells you to. • your doctor may change your transderm scōp dose. do not change your transderm scōp dose without talking to your doctor. • wear only one transderm scōp at any time. • if you use too much transderm scōp, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away. what should i avoid while using transderm scōp? • you should not drink alcohol while using transderm scōp. it can increase your chances of having serious side effects. • you should not drive, operate heavy machinery, or do other dangerous activities until you know how transderm scōp affects you. • you should not use transderm scōp during a magnetic resonance imaging scan (mri). remove transderm scōp before undergoing an mri. it can cause your skin to burn. • you should be careful if you use transderm scōp while you participate in watersports because you may feel lost or confused (disoriented). • limit contact with water while swimming and bathing because transderm scōp may fall off. if transderm scōp falls off, throw it away and apply a new one on the hairless area behind your other ear. what are the possible side effects of transderm scōp? transderm scōp may cause serious side effects, including: • angle closure glaucoma. if you have open angle glaucoma and use transderm scōp, remove transderm scōp and call a doctor right away if you feel pain or discomfort, have blurred vision, or see halos or colored images around lights and reddening of your eyes. • worsening of seizures. tell your doctor about any worsening of seizures while using transderm scōp. • an unusual reaction called acute psychosis. tell your doctor if you have any of these symptoms: • confusion • agitation • rambling speech • hallucinations (seeing or hearing things that are not there) • paranoid behaviors and delusions (false belief in something) • worsening of your preeclampsia during pregnancy. some pregnant women with severe preeclampsia have had seizures after getting scopolamine by injection in the muscle (intramuscular) or injection in the vein (intravenous). • difficulty urinating. • difficulties in food passing from the stomach to the small intestines, which may cause abdominal pain, nausea or vomiting. • withdrawal symptoms after removing transderm scōp after using it for several days. some people may have certain symptoms such as difficulty with balance, dizziness, nausea, vomiting, stomach cramps, sweating, confusion, muscle weakness, low heart rate or low blood pressure that could start 24 hours or more after removing transderm scōp. call your doctor right away if your symptoms become severe. • temporary increase in the size of your pupil and blurry vision, especially if transderm scōp comes in contact with your eyes. • skin burns at the site of transderm scōp. this can happen during a medical test called a magnetic resonance imaging scan (mri). transderm scōp contains aluminum and should be removed from your skin before you have an mri. the most common side effects of using transderm scōp include: • dry mouth • blurred vision or eye problems • feeling sleepy or drowsy • disorientation (confusion) • dizziness • feeling agitated or irritable • pharyngitis (sore throat) tell your doctor if you have any side effect that bothers you or that does not go away. these are not all the possible side effects of transderm scōp. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. general information about the safe and effective use of transderm scōp. medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use transderm scōp for a condition for which it was not prescribed. do not give transderm scōp to other people, even if they have the same symptoms you have. it may harm them. you can ask your pharmacist or doctor for information about transderm scōp that is written for health professionals. what are the ingredients in transderm scōp? active ingredient: scopolamine inactive ingredients: light mineral oil, polyisobutylene, polypropylene and aluminized polyester film marketed by: baxter healthcare corporation , deerfield, il 60015 usa manufactured by: alza corporation, vacaville, ca 95688 for gsk consumer healthcare , warren, nj 07059 for product inquiry 1 800 ana drug (1-800-262-3784) trademarks are owned by or licensed to the gsk group of companies. ©2019 gsk group of companies or its licensor. for more information, go to www.transdermscop.com or call gsk consumer healthcare at 1-800-398-5876. instructions for use transderm scōp (trans-derm skōp) (scopolamine transdermal system) read this instructions for use before you start using transderm scōp and each time you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or your treatment. information about transderm scōp: • transderm scōp is a tan-colored, circle shaped transdermal system (patch) with “scopolamine 1 mg/3 days” printed on it. • wear only one transderm scōp at any time. • do not cut transderm scōp. to help prevent nausea and vomiting from motion sickness: • apply one transderm scōp to your skin on a hairless area behind one ear at least 4 hours before the activity to prevent nausea and vomiting. • if the treatment is needed for longer than 3 days, remove transderm scōp from the hairless area behind your ear. get a new transderm scōp and place it on the hairless area behind your other ear. to help prevent nausea and vomiting after surgery: • follow your doctor’s instructions about when to apply transderm scōp before your scheduled surgery. • transderm scōp should be left in place for 24 hours after surgery. after 24 hours, transderm scōp should be removed and thrown away. how to use transderm scōp: inside the transderm scōp package, you will find one transderm scōp. an imprinted, tan backing membrane with a metallic (silver) sticky surface is adhered to a clear, disposable release liner (see figure 1). 1. select a hairless area of skin behind one of your ears. avoid areas on your skin that may have cuts, pain or tenderness. wipe the area of your skin with a clean, dry tissue. 2. cut along the dashed line on the transderm scōp package to open (see figure 2). 1. remove the clear plastic backing from the tan-colored round transderm scōp (see figure 3). 1. do not touch the metallic adhesive (sticky) surface on transderm scōp with your hands (see figure 4). 1. apply the metallic adhesive surface of transderm scōp firmly to the dry area of skin behind your ear. the imprinted, tan colored side of the transdermal system should be facing up and showing (see figure 5). wash your hands with soap and water right away after applying transderm scōp, so that any medicine from transderm scōp that gets on your hands will not get into your eyes. how to remove transderm scōp: after removing transderm scōp, be sure to wash your hands and the area behind your ear thoroughly with soap and water. please note that the used transderm scōp will still contain some of the active ingredient after use. to avoid accidental contact or ingestion by children, pets or others, fold the used transderm scōp in half with the sticky side together. throw away (dispose of) transderm scōp in the household trash out of the reach of children, pets or others. how should i store transderm scōp? • store transderm scōp at room temperature between 68°f and 77°f (20°c and 25°c) until you are ready to use it. • store transderm scōp in an upright position. • do not bend or roll transderm scōp. keep transderm scōp and all medicines out of reach of children. the medication guide and instructions for use have been approved by the u.s. food and drug administration revised: march 2019 figure 1 figure 2 figure 3 figure 4 figure 5