Topical Controlled-release Patch
Medicinal Ingredient: Scopolamine. Non-medicinal Ingredients (alphabetically): Light mineral oil, Polyisobutylene 1200000, Polyisobutylene 35000
Prevention of symptoms of motion sickness such as nausea and vomiting for up to 6 days (2 discs for a maximum of 3 days each).
Adult dosage: Apply one disc to the hairless area of the head behind one ear 12 hours before needed. May be left in place for 3 days.
Make sure to wash hands following the application or the removal of the patch and before coming in contact with sensitive tissues (ex: rubbing eyes). Since drowsiness, disorientation, and confusion may occasionally occur with the use of scopolamine, patients should be cautioned about engaging in activities that require mental alertness, such as driving a motor vehicle or operating dangerous machinery. Potentially alarming idiosyncratic reactions may occur with ordinary therapeutic doses of scopolamine. In patients with a history of possible raised intraocular pressure (pressure pain, blurred vision, glaucomatous halo), Transderm-V® should be employed only after ophthalmologic examination excludes glaucoma. Transderm-V® should be discontinued if it causes blurring of vision with pressure pain within the eye. Care should be taken after removal of the system as side effects may persist for up to 24 hours or longer. Due to the presence of aluminum in one of the layers of the system, the patch should be removed before medical scans.
Transderm-V® (scopolamine) should be used with caution in patients with dysuria, eg. due to urinary bladder neck obstruction. Caution should be exercised when administering an antiemetic or antimuscarinic drug to patients suspected of having intestinal obstruction, eg. pyloric stenosis. Transderm-V® should be used with caution in the elderly or in individuals with impaired metabolic, liver or kidney functions. In certain cases, especially in the elderly, confusional states and/or visual hallucinations may occur. Should this occur, Transderm-V® should be removed at once. If severe symptoms persist, appropriate countermeasures should be taken. In epileptic patients, isolated cases of increased seizure frequency have been reported. Use in Children: Children are particularly susceptible to the side effects of belladonna alkaloids. Transderm-V® should not be used in children because it is not known whether the amount of scopolamine released could produce serious adverse effects in children. Pregnancy: Transderm-V® should be used during pregnancy only if the anticipated benefit justifies the potential risk to the mother and fetus. Lactation: Transderm-V® should not be administered to nursing mothers since scopolamine is excreted into breast milk. Drug Interactions: Transderm-V® should be employed with caution in patients taking drugs which act on the central nervous system (CNS). This applies particularly to patients under treatment with drugs displaying anticholinergic properties, for example, belladonna alkaloids, antihistamines, antidepressants (tricyclics and MAO (monoamine oxidase) inhibitors), phenothiazines, amantadine and quinidine. Any parasympatholytic or sympathomimetic agent, or barbiturate should be administered with caution to persons wearing Transderm-V®. Patients should refrain from consuming alcohol while using Transderm-V®. Alcohol may interfere with the metabolism of the drug and could thus cause plasma levels to become elevated, which could intensify the side effects.
Consult a health care practitioner prior to use if you are pregnant or breastfeeding (due to lack of sufficient safety evidence for these subpopulations). Known hypersensitivity to scopolamine or any component of the system. Glaucoma or a predisposition to angle-closure glaucoma.
Known Adverse Reactions:
Gastrointestinal: Very common: Dryness of the mouth. Ophthalmic: Very common: Transient impairment of eye accommodation (cycloplegia), including blurred vision, myopia and dilatation of the pupils (sometimes in one eye only), especially if traces of active substance on the hands enter the eyes. Common: Irritation of the eyelids. Very rare: Angle-closure glaucoma. Central Nervous System: Very common: Somnolence, dizziness. Rare: Impairment of memory or concentration, restlessness. Psychiatric: Rare: disorientation, confusion, hallucinations. Dermatological: Common: Skin irritation. Very rare: Generalized skin rash. Renal and Urinary: Rare: Disturbances of micturition (retention of urine). Cardiovascular: Very rare: Slight variations in blood pressure. General disorders and administration: Unknown frequency: Application site burning. Adverse effects after withdrawal of Transderm-V®: In certain instances, there have been complaints of transient dizziness, nausea, vomiting, headache and disturbances of balance following discontinuation of Transderm-V®, usually after several days of use.
Not to be used by persons suffering from glaucoma or where it causes blurring of the vision or pressure pain within the eye. Not recommended for use in children or pregnancy. Keep out of reach of children.
Store below 25°C. Do not freeze.
Transderm-V® is a registered trademark of Novartis.
These products may not be suitable for everyone. Read the labels and follow the directions of use.
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