Keep out of reach of children.

17  PATIENT COUNSELING INFORMATION
[See FDA-Approved Patient Labeling]

17.1 Instructions for Use
GELNIQUE is for topical application only and should not be ingested.

GELNIQUE should not be applied to recently shaved skin surfaces. Patients should wash hands immediately after product application. Application sites should not be subject to showering or water immersion for 1 hour after product application. Application sites should be covered with clothing if close skin-to-skin contact at the application site is anticipated.

Alcohol based gels are flammable. Avoid open fire or smoking until the gel has dried.

17.2 Important Anticholinergic Adverse Reactions
Patients should be informed that anticholinergic (antimuscarinic) agents, such as GELNIQUE, may produce clinically significant adverse reactions related to anticholinergic pharmacological activity including:

Urinary retention and constipation.
Heat prostration (due to decreased sweating) when anticholinergics such as GELNIQUE are used in a hot environment.
Dizziness or blurred vision. Patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until GELNIQUE’s effects have been determined.
Drowsiness that may be worsened by alcohol.

FDA-Approved Patient Labeling
PATIENT INFORMATION

GELNIQUE [Gel-nēk]
(oxybutynin chloride) 10% gel Topical

IMPORTANT: For use on the skin only (topical). Do not use GELNIQUE in or near your eyes, nose, or mouth.

Read the Patient Information that comes with GELNIQUE before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you do not understand the information, or have any questions about GELNIQUE, talk with your healthcare provider or pharmacist.

What is GELNIQUE?

GELNIQUE is a prescription medicine used to treat the symptoms of overactive bladder:

Urge urinary incontinence (a strong need to urinate with leaking or wetting accidents).
Urgency (a strong need to urinate right away).
Frequency (urinating often)
Who should not use GELNIQUE?

Do not use GELNIQUE if you have:

Urinary retention. Your bladder does not empty or does not empty completely when you urinate.

Gastric retention. Your stomach empties slowly or incompletely after a meal.

Uncontrolled narrow-angle glaucoma (high pressure in your eye).

An allergy to oxybutynin or the inactive ingredients in GELNIQUE. (See the end of this Patient Information leaflet for a complete list of ingredients in GELNIQUE).

What should I tell my healthcare provider before using GELNIQUE?

Before you use GELNIQUE, tell your healthcare provider if you:

have problems emptying your bladder completely
have stomach problems including:
constipation or difficulty emptying your bowels
ulcerative colitis (inflamed bowels)
gastric reflux disease or esophagitis (inflammation of the tube between your mouth and stomach)
have Myasthenia Gravis (generalized muscle weakness)
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed
use medicines called “bisphosphonates” to treat osteoporosis
use med