Gelnique (oxybutynin chloride) 10% gel Topical – Consumer Medicine Information
|Condition:||Dysuria, Overactive Bladder, Urinary Incontinence|
|Form:||Cream, gel, liniment or balm, lotion, ointment, etc|
|Ingredients:||oxybutynin chloride, alcohol, USP, glycerin, USP, hydroxypropyl cellulose, NF, sodium hydroxide, NF, purified water, USP|
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 medicines called “anticholinergic”
Tell your healthcare provider about all the medicines you take, including prescription and non- prescription medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use Gelnique?
- GELNIQUE is for skin use only.
- Use GELNIQUE exactly as your healthcare provider tells you to use it.
- GELNIQUE should only be applied to dry intact skin on your stomach (abdomen), upper arms, shoulders, or thighs.
- Do not put GELNIQUE on open sores, recently shaved skin, or skin with rashes.
- You should change your application site every day. Do not use the same site 2 days in a row. Changing application sites every day can help reduce your chance of getting skin irritation.
- GELNIQUE contains alcohol and is flammable. Avoid fire, flames or smoking until GELNIQUE has dried.
- After applying GELNIQUE, wash your hands with soap and water right away.
- Cover the application site with clothing if skin-to-skin contact between another person and the application site is expected.
- If someone else is exposed to GELNIQUE by direct contact with the gel or at the application site, that person should wash the area of contact with soap and water as soon as possible.
- If you get GELNIQUE in your eyes, rinse your eyes right away with warm, clean water to flush out any GELNIQUE.
- GELNIQUE may be used with sunscreen.
Selecting your application s ite:
Apply GELNIQUE only to 1 of the shaded areas shown in the figure below: (See Figure A)
- stomach (abdomen)
- upper arms
- shoulder thigh
- Wash the area where GELNIQUE will be applied with mild soap and water. Allow the area to dry completely.
- Wash your hands with soap and water.
How to use the GELNIQUE packets (sachets):
- Find the notch at the top of your GELNIQUE packet. Tear off the top of the GELNIQUE packet at the notch (See Figure B).
- Squeeze all of the GELNIQUE out of the packet onto your hand (palm or fingertips) or you can squeeze all of the GLENIQUE from the packet right onto the application site (See Figure C).
- Squeeze from the bottom of the packet toward the open end. Repeat until the packet is empty. The amount of GELNIQUE in each packet will be about the size of a nickel. Apply GELNIQUE to your skin (shown in Figure C).
- Wash your hands with soap and water right away.
- Throw away the packet in the trash out of the reach of children to avoid accidental exposure.
What should I avoid while using Gelnique?
- GELNIQUE can cause tiredness, drowsiness, dizziness or blurred vision. Do not drive, operate machinery, or do other dangerous activities until you know how GELNIQUE affects you.
- Do not take a bath, swim, shower, exercise, or get the application site wet for at least 1 hour after you apply your dose.
What are the possible side effects of Gelnique?
GELNIQUE can cause serious s ide effects including:
- Allergic reactions, including allergic skin reactions
The most common s ide effects of GELNIQUE include:
- dry mouth
- redness, rash, itching, pain at the application site
- Other side effects that have been seen with drugs containing oxybutynin, like GELNIQUE, include: dizziness and blurred vision, drowsiness that may be increased with alcohol (beer, wine, or hard liquor), and decreased sweating that may lead to overheating.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of GELNIQUE. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1- 800-FDA-1088.
How should I store Gelnique?
- Store GELNIQUE at 68°F to 77°F (20°C to 25°C).
- Safely throw away GELNIQUE in household trash. Be careful to prevent accidental exposure to children or pets. >
- Keep GELNIQUE sachets in a dry place.
Keep GELNIQUE and all medicines out of the reach of children. General information about GELNIQUE
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use GELNIQUE for a condition for which it was not prescribed. Do not give GELNIQUE to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about GELNIQUE. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about GELNIQUE that is written for health professionals.
For more information about GELNIQUE call 1-800-272-5525 or go to www.GELNIQUE.com
What are the ingredients of Gelnique?
Active Ingredient: oxybutynin chloride
Inactive Ingredients: alcohol, USP; glycerin, USP; hydroxypropyl cellulose, NF; sodium hydroxide, NF; and purified water, USP.