Gelnique 3% – Consumer Medicine Information
|Condition:||Dysuria, Overactive Bladder, Urinary Incontinence|
|Form:||Cream, gel, liniment or balm, lotion, ointment, etc|
|Ingredients:||oxybutynin chloride, diethylene glycol monoethyl ether, NF, alcohol, USP, hydroxypropyl cellulose, NF, propylene glycol, NF, butylated hydroxytoluene, NF, HCl 0.1 M, NF, purified water, USP|
(oxybutynin) gel 3%
Important: For use on the skin only (topical). Do not get GELNIQUE 3% in or near your eyes, nose, or mouth.
Read this Patient Information carefully before you use GELNIQUE 3% and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is Gelnique 3%?
GELNIQUE 3% is a prescription medicine used to treat the symptoms of overactive bladder
- ncluding: a strong need to urinate with leaking or wetting accidents (urge urinary incontinence)
- a strong need to urinate right away (urgency)
- urinating often (frequency)
It is not known if GELNIQUE 3% is safe or effective in children.
Who should not use Gelnique 3%?
Do not use GELNIQUE 3% if:
- Your bladder does not empty or does not empty completely when you urinate (urinary retention).
- Your stomach empties slowly or incompletely after a meal (gastric retention).
- You have high pressure in your eye (uncontrolled narrow-angle glaucoma).
- You have an allergy to oxybutynin or any of the ingredients in GELNIQUE 3%. See the end of this leaflet for a complete list of ingredients in GELNIQUE 3%.
Talk to your healthcare provider before taking this medicine if you have any of these conditions.
What should I tell my doctor before using Gelnique 3%?
Before you use GELNIQUE 3%, tell your doctor if you:
- have problems emptying your bladder completely
- have stomach problems including:
- constipation or difficulty in emptying your bowels inflamed
- bowels (ulcerative colitis)
- inflammation of the tube between your mouth and stomach (gastric reflux disease or esophagitis)
- have generalized muscle weakness (myasthenia gravis)
- are pregnant or are planning to become pregnant. It is not known if GELNIQUE 3% will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if GELNIQUE 3% passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use GELNIQUE 3%.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
GELNIQUE 3% may affect the way other medicines work, and other medicines may affect how GELNIQUE 3% works.
Especially tell your doctor if you take:
- medicines used to treat osteoporosis (Bisphosphonates)
- other medicines used to treat overactive bladder (Anticholinergic)
Ask your doctor if you are not sure if your medicine is one listed above.
Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.
How should I use Gelnique 3%?
GELNIQUE 3% is for skin use only.
- Use GELNIQUE 3% exactly as your doctor tells you to use it.
- GELNIQUE 3% should only be applied to dry intact skin on your stomach (abdomen), upper arms, or thighs.
- Do not put GELNIQUE 3% on recently shaved skin, open sores, scars, tattoos, or skin with rashes.
- Do not put GELNIQUE 3% on your breasts or genital area.
- GELNIQUE 3% contains alcohol and is flammable. Avoid fire, flames, or smoking until the product has dried.
- Cover the application site with clothing after the gel has dried, if skin-to-skin contact between another person and the application site is expected.
- After applying GELNIQUE 3%, wash your hands with soap and water right away.
- GELNIQUE 3% may be used with sunscreen.
- If you get GELNIQUE 3% in your eyes: Rinse your eyes well right away with clean and warm water. Seek medical attention if needed.
How to use the Gelnique 3% pump:
You must prime the pump before you use it for the firs t time. To prime the pump:
- To prime the GELNIQUE 3% pump, hold the pump upright and fully press down (depress) the pump 4 times. Now GELNIQUE 3% is ready to use.
- Do not use any product that came out while priming.
Applying GELNIQUE 3%:
Selecting your application s ite:
Apply GELNIQUE 3% only to 1 of the shaded areas shown in the figure below: (See Figure A).
- stomach area (abdomen)
- upper arms
- Wash the area where GELNIQUE 3% will be applied with mild soap and water. Allow the area to dry completely.
- Wash your hands with soap and water.
- Application sites may be rotated to reduce the potential for local site reactions.
Dispensing your dose of GELNIQUE 3%:
- Place your hand under the pump. Press the pump all the way down 3 times (See Figure B). You can also place the pump right over the application site then press the pump all the way down 3 times to dispense your dose (See Figure C).
- You should apply GELNIQUE 3% right after you dispense your dose.
- Wash your hands with soap and water right away.
What should I avoid while using Gelnique 3%?
- Do not take a bath, swim, shower, exercise, or get the application site wet for 1 hour after you apply your dose.
- GELNIQUE 3% can cause dizziness or blurred vision. Do not drive, operate heavy machinery, or do other dangerous activities until you know how GELNIQUE 3% affects you.
- You should not drink alcohol while using GELNIQUE 3%. It can increase your chances of getting serious side effects.
What are the possible side effects of Gelnique 3%?
The most common s ide effects of GELNIQUE 3% include:
- dry mouth
- urinary tract infections
- dry eyes
- blurry vision
- redness, rash, itching, pain at the application site
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 GELNIQUE 3%. For more information, ask your doctor 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 3%?
- Store GELNIQUE 3% at room temperature between 68°F to 77°F (20°C to 25°C).
Keep GELNIQUE 3% and all medicines out of the reach of children.
General information about the safe and effective use of GELNIQUE 3%.
Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Do not use GELNIQUE 3% for a condition for which it was not prescribed. Do not give GELNIQUE 3% 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 3%. If you would like more information about GELNIQUE 3%, talk with your doctor. You can ask your pharmacist or doctor for information about GELNIQUE 3% that is written for health professionals.
For more information go to www.gelnique.com or call 1-800-272-5525.
What are the ingredients in Gelnique 3%?
Active ingredient: oxybutynin
Inactive ingredients: diethylene glycol monoethyl ether, NF; alcohol, USP; hydroxypropyl cellulose, NF; propylene glycol, NF; butylated hydroxytoluene, NF; HCl 0.1 M, NF; and purified water, USP.