Patient Medication Information: uses, side effects, how to take - Gelnique (Watson Laboratories)
ABOUT THIS MEDICATION
What the medication is used for:
GELNIQUE is used to relieve symptoms of overactive bladder which include the frequent and urgent need to urinate with or without urine leakage.
What it does:
GELNIQUE works on special areas of the bladder nerves which cause the bladder muscles to stop contracting and become relaxed.
The bladder relaxes and is able to hold more urine allowing for longer periods of time between having to urinate. You may not have to urinate as frequently, with as great urgency, and therefore may be able to expel a larger amount of urine when you urinate.
When it should not be used:
Do not use GELNIQUE if you have the following medical conditions:
- 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).
- Allergy (serious hypersensitivity) to oxybutynin chloride or the inactive ingredients in GELNIQUE.
What the medicinal ingredient is:
Oxybutynin chloride
What the nonmedicinal ingredients are:
Alcohol, glycerin, hydroxypropyl cellulose, sodium hydroxide, and purified water.
What dosage form it comes in:
GELNIQUE is gel for topical skin application. Each gram of gel contains 100 mg oxybutynin chloride.
WARNINGS AND PRECAUTIONS
Before you use GELNIQUE, tell your doctor about all your medical conditions, especially if you have any of the following:
- Heart disease
- Liver disease
- Kidney disease
- Difficulty in emptying bladder completely
- Constipation or difficulty in emptying bowels
- Ulcerative colitis (inflamed bowels)
- Gastric reflux disease or esophagitis (inflamed esophagus, the tube between your mouth and stomach), or are taking drugs to prevent bone thinning (bisphosphonates).
- Skin problems such as eczema, seborrhea, or psoriasis. GELNIQUE has not been tested on patients with these skin disorders.
Angioedema (a swelling on the face, hands, throat, and tongue) required emergency treatment has been reported with the use of oral oxybutynin.
GELNIQUE may cause sleepiness or blurred vision. Do not driving or operate machinery until
you know how GELNIQUE affects you. Drinking alcoholic beverages may increase these effects.
GELNIQUE treatment may decrease sweating. You may overheat or have fever, heat stroke, or heat prostration if you are in warm or hot temperatures.
INTERACTIONS WITH THIS MEDICATION
Before you use GELNIQUE, tell your doctor or pharmacist if you are taking other anticholinergic medicines, or certain antibiotic medicines such as erythromycin, clarithromycin, or certain antifungal medicines such as ketoconazole, itraconazole, and miconazole, or any other medicines, including non-prescription medicines and supplements. During your treatment with GELNIQUE, do not start taking a new medicine before checking with your doctor or pharmacist.
PROPER USE OF THIS MEDICATION
GELNIQUE is a gel which contains alcohol. Gels with alcohol are flammable. Avoid fire, flame or smoking until the gel has dried.
GELNIQUE should be applied to the skin only. GELNIQUE SHOULD NOT BE TAKEN BY MOUTH.
Important: Avoid contact with eyes, nose, open sores, recently shaved skin, and skin with rashes or other areas not approved for the application of GELNIQUE.
Do not apply GELNIQUE to areas of the skin that have been treated with oils, lotions, or powders as that could affect the amount of oxybutynin absorbed through the skin. However, GELNIQUE may be used with oil-free sunscreen.
Step 1. The approved application sites for GELNIQUE are the abdomen (stomach), upper arms/shoulder, and thigh. The approved application sites are shown below.
Step 2. Wash your hands with soap and water before applying GELNIQUE.
Step 3. Wash the area where GELNIQUE will be applied with mild soap and water. Allow the area to dry completely.
Step 4. Gently rub GELNIQUE into your skin until it dries. Do not continue rubbing after GELNIQUE has dried. If applying GELNIQUE to the stomach, care should be taken to avoid the area around the navel (belly-button).
Step 5. After applying GELNIQUE, immediately wash your hands thoroughly with soap and water.
Avoid bathing, swimming, showering, exercising or immersing the application site in water for one hour after application.
The application site may be covered with clothing once GELNIQUE has dried.
How to use the GELNIQUE packets:
Step 1. Tear the sachet of GELNIQUE open at the indentation just before use.
Squeeze the entire contents of the packet (1.14 mL) into the palm of your hand. Squeeze from the bottom of the packet toward the open end. Repeat until the packet is empty. The contents of the sachet can also be squeezed directly onto the site of application. The amount of gel in each packet is 1.14 mL. It will be about the size of a nickel in your hand.
Step 2. Carefully throw away the open packet of GELNIQUE so that children and pets are not exposed to it.
Overdose:
If you apply more than the recommended dose of GELNIQUE, contact your doctor or the nearest regional Poison Control Centre.
Missed dose:
If you miss a dose, take the next dose the following day. Do not try to make up for the missed dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, GELNIQUE may have some side effects.
Common side effects include dry mouth, constipation, headaches, dizziness, and a local skin reaction such as itching and redness. These reactions generally are mild and disappear after a few days. If they become worse or do not go away once you stop using GELNIQUE, tell your doctor.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your Doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
Only if severe | In all cases | |||
| Common | Dizziness | √ | ||
| Constipation | √ | |||
| Uncommon | Difficulty urinating | √ | ||
| Application site reaction (blisters, numbness, redness, dryness, and/or pain) | √ | |||
This is not a complete list of side effects. For any unexpected effects while taking GELNIQUE, contact your doctor or pharmacist.
HOW TO STORE GELNIQUE
Store at controlled room temperature (15 to 30° C). Protect from moisture. Apply immediately after the sachets are opened. Discard used sachets in household trash in a manner that prevents accidental application or ingestion by children, pets, or others.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals, can be found by contacting the distributor, Actavis Specialty Pharmaceuticals Co. at 1-855-892-8766.
Watson Laboratories, Inc.
Salt Lake City, Utah 84108
USA
Distributed in Canada by:
Actavis Specialty Pharmaceuticals Co.
Mississauga, Ontario L5N 2B8
CANADA
GELNIQUE is a registered trademark of Actavis, Inc. used under license by Actavis Specialty Pharmaceuticals Co.
Date of Revision: October 1, 2013
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: _______________________________________
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and :
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect TM Canada Web site at www.healthcanada.gc.ca/medeffect
Note: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.