What is Gelnique?

Oxybutynin is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control) or a frequent need to urinate.

The gel form is available only with a doctor's prescription. The Oxytrol® for Men skin patch is available only with a doctor's prescription, but the Oxytrol® for Women skin patch is available without a prescription or over-the counter (OTC).

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use on the skin only. Do not get it into your eyes, nose, mouth, breasts, or genital area. Do not use it on skin areas that have cuts, scrapes, burns, scars, on irritated skin, or on recently shaved skin. If it does get on these areas, rinse it off right away.

To use the gel (packet or metered-dose pump):

• Wash your hands with soap and water before and after using this medicine.
• Before applying this medicine, wash the application site (eg, stomach, upper arms, shoulders, or thighs) with mild soap and water. Rinse well and pat dry.
  • Packet—Tear and squeeze the entire contents of the packet into the palm of your hand or directly on the application site. Gently rub it until the gel dries.
  • Metered-dose pump—Prime the pump before use by pressing all the way down 4 times or until you see the gel come out. Do not use any medicine that came out while you were priming the pump. Fully-pressed the pump one time to get your dose. It should be about the size of a nickel. Apply it into your hand or directly on the application site. Gently rub it until the gel dries.
• Do not apply this medicine on the same application site you applied the last one.
• Do not bathe, swim, shower, or exercise for 1 hour after applying oxybutynin.
• Cover the application site with a dry cloth after the medicine has dried to avoid direct contact or transfer of oxybutynin to another person.

To use the skin patch:

• Use this medicine exactly as directed by your doctor. It will work only if applied correctly.
• Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.
• Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.
• Apply the patch to a clean, dry, and intact skin area on your stomach, hips, or buttocks. Choose an area with little or no hair and free of scars, cuts, or irritation. Avoid putting the patch on areas where it could be rubbed off by tight clothing.
• Press the patch firmly in place with your fingertips to make sure that the edges of the patch stick well.
• When putting on each new patch, choose a different place within these areas. Do not put the new patch on the same place you wore the last one. Be sure to remove the old patch before applying a new one.

The gel form contains alcohol which is flammable. Do not use this medicine near heat, an open flame, or while smoking.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For bladder problems:
  • For transdermal dosage form (gel):
    • Adults—
      • Anturol™: 84 milligrams (mg) or 3 pumps of gel applied on dry, intact skin once a day.
      • Gelnique®: Apply one packet or one pump of the gel on dry, intact skin once a day.
    • Children—Use and dose must be determined by your doctor.
  • For transdermal dosage form (skin patch):
    • Adults—Apply one patch two times per week, which is one patch every 3 to 4 days.
    • Children—Use and dose must be determined by your doctor.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away the pump dispenser after 30 pumps.

After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of oxybutynin in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxybutynin in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Potassium

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Donepezil
• Glycopyrrolate
• Glycopyrronium Tosylate
• Secretin Human
• Tiotropium

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Galantamine
• Ketoconazole
• Rivastigmine

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Esophagitis (inflamed esophagus) or
• Gastroesophageal reflux disease (GERD) or
• Intestinal atony (bowels do not move) or
• Intestinal blockage (blocked bowels) or
• Ulcerative colitis (inflamed bowels) or
• Urinary problems (eg, blockage)—Use with caution. May make side effects become worse.

• Myasthenia gravis (muscle disorder)—Use with caution. May make this condition worse.

• Narrow-angle glaucoma, poorly controlled or
• Stomach problems (eg, blocked bowels, gastric retention) or
• Urinary retention (hard to pass urine)—Should not be used in patients with these conditions.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause a serious type of allergic reaction called angioedema, which may be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble with breathing, or chest tightness while you are using this medicine.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are using this medicine, since overheating may result in heat stroke.

This medicine may cause some people to become dizzy, drowsy, or have blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Avoid drinking alcohol while you are using this medicine.

Do not use cosmetics or other skin care products on the treated skin areas. However, you may use this medicine with a sunscreen.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.