Gelnique

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Patch, Extended Release


• Gel/Jelly

Before Using

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:

Allergies

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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxybutynin in the elderly.

Pregnancy

Breastfeeding

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.

Drug Interactions

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 Chloride

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.

• Donepezil


• Galantamine


• Ketoconazole


• Rivastigmine

Other Interactions

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.

Other Medical Problems

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:

• Intestinal or stomach problems (e.g., constipation, ulcerative colitis, or gastroesophageal reflux disease [GERD]) or


• Myasthenia gravis (severe muscle weakness) or


• Urinary problems (e.g., blockage)a€”Use with caution. May make these conditions worse.

• Narrow-angle glaucoma, uncontrolled or


• Stomach problems (e.g., gastric retention) or


• Urinary retention (hard to pass urine)a€”Should not be used in patients with these conditions.

Proper Use

It is very important that you use this medicine only as directed . 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 in the insert carefully. Talk to your doctor if you have any questions.

This medicine is for use on the skin only . Do not get it in your eyes, nose, or mouth . Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

To use the gel:

• Wash your hands with soap and water before and after using this medicine.


• Before applying this medicine, wash the application site (e.g., stomach, upper arms, shoulders, or thighs) with mild soap and water . Rinse well and pat dry.


• 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.


• 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.

Dosing

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):
    
    
    
    • Adultsa€”Apply the gel on dry, intact skin once a day.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  
  
  
  • For transdermal dosage form (skin patch):
    
    
    
    • Adultsa€”Apply one patch two times per week, which is one patch every 3 to 4 days.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

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.

Storage

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.

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.

Precautions

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 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 . Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy, not alert, or not able to see well .

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 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.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

More common

• Bladder pain


• Blistering, crusting, irritation, itching, or reddening of the skin


• Bloody or cloudy urine


• Burning, skin rash, swelling, or soreness at the application site


• Cracked, dry, or scaly skin


• Difficult, burning, or painful urination


• Frequent urge to urinate


• Lower back or side pain


• Unusually warm skin

Less common

• Abdominal or stomach pain


• Diarrhea


• Loss of appetite


• Nausea


• Weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Chest pain or discomfort


• Confusion


• Decrease in frequency of urination


• Decrease in urine volume


• Decreased urination


• Difficulty in passing urine (dribbling)


• Dizziness


• Dry mouth


• Fainting


• Fast, slow, or irregular heartbeat


• Feeling of warmth


• Fever


• Increase in heart rate


• Lightheadedness


• Pounding or rapid pulse


• Rapid breathing


• Redness of the face, neck, arms, and occasionally, upper chest


• Sunken eyes


• Thirst


• Unusual tiredness or weakness


• Vomiting


• Wrinkled skin

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Body aches or pain


• Chills


• Cough


• Difficulty with breathing


• Ear congestion


• Headache


• Loss of voice


• Nasal congestion


• Runny nose


• Sneezing


• Sore throat

Less common

• Back pain


• Bloated


• Changes in vision


• Constipation


• Excess air or gas in the stomach or intestines


• Full feeling


• Muscle aches


• Passing gas


• Sleepiness or unusual drowsiness


• Stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.