Gelnique topical

Oxybutynin reduces muscle spasms of the bladder and urinary tract.

Oxybutynin topical (for the skin) is used to treat symptoms of overactive bladder such as frequent or urgent urination, and incontinence (urine leakage).

Oxybutynin topical may also be used for purposes not listed in this medication guide.

You should not use oxybutynin topical if you have uncontrolled narrow-angle glaucoma, a blockage in your stomach or intestines, or if you are unable to urinate.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Oxybutynin topical can be applied to the skin on your stomach, upper arm, shoulder, or thigh. Apply the gel to a different place on any of these skin areas each time you use it. Do not apply the gel to the same skin two days in a row.

Wash your hands with soap and water before and after applying this medication. Also wash the skin area to be treated, using a mild soap or cleanser. Allow the skin to dry completely before applying oxybutynin topical.

Tear open the sealed Gelnique packet and empty the entire contents into your hand. You may also empty the packet directly onto the treatment area. Each packet of Gelnique is for one use only. Throw away the empty packet in a place where children and pets cannot get to it.

To get the correct amount of Anturol gel for one application, press the pump down 3 times. You may pump the gel directly onto the treatment area.

Do not apply the gel to recently shaved skin, open wounds, scars, tattoos, or irritated or broken skin. Do not apply to the breasts or genital areas.

Do not bathe, shower, swim, use a hot tub, or exercise vigorously for at least 1 hour after applying this medication.

It is best to cover treated skin areas with clothing after the gel has dried completely. This will help prevent getting this medicine on your other skin or on other people. If someone else does come into contact with a treated skin area, they should wash the contact area right away with soap and water.

Oxybutynin gel is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include restlessness, tingly feeling, fever, uneven heart rate, vomiting, and little or no urinating.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction to Gelnique: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Gelnique and call your doctor at once if you have:

• little or no urinating;

• confusion, hallucinations;

• vomiting, severe heartburn or upper stomach pain;

• pain or burning when you urinate; or

• dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Common Gelnique side effects may include:

• dry mouth;

• dry eyes;

• blurred vision; or

• redness or mild skin irritation where the gel was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to oxybutynin: oral syrup, oral tablet, oral tablet extended release

Other dosage forms:

• transdermal gel/jelly, transdermal patch extended release

Along with its needed effects, oxybutynin (the active ingredient contained in Gelnique) 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 while taking oxybutynin:

• Eye pain
• skin rash or hives

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

• Clumsiness or unsteadiness
• confusion
• convulsions
• dizziness
• drowsiness (severe)
• fainting
• fast, slow, or irregular heartbeat
• fever
• flushing or redness of the face
• hallucinations (seeing, hearing, or feeling things that are not there)
• troubled breathing
• unusual excitement, nervousness, restlessness, or irritability

Some side effects of oxybutynin 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:

• Acid or sour stomach
• belching
• decreased sweating
• diarrhea
• difficulty having a bowel movement (stool)
• drowsiness
• dryness of the eyes, mouth, nose, or throat
• heartburn
• indigestion
• runny nose
• stomach discomfort, upset, or pain

• Blurred vision
• decreased flow of breast milk
• decreased sexual ability
• difficulty in swallowing
• feeling of warmth or heat
• headache
• increased sensitivity of the eyes to light
• nausea or vomiting
• trouble with sleeping
• unusual tiredness or weakness

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss

Applies to oxybutynin: oral syrup, oral tablet, oral tablet extended release, transdermal film extended release, transdermal gel

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity
Frequency not reported: Anaphylactic reaction[Ref]

Cardiovascular

Common (1% to 10%): Palpitations
Uncommon (0.1% to 1%): Cardiac arrhythmia tachycardia, vasodilation, hypertension, flushing
Frequency not reported: Heat stroke[Ref]

Dermatologic

Very common (10% or more): Dry skin, pruritus
Common (1% to 10%): Flushing, rash
Frequency not reported: Angioedema, hypohidrosis[Ref]

Endocrine

Postmarketing reports: Decreased lactation[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 72%), constipation (up to 15%), nausea
Common (1% to 10%): Diarrhea, dyspepsia, abdominal pain, vomiting, flatulence, gastroesophageal reflux disease
Uncommon (0.1% to 1%): Abdominal discomfort
Frequency not reported: Pseudo-obstruction in patients at risk (elderly or patients with constipation and treated with other drugs that decrease intestinal motility), decreased GI motility[Ref]

General

The most common (incidence 5% or greater) adverse reactions were dry mouth, constipation, diarrhea, headache, somnolence, and dizziness.[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, urinary hesitation, urinary retention, dysuria, increased post void retention
Frequency not reported: Impotence, suppression of lactation, cystitis, aggravation of prostatic hypertrophy[Ref]

Immunologic

Uncommon (0.1% to 1%): Fungal infection[Ref]

Local

Very common (10% or more): Application site pruritus (16.8%)
Common (1% to 10%): Application site erythema, application site vesicles, application site rash, application site macules[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia, fluid retention[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 17%), somnolence (up to 14%), headache, drowsiness, confusion
Common (1% to 10%): Dysgeusia
Uncommon (0.1% to 1%): Dysphagia, convulsions
Frequency not reported: Cognitive disorders in elderly, convulsions, agitation, nightmares, anxiety, paranoia, symptoms of depression, hallucinations, asthenia, insomnia, restlessness, dependence to this drug (in patients with history of drug or substance abuse)[Ref]

Ocular

Common (1% to 10%): Blurred vision, dry eye, abnormal vision
Uncommon (0.1% to 1%): Angle closure glaucoma
Frequency not reported: Onset of narrow-angle glaucoma, mydriasis, intraocular hypertension, amblyopia, cycloplegia, decreased lacrimation[Ref]

Other

Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Dysphonia, thirst
Frequency not reported: Falls, accidental injury[Ref]

Psychiatric

Common (1% to 10%): Insomnia, nervousness
Uncommon (0.1% to 1%): Hallucinations, confusional state, agitation, memory impairment
Frequency not reported: Psychotic disorder, anxiety, nightmares, paranoia[Ref]

Respiratory

Common (1% to 10%): Cough, oropharyngeal pain, dry throat, nasal dryness
Uncommon (0.1% to 1%): Upper respiratory tract infection, rhinitis, chest discomfort, hoarseness
Rare (0.01% to 0.1%): Nasal congestion, throat irritation[Ref]

Some side effects of Gelnique may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.