PAT-Oxybutynin Chloride ER: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

PAT-oxybutynin chloride ER is used to relieve the symptoms of overactive bladder which include the frequent and urgent need to urinate with or without urine leakage.

What it does:

PAT-oxybutynin chloride ER relaxes the smooth muscle of the bladder which results in a decreased urgency and frequency of urination and episodes of urine leakage.

When it should not be used:

You should not take PAT-oxybutynin chloride ER if:

• you have difficulty urinating, or stomach problems

  affecting passage and digestion of food;

• you have uncontrolled narrow-angle glaucoma (high

  pressure and pain in the eyes);

• you are allergic to oxybutynin or any of the other

  ingredients in PAT-oxybutynin chloride ER (see What the nonmedicinal ingredients are).

What the medicinal ingredient is:

oxybutynin chloride

What the nonmedicinal ingredients are:

butylated hydroxytoluene, cellulose acetate, hydroxypropyl methylcellulose, lactose, magnesium stearate, polyethylene glycol, polyethylene oxide, polysorbate 80, propylene glycol, sodium chloride, synthetic iron oxides and titanium dioxide

What dosage forms it comes in:

extended-release tablets: 5, 10, and 15 mg

WARNINGS AND PRECAUTIONS

BEFORE you use PAT-oxybutynin chloride ER talk to your doctor or pharmacist if you:

$ have stomach problems affecting passage and

digestion of food;

$ have glaucoma (high pressure and pain in the eyes); $ have gastroesophageal reflux or are taking drugs

(such as bisphosphonates which are used to prevent bone thinning and fractures caused by osteoporosis)

that can worsen esophagitis (inflammation of the tube that connects the mouth and the stomach); $ have ulcerative colitis (inflammatory bowel disease); $ have myasthenia gravis (a muscle weakening disease);

$ have heart problems;

$ have kidney and liver problems;

$ take certain drugs for treatment of dementia (such as

Alzheimer’s Disease);

$ have difficulty urinating;

$ are pregnant or trying to become pregnant; $ are breast-feeding.

PAT-oxybutynin chloride ER use in patients under 18 years of age has not been established.

PAT-oxybutynin chloride ER is contained within a nonabsorbable shell designed to release the drug at a controlled rate. It is normal that the shell that looks like a tablet may pass through the stomach and intestine and appears in the stool.

In hot weather, PAT-oxybutynin chloride ER can cause heat prostration (fever and heat stroke due to decreased sweating).

PAT-oxybutynin chloride ER may produce drowsiness or blurred vision. Do not drive or operate machinery until you know how the medication affects you.

Alcohol may add to the drowsiness caused by PAT-oxybutynin chloride ER.

PAT-oxybutynin chloride ER may cause central nervous system (CNS) effects (symptoms referring to changes in thinking or emotions) such as anxiety, nervousness, difficulty remembering, seeing or hearing things that are not actually there, and trouble thinking clearly or making decisions. If you experience any CNS effects, please contact your doctor immediately.

PAT-oxybutynin chloride ER may cause severe allergic reactions such as swelling of the face, lips, tongue, and upper airway that may become life-threatening.

INTERACTIONS WITH THIS MEDICATION

Always tell your doctor about all medicines you are taking. Your doctor will decide if it is safe for you to use PAT-oxybutynin chloride ER with other medicines. If you take any of the following medicines with PAT-oxybutynin chloride ER, it may affect how well they work or increase the likelihood of side effects:

• drugs that could result in serious adverse effects if small changes in dosage occur (such as digoxin for heart problems)
• other anticholinergic drugs, used to treat a number of different medical conditions (a few examples are atropine for glaucoma or hyoscine for nausea), or drugs with similar undesired effects (such as dry mouth, constipation, drowsiness, and blurred vision)

• certain antibiotics (such as erythromycin and

  clarithromycin)

• certain medicines for the treatment of fungal

  infections (such as oral ketoconazole, itraconazole, and miconazole)

PROPER USE OF THIS MEDICATION

PAT-oxybutynin chloride ER tablets should be swallowed whole with water or liquids. Do not chew, divide, or crush the tablets.

PAT-oxybutynin chloride ER may be taken with or without food.

Usual dose:

The usual starting dose of PAT-oxybutynin chloride ER is 5 or

10 mg once daily at a consistent time each day. The maximum daily dose is 30 mg. Your dose may be adjusted as recommended by your doctor.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Instead, take the next scheduled dose. Do not try to make up for the missed dose by taking a double dose next time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, PAT-oxybutynin chloride ER can cause side effects, although not everyone gets them. The following side effects may occur with this medicine:

Very common side effects (may affect more than 1 in 10 people):

• Dry mouth

Common side effects (affects less than 1 in 10 people):

• Pain passing urine, delay when starting to pass

  urine

• Urinary tract infection
• Stuffy nose (rhinitis)
• Back pain, joint pain
• Swelling feet and hands (retaining water)

• Constipation, diarrhea, indigestion, nausea,

  vomiting, stomach pain, flatulence, heartburn

• Problems sleeping, feeling sleepy, feeling tired
• Cough, sore or dry throat, dry nose
• Change in the way things taste

• Dry eyes, blurred eye sight

  • Dry skin, itching
  • Feeling dizzy
  • Headache
  • Chest pain
  • Increased blood pressure
  • Confusion, depression, nervousness

Uncommon side effects (affects less than 1 in 100 people):

• Abdominal discomfort, frequent bowel movements
• Hoarseness, throat irritation
• Flushing, hot flush
• Chest discomfort, mucosal dryness
• Bladder cannot be fully emptied (residual urine)

The following side effects have been reported with the use of PAT-oxybutynin chloride ER:

• Central nervous system (CNS) effects, their symptoms include anxiety, agitation, difficulty remembering
• Difficulty getting or keeping an erection
• Skin rash, angioedema, hives
• Falling

This is not a complete list of side effects. For any unexpected effects while taking PAT-oxybutynin chloride ER, contact your doctor or pharmacist.

HOW TO STORE IT

Store between 15 and 30°C. Protect from moisture and humidity.

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, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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.

MORE INFORMATION

This document plus the full Product Monograph prepared for health professionals can be found at: http://www.patriot-canada.ca

or by contacting the sponsor, Patriot, a division of Janssen Inc., at:

1-800-567-3331 or 1-800-387-8781.

Patriot, a Division of Janssen Inc.

Toronto, Ontario M3C 1L9

Last revised: January 24, 2014

All listed brand names are registered trademarks of their respective manufacturers.