Patient Medication Information: uses, side effects, how to take - Apo-Oxybutynin
ABOUT THIS MEDICATION
What the medication is used for:
APO-OXYBUTYNINis 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:
APO-OXYBUTYNIN decreases the urgency and frequency of both incontinent episodes and voluntary urination.
When it should not be used:
You should not take APO-OXYBUTYNIN if:
you have difficulty urinating, passing and digesting
food, or suffer from glaucoma (high pressure and pain in the eyes), or if you are at risk for these conditions;
you are allergic to oxybutynin chloride or any of the
other ingredients in APO-OXYBUTYNIN (see What the nonmedicinal ingredients are).
What the medicinal ingredient is:
oxybutynin chloride
What the nonmedicinal ingredients are:
Tablets: lactose monohydrate, magnesium stearate, microcrystalline cellulose and FD&C blue #1 aluminum lake 12%.
Syrup: artificial berry flavour, citric acid monohydrate, glycerin, methyl paraben, purified water, sodium citrate dihydrate, sorbitol solution, sucrose and FD&C green #3.
What dosage forms it comes in:
Tablets: 5 mg
Syrup: 1 mg/mL
WARNINGS AND PRECAUTIONS
BEFORE you use APO-OXYBUTYNIN talk to your doctor or pharmacist if:
- you suffer from stomach problems affecting passage and digestion of food;
- you suffer from glaucoma (high pressure and pain in the eyes);
- you suffer from 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);
you suffer from ulcerative colitis
(inflammatory bowel disease);
- you suffer from myasthenia gravis (a muscle weakening disease);
- you suffer from kidney and liver problems;
- you are taking certain drugs for treatment of dementia (such as Alzheimer’s disease);
- you have difficulty urinating;
- you have had a reaction to oxybutynin chloride or any of the other ingredients;
you are pregnant or trying to become pregnant;
- you are breast-feeding;
- you are taking or have recently taken any other medication including medications bought without a prescription.
You should be informed of the following information when taking APO-OXYBUTYNIN:
- When administered in high environmental temperature, APO-OXYBUTYNIN can cause heat prostration (fever and heat stroke due to decreased sweating).
APO-OXYBUTYNIN may produce drowsiness or blurred vision. You should exercise caution while driving or operating machinery.
Alcohol may enhance the drowsiness caused by anticholinergic agents such as APO-OXYBUTYNIN
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 APO-OXYBUTYNIN with other medicines. If you take any of the following medicines with APO-OXYBUTYNIN, it may affect ow 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,
| IMPORTANT: PLEASE READ |
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
Usual dose:
Adults
The usual dose is one 5 mg tablet or one teaspoon (5 mL) syrup two or three times a day. The maximum recommended dose is one 5 mg tablet or one teaspoon (5 mL) syrup four times a day.
Children Over 5 Years of Age
The usual dose is one 5 mg tablet or one teaspoon (5 mL) syrup two times a day. The maximum recommended dose is one 5 mg tablet or one teaspoon (5 mL) syrup three times a day.
Overdose:
If you take more tablets than your doctor prescribed, call your doctor or regional Poison Control Centre immediately.
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
In clinical studies with APO-OXYBUTYNIN, the most common side effects reported by patients were dry mouth, constipation, nausea, drowsiness and dizziness.
This is not a complete list of side effects. For any unexpected effects while taking APO-OXYBUTYNIN, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature 15°C to 30°C in tight, light-resistant containers. Keep out of the reach and sight of children.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction
Reporting (https://www.canada.ca/en/health-
canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice
MORE INFORMATION
If you want more information about APO-OXYBUTYNIN:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website ( https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website
http://www.apotex.ca/products, or by calling 1-800-667-4708.
Apotex Inc.
Toronto, Ontario
M9L 1T9.