Sanctura XR: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

SANCTURA XR^® is an antispasmodic agent used to treat symptoms of overactive bladder. Patients with overactive bladder have these symptoms: a strong need to urinate right away (urgency) with or without urge incontinence (leaking or wetting accidents caused by a sudden, unstoppable urge to urinate), usually with a need to urinate often (frequent bathroom visits).

What it does:

The term “overactive bladder” refers to the involuntary spasm of the bladder muscle (detrusor). Overactive bladder happens when you cannot control your bladder muscle contractions. When these muscle contractions happen too often or cannot be controlled, you get symptoms of overactive bladder (see “What the medication is used for:”).

SANCTURA XR^® works to prevent involuntary contractions of the bladder muscle (detrusor) which allows the muscle to relax, giving you better control of your bladder.

When it should not be used:

SANCTURA XR^® should not be used by patients with or at risk for:

• an inability to empty the bladder (urinary retention);
• delayed emptying of the stomach (gastric retention);
• an eye problem called “uncontrolled narrow-angle glaucoma”;
• allergic reaction to trospium chloride or any of the other ingredients of SANCTURA XR^®.

What the medicinal ingredient is:

Trospium chloride

What the important nonmedicinal ingredients are:

Ammonium hydroxide, ethyl cellulose, hypromellose, macrogol/PEG 400, medium chain triglycerides, methacrylic acid copolymer, polysorbate 80, oleic acid, sugar spheres, talc, titanium dioxide, triethyl citrate. Capsule shells are composed of: gelatin, red iron oxide, titanium dioxide and yellow iron oxide.

What dosage forms it comes in:

SANCTURA XR^® is available as an extended release capsule (60 mg).

WARNINGS AND PRECAUTIONS

BEFORE you use SANCTURA XR^® talk to your doctor or pharmacist if:

• you have trouble emptying your bladder (slow urinary stream), because of the risk of urinary retention;
• you have delayed or slow emptying of your stomach because of the risk of gastric retention;
• you have ulcerative colitis (ulcers in the large intestine or colon), intestinal atony or myasthenia gravis (muscle weakness);
• you have an eye problem called “narrow-angle glaucoma” that is being treated;
• you have liver disease;
• you have kidney disease; SANCTURA XR^® is not recommended for use in patients with severely decreased kidney function.
• you have congestive heart failure or any other heart condition, hypokalemia (low potassium), or other conditions which may increase the risk of SANCTURA XR^® affecting your heart rate;

• you are pregnant, planning on becoming pregnant or are breastfeeding;

The safety and effectiveness of SANCTURA XR^® has not been studied in children.

Although uncommon, SANCTURA XR^® may caused blurred vision and/or drowsiness in some people. Until you know how SANCTURA XR^® affects you, caution should be exercised when driving or operating heavy machinery.

Consumption of alcohol while taking SANCTURA XR^® may make drowsiness worse.

Due to decreased sweating, heat prostration (overheating of the body) can occur when drus such as SANCTURA XR^® are used in a hot environment.

SANCTURA XR^® may produce angioedema with symptoms including: swelling of the face, lips, tongue and /or throat which may cause difficulty in breathing or swallowing. If you have these life threatening symptoms, tell you physician or pharmacist.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist about every medication you are taking including those you are taking without a prescription as well as any natural health products (herbal or vitamins).

Drugs that may interact with SANCTURA XR^® include:

• anticholinergic agents (such as amantadine, tricyclic antidepressants, quinidine, antihistamines, and disopyramide),
• beta agonists (such as salbutamol or formoterol),
• prokinetic agents (such as metoclopramide) and
• drugs that are eliminated by active renal secretion (such as procainamide, pancuronium, morphine, vancomycin, metformin and tenofovir).

Consumption of alcohol while taking SANCTURA XR^® may increase drowsiness.

Interactions with herbal medicines have not been studied.

Taking SANCTURA XR^® with food reduces the amount of medication that will get into your body. (see “PROPER USE OF THIS MEDICATION”).

PROPER USE OF THIS MEDICATION

Usual dose:

Take one SANCTURA XR^® capsule daily in the morning with water. Take SANCTURA XR^® on an empty stomach or at least 1 hour before a meal.

Do not take alcohol within 2 hours of taking SANCTURA XR^®.

Overdose:

Overdosage with SANCTURA XR^® may result in severe anticholinergic effects such as rapid and irregular heartbeat, flushed face, fever, ringing in the ears and muscle spasms.

If you think you have taken more SANCTURA XR^® extended release capsules than you should, contact a poison control centre or, go to your nearest emergency room immediately. If possible, bring the package with you.

Missed Dose:

If you miss a dose, take your next dose at the usual time (on an empty stomach at least 1 hour before your next meal). Do not double the next dose to make up for the missed one.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Common side effects:

In clinical studies, the most common side effects with SANCTURA XR^® were dry mouth and constipation.

Other side effects:

The following less common events may also occur with the use of SANCTURA XR^®:

• trouble emptying the bladder
• blurred vision and drowsiness
• heat prostration.

Due to decreased sweating, heat prostration (overheating of the body) can occur when drugs such as SANCTURA XR^® are used in a hot environment. Be sure to consume adequate amounts of liquid if you are in a hot environment for a prolonged period of time.

Tell your doctor or pharmacist if you have any side effects that bother you or don’t go away.

The following events have been infrequently reported during use of the medicinal ingredient in other forms: Anaphylactic reactions and Stevens-Johnson syndrome (infrequent, life-threatening, allergic reactions), tachycardia (rapid heart beat), syncope (fainting), rhabdomyolysis (destruction of muscle tissue) and hypertensive crisis (sudden, marked increase in blood pressure). If you think you are experiencing any of these effects, stop taking SANCTURA XR^® immediately and go to the emergency room.

This is not a complete list of side effects. For any unexpected effects while taking SANCTURA XR^® contact your doctor or pharmacist.

HOW TO STORE IT

Store at room temperature 15°C to 30°C.

Keep out of reach of children.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Allergan Inc., at: 1-800-668-6424.

Last revised: October 10, 2013

©2013 Allergan Inc., Markham, ON L6G 0B5. ^®Marks owned by Allergan Inc. All rights reserved.

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:

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• $ 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 0701D

    Ottawa, Ontario

    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.