Patient Medication Information: uses, side effects, how to take - Mar-Trospium
What the medication is used for:
MAR-TROSPIUM is an antispasmodic agent used to treat 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), and nocturia (having to urinate frequently during the night).
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:”).
MAR-TROSPIUM blocks involuntary contractions of the bladder muscle (detrusor) which allows the muscle to relax giving you better control of your bladder.
MAR-TROSPIUM reduces (see also “What this medication is used for”):
- the strong need to urinate right away
- the number of bathroom visits during the day or night
- the number of wetting accidents
You should begin to notice an improvement in your symptoms in about a week.
When it should not be used:
MAR-TROSPIUM 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”;
- a history of any allergic or other severe reaction to MAR-TROSPIUM or any of its components.
What the medicinal ingredient is:
Trospium chloride
What the nonmedicinal ingredients are:
Lactose Monohydrate, Croscarmellose Sodium, Povidone, Confectioner’s Sugar, Microcrystalline Cellulose, Silicon Dioxide, Magnesium Stearate, Hypromellose, Talc, Polyethylene Glycol, Titanium Dioxide, Shellac and Iron Oxide Black.
What dosage forms it comes in:
MAR-TROSPIUM is available as a coated tablet (20 mg).
BEFORE you use MAR-TROSPIUM 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 or kidney disease (see “PROPER USE OF THIS MEDICATION”, Usual dose);
- you have congestive heart failure, hypokalemia (low potassium), or other conditions which may increase the risk of MAR-TROSPIUM affecting your heart rate;
- you have heart disease
you are pregnant, planning on becoming pregnant or are breast feeding;
The safety and effectiveness of MAR-TROSPIUM has not been studied in children.
Although uncommon, MAR-TROSPIUM may cause blurred vision and/or drowsiness in some people. Until you know how MAR-TROSPIUM affects you, caution should be exercised when driving or operating heavy machinery.
Consumption of alcohol while taking MAR-TROSPIUM may make drowsiness worse.
Due to decreased sweating, heat prostration (overheating of the body) can occur when drugs such as MAR-TROSPIUM are used in a hot environment.
Drugs that may interact with MAR-TROSPIUM include: anticholinergic agents (such as amantadine, tricyclic antidepressants, quinidine, antihistamines, and disopyramide), beta agonists (such as salbutamol or
INTERACTIONS WITH THIS MEDICATION
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
formoterol), prokinetic agents (such as metoclopramide) and drugs that are eliminated by active renal secretion (such as digoxin, procainamide, pancuronium, morphine, vancomycin, metformin and tenofovir).
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).
Interactions with herbal medicines have not been studied.
Taking MAR-TROSPIUM with food reduces the amount of medication that will get into your body. (see “PROPER USE OF THIS MEDICATION”)
Usual dose:
Take one MAR-TROSPIUM 20 mg tablet twice a day on an empty stomach at least one hour before meals. For patients with kidney disease the recommended dose of MAR-TROSPIUM is 20 mg once a day. In geriatric patients 75 years of age and older, the dose may be reduced to 20 mg once daily if twice daily dosing is not well tolerated.
MAR-TROSPIUM has not been studied in children.
Overdose:
Overdosage with MAR-TROSPIUM 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 an overdose of MAR-TROSPIUM, 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 dose.
Common Side effects:
In clinical studies, the most common side effects with Trospium chloride were dry mouth, constipation and abdominal pain.
Other side effects:
The following less common events may also occur with the use of Trospium chloride: dyspepsia (upset stomach), nausea, dizziness, flatulence, chest pain, dry eyes, blurred vision, increased heart rate, palpitation, urinary retention, and heat prostration.
Due to decreased sweating, heat prostration (overheating of the body) can occur when drugs such as MAR-TROSPIUM 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 rarely been reported during Trospium chloride use: Anaphylactic, Stevens-Johnson and toxic epidermal necrolysis reactions (rare, life-threatening, allergic reactions), angioedema (serious allergic reaction which can cause swelling of the face or throat), tachycardia (rapid heartbeat), syncope (fainting), myalgia (muscle pain), arthralgia (joint pain), rhabdomyolysis (destruction of muscle tissue), hallucinations, confusion, agitation, and hypertensive crisis (sudden, marked increase in blood pressure). If you think you are experiencing any of these rare effects, stop taking MAR-TROSPIUM immediately and go to the emergency room.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||||
| Only if severe | In all cases | |||||
| Uncommon | Urinary retention (inability to empty your bladder) | √ | ||||
| Constipation | √ | |||||
This is not a complete list of side effects. For any unexpected effects while taking MAR-TROSPIUM, contact your doctor or pharmacist.
Store at controlled room temperature 15° to 30°C.
Keep out of reach and sight of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
HOW TO STORE IT
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
PROPER USE OF THIS MEDICATION
If you want more information about MAR-TROSPIUM:
- 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://www.canada.ca/en/health-canada.html); or by contacting the sponsor, Marcan Pharmaceuticals Inc. Canada, at: 1-855-627-2261.
Date of Preparation: May 8, 2019