Details for: MAR-TROSPIUM
Company: MARCAN PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02488353 | MAR-TROSPIUM | TROSPIUM CHLORIDE | 20 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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
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 non-medicinal 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 form it comes in
MAR-TROSPIUM is available as a coated tablet (20 mg).
Warnings and precautions
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 ofurinary 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;
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.
Interactions with this medication
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 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”)
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 MARTROSPIUM 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 MARTROSPIUM, 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.
Side effects and what to do about them
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.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| 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.
How to store
Store at controlled room temperature 15° to 30°C.
Keep out of reach and sight of children.
Reporting 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 three 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 MedEffectTM 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
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