Details for: TROSEC
Company: SUNOVION PHARMACEUTICALS CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02275066 | TROSEC | TROSPIUM CHLORIDE | 20 MG | TABLET | ORAL |
Summary Reports
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
TROSEC 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:”).
TROSEC blocks involuntary contractions of the bladder
muscle (detrusor) which allows the muscle to relax giving you
better control of your bladder.
TROSEC 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
TROSEC 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 TROSEC or any of its components.
What the medicinal ingredient is
Trospium chloride
What the non-medicinal ingredients are
calcium carbonate, carboxymethylcellulose sodium, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxide, lactose monohydrate, microcrystalline cellulose, polyethylene glycol 8000, povidone, stearic acid, sucrose, talc, titanium dioxide, wheat starch, white wax.
What dosage form it comes in
TROSEC is available as a coated tablet (20 mg).
Warnings and precautions
BEFORE you use TROSEC 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 TROSEC affecting your heart rate;
- you have heart disease
- you are pregnant, planning on becoming pregnant or are breast feeding;
Although uncommon, TROSEC may cause blurred vision and/or drowsiness in some people. Until you know how TROSEC affects you, caution should be exercised when driving or operating heavy machinery.
Consumption of alcohol while taking TROSEC may make drowsiness worse.
Due to decreased sweating, heat prostration (overheating of the body) can occur when drugs such as TROSEC are used in a hot environment.
Interactions with this medication
Drugs that may interact with TROSEC 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 TROSEC 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 TROSEC 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 TROSEC 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.
TROSEC has not been studied in children.
Overdose
Overdosage with TROSEC 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 TROSEC, go to
your nearest emergency room immediately. If possible, bring
the package with you.
Missed Dose
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 TROSEC
were dry mouth, constipation and abdominal pain.
Other side effects:
The following less common events may also occur with the use
of TROSEC: 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 TROSEC 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
TROSEC 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 TROSEC 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 TROSEC, contact your doctor or pharmacist.
How to store
Store at controlled room temperature 15° to 30°C.
Keep out of reach of children.
Reporting side effects
Reporting Side Effects
To monitor drug safety, Health Canada collects
information on serious and unexpected effects of drugs. If
you suspect you have had a serious or unexpected reaction
to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
Canadian Adverse Drug Reaction Monitoring Program
(CADRMP)
Health Canada
Address Locator: 0201C2
Ottawa, ON K1A 1B9
NOTE: Before contacting Health Canada, you should
contact your physician or pharmacist.
More information
This document plus the full product monograph, prepared for
health professionals can be found at:
http://www.sunovion.ca
or by contacting the sponsor, Sunovion Pharmaceuticals Canada
Inc., at: 1-866-260-6291
This leaflet was prepared by Sunovion Pharmaceuticals Canada
Inc.
Last revised: November 4, 2019