Consumer Information for: TEVA-TOLTERODINE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

The name of this medication is TEVA-TOLTERODINE. It is used for the treatment of the symptoms of overactive bladder which include frequency, urgency, and urge incontinence.

REMEMBER: This medication is for YOU. Never give it to others. It may harm them even if their symptoms are the same as yours.

What it does

Tolterodine prevents abnormal bladder contractions. This results in more bladder capacity and less frequency, urgency and involuntary loss of urine.

When it should not be used

You should not take TEVA-TOLTERODINE if you have:

  • Urinary retention,
  • gastric retention
  • uncontrolled narrow angle glaucoma,
  • known hypersensitivity to the drug or any of the other ingredients.
What the medicinal ingredient is

Each tablet contains 1 mg or 2 mg of the active ingredient tolterodine L-tartrate.

What the non-medicinal ingredients are

Calcium Phosphate Dibasic Dihydrate, Colloidal Silicon Dioxide, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol-Partially Hydrolyzed, Sodium Starch Glycolate, Talc and Titanium Dioxide.

What dosage form it comes in

Tablets, 1 mg and 2 mg

Warnings and precautions

TEVA-TOLTERODINE may have an effect on the electrical activity of the heart. This effect can be measured as a change in the electrocardiogram (ECG). It is important to follow the instructions of your doctor with regard to dosing or any special tests. In very rare cases, drugs with an effect on the ECG can lead to disturbances in heart rhythm (arrhythmias/dysrhythmias). These heart rhythm disturbances are more likely in patients with risk factors, such as heart disease, or in the presence of certain interacting drugs. If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting, or seizures, you should stop taking TEVA-TOLTERODINE and seek immediate medical attention.

BEFORE you use TEVA-TOLTERODINE talk to your doctor or pharmacist if:

  • you are pregnant, or trying to become pregnant
  • you are breastfeeding your child
  • you have myasthenia gravis (a chronic autoimmune neuromuscular disease which cause muscle weakness)
  • you have stomach problems affecting passage and digestion of food
  • you have liver problems
  • you have kidney problems
  • you are taking medication bought without a prescription. They may affect your condition, or how TEVA-TOLTERODINE works for you.
  • you are a female or are over 65 years of age; you have a disorder known as Long QT Syndrome; a heart disease; a history of stroke or brain hemorrhage; a personal history of fainting spells; a family history of sudden cardiac death at <50 years; electrolyte disturbances (e.g., low blood potassium levels); an eating disorder or are following an extreme diet; diabetes, especially with associated nerve disorders
Interactions with this medication

The following list includes some, but not all, of the drugs that may increase the risk of side effects while receiving TEVA-TOLTERODINE. You should check with your doctor or pharmacist before taking any other medication with TEVA-TOLTERODINE.

Drugs that may interact with TEVA-TOLTERODINE INCLUDE:

  • other drugs that possess antimuscarinic/anticholinergic properties (drugs that cause blurred vision, constipation, dry mouth, etc.)
  • antifungals (drugs to treat fungal infections, such as, fluconazole, ketoconazole, or itraconazole)
  • antibiotics (i.e. erythromycin, clarithromycin)
  • cyclosporine (a drug to prevent rejection of organ transplants)
  • vinblastine (a drug to treat some types of cancer)
  • antiarrhythmics (drugs that stabilize the heart rhythm function, such as procainamide, quinidine amiodarone, sotalol, etc.)
  • antidepressants (mood disorder drugs)
  • antipsychotics (drugs to stabilize thinking and behavior)
  • anti-asthmatic (salmeterol)
Proper use of this medication

Take TEVA-TOLTERODINE as instructed by your doctor. Do not increase, decrease or stop taking TEVA-TOLTERODINE without first talking to your doctor.

Usual Dose

Adults and Elderly: The usual starting dose is 2 mg twice daily, but may be decreased to 1 mg twice daily.

Overdose

Do not take more tablets than your doctor has told you to. If you take too many tablets by accident, call your doctor or pharmacist or a poison control centre immediately.

Missed Dose

If you should forget to take your tablet at the usual time, take it as soon as you remember unless it is time to take the next one. Continue with the remaining doses as before. Do not take more than one dose at a time.

Side effects and what to do about them

As with most drugs, TEVA-TOLTERODINE can cause some side effects.

Tell your doctor or pharmacist right away if you suffer from any of the following side effects while taking this medication:

  • dry mouth
  • decreased tear production (dry irritable eye)
  • heartburn
  • blurred vision
  • dizziness
  • palpitations (sensation of rapid, pounding, or irregular heart beat)
  • fainting
  • difficulty in urination (passing water)

The most common side effects are dry mouth and headache. Less commonly reported side effects are dizziness, fatigue, abdominal pain, constipation and heartburn.

If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations (sensations of rapid, pounding, or irregular heart beat), fainting, or seizures, you should stop taking TEVA-TOLTERODINE and seek immediate medical attention.

Check with your doctor or pharmacist right away if you have any bothersome or unusual effects while taking TEVA-TOLTERODINE.

Use caution while driving or using machinery until you know how TEVA-TOLTERODINE affects you.

Serious side effects, how often they happen and what to do about them
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 seek emergency medical assistance
Uncommon
Allergic reaction     ✔

This is not a complete list of side effects. For any unexpected effects while taking TEVA-TOLTERODINE, stop taking the drug and contact your doctor or pharmacist.

How to store

Store at room temperature 15°C to 30°C. Keep the product in the original packaging.

You should not use your medication after the expiration date printed on the carton and label.

Keep all medications out of the reach of children. This medication could harm them.

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

This document plus the full product monograph prepared for health professionals can be found by contacting Teva Canada Limited at:

1-800-268-4127 ext. 1255005 (English)

1-877-777-9117 (French)

or druginfo@tevacanada.com

This leaflet was prepared by:

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: June 26, 2015

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