Apo-Tolterodine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

The name of this medication is APO-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 bladder contractions or spasms. 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 APO-TOLTERODINE if you have:

• urinary retention,
• gastric retention
• uncontrolled narrow angle glaucoma,
• known hypersensitivity to the tolterodine tartrate or any of the other ingredients.

What the medicinal ingredient is:

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

What the important nonmedicinal ingredients are:

The tablets also contain the following inactive ingredients: Colloidal Silicon dioxide, Dibasic calcium phosphate dehydrate, Hypromellose 2910 E5, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol 8000, Sodium starch glycolate, Titanium Dioxide.

What dosage forms it comes in:

APO-TOLTERODINE 1 mg tablets are white to off-white, round, film coated, biconvex tablets, engraved "APO" on one side and "TL1" on the other side.

APO-TOLTERODINE 2 mg tablets are White to off-white, round, film coated, biconvex tablets, engraved "APO" on one side and "TL2" on the other side.

WARNINGS AND PRECAUTIONS

APO-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 APO-TOLTERODINE and seek immediate medical attention.

BEFORE you use APO-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 APO-TOLTERODINE works for you.
• you are a female or are over 65 years in 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

The following list includes some, but not all, of the drugs that may increase the risk of side effects while receiving APO-TOLTERODINE.

You should check with your doctor or pharmacist before taking any other medication with APO-TOLTERODINE.

Drugs that may interact with APO-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 (ie. 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 APO-TOLTERODINE as instructed by your doctor. Do not increase, decrease or stop taking APO-TOLTERODINE without first talking to your doctor.

Usual dose:

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, APO-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 (sensation of rapid, pounding, or irregular heart beat), fainting, or seizures, you should stop taking APO-TOLTERODINE and seek immediate medical attention.

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

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

This is not a complete list of side effects. For any unexpected effects while taking APO-TOLTERODINE, contact your doctor or pharmacist

HOW TO STORE IT

Store at Controlled Room Temperature 15°- 30°C.

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

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at http://www.apotex.ca/products or by contacting DISpedia, Apotex's Drug Information Service at: 1-800-667-4708.

Last prepared: January 29, 2016