ACH-Tolterodine Tartrate Extended Release: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

The name of this medication is ACH-Tolterodine Tartrate Extended Release. 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 works to prevent 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 ACH-Tolterodine Tartrate Extended Release if you have:

• urinary retention,
• gastric retention
• uncontrolled narrow angle glaucoma,
• known hypersensitivity to tolterodine L-tartrate or any of the other ingredients in ACH- Tolterodine Tartrate Extended Release.

What the medicinal ingredient is:

Each capsule contains film-coated beads of 2 mg or 4 mg of the active ingredient, tolterodine L-tartrate. The film- coated beads dissolve over time, releasing the active ingredient over 24 hours.

What the important nonmedicinal ingredients are:

The tablets also contain the following inactive ingredients: Hypromellose, microcrystalline cellulose, purified talc,

ethylcellulose, ammonium hydroxide, medium chain triglycerides, oleic acid. The 2 mg capsules also contain gelatin, titanium dioxide, FD&C Blue #2 and iron oxide yellow & 4 mg capsules contain gelatin, titanium dioxide, FD&C Blue #2. Both capsule strengths are imprinted with a pharmaceutical grade ink, Tek print TM SW-9008 that contains shellac, titanium dioxide, propylene glycol ammonium hydroxide and potassium hydroxide.

What dosage forms it comes in:

ACH-Tolterodine Tartrate Extended Release 2 mg capsules are dark green – dark green imprinted with bar lines on cap and body with white ink.

ACH-Tolterodine Tartrate Extended Release 4 mg capsules are dark blue – dark blue imprinted with bar lines on cap and body with white ink.

WARNINGS AND PRECAUTIONS

ACH-Tolterodine Tartrate Extended Release 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 ACH- Tolterodine Tartrate Extended Release and seek immediate medical attention.

BEFORE you use ACH-Tolterodine Tartrate Extended Release 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 ACH- Tolterodine Tartrate Extended Release 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

INTERACTIONS WITH THIS MEDICATION

If you miss taking your capsule, take it as soon as you remember. But if it is almost time for the next dose, skip the missed dose and just take the next dose. Do not take more than one dose at a time.

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

Drugs that may interact with ACH-Tolterodine Tartrate Extended Release 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 ACH-Tolterodine Tartrate Extended Release as instructed by your doctor. Do not increase, decrease or stop taking ACH-Tolterodine Tartrate Extended Release without first talking to your doctor.

Usual dose:

The usual starting dose is 4 mg once daily, but may be decreased to 2 mg once daily. The capsule should be swallowed whole. ACH-Tolterodine Tartrate Extended Release can be taken with food.

Overdose:

Do not take more capsules 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:

As with most drugs, ACH-Tolterodine Tartrate Extended Release 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
• stomach pain
• 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 effect is dry mouth. Less commonly reported side effects are headache, constipation, dizziness, fatigue, abdominal pain and dry eyes.

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 ACH-Tolterodine Tartrate Extended Release and seek mediate medical attention.

Check with your doctor or pharmacist right away if you have any bothersome or unusual effects while taking ACH- Tolterodine Tartrate Extended Release.

Use caution while driving or using machinery until you know how ACH-Tolterodine Tartrate Extended Release affects you.

This is not a complete list of side effects. For any unexpected effects while taking ACH-Tolterodine Tartrate Extended Release, stop taking the drug and contact your

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

doctor or pharmacist.

HOW TO STORE IT

Store at room temperature 15ºC to 30ºC. Protect from light.

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.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Accord Healthcare Inc. at:

Accord Healthcare Inc.

3535 boul. St. Charles, Suite 704 Kirkland, QC, H9H 5B9

Canada

Tel: 1-866-296-0354

Last prepared: February 5, 2016

REPORTING SUSPECTED 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 3 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 0701C Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TM 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.