Patient Medication Information: uses, side effects, how to take - Teva-Tolterodine LA

ABOUT THIS MEDICATION

What the medication is used for:

The name of this medication is TEVA-TOLTERODINE LA. 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 TEVA-TOLTERODINE LA

if you have:

urinary retention,
gastric retention
uncontrolled narrow angle glaucoma,
known hypersensitivity to tolterodine L-tartrate or any of the other ingredients in TEVA-TOLTERODINE LA.

What the medicinal ingredient is:

Each capsule contains 2 mg or 4 mg of the active ingredient, tolterodine L-tartrate. TEVA-TOLTERODINE LA capsules dissolve over time, releasing the active ingredient over 24 hours.

What the important nonmedicinal ingredients are:

TEVA-TOLTERODINE LA capsules containing the following non-medicinal ingredients: cellulose microcrystalline, colloidal anhydrous silica, docusate sodium, ethylcellulose, hydroxypropylmethylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid/ethylacrylate copolymer dispersion, polyvinyl acetate, povidone, propylene glycol, sodium lauryl sulfate and triethyl citrate and capsule shell and ink containing the following:

Capsule shell:

2 mg: Gelatin, indigotine-FD&C Blue 2, yellow iron oxide and titanium dioxide

4 mg: Gelatin, indigotine-FD&C Blue 2 and titanium dioxide

Ink: Propylene glycol, providone, shellac, sodium hydroxide, titanium dioxide

What dosage form it comes in:

TEVA-TOLTERODINE LA:

2 mg capsules are opaque green-opaque green, imprinted with “2mg” (body) and ''A129'' (cap) with white ink.

4 mg capsules are opaque light blue-opaque light blue, imprinted with “4mg” (body) and ''A130'' (cap) with white ink.

WARNINGS AND PRECAUTIONS

TEVA-TOLTERODINE LA 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 LA and seek immediate medical attention.

BEFORE you use TEVA-TOLTERODINE LA 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 LA 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

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

Drugs that may interact with TEVA-TOLTERODINE LA 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 TEVA-TOLTERODINE LA as instructed by your doctor. Do not increase, decrease or stop taking TEVA-TOLTERODINE LA 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. TEVA-TOLTERODINE LA can be taken with food.

Overdose:

If you think you have taken too much TEVA-TOLTERODINE LA, contact a health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Do not take more capsules than your doctor has told you to.

Missed Dose:

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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

As with most drugs, TEVA-TOLTERODINE LA 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 TEVA-TOLTERODINE LA and seek mediate medical attention.

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

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

SERIOUS SIDE EFFECTS, HOW OFTEN THEY

HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

doctor or

pharmacist

Stop taking drug and seek immediate emergency medical attention

Only if

severe

In all

cases

Uncommon

Allergic

reaction

√

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

HOW TO STORE IT

Store at room temperature 15ºC to 25ºC.

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

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

REPORTING SIDE EFFECTS

You can help improve the safe use of health products by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

Report online at www.healthcanada.gc.ca/medeffect
Call toll-free at 1-866-234-2345
By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
  Health Canada
  Postal Locator 0701E
  Ottawa, ON K1A 0K9

Postage paid labelsand the Consumer Side Effect Reporting Form are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE:Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

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)

or 1-877-777-9117 (French)

or druginfo@tevacanada.com