Details for: TEVA-TOLTERODINE LA
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02412195 | TEVA-TOLTERODINE LA | TOLTERODINE TARTRATE | 2 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
| 02412209 | TEVA-TOLTERODINE LA | TOLTERODINE TARTRATE | 4 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
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
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 non-medicinal 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
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)
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.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and seek immediate emergency medical attention |
|---|---|---|---|
| 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
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 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)
or 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 29, 2015