Consumer Information for: SANDOZ TOLTERODINE LA
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 Sandoz 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 Sandoz 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 Sandoz Tolterodine LA.
What the medicinal ingredient is
Each capsule contains 2 mg or 4 mg of the active ingredient, tolterodine L-tartrate. The product dissolves over time, releasing the active ingredient over 24 hours.
What the non-medicinal ingredients are
The capsules also contain the following inactive ingredients: cellulose microcrystalline, colloidal anhydrous silica, dioctyl sodium sulfosuccinate, ethylcellulose, gelatin, hydroxypropylmethylcellulose, indigotine – FD&C Blue2, lactose monohydrate, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, poly(vinyl acetate), povidone, propylene glycol, titanium dioxide, triethyl citrate and sodium lauryl sulphate.The 4 mg capsules also contain yellow iron oxide. Both capsule strengths are imprinted with a pharmaceutical grade ink, that contains sodium hydroxide, shellac, povidone, propylene glycol and titanium dioxide.
What dosage form it comes in
Sandoz Tolterodine LA 2 mg capsules are opaque-green with symbol “2mg” (body) and ''A129'' (cap) printed in white ink.
Sandoz Tolterodine LA 4 mg capsules are opaque light blue with symbol “4mg” (body) and ''A130'' (cap) printed in white ink.
Warnings and precautions
Sandoz 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 Sandoz Tolterodine LA and seek immediate medical attention.
BEFORE you use Sandoz 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 Sandoz 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 Sandoz Tolterodine LA. You should check with your doctor or pharmacist before taking any other medication with Sandoz Tolterodine LA.
Drugs that may interact with Sandoz 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 Sandoz Tolterodine LA as instructed by your doctor. Do not increase, decrease or stop taking Sandoz 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. Do not crush or chew. Sandoz Tolterodine LA 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
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, Sandoz 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 Sandoz 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 Sandoz Tolterodine LA.
Use caution while driving or using machinery until you know how Sandoz Tolterodine LA affects you.
| 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 immediate emergency medical attention |
|---|---|---|---|
| Uncommon | |||
| Allergic reaction | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Sandoz Tolterodine LA, stop taking the drug and contact your doctor or pharmacist.
How to store
Store bottles at room temperature 15ºC to 30ºC.
Store blisters at temperature 15ºC to 25ºC. Protect from moisture and heat.
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 the sponsor, Sandoz Canada Inc., at:
1-800-361-3062
or by written request at:
145 Jules-Léger
Boucherville QC
J4B 7K8
Or by e-mail at:
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc.
Last prepared: May 04, 2015
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