Patient Medication Information: uses, side effects, how to take - Ran-Tolterodine
ABOUT THIS MEDICATION
ABOUT THIS MEDICATION
What the medication is used for:
The name of this medication is RAN-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 RAN-TOLTERODINE if you have:
- urinary retention,
- gastric retention
- uncontrolled narrow angle glaucoma,
- known hypersensitivity to the tolterodine L-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 L-tartrate.
What the important nonmedicinal ingredients are:
The tablets also contain the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate (dihydrate), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, talc, and titanium dioxide.
What dosage forms it comes in:
RAN-TOLTERODINE is available in 1 mg & 2 mg film coated tablets.
WARNINGS AND PRECAUTIONS
RAN-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 RAN-TOLTERODINE and seek immediate medical attention.
BEFORE you use RAN-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 RAN-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
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 RAN-TOLTERODINE. You should check with your doctor or pharmacist before taking any other medication with RAN-TOLTERODINE.
Drugs that may interact with RAN-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 RAN-TOLTERODINE as instructed by your doctor. Do not increase, decrease or stop taking RAN-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.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
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, RAN-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 RAN-TOLTERODINE and seek immediate medical attention.
Check with your doctor or pharmacist right away if you have any bothersome or unusual effects while taking RAN-TOLTERODINE.
Use caution while driving or using machinery until you know how RAN-TOLTERODINE 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 assistance |
| Only if severe | In all cases | |
| Uncommon | ||
| Allergic reaction | ||
| √ | ||
This is not a complete list of side effects. For any unexpected effects while taking RAN-TOLTERODINE, stop taking the drug and contact your doctor or pharmacist.
HOW TO STORE IT
HOW TO STORE IT
Store at room temperature 15º C to 30º C.
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 for Canadians 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:
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php). 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. |
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MORE INFORMATION
This document plus the full Product Monograph, prepared for Health Professionals can be found by contacting the sponsor,
Ranbaxy Pharmaceuticals Canada Inc., at: 1-866-840-1340.
RANBAXY
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. E., Suite 200
Mississauga, Ontario
L4W 0A5
Last prepared: May 27, 2015