FESOTERODINE FUMARATE (Page 6 of 7)
16 HOW SUPPLIED/STORAGE AND HANDLING
Fesoterodine fumarate extended-release tablets 4 mg are light blue, oval, biconvex, film coated tablets debossed with “K46” on one side and plain on other side. They are supplied as follows:
Bottles of 30 NDC 65862-766-30
Fesoterodine fumarate extended-release tablets 8 mg are blue, oval, biconvex, film coated tablets debossed with “K47” on one side and plain on other side. They are supplied as follows:
Bottles of 30 NDC 65862-767-30
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-Approved Patient Labeling (Patient Information).
Angioedema
Inform patients and/or their caregivers that fesoterodine fumarate extended-release tablets may cause angioedema, which could result in life-threatening airway obstruction. Advise patients and/or their caregivers to promptly discontinue fesoterodine fumarate extended-release tablets and seek immediate medical attention if they experience edema of the lips, tongue or laryngopharynx, or difficulty breathing.
Antimuscarinic Effects
Inform patients that fesoterodine fumarate extended-release tablets, like other antimuscarinic agents, may produce clinically significant adverse effects related to antimuscarinic pharmacological activity including constipation and urinary retention. Fesoterodine fumarate extended-release tablets, like other antimuscarinics, may be associated with blurred vision, therefore, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug’s effects on the patient have been determined. Heat prostration (due to decreased sweating) can occur when fesoterodine fumarate extended-release tablets, like other antimuscarinic drugs, is used in a hot environment.
Alcohol
Patients should also be informed that alcohol may enhance the drowsiness caused by fesoterodine fumarate extended-release tablets, like other anticholinergic agents.
| Patient Information Fesoterodine Fumarate Extended-release Tablets, for oral use (FES-oh-TER-oh-deen FUE-ma-rate) |
| Read the Patient Information that comes with fesoterodine fumarate extended-release tablets before you start taking them and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment. |
What are fesoterodine fumarate extended –release tablets? Fesoterodine fumarate extended-release tablets are a prescription medicine used:
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Who should not take fesoterodine fumarate extended-release tablets? Do not take fesoterodine fumarate extended-release tablets if you:
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Before you take fesoterodine fumarate extended-release tablets, tell your healthcare provider about all your medical conditions, including if you:
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How should I take fesoterodine fumarate extended-release tablets?
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What should I avoid while taking fesoterodine fumarate extended-release tablets?
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What are the possible side effects of fesoterodine fumarate extended –release tablets? Fesoterodine fumarate extended-release tablets may cause serious side effects, including:
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How should I store fesoterodine fumarate extended –release tablets?
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| General information about the safe and effective use of fesoterodine fumarate extended-release tablets. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use fesoterodine fumarate extended– release tablets for a condition for which it was not prescribed. Do not give fesoterodine fumarate extended– release tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about fesoterodine fumarate extended– release tablets that is written for health professionals. |
| What are the ingredients in fesoterodine fumarate extended –release tablets? Active ingredient: fesoterodine fumarate.Inactive ingredients: FD&C Blue #2/indigo carmine aluminum lake, glyceryl dibehenate, hypromellose, lactose monohydrate, lecithin (soya), microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol.Pediatric use information is approved for Pfizer Inc.’s TOVIAZ® (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.Distributed by:Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by:Aurobindo Pharma Limited Hyderabad-500 032, India For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876. |
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 11/2021
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