Toviaz ER 4mg Tablets (30 Count Bottle)

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

FESOTERODINE EXTENDED-RELEASE - ORAL

(FES-oh-TER-oh-deen)

COMMON BRAND NAME(S): Toviaz

USES: This medication is used to treat an overactive bladder. By relaxing the muscles in the bladder, fesoterodine improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. This medication belongs to the class of drugs known as antispasmodics.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using fesoterodine and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Take this medication by mouth, with or without food, usually once a day, or as directed by your doctor. Take each dose with a full glass of liquid. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. Dosage is based on your medical condition, other medications you are taking, and response to treatment. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Do not increase your dose or take this medication more often without your doctor\'s approval. Your condition will not improve any faster and the risk of serious side effects may be increased. Inform your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Dry mouth, dry eyes, constipation, dizziness, drowsiness, or blurred vision may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated, consult your pharmacist for help in choosing a laxative (such as stimulant-type with stool softener). Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: constipation lasting 3 or more days, severe stomach/abdominal pain, trouble urinating, signs of kidney infection (such as burning/painful urination, lower back pain, fever). Seek immediate medical attention if any of these rare but serious side effects occur: fast heartbeat, fainting. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following signs of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking fesoterodine, tell your doctor or pharmacist if you are allergic to it; or to tolterodine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: problems emptying your bladder (urinary retention), severe blockage of stomach/intestines (gastric obstruction/retention). Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bladder problems (such as bladder outflow obstruction, enlarged prostate), slowed movement of stomach/intestines, stomach/intestinal disease (such as ulcerative colitis), severe constipation, a certain eye condition (narrow-angle glaucoma), kidney disease, liver disease, a certain muscle disease (myasthenia gravis). This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. This medication can cause decreased sweating. Avoid becoming overheated in hot weather, saunas, or during exercise or other strenuous activities since heatstroke may occur. Kidney function declines as you grow older. This medication is removed by the kidneys. Older adults may be more sensitive to the effects of this drug, especially dizziness, dry mouth, and constipation. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Some products that may interact with this drug include: pramlintide, potassium tablets/capsules, other drugs that can cause dry mouth and constipation (including anticholinergic medications such as atropine/scopolamine, antihistamines such as diphenhydramine, other antispasmodics including dicyclomine, belladonna alkaloids). Other medications can affect the removal of fesoterodine from your body, which may affect how fesoterodine works. Examples include certain azole antifungals (such as itraconazole, ketoconazole), among others. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that can cause drowsiness, constipation or blurred vision. Ask your pharmacist about the safe use of those products.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe drowsiness or unconsciousness, unusual excitement, mental/mood changes.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised June 2018. Copyright(c) 2018 First Databank, Inc.