TOVIAZ® Medication Guide

(fesoterodine fumarate)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-Approved Patient Labeling (Patient Information).

Angioedema

Inform patients and/or their caregivers that Toviaz may cause angioedema, which could result in life-threatening airway obstruction. Advise patients and/or their caregivers to promptly discontinue Toviaz and seek immediate medical attention if they experience edema of the lips, tongue or laryngopharynx, or difficulty breathing.

Antimuscarinic Effects

Inform patients that Toviaz, like other antimuscarinic agents, may produce clinically significant adverse effects related to antimuscarinic pharmacological activity including constipation and urinary retention. Toviaz, 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 Toviaz, like other antimuscarinic drugs, is used in a hot environment.

Alcohol

Patients should also be informed that alcohol may enhance the drowsiness caused by Toviaz, like other anticholinergic agents.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Patient Information
TOVIAZ (TOH-vee-as)
(fesoterodine fumarate)
extended-release tablets, for oral use

Read the Patient Information that comes with TOVIAZ before you start taking it 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 is TOVIAZ?
TOVIAZ is a prescription medicine used:

•
in adults to treat symptoms of a condition called overactive bladder (OAB), including urge urinary incontinence (leaking or wetting accidents due to a strong need to urinate), urinary urgency (having a strong need to urinate right away), or urinary frequency (having to urinate too often).
•
in children 6 years of age and older with a body weight greater than 55 pounds (25 kg) to treat neurogenic detrusor overactivity (NDO). TOVIAZ is used to increase the amount of urine your bladder can hold and reduce urine leakage.

It is not known if TOVIAZ is safe and effective in children younger than 6 years of age or with a body weight 55 pounds (25-kg) or less.

Who should not take TOVIAZ?
Do not take TOVIAZ if you:

•
are allergic to TOVIAZ or any of its ingredients. See the end of this leaflet for a complete list of ingredients.
•
are allergic to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules.
•
are not able to empty your bladder (urinary retention).
•
have delayed or slow emptying of your stomach (gastric retention).
•
have an eye problem called uncontrolled narrow-angle glaucoma.

Before you take TOVIAZ, tell your healthcare provider about all your medical conditions, including if you:

•
have problems emptying your bladder or you have a weak urine stream.
•
have any stomach or intestinal problems, or problems with constipation.
•
are receiving treatment for an eye problem called narrow-angle glaucoma.
•
have a condition called Myasthenia Gravis.
•
have kidney problems.
•
have liver problems.
•
are pregnant or plan to become pregnant. It is not known if TOVIAZ will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
•
are breastfeeding or plan to breastfeed. It is not known if TOVIAZ passes into your breast milk. You should talk to your healthcare provider about the best way to feed your baby while taking TOVIAZ.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products. TOVIAZ may affect the way other medicines work, and other medicines may affect how TOVIAZ works. Especially tell your healthcare provider if you are taking antimuscarinic, antibiotics, or antifungal medicines.

Know all the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I take TOVIAZ?

•
Take TOVIAZ exactly as your healthcare provider tells you to take it.
•
Your healthcare provider may lower your dose of TOVIAZ if you are an adult with severe kidney problems.
•
Your healthcare provider may lower or stop your dose of TOVIAZ if you are a child 6 years of age and older with a body weight greater than 77 pounds (35 kg) and have severe kidney problems or are taking certain medicines.
•
Take TOVIAZ with liquid and swallow the tablet whole. Do not chew, divide, or crush the tablet.
•
Take TOVIAZ with or without food.
•
If you miss a dose of TOVIAZ, begin taking TOVIAZ again the next day. Do not take 2 doses of TOVIAZ in the same day.
•
If you take too much TOVIAZ, call your healthcare provider or go to an emergency department right away.

What should I avoid while taking TOVIAZ?

•
TOVIAZ can cause blurred vision, dizziness, and drowsiness. Do not drive, operate machinery, or do other dangerous activities until you know how TOVIAZ affects you.
•
Use caution in hot environments. Decreased sweating and severe heat illness can happen when medicines such as TOVIAZ are used in a hot environment.
•
Drinking alcohol while taking medicines such as TOVIAZ may cause increased drowsiness.

What are the possible side effects of TOVIAZ?
TOVIAZ may cause serious side effects, including:

•
serious allergic reactions. Symptoms of a serious allergic reaction may include swelling of the face, lips, throat, or tongue. If you have any of these symptoms, you should stop taking TOVIAZ and get emergency medical help right away.
•
inability to empty bladder (urinary retention). TOVIAZ may increase your chances of not being able to empty your bladder if you have bladder outlet obstruction. Tell your healthcare provider right away if you are unable to empty your bladder.
•
central nervous system (CNS) effects. Talk to your healthcare provider right away if you get any of these side effects: headache, dizziness, and drowsiness.
•
worsening of Myasthenia Gravis symptoms.

The most common side effects of TOVIAZ in adults include:

•
dry mouth
•
constipation

The most common side effects of TOVIAZ in children 6 years of age and older include:

•
diarrhea
•
urinary tract infection
•
dry mouth
•
constipation
•
stomach pain
•
nausea
•
weight gain
•
headache

Talk to your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of TOVIAZ. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store TOVIAZ?

•
Store TOVIAZ at room temperature between 68° to 77°F (20° to 25°C).
•
Protect the medicine from moisture by keeping the bottle closed tightly.
•
Keep TOVIAZ and all medicines out of the reach of children.

General information about the safe and effective use of TOVIAZ.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TOVIAZ for a condition for which it was not prescribed. Do not give TOVIAZ 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 TOVIAZ that is written for health professionals.

What are the ingredients in TOVIAZ?
Active ingredient: fesoterodine fumarate.
Inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

logo

LAB-0382-14.0
For more information, go to www.TOVIAZ.com or call 1-877-9-TOVIAZ (1-877)-986-8429.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 2/2024

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Find TOVIAZ® medical information:

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Prescribing Information
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Health Professional Information

Medication Guide

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-Approved Patient Labeling (Patient Information).

Angioedema

Inform patients and/or their caregivers that Toviaz may cause angioedema, which could result in life-threatening airway obstruction. Advise patients and/or their caregivers to promptly discontinue Toviaz and seek immediate medical attention if they experience edema of the lips, tongue or laryngopharynx, or difficulty breathing.

Antimuscarinic Effects

Inform patients that Toviaz, like other antimuscarinic agents, may produce clinically significant adverse effects related to antimuscarinic pharmacological activity including constipation and urinary retention. Toviaz, 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 Toviaz, like other antimuscarinic drugs, is used in a hot environment.

Alcohol

Patients should also be informed that alcohol may enhance the drowsiness caused by Toviaz, like other anticholinergic agents.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Patient Information
TOVIAZ (TOH-vee-as)
(fesoterodine fumarate)
extended-release tablets, for oral use

Read the Patient Information that comes with TOVIAZ before you start taking it 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 is TOVIAZ?
TOVIAZ is a prescription medicine used:

•
in adults to treat symptoms of a condition called overactive bladder (OAB), including urge urinary incontinence (leaking or wetting accidents due to a strong need to urinate), urinary urgency (having a strong need to urinate right away), or urinary frequency (having to urinate too often).
•
in children 6 years of age and older with a body weight greater than 55 pounds (25 kg) to treat neurogenic detrusor overactivity (NDO). TOVIAZ is used to increase the amount of urine your bladder can hold and reduce urine leakage.

It is not known if TOVIAZ is safe and effective in children younger than 6 years of age or with a body weight 55 pounds (25-kg) or less.

Who should not take TOVIAZ?
Do not take TOVIAZ if you:

•
are allergic to TOVIAZ or any of its ingredients. See the end of this leaflet for a complete list of ingredients.
•
are allergic to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules.
•
are not able to empty your bladder (urinary retention).
•
have delayed or slow emptying of your stomach (gastric retention).
•
have an eye problem called uncontrolled narrow-angle glaucoma.

Before you take TOVIAZ, tell your healthcare provider about all your medical conditions, including if you:

•
have problems emptying your bladder or you have a weak urine stream.
•
have any stomach or intestinal problems, or problems with constipation.
•
are receiving treatment for an eye problem called narrow-angle glaucoma.
•
have a condition called Myasthenia Gravis.
•
have kidney problems.
•
have liver problems.
•
are pregnant or plan to become pregnant. It is not known if TOVIAZ will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
•
are breastfeeding or plan to breastfeed. It is not known if TOVIAZ passes into your breast milk. You should talk to your healthcare provider about the best way to feed your baby while taking TOVIAZ.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products. TOVIAZ may affect the way other medicines work, and other medicines may affect how TOVIAZ works. Especially tell your healthcare provider if you are taking antimuscarinic, antibiotics, or antifungal medicines.

Know all the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I take TOVIAZ?

•
Take TOVIAZ exactly as your healthcare provider tells you to take it.
•
Your healthcare provider may lower your dose of TOVIAZ if you are an adult with severe kidney problems.
•
Your healthcare provider may lower or stop your dose of TOVIAZ if you are a child 6 years of age and older with a body weight greater than 77 pounds (35 kg) and have severe kidney problems or are taking certain medicines.
•
Take TOVIAZ with liquid and swallow the tablet whole. Do not chew, divide, or crush the tablet.
•
Take TOVIAZ with or without food.
•
If you miss a dose of TOVIAZ, begin taking TOVIAZ again the next day. Do not take 2 doses of TOVIAZ in the same day.
•
If you take too much TOVIAZ, call your healthcare provider or go to an emergency department right away.

What should I avoid while taking TOVIAZ?

•
TOVIAZ can cause blurred vision, dizziness, and drowsiness. Do not drive, operate machinery, or do other dangerous activities until you know how TOVIAZ affects you.
•
Use caution in hot environments. Decreased sweating and severe heat illness can happen when medicines such as TOVIAZ are used in a hot environment.
•
Drinking alcohol while taking medicines such as TOVIAZ may cause increased drowsiness.

What are the possible side effects of TOVIAZ?
TOVIAZ may cause serious side effects, including:

•
serious allergic reactions. Symptoms of a serious allergic reaction may include swelling of the face, lips, throat, or tongue. If you have any of these symptoms, you should stop taking TOVIAZ and get emergency medical help right away.
•
inability to empty bladder (urinary retention). TOVIAZ may increase your chances of not being able to empty your bladder if you have bladder outlet obstruction. Tell your healthcare provider right away if you are unable to empty your bladder.
•
central nervous system (CNS) effects. Talk to your healthcare provider right away if you get any of these side effects: headache, dizziness, and drowsiness.
•
worsening of Myasthenia Gravis symptoms.

The most common side effects of TOVIAZ in adults include:

•
dry mouth
•
constipation

The most common side effects of TOVIAZ in children 6 years of age and older include:

•
diarrhea
•
urinary tract infection
•
dry mouth
•
constipation
•
stomach pain
•
nausea
•
weight gain
•
headache

Talk to your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of TOVIAZ. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store TOVIAZ?

•
Store TOVIAZ at room temperature between 68° to 77°F (20° to 25°C).
•
Protect the medicine from moisture by keeping the bottle closed tightly.
•
Keep TOVIAZ and all medicines out of the reach of children.

General information about the safe and effective use of TOVIAZ.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TOVIAZ for a condition for which it was not prescribed. Do not give TOVIAZ 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 TOVIAZ that is written for health professionals.

What are the ingredients in TOVIAZ?
Active ingredient: fesoterodine fumarate.
Inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

logo

LAB-0382-14.0
For more information, go to www.TOVIAZ.com or call 1-877-9-TOVIAZ (1-877)-986-8429.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 2/2024
Medication Guide

Health Professional Information

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