In the U.S.—

In Canada—

• Antispasmodic, urinary tract

Flavoxate (fla-VOX-ate) belongs to the group of medicines called antispasmodics. It is taken by mouth to help decrease muscle spasms of the bladder and relieve difficult urination.

Flavoxate is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For flavoxate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to flavoxate. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Flavoxate has not been studied in pregnant women. However, flavoxate has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—It is not known whether flavoxate passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients and in children over 12 years of age. Flavoxate is not recommended for children younger than 12 years of age because safety and efficacy have not been established.

Older adults—Confusion may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of flavoxate.

Other medicines—Although certain medicines should not be used together at all in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Bleeding (severe) or
• Glaucoma or
• Intestinal blockage or other intestinal or stomach problems or
• Urinary tract blockage—Use of flavoxate may make these conditions worse

• Enlarged prostate—Use of flavoxate may cause difficult urination

This medicine is usually taken with water on an empty stomach. However, your doctor may want you to take it with food or milk to lessen stomach upset.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing—

The dose of flavoxate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average dose of flavoxate. If your dose is different, do not change it unless your doctor tells you to do so. The number of tablets that you take depends on the strength of the medicine.

• Adults and children 12 years of age and older: 100 to 200 milligrams three or four times a day.
• Children up to 12 years of age: Use and dose must be determined by the doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

This medicine may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses may help lessen the discomfort from bright light.

This medicine may cause some people to become drowsy or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see well.

Flavoxate may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

Your mouth and throat may feel very dry while you are taking this medicine. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Rare
  • Confusion;  eye pain;  skin rash or hives;  sore throat and fever 
  
  

• Symptoms of overdose
  • Clumsiness or unsteadiness;  dizziness (severe);  drowsiness (severe);  fever;  flushing or redness of face;  hallucinations (seeing, hearing, or feeling things that are not there);  shortness of breath or troubled breathing ;  unusual excitement, nervousness, restlessness, or irritability 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Drowsiness;  dryness of mouth and throat  
  
  

• Less common or rare
  • Blurred vision;  constipation;  difficult urination;  difficulty concentrating ;  dizziness;  fast heartbeat ;  headache;  increased sensitivity of eyes to light;  increased sweating;  nausea or vomiting;  nervousness;  stomach pain 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.