Urispas

DRUG DESCRIPTION

Urispas (flavoxate HCl) tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic.

Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C₂₄H₂₅NO₄HCl.The molecular weight is 427.94, with the following structure:

Urispas (flavoxate hcl) is supplied in tablets for oral administration. Each round, white, film-coated Urispas (flavoxate hcl) tablet is debossed URISPAS (flavoxate hcl) SKF and contains flavoxate hydrochloride, 100 mg. Inactive ingredients consist of calcium phosphate, castor oil, cellulose acetate phthalate, magnesium stearate, polyethylene glycol, starch and talc.

What are the possible side effects of flavoxate (Urispas)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using flavoxate and call your doctor at once if you have any of these serious side effects:

• hot, dry skin and extreme thirst;


• confusion;


• pounding heartbeats, fluttering in your chest; or


• urinating less than usual or not at all.

Less serious side effects may include:

• dry mouth;


• blurred...

Read All Potential Side Effects and See Pictures of Urispas »

What are the precautions when taking flavoxate hcl (Urispas)?

Before taking flavoxate, tell your doctor or pharmacist if you are allergic to it; 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: stomach/intestinal blockage (e.g., pyloric/duodenal obstruction, ileus), bleeding from the stomach or intestines, bladder blockage.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., fast/irregular heartbeat, heart failure), a certain eye condition (glaucoma), kidney problems, a certain muscle disease...

Read All Potential Precautions of Urispas »

Urispas Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, dry mouth, headache, drowsiness, dizziness, blurred vision, and nervousness may occur. If any of these effects persist or worsen, tell 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 (e.g., 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 immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., confusion), eye pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: chest pain, fast/pounding heartbeat, signs of infection (e.g., fever, persistent sore throat), stomach/intestinal blockage (e.g., persistent nausea/vomiting, long-lasting constipation), difficult/painful urination.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.

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 flavoxate, tell your doctor or pharmacist if you are allergic to it; 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: stomach/intestinal blockage (e.g., pyloric/duodenal obstruction, ileus), bleeding from the stomach or intestines, bladder blockage.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., fast/irregular heartbeat, heart failure), a certain eye condition (glaucoma), kidney problems, a certain muscle disease (myasthenia gravis), enlarged prostate gland, stomach/intestinal problems (e.g., infection, acid-reflux disease, chronic constipation, ulcerative colitis), overactive thyroid (hyperthyroidism).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication can cause decreased sweating. To reduce the risk of a serious reaction to too much heat (heatstroke), avoid becoming overheated in hot weather, saunas, or during exercise or other strenuous activities.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially confusion.

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. Consult your doctor before breast-feeding.

Urispas Patient Information Including Side Effects

Brand Names: Urispas

Generic Name: flavoxate (Pronunciation: flah VOX ate)

• What is flavoxate (Urispas)?


• What are the possible side effects of flavoxate (Urispas)?


• What is the most important information I should know about flavoxate (Urispas)?


• What should I discuss with my health care provider before taking flavoxate (Urispas)?


• How should I take flavoxate (Urispas)?


• What happens if I miss a dose (Urispas)?


• What happens if I overdose (Urispas)?


• What should I avoid while taking flavoxate (Urispas)?


• What other drugs will affect flavoxate (Urispas)?


• Where can I get more information?

What is flavoxate (Urispas)?

Flavoxate reduces muscle spasms of the bladder and urinary tract.

Flavoxate is used to treat bladder symptoms such as frequent or urgent urination, increased night-time urination, bladder pain, and incontinence (urine leakage). These bladder symptoms are often caused by overactive bladder, prostate enlargement, bladder infections, or irritation of the urethra.

Flavoxate will not treat a bacterial or fungal bladder infection. Infections must be treated with an antibiotic.

Flavoxate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of flavoxate (Urispas)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using flavoxate and call your doctor at once if you have any of these serious side effects:

• hot, dry skin and extreme thirst;


• confusion;


• pounding heartbeats, fluttering in your chest; or


• urinating less than usual or not at all.

Less serious side effects may include:

• dry mouth;


• blurred vision;


• nausea, vomiting;


• drowsiness, nervousness;


• spinning sensation;


• headache; or


• fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about flavoxate (Urispas)?

You should not use this medication if you are allergic to flavoxate, or if you have untreated or uncontrolled narrow-angle glaucoma, a blockage in your digestive tract (stomach or intestines), or if you are unable to urinate.

Before using flavoxate, tell your doctor if you have glaucoma or urinary problems.

Flavoxate can cause drowsiness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

There may be other medicines that can interact with flavoxate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Stop using this medication and call your doctor if you have serious side effects such as hot and dry skin, confusion, pounding heartbeats, fluttering in your chest, or if you stop urinating.

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