VESIcare

DRUG DESCRIPTION

VESIcare® (solifenacin succinate) is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C23H26N2O2•C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:

VESIcare® (solifenacin succinate) Structural Formula Illustration

Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each VESIcare tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, each VESIcare (solifenacin succinate) tablet also contains the following inert ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol 8000 and titanium dioxide with yellow ferric oxide (5 mg VESIcare (solifenacin succinate) tablet) or red ferric oxide (10 mg VESIcare (solifenacin succinate) tablet).

What are the possible side effects of solifenacin (VESIcare)?

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

  • hot, dry skin and extreme thirst;
  • severe stomach pain, or constipation for 3 days or longer;
  • pain or burning when you urinate; or
  • urinating less than usual or not at all.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of VESIcare »

What are the precautions when taking solifenacin succinate (VESIcare)?

Before taking solifenacin, 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: problems emptying your bladder (urinary retention), severe blockage of stomach/intestines (gastric retention), a certain eye condition (uncontrolled narrow angle glaucoma), severe liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bladder problems (e.g., bladder outflow obstruction),...

Read All Potential Precautions of VESIcare »


VESIcare Consumer (continued)

SIDE EFFECTS: Dry mouth, constipation, stomach upset, stomach pain, blurred vision, dry eyes, or unusual tiredness/weakness 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 (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: severe stomach/abdominal pain, constipation for 3 or more days, difficulty urinating, signs of kidney infection (e.g., burning/painful urination, lower back pain, fever).

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 solifenacin, 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: problems emptying your bladder (urinary retention), severe blockage of stomach/intestines (gastric retention), a certain eye condition (uncontrolled narrow angle glaucoma), severe liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bladder problems (e.g., bladder outflow obstruction), stomach/intestinal disease (e.g., ulcerative colitis), slowed movement of stomach/intestines, severe constipation, controlled narrow angle glaucoma, kidney disease, liver disease, enlarged prostate, a certain muscle disease (myasthenia gravis).

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

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. Therefore, elderly people may be more sensitive to this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


VESIcare Patient Information Including Side Effects

Brand Names: VESIcare

Generic Name: solifenacin (Pronunciation: sol ee FEN a sin)

  • What is solifenacin (VESIcare)?
  • What are the possible side effects of solifenacin (VESIcare)?
  • What is the most important information I should know about solifenacin (VESIcare)?
  • What should I discuss with my health care provider before taking solifenacin (VESIcare)?
  • How should I take solifenacin (VESIcare)?
  • What happens if I miss a dose (VESIcare)?
  • What happens if I overdose (VESIcare)?
  • What should I avoid while taking solifenacin (VESIcare)?
  • What other drugs will affect solifenacin (VESIcare)?
  • Where can I get more information?

What is solifenacin (VESIcare)?

Solifenacin reduces muscle spasms of the bladder and urinary tract.

Solifenacin is used to treat symptoms of overactive bladder, such as frequent or urgent urination, and incontinence (urine leakage).

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

What are the possible side effects of solifenacin (VESIcare)?

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

  • hot, dry skin and extreme thirst;
  • severe stomach pain, or constipation for 3 days or longer;
  • pain or burning when you urinate; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • dry mouth;
  • dry eyes, blurred vision;
  • mild constipation;
  • nausea, mild stomach pain or upset;
  • dizziness, tired feeling; or
  • fever, sore throat, body aches, or other flu symptoms.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about solifenacin (VESIcare)?

You should not use this medication if you are allergic to solifenacin, 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 solifenacin, tell your doctor if you have glaucoma, liver disease, kidney disease, a blockage in your stomach or intestines, or a history of "Long QT syndrome."

Avoid becoming overheated or dehydrated during exercise and in hot weather. Solifenacin can decrease perspiration and you may be more prone to heat stroke.

Solifenacin can cause side effects that may impair your vision or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

There are many other medicines that can interact with solifenacin. 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, extreme thirst, severe stomach pain or constipation, pain or burning when you urinate, or if you stop urinating.

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