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

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.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is solifenacin?

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.


Precautions

You should not use this medication if you are allergic to solifenacin, or have certain conditions. Be sure your doctor knows if you have:

  • untreated or uncontrolled narrow-angle glaucoma;
  • a stomach disorder causing delayed emptying; or
  • if you are unable to urinate.

Before using solifenacin, tell your doctor if you are allergic to any drugs, or if you have:

  • glaucoma;
  • liver disease;
  • kidney disease;
  • a blockage in your stomach or intestines; or
  • a history of "Long QT syndrome."

If you have any of these conditions, you may need a dose adjustment or special tests to safely take solifenacin.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether solifenacin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include severe constipation or stomach pain, or urinating less than usual or not at all.

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

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Side-effects

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.

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Interactions

The following drugs can interact with solifenacin. Tell your doctor if you are using any of these:

  • arsenic trioxide (Trisenox);
  • chloroquine (Arelan) or halofantrine (Halfan);
  • droperidol (Inapsine);
  • HIV/AIDS medicine such as nelfinavir (Viracept) or ritonavir (Norvir);
  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin), itraconazole (Sporanox), ketoconazole (Nizoral), pentamidine (NebuPent, Pentam), or troleandomycin (Tao);
  • narcotic medication such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose);
  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), or thioridazine (Mellaril);
  • heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), ibutilide (Corvert), procainamide (Procan, Pronestyl), quinidine (Quinidex, Quin-Release Quin-G), or sotalol (Betapace); or
  • an antidepressant such as amitriptyline (Elavil, Etrafon), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), and others.

This list is not complete and there may be other drugs that can interact with solifenacin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04

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