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18 views2 pages

254285-Ves Ppi 26may2020 0

Uploaded by

gpkjs314
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Patient Information

VESIcare® (VES-ih-care)
(solifenacin succinate)
Tablet
Read the Patient Information that comes with VESIcare® 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 doctor about your medical condition or
treatment.
What is VESIcare?
VESIcare is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive
bladder:
• Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
• Urgency: a strong need to urinate right away
• Frequency: urinating often
VESIcare 5 mg and 10 mg tablets are not approved for use in children.
Who should not take VESIcare?
Do not take VESIcare if you:
• 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”
• are allergic to solifenacin succinate or any of the ingredients in VESIcare. See the end of this leaflet for a
complete list of ingredients.
What should I tell my doctor before taking VESIcare?
Before you take VESIcare, tell your doctor if you:
• have any stomach or intestinal problems or problems with constipation
• have trouble emptying your bladder or you have a weak urine stream
• have an eye problem called “narrow-angle glaucoma”
• have liver problems
• have kidney problems
• have a rare heart problem called “QT prolongation”
• are pregnant or plan to become pregnant. It is not known if VESIcare will harm your unborn baby. Talk to your
doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if VESIcare passes into your breast milk. You and your
doctor should decide if you will take VESIcare or breastfeed.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and
herbal supplements. VESIcare may affect the way other medicines work, and other medicines may affect how VESIcare
works.
How should I take VESIcare?
• Take VESIcare exactly as your doctor tells you to take it.
• You should take 1 VESIcare tablet 1 time a day.
• You should take VESIcare with water and swallow the tablet whole.
• You can take VESIcare with or without food.
• If you miss a dose of VESIcare, begin taking VESIcare again the next day. Do not take 2 doses of VESIcare the
same day.
• If you take too much VESIcare, call your doctor or go to the nearest hospital emergency room
right away.
What should I avoid while taking VESIcare?
VESIcare can cause blurred vision or drowsiness. Do not drive or operate heavy machinery until you know how VESIcare
affects you.
What are the possible side effects of VESIcare?
VESIcare may cause serious side effects including:
• Serious allergic reaction. Stop taking VESIcare and get medical help right away if you have:
• hives, skin rash or swelling
• severe itching
• swelling of your face, mouth or tongue
• trouble breathing
The most common side effects of VESIcare include:
• dry mouth
• constipation. Call your doctor if you get severe stomach area (abdominal) pain or become constipated for 3 or
more days.
• urinary tract infection
• blurred vision
Other side effects have been observed with anticholinergic drugs such as VESIcare and may include:
• dry skin due to decreased sweating. Heat exhaustion or heat stroke can happen due to decreased sweating when
VESIcare is used in hot environments. Symptoms may include:
• decreased sweating
• dizziness
• tiredness
• nausea
• increase in body temperature
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of VESIcare. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store VESIcare?
• Store VESIcare between 59°F to 86°F (15°C to 30°C). Keep the bottle closed.
• Safely throw away medicine that is out of date or no longer needed.
Keep VESIcare and all medicines out of the reach of children.
General information about the safe and effective use of VESIcare
Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use
VESIcare for a condition for which it was not prescribed. Do not give VESIcare to other people, even if they have the
same symptoms you have. It may harm them.
This leaflet summarizes the most important information about VESIcare. If you would like more information, talk with
your doctor. You can ask your doctor or pharmacist for information about VESIcare that is written for health
professionals.
What are the ingredients in VESIcare?
Active ingredient: solifenacin succinate
Inactive ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene
glycol 8000 and titanium dioxide with yellow ferric oxide (5 mg VESIcare tablet) or red ferric oxide (10 mg VESIcare
tablet)
What is overactive bladder?
Overactive bladder occurs when you cannot control your bladder contractions. When these muscle contractions happen
too often or cannot be controlled you can get symptoms of overactive bladder, which are urinary frequency, urinary
urgency, and urinary incontinence (leakage).

Marketed and Distributed by:


Astellas Pharma US, Inc.
Northbrook, Illinois 60062

VESIcare is a registered trademark of Astellas Pharma Inc.

© 2004 – 2022 Astellas Pharma US, Inc.

For more information, call 1-800-727-7003.

361078-VES
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 10/2022

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