Solifenacin

What it is used for

Solifenacin succinate tablets are 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

Solifenacin succinate tablets 5 mg and 10 mg tablets are not approved for use in children.

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).

Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540

Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA

All Other Trademarks herein are the property of their respective owners.

For more information, call 1-888-943-3210 or 1-855-926-3384.

This Patient Information has been approved by the U.S. Food and Drug Administration

Revised: 03/2024

How to take it

• Take solifenacin succinate tablets exactly as your doctor tells you to take it.
• You should take 1 solifenacin succinate tablet 1 time a day.
• You should take solifenacin succinate tablets with water and swallow the tablet whole.
• You can take solifenacin succinate tablets with or without food.
• If you miss a dose of solifenacin succinate tablets, begin taking solifenacin succinate tablets again the next day. Do not take 2 doses of solifenacin succinate tablets the same day.
• If you take too much solifenacin succinate tablets, call your doctor or go to the nearest hospital emergency room right away.

Side effects, and when to stop

Solifenacin succinate tablets may cause serious side effects including:

• Se rious allergic reaction. Stop taking solifenacin succinate tablets 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 solifenacin succinate tablets 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 solifenacin succinate tablets and may include:

• dry skin due to decreased sweating. Heat exhaustion or heat stroke can happen due to decreased sweating when solifenacin succinate tablets are 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 solifenacin succinate tablets. 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.

Who should not take it

Do not take solifenacin succinate tablets 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 solifenacin succinate tablets. See the end of this leaflet for a complete list of ingredients.

What to say before you start

Before you take solifenacin succinate tablets, 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 solifenacin succinate tablets 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 solifenacin succinate passes into your breast milk. You and your doctor should decide if you will take solifenacin succinate tablets or breastfeed.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Solifenacin succinate tablets may affect the way other medicines work, and other medicines may affect how solifenacin succinate tablets works.

What to avoid

Solifenacin succinate tablets can cause blurred vision or drowsiness. Do not drive or operate heavy machinery until you know how solifenacin succinate tablets affect you.

Storing it

• Store at 20ºC to 25ºC (68ºF to 77ºF) with excursions permitted from 15ºC to 30ºC (59°F to 86ºF). Keep the bottle closed.
• Safely throw away medicine that is out of date or no longer needed.

Keep solifenacin succinate tablets and all medicines out of the reach of children. General information about the safe and effective use of solifenacin succinate tablets. Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use solifenacin succinate tablets for a condition for which it was not prescribed. Do not give solifenacin succinate tablets to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about solifenacin succinate tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about solifenacin succinate tablets that is written for health professionals.