TROSPIUM CHLORIDE (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-5994

NDC: 50090-5994-0 90 CAPSULE, EXTENDED RELEASE in a BOTTLE

17 PATIENT COUNSELING INFORMATION

“See FDA-Approved Patient Labeling (Patient Information)”

17.1 Angioedema

Patients should be informed that trospium chloride extended-release capsules may produce angioedema which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue trospium chloride extended-release capsules therapy and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing.

17.2 When Not to Use

Prior to treatment, patients should fully understand the risks and benefits of trospium chloride extended-release capsules. In particular, patients should be informed not to take trospium chloride extended-release capsules if they:
• have urinary retention;
• gastric retention;
• uncontrolled narrow-angle glaucoma;
• are allergic to any component of trospium chloride extended-release capsules.

17.3 Administration

Patients should be instructed regarding the recommended dosing and administration of trospium chloride extended-release capsules:
• Take one trospium chloride extended-release capsules daily in the morning with water.
• Take trospium chloride extended-release capsules on an empty stomach or at least 1 hour before a meal.
• Use of alcoholic beverages within 2 hours of dosing with trospium chloride extended-release capsules is not recommended.

17.4 Adverse Reactions

Patients should be informed that the most common side effects with trospium chloride extended-release capsules are dry mouth and constipation and that other less common side effects include trouble emptying the bladder, blurred vision, and heat prostration. Because anticholinergics, such as trospium chloride extended-release capsules, may produce dizziness or blurred vision, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug’s effects have been determined. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents.

Manufactured by:
Yichang Humanwell Oral Solid Dosage Plant
Yichang, Hubei, China 443112

Distributed by:
Slate Run Pharmaceuticals, LLC
Columbus, Ohio 43215

Revised: 05/2021

Patient Information

Trospium (TROSE-pee-um) Chloride Extended-Release Capsules

Read the Patient Information that comes with trospium chloride extended-release capsules 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 your treatment.

What are Trospium Chloride Extended-Release Capsules?

Trospium chloride extended-release capsules are a prescription medicine used to treat adults with overactive bladder who have the following symptoms:
• a strong need to urinate right away;
• leaking or wetting accidents due to a strong need to urinate right away;
• a need to urinate often.

Who should not take Trospium Chloride Extended-Release Capsules?

Do not take trospium chloride extended-release capsules if you:
• have trouble emptying your bladder;
• have delayed or slow emptying of your stomach;
• have an eye problem called “uncontrolled narrow-angle glaucoma”;
• are allergic to trospium chloride extended-release capsules or any of its ingredients. See the end of this leaflet for a complete list of ingredients.

Trospium chloride extended-release capsules have not been studied in children under the age of 18 years.

What should I tell my doctor before starting Trospium Chloride Extended-Release Capsules?

Tell your doctor about all of your medical conditions including if you:
• have any stomach or intestinal problems or problems with constipation;
• have trouble emptying your bladder or have a weak urine stream;
• have an eye problem called narrow-angle glaucoma;
• have kidney problems;
• have liver problems;
• are pregnant or planning to become pregnant. It is not known if trospium chloride extended-release capsules can harm your unborn baby.
• are breastfeeding. It is not known if trospium chloride extended-release capsules pass into breast milk and if it can harm your baby. You should talk to your doctor about the best way to feed your baby if you are taking trospium chloride extended-release capsules.
Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Trospium chloride extended-release capsules and certain other medicines can interact and make some side effects worse. Trospium chloride extended-release capsules can affect how other medicines are handled by the body.
Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.

How should I take Trospium Chloride Extended-Release Capsules?

Take trospium chloride extended-release capsules exactly as prescribed.
• Take one trospium chloride extended-release capsules daily in the morning with water.
• Take trospium chloride extended-release capsules on an empty stomach or at least 1 hour before a meal.
• Do not take alcohol within 2 hours of taking trospium chloride extended-release capsules.
• If you take too much trospium chloride extended-release capsules, call your local Poison Control Center or go to an emergency room right away.

What are the possible side effects of Trospium Chloride Extended-Release Capsules?

Trospium chloride extended-release capsules may cause allergic reactions that may be serious. Symptoms of a serious allergic reaction may include swelling of the face, lips, throat or tongue. If you experience these symptoms, you should stop taking trospium chloride extended-release capsules and get emergency medical help right away.

The most common side effects with trospium chloride extended-release capsules are:
• dry mouth;
• constipation.

Trospium chloride extended-release capsules may cause other less common side effects, including:
• trouble emptying the bladder;
• blurred vision and drowsiness. Do not drive or operate heavy machinery until you know how trospium chloride extended-release capsules affect you.
• heat prostration. Due to decreased sweating, heat prostration can occur when drugs such as trospium chloride extended-release capsules are used in a hot environment.
Tell your doctor if you have any side effects that bother you or that do not go away.

These are not all possible side effects of trospium chloride extended-release capsules. For more information, ask your doctor, healthcare professional or pharmacist.

How should I store Trospium Chloride Extended-Release Capsules?

• Keep trospium chloride extended-release capsules and all other medicines out of the reach of children.
• Store trospium chloride extended-release capsules at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]
• Safely dispose of trospium chloride extended-release capsules that are out of date or that you no longer need.

General information about Trospium Chloride Extended-Release Capsules

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use trospium chloride extended-release capsules for a condition for which it was not prescribed. Do not give trospium chloride extended-release capsules to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about trospium chloride extended-release capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about trospium chloride extended-release capsules that is written for health professionals. For more information, please call 1-888-341-9214.

What are the ingredients in Trospium Chloride Extended-Release Capsules?

Active Ingredient: trospium chloride, USP.

Inactive ingredients: ethylcellulose, FD&C Yellow 6, gelatin, hypromellose, methacrylic acid, methyl acrylate, methyl methacrylate, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, and triethyl citrate.
The imprinting ink have the following ingredients: ferrosoferric oxide, potassium hydroxide and shellac.

*Listed trademarks are the property of their respective owners.

Manufactured by:
Yichang Humanwell Oral Solid Dosage Plant
Yichang, Hubei, China 443112

Distributed by:
Slate Run Pharmaceuticals, LLC Columbus, Ohio 43215

Revised: 05/2021