Trospium Chloride, Xanomeline (zan-OH-me-leen)

Treats schizophrenia.

Brand Name(s):

Cobenfy, Cobenfy Starter Pack

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine at least 1 hour before a meal or at least 2 hours after a meal. Do not open the capsules.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how xanomeline/trospium works. Tell your doctor if you are using metformin or any other medicines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, enlarged prostate, eye problems, gallstones, myasthenia gravis (severe muscle weakness), pancreas problems, problems passing urine, stomach or bowel problems (including constipation, ulcerative colitis), or urinary problems (including blockage).
• This medicine may cause the following problems:
  • Increased risk of urinary retention (trouble passing urine or not fully emptying the bladder)
  • Liver problems
  • Increased risk of gallbladder problems, which may lead to gallstones and pancreatitis (swelling of the pancreas)
  • Stomach or bowel problems (slow emptying of food in the stomach)
  • Increased heart rate
• This medicine may make you confused, dizzy, drowsy, or see, hear, or feel things that are not there. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, dizziness, headache, nervousness, pounding in the ears
• Change in how much or how often you urinate, painful or difficult urination
• Constipation, stomach upset
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Fast, pounding, or uneven heartbeat
• Sudden and severe stomach pain, nausea, vomiting, fever, lightheadedness
• Twitching or muscle movements you cannot control, problems with balance or walking

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088