Important Safety Information

Do not take Dartisla ODT if you:

• Have glaucoma
• Have problems with urinating
• Have obstructive disease of the stomach
• Have severe ulcerative colitis or any other serious bowel problems
• Have myasthenia gravis  
• Have hypersensitivity and/or allergy to glycopyrrolate

Before you take Dartisla ODT, tell your doctor about all your medical conditions, including if you:

• Have any allergies
• Have eye problems (such as glaucoma)
• Have problems with urinating
• Have stomach or bowel problems (such as ulcerative colitis)
• Have any other medical conditions
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed

Tell your doctor about all of the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect the way Dartisla ODT works, and Dartisla ODT may affect how other medicines work.

Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention.

Warnings: Dartisla ODT can cause serious side effects, including:

• Precipitation of acute glaucoma:  Glycopyrrolate may cause increased pressure in the eye(s). Call your doctor right away if you experience pain and reddening of the eyes accompanied by dilated pupils.
• Diarrhea and intestinal blockage: Diarrhea may be an early symptom of blockage in the intestines. This is especially likely if you have an ileostomy or colostomy. Tell your doctor if you experience diarrhea while taking Dartisla ODT.
• Adverse reactions due to decreased stomach or intestinal motility: Delayed stomach emptying, constipation, and intestinal blockage may occur and worsen paralytic ileus and toxic megacolon. Dartisla ODT is not recommended for use with other medications that decrease stomach motility.
• Cognitive and visual adverse reactions: Glycopyrrolate may impair the mental and/or physical function. Do not operate motor vehicles or perform other hazardous tasks until reasonably certain you are not adversely affected.
• Problems with body temperature control (overheating/heat stroke): In high temperature environments, overheating of the body resulting in fever and heat stroke can occur, especially in geriatric patients. Avoid exposure to hot or very warm environmental temperatures.
• Other conditions exacerbated by anticholinergic adverse reactions:  Dartisla ODT is not recommended in patients with autonomic neuropathy, hyperthyroidism, cardiac disease, hiatal hernia, etc.
• Increased risk of anticholinergic adverse reactions in geriatric patients:  Patients 65 years of age and older are at an increased risk of adverse reactions that may lead to complications of urinary retention, bowel obstruction, heat prostration, arrhythmias, delirium, and falls or fractures.

What is Dartisla ODT?
Dartisla ODT is a prescription medication to help reduce symptoms of a peptic ulcer as an add-on to treatment of peptic ulcer in adults.

Please click here to see the Full Prescribing Information for Dartisla ODT.