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The following safety and warning information is designed to help you understand the potential risks and necessary precautions when using Cuvposa (glycopyrrolate). Please review these details carefully and discuss any concerns with your healthcare provider.

• Constipation: Constipation may occur, particularly during the first few days of treatment or after a dose increase. If your child experiences constipation, stomach pain, swelling, nausea, or vomiting, discontinue use and contact their pediatrician. This could indicate intestinal pseudo-obstruction, a rare condition where the intestinal muscles cease to function properly. Increased risk if taking other constipation-inducing medications.

• Intestinal Blockage: This medication may lead to intestinal blockage. Diarrhea could be an early symptom, especially in children with a history of intestinal surgeries such as ileostomy or colostomy. If diarrhea occurs, stop the medication and inform the pediatrician. Risk is higher in those with previous intestinal surgical history.

• Heat Stroke or Fever: Cuvposa (glycopyrrolate) can reduce sweating, potentially causing heat stroke or fever in hot weather. To prevent overheating, ensure your child stays cool, rests in shaded areas, drinks cold water, and takes breaks during physical activities. Immediately contact the pediatrician if symptoms of heat stroke occur, such as hot and red skin, rapid heartbeat, difficulty breathing, or fever. Risk factors include hot weather, strenuous activities, and concurrent use of other anticholinergic medications.

• Sleepiness or Blurred Vision: This medication may cause drowsiness or blurred vision. Avoid allowing your child to engage in activities requiring alertness until you are aware of how they react to the medication. Risk is heightened when taken with other medications that cause similar effects.

• Exacerbation of Existing Health Conditions: Cuvposa (glycopyrrolate) might worsen certain health conditions. Caution is advised if your child has heart issues, as the medication can increase heart rate.

Contraindications: Cuvposa (glycopyrrolate) should be avoided in the following conditions due to significant health risks:

• Concurrent use of oral potassium chloride
• Glaucoma
• Paralytic ileus (loss of movement in the intestinal muscles)
• Unstable heart condition during severe blood loss
• Ulcerative colitis (inflammation of the intestines)
• Toxic megacolon (life-threatening colon inflammation)
• Myasthenia gravis (abnormal muscle weakness)

Please consult with a healthcare provider if any of these conditions apply before using this medication.

When using this medication, some individuals may experience common side effects such as dry mouth, vomiting, constipation, flushing, nasal congestion, headache, sinus inflammation, upper respiratory infection, and difficulty urinating. These effects are generally mild and should subside with time, but if they persist or worsen, it's advisable to consult a healthcare provider. To alleviate constipation, it's beneficial to consume dietary fiber, stay hydrated, and engage in regular physical activity. Selecting the appropriate type of laxative can also be helpful.

Other side effects that have been reported include stomach bloating, stomach pain, chapped lips, gas, feelings of irritation or agitation, pneumonia, urinary tract infections, a faster heart rate, dehydration, changes in taste, uncontrolled eye movement, restlessness, aggressive behavior, crying, moaning, mood changes, dry nose, dry skin, itching, and rash. While these might be less common, it's important to monitor them and consult a healthcare provider if they become severe.

Serious side effects, though rare, demand immediate medical attention. These include intestinal blockage characterized by diarrhea, stomach pain, bloating, nausea, vomiting, and serious allergic reactions such as itchy red rash, shortness of breath, chest tightness, or swelling of the lips, tongue, face, or eyes. Additionally, if you experience eye pain, swelling, redness, or vision changes like seeing rainbows around lights at night, seek urgent medical care. Always be vigilant for any other unlisted side effects and discuss them with a healthcare provider for appropriate advice and intervention.