PRUCANETIC 1 MG (Prucalopride)

Prescription Medicine — 20 Film-Coated Tablets

Medical Description

PRUCANETIC 1 MG contains prucalopride, a selective serotonin type 4 (5-HT₄) receptor agonist used for the treatment of chronic idiopathic constipation (CIC) in adults. It enhances intestinal motility by stimulating the natural nerve pathways that regulate bowel movements, helping improve colonic transit and facilitate bowel evacuation. The 1 mg strength may be prescribed for specific patient groups, including patients with severe renal impairment and certain older adults, depending on the applicable prescribing guidance.

Indications and Benefits

• Chronic idiopathic constipation: Helps manage persistent constipation in adults.
• Improved bowel movement frequency: Promotes spontaneous bowel movements and supports regular bowel function.
• Enhanced colonic motility: Stimulates the coordinated muscular activity that moves intestinal contents through the colon.
• Constipation symptom relief: May help reduce straining and difficulty with bowel evacuation in patients who respond to treatment.

Mechanism of Action

Prucalopride selectively activates 5-HT₄ receptors in the gastrointestinal tract. This enhances enteric nerve signaling and stimulates propulsive colonic contractions, helping accelerate intestinal transit and promote bowel movements.

Dosage and Directions for Use

• Usual adult dose: The standard recommended dose for chronic idiopathic constipation is 2 mg once daily.
• 1 mg dose: May be prescribed for patients with severe renal impairment (creatinine clearance below 30 mL/min). Some prescribing guidelines also recommend starting older adults over 65 years at 1 mg once daily, with adjustment if needed.
• May be taken with or without food.
• Patients with end-stage renal disease requiring dialysis should avoid prucalopride under the U.S. prescribing information.
• Use only as directed by a qualified healthcare professional. Do not increase the dose without medical advice.

Possible Side Effects

Common side effects include:

• Headache.
• Nausea.
• Abdominal pain or discomfort.
• Diarrhea.
• Abdominal distension and flatulence.
• Dizziness and fatigue.
• Vomiting.

Important warning: New or worsening depression, unusual changes in mood or behavior, and suicidal thoughts or behaviors have been reported. Stop taking the medicine and contact a healthcare professional promptly if these symptoms occur. Seek emergency assistance if there is an immediate risk of self-harm.

Contraindications and Precautions

Prucalopride should not be used in patients with:

• Hypersensitivity to prucalopride or any of the product's ingredients.
• Intestinal perforation or obstruction caused by a structural or functional disorder of the intestinal wall.
• Obstructive ileus.
• Severe inflammatory intestinal conditions, such as severe Crohn's disease, ulcerative colitis, or toxic megacolon/megarectum.

Additional precautions:

• Inform your healthcare professional about kidney or liver disease and any history of depression or suicidal thoughts.
• Tell your doctor or pharmacist about all medicines and supplements you take.
• Seek urgent medical assessment for severe abdominal pain, vomiting, marked abdominal swelling, or inability to pass gas.
• Consult a healthcare professional before use during pregnancy or breastfeeding.
• If symptoms persist or worsen, seek medical reassessment.

Storage

• Store according to the manufacturer's instructions.
• Protect from excessive heat and moisture.
• Keep out of reach of children.

References

1. U.S. National Library of Medicine — DailyMed: Prucalopride prescribing information.
2. U.S. Food and Drug Administration (FDA): Prucalopride clinical and prescribing information.
3. UK Medicines and Healthcare products Regulatory Agency (MHRA): Prucalopride film-coated tablets — Summary of Product Characteristics.