Prulicon 2 Tablet

Prulicon is prescribed for the symptomatic management of chronic constipation in adults when conventional laxatives do not provide sufficient relief.

• Adults: 2 mg once daily, with or without food, at any convenient time of day.
• Taking more than 2 mg per day is not expected to provide additional therapeutic benefit.
• Older adults: Start with 1 mg once daily; the dose may be increased to 2 mg once daily if necessary.
• Children and adolescents below 18 years: Prucalopride is not recommended.

Renal impairment:

• Mild to moderate impairment: No dose adjustment is generally required.
• Severe renal impairment (GFR below 30 mL/min/1.73 m²): 1 mg once daily is recommended.
• Dialysis-dependent patients: Contraindicated.

Hepatic impairment:

• Mild to moderate impairment: No dose adjustment is generally required.
• Severe hepatic impairment (Child-Pugh Class C): Start with 1 mg once daily. The dose may be increased to 2 mg if needed and well tolerated.

Drug Interactions

Prulicon generally has a low potential for clinically significant drug interactions and is not expected to substantially interfere with CYP-mediated metabolism of other medicines.

Ketoconazole may increase prucalopride exposure by approximately 40%, although this increase is generally not considered clinically important. Similar effects may occur with potent P-glycoprotein inhibitors such as verapamil, cyclosporine A, and quinidine.

Studies have not shown clinically meaningful effects of prucalopride on the pharmacokinetics of warfarin, digoxin, alcohol, paroxetine, or oral contraceptives.

Contraindications

Prulicon should not be used in patients who:

• Are allergic to prucalopride or any of the ingredients in the medicine
• Have severe renal impairment requiring dialysis

Side Effects

The most frequently reported adverse effects include:

• Headache
• Abdominal pain
• Nausea
• Diarrhea

These effects are generally more common when treatment begins and often improve within a few days. Most reported reactions are mild to moderate.

Pregnancy & Breastfeeding

Prucalopride is not recommended during pregnancy. Women who could become pregnant should use reliable contraception while receiving treatment.

Although animal studies have not demonstrated harmful effects on pregnancy or fetal development, there is insufficient human experience.

Because it is not known whether prucalopride passes into human breast milk, its use during breastfeeding is not recommended.

Precautions & Warnings

Prucalopride is primarily eliminated through the kidneys, so patients with significant renal impairment may require a lower dose.

Caution is advised in people with severe liver impairment, as limited clinical data are available for this group.

Severe diarrhea may reduce the effectiveness of oral contraceptive pills. An additional contraceptive method may therefore be necessary if severe diarrhea occurs.

Prulicon tablets contain lactose and should not be used by individuals with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Overdose

An excessive dose may intensify the usual effects of prucalopride and cause symptoms such as headache, nausea, and diarrhea.

There is no specific antidote. Treatment is mainly supportive and aimed at relieving symptoms. Significant fluid loss from vomiting or diarrhea may require replacement of fluids and electrolytes.

Therapeutic Class

Osmotic purgatives

Storage

Store Prulicon at room temperature below 30°C, protected from unsuitable environmental conditions. Keep the desiccant inside the original bottle and dispense/store the tablets in their original container. Keep out of reach of children.