RESOLOR 1 MG & 2 MG (Prucalopride)

Prescription Medicine — 28 Film-Coated Tablets per Pack

Medical Description

RESOLOR contains prucalopride, a selective serotonin type 4 (5-HT₄) receptor agonist indicated for the symptomatic treatment of chronic constipation in adults when laxatives do not provide adequate relief.

Prucalopride enhances intestinal motility by stimulating the natural nerve pathways involved in colonic contractions. This helps accelerate colonic transit, increase spontaneous bowel movement frequency, and improve bowel evacuation. RESOLOR is available in 1 mg and 2 mg strengths, allowing the dose to be selected according to the patient's clinical needs and kidney function.

Available Strengths and Composition

Prucalopride is the active pharmaceutical ingredient responsible for the medicine's prokinetic effect.

Indications and Benefits

RESOLOR is indicated for the symptomatic treatment of chronic constipation in adults when conventional laxatives do not provide adequate relief.

• Chronic constipation relief: Helps manage persistent constipation when laxative treatment has been insufficient.
• Improved bowel movement frequency: Helps increase the frequency of complete spontaneous bowel movements.
• Enhanced intestinal motility: Stimulates propulsive contractions in the colon, supporting intestinal transit.
• Improved bowel evacuation: May help reduce straining and difficulty passing stools in patients who respond to treatment.

Mechanism of Action

Prucalopride selectively stimulates serotonin 5-HT₄ receptors in the gastrointestinal tract. This enhances enteric nerve signaling and promotes propulsive colonic contractions, accelerating intestinal transit and facilitating bowel movements.

Dosage and Directions for Use

• Usual adult dose: 2 mg once daily, with or without food.
• Adults over 65 years: Start with 1 mg once daily; the dose may be increased to 2 mg if necessary and tolerated.
• Severe renal impairment: The recommended dose is 1 mg once daily. Prucalopride is contraindicated in patients with renal impairment requiring dialysis.
• Severe hepatic impairment: A starting dose of 1 mg once daily is recommended, with adjustment only when clinically appropriate.
• Swallow the tablet with water.
• If treatment is ineffective after four weeks, the patient should be reassessed by a healthcare professional.

RESOLOR is not recommended for children and adolescents under 18 years of age.

Possible Side Effects

Common adverse effects include:

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

These effects are often most noticeable at the beginning of treatment and may improve with continued use.

Important warning: Mood changes, depression, and suicidal thoughts or behaviors have been reported with prucalopride. Seek prompt medical advice if significant mood or behavioral changes occur, and seek emergency assistance for suicidal thoughts or immediate risk of self-harm.

Contraindications and Precautions

RESOLOR should not be used in patients with:

• Hypersensitivity to prucalopride or any of the product's ingredients.
• Renal impairment requiring dialysis.
• Intestinal perforation or obstruction.
• Obstructive ileus.
• Severe inflammatory intestinal conditions, including severe Crohn's disease, ulcerative colitis, or toxic megacolon/megarectum.

Additional precautions:

• Use cautiously in patients with severe liver disease or significant cardiovascular, neurological, or psychiatric conditions.
• Inform your doctor or pharmacist about all medicines you take.
• Severe diarrhea may reduce the effectiveness of oral contraceptives; additional contraceptive precautions may be needed.
• Seek medical assessment if constipation is accompanied by severe abdominal pain, vomiting, or marked abdominal swelling.
• Consult a healthcare professional before use during pregnancy or breastfeeding.

Storage

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

References

1. European Medicines Agency (EMA): RESOLOR — European Public Assessment Report.
2. Electronic Medicines Compendium (eMC): RESOLOR 1 mg — Summary of Product Characteristics.
3. Electronic Medicines Compendium (eMC): RESOLOR 2 mg — Summary of Product Characteristics.