Unicalo Tablet 1mg (Prucalopride Succinate)

Adult dose

This medication is administered orally and can be taken at any time of the day regardless of meals. Adults: 2mg once daily. Elderly (65 years and older): The initial dose is 1mg once daily, which may be increased to 2mg once daily if necessary. Patients with renal impairment: In patients with severe renal impairment (GFR < 30 ml/min/1.73 m2), 1mg is administered once daily. No dosage adjustment is needed for mild to moderate renal impairment patients.

This medication should not be used in certain patients. For example, individuals who are allergic to the active ingredient or excipients should not take this drug. Additionally, patients with severely impaired kidney function requiring dialysis or those with serious gastrointestinal problems (e.g., bowel perforation, bowel obstruction, Crohn's disease, ulcerative colitis) should not use this medication. This drug contains lactose, therefore individuals with genetic metabolic disorders such as lactose intolerance or galactose intolerance should not take this medication. Patients with severe renal impairment should take this drug with caution and at a reduced dosage. Special caution is also necessary for patients with serious conditions such as liver disease, heart disease, lung disease, neurological disorders, malignancies, AIDS, endocrine disorders, etc. Particularly, patients with a history of arrhythmias or ischemic heart disease should take this medication carefully. It may also be recommended to administer the drug at a reduced dose for patients with severe liver dysfunction. Furthermore, caution should be exercised when taking this medication alongside drugs that can prolong the QT interval. The most common side effects when taking this medication are headaches and gastrointestinal symptoms (abdominal pain, nausea, diarrhea). These side effects generally occur early in treatment and often disappear naturally over time. Other side effects reported include dizziness, tremors, palpitations, vomiting, dyspepsia, rectal bleeding, frequent urination, fatigue, fever, lethargy, bloating, abdominal discomfort, gastroesophageal reflux disease, anal pain, hemorrhoids, functional gastrointestinal disorders, loose stools, esophagitis, duodenal ulcers, nasopharyngitis, bronchitis, herpes zoster, athlete's foot, bacterial vaginosis, bacterial bronchitis, facial swelling, and chest discomfort. In cases of severe diarrhea, the effectiveness of oral contraceptives may be reduced, and additional contraceptive methods are recommended. This medication has a low likelihood of drug interactions; however, certain strong medications can alter its serum concentration, so caution is advised. Special monitoring is necessary when used in conjunction with drugs that prolong the QT interval. Additionally, medications with atropine-like effects may reduce the efficacy of this drug. Data on the safety of this medication during pregnancy is insufficient, so it is recommended not to use it while pregnant, and women of childbearing age should utilize effective contraceptive methods during the course of this treatment. While breastfeeding, this medication may pass into breast milk, but the effects on infants are not yet clear, so its use is not recommended. This drug is not recommended for children or adolescents under 18 years of age. In cases of overdose, symptoms such as headache, nausea, and diarrhea may occur, and there is no specific antidote, so appropriate treatment should be administered based on symptoms. Electrolyte supplementation may be necessary in cases of severe fluid loss due to diarrhea or vomiting. This drug may induce dizziness and fatigue on the first day of administration, so caution is required when driving or operating machinery.

Serious side effects

Chest discomfort

Mild side effects

• Headache
• abdominal pain
• nausea
• diarrhea
• dizziness
• tremors
• palpitations
• vomiting
• dyspepsia
• rectal bleeding

This medication should be stored in a special container to protect it from light and air. It is also important to avoid humid areas and store at a temperature between 1 to 30 degrees Celsius.

Appearance

White to off-white round film-coated tablet

Package unit

28 tablets/PTP[(14 tablets/PTP X 2)]