Samsung Prucalopride Tablet 2 mg (Prucalopride Succinate)

Adult dose

This medicine is administered orally and can be taken at any time of the day, regardless of meals. Adults should take 2 mg once daily. For elderly patients aged 65 and over, the initial dose is 1 mg once daily, which can be increased to 2 mg once daily if necessary. For patients with severe renal impairment (GFR < 30 ml/min/1.73 m2) and severe liver disease (Child-Pugh class C), the dosage should be 1 mg once daily.

This medicine should not be administered to certain patients. Patients allergic to the active ingredient or excipients should not take this medicine, nor should patients with severely impaired kidney function or serious gastrointestinal issues. Additionally, patients with genetic issues such as lactose intolerance should also avoid using this medicine. Patients with severe renal impairment should use this medicine cautiously with a reduced dosage. Patients with other serious conditions affecting the heart, liver, lungs, or nervous system should also be careful when taking this medication. Special caution is required for patients with a history of arrhythmias or ischemic cardiovascular diseases. The most common side effects of this medicine include headaches and gastrointestinal symptoms, such as nausea, diarrhea, and abdominal pain. These symptoms typically appear early in treatment and may resolve over time. Other reported symptoms include dizziness, fatigue, and increased urination. Severe diarrhea may reduce the effectiveness of oral contraceptives, so it is advisable to use additional contraceptive methods. This medicine has a lower likelihood of drug interactions; however, caution is necessary when used in combination with certain medications. Special care is advised when used with drugs that prolong the QTc interval. Use of this medicine during pregnancy is not recommended, and women of childbearing age should employ effective contraception while using it. Nursing women are also advised against using this medicine. It is recommended not to use this medicine in children or adolescents under 18 years of age. Overdosage may result in headaches, nausea, and diarrhea, and appropriate treatment is required based on symptoms. Specifically, if there is significant fluid loss due to diarrhea and vomiting, electrolyte supplementation may be necessary. This medicine may cause dizziness and fatigue at the beginning of treatment, so caution is needed when driving or operating machinery.

Serious side effects

Chest discomfort, ventricular ectopic beats

Mild side effects

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

This medicine should be stored in a container that prevents light and air exposure, and in a dry place. The appropriate storage temperature is room temperature between 1 and 30 degrees Celsius.

Appearance

Pink, round, film-coated tablet

Package unit

28 tablets/PTP [(14 tablets/Alu-Alu×2)]