Enticalo Tablet 2 mg (Prucalopride Succinate)

Adult dose

This medication is administered orally and can be taken at any time of the day regardless of meals. The standard adult dosage is 2 mg once daily. For elderly patients over 65 years, the initial dosage 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 impairment (Child-Pugh class C), the dosage is 1 mg once daily.

This drug should not be used in certain patients. For example, individuals allergic to the main ingredient or excipients of this drug should not take it. Additionally, patients with severely impaired kidney function requiring dialysis or those with serious gastrointestinal issues should not take this medication. This drug contains lactose, so individuals with lactose intolerance or related genetic conditions should use caution. For patients with severe renal impairment, the dosage must be reduced and used cautiously. Patients with severe diseases of the liver, heart, lungs, or nervous system should also take special care when using this drug. Individuals with a history of arrhythmia or ischemic heart disease should be particularly cautious when taking this medication. For patients with very poor liver function, it is recommended to reduce the dosage before administration. This medication requires caution when taken with other drugs that may cause QT interval prolongation. The most common side effects during the use of this drug include headaches and gastrointestinal symptoms, including abdominal pain, nausea, and diarrhea. These symptoms usually appear in the early stages of treatment and often resolve over time. Other reported side effects include dizziness, tremors, palpitations, vomiting, dyspepsia, frequent urination, fatigue, fever, malaise, abdominal distension, abdominal discomfort, gastroesophageal reflux disease, rectal pain, hemorrhoids, functional dyspepsia, loose stools, esophagitis, duodenal ulcers, rhinitis, bronchitis, herpes zoster, athlete’s foot, bacterial vaginosis, bacterial bronchitis, facial swelling, and chest discomfort. If new palpitations occur, it is advisable to consult a physician. In the case of severe diarrhea, the effectiveness of oral contraceptives may be diminished, so additional contraceptive methods are recommended. This drug has a low potential for interactions with other drugs, but caution is necessary when used with certain antifungals or cardiac-related medications. Also, drugs like atropine may reduce the effectiveness of this drug. There are no special interactions with food, thus it can be taken irrespective of meals. The use of this drug is not recommended during pregnancy, and women of childbearing age should use effective contraceptive methods during treatment. Breastfeeding women are also advised to avoid using this medication. It is recommended that this drug is not used in children or adolescents under the age of 18. Overdosage may result in symptoms such as headaches, nausea, or diarrhea, necessitating appropriate treatment based on the symptoms. In particular, care should be taken to avoid dehydration or electrolyte imbalances due to diarrhea and vomiting. This drug can cause dizziness or fatigue initially, so caution is advised when driving or operating machinery. When storing, keep it out of reach of children and store it in its original container to prevent moisture.

Serious side effects

Ventricular extrasystole, chest discomfort.

Mild side effects

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

This drug should be stored in a container that protects it from light and air, and it is important to avoid storing it in humid areas. The appropriate storage temperature is between 1 and 30 degrees Celsius.

Appearance

Pink round film-coated tablet

Package unit

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