Osscalo Tablets 2mg (Prucalopride Succinate)

Adult dose

This medication is taken orally and can be administered at any time of the day, with or without food. Adults should take 2mg once daily. For elderly patients aged 65 and older, the initial dosage is 1mg once daily, which may be increased to 2mg once daily if necessary. For patients with renal impairment, a dose of 1mg once daily should be administered in cases of severe renal impairment (GFR < 30 ml/min/1.73 m2).

This medicine should not be used in certain patients. First, it must not be administered to patients with allergic reactions to any of the active ingredients or excipients. Second, it should not be used in patients with severe renal impairment requiring dialysis. Third, do not administer to patients with severe intestinal inflammatory conditions such as bowel perforation, bowel obstruction, Crohn's disease, or ulcerative colitis. Fourth, this medication contains lactose and should not be used in patients with lactose intolerance or certain genetic metabolic disorders. This medication should be used with caution and a reduced dosage in patients with very poor renal function. Moreover, its safety in patients with serious conditions of the liver, heart, lungs, or nervous system has not been thoroughly studied, so care should be taken. Specifically, patients with a history of arrhythmia or ischemic heart disease should be cautious. In patients with severe liver impairment, the dosage should also be reduced, and care should be taken when taken with medications that prolong the QTc interval. Taking this medication may commonly cause gastrointestinal symptoms such as headache, abdominal pain, nausea, and diarrhea. These symptoms typically occur early in treatment and will mostly resolve over time. Rarely, symptoms such as dizziness, tremors, palpitations, and fatigue have also been reported, so if symptoms are severe, medical consultation is advised. In cases of severe diarrhea, the effectiveness of oral contraceptives may diminish, so it is advisable to use additional contraceptive methods. This medication has a low potential for drug interactions; however, caution is necessary when used with certain antifungal agents or cardiac-related medications, as there may be changes in drug concentrations. Additionally, drugs like atropine may reduce the effect of this medication. Experience with this medication during pregnancy is limited, so it is recommended not to use it while pregnant. Women of childbearing age should utilize effective contraception while taking this medication. Use during breastfeeding is also not recommended. It is advised not to use this medication in adolescents and children under 18 years of age. In cases of overdose, symptoms such as headache, nausea, and diarrhea may occur, and as there are no specific antidotes, appropriate treatment should be administered according to the symptoms. Electrolyte replenishment may be needed in cases of significant fluid loss due to severe diarrhea or vomiting. This medication may cause dizziness or fatigue at the beginning of treatment, so caution is advised 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 protected from light and moisture, and it is safely stored at room temperature between 1°C and 30°C. Therefore, it is best kept in a dark place away from direct sunlight and in a dry location.

Appearance

Pink round film-coated tablets

Package unit

28 tablets/box [14 tablets/Alu-Alu X 2]