Welluro tablet 5mg (Solipecan Sodium Succinate)

Adult dose

The usual recommended dose for adults (including elderly patients) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This medicine may be taken without regard to meals and should be swallowed whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment: No dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), use with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment: No dose adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), use with caution and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors: Limit the maximum daily dose to 5mg in patients receiving ketoconazole or other potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole).

This drug should not be used in certain patients. For example, patients with difficulty urinating, severe gastrointestinal problems, myasthenia gravis, glaucoma with high intraocular pressure, and those allergic to this drug or its components may be at risk if they take this drug. In addition, patients undergoing hemodialysis or with severely impaired liver and kidney function, as well as those with certain genetic metabolic disorders, should also avoid this drug. There are also patients who require caution when using this drug. For instance, patients who may have difficulty urinating or are at risk of gastrointestinal obstruction, patients with moderate to severe renal or hepatic impairment, and those who take it in combination with certain antifungals or other medications may need dose adjustments. Common side effects of this drug may include dry mouth, constipation, blurred vision, dyspepsia, and abdominal discomfort. Serious gastrointestinal issues, angioedema, or allergic reactions may occur occasionally; therefore, immediate consultation with a physician is required if these symptoms appear. This drug may affect heart rate; thus, patients with heart disease or electrolyte imbalances need to exercise caution. Special precautions are required for pregnant or breastfeeding women when using this drug, and it is recommended that breastfeeding women avoid this drug. Children should not be used since the safety and efficacy have not been established. Overdosage of this drug may lead to symptoms such as headache, dizziness, drowsiness, and blurred vision; in severe cases, appropriate emergency treatment may be necessary. If taken with other anticholinergic drugs, the effect may increase or side effects may worsen, so it is essential to discuss interactions with healthcare providers regarding any other medications being taken. Lastly, it may take about 4 weeks for the maximum effect of this drug to manifest; therefore, consistent usage is important.

• Dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• fecal impaction
• colonic obstruction
• intestinal obstruction
• angioedema
• nausea

This drug may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it is best to keep the drug at room temperature between 1 degree and 30 degrees Celsius, avoiding excessively hot or cold areas.

Appearance

Bright yellow round film-coated tablets

Package unit

100 tablets/box [10 tablets/PTP x 10], 30 tablets/bottle, 100 tablets/bottle