Solperac 5 mg (Sulpiride Succinate)

Adult dosage

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

This medication should not be used in patients with urinary retention symptoms or severe gastrointestinal conditions. Patients with myasthenia gravis, angle-closure glaucoma, or allergies to this medication or its components should also not use it. Patients undergoing hemodialysis or those with severe liver or kidney impairment should not take this medication either. Patients with genetic issues such as lactose intolerance should avoid taking this medication. Caution should be exercised in patients at risk of urinary retention or with gastrointestinal obstructive diseases, or at risk of decreased gastrointestinal motility. Patients with severe kidney impairment or moderate liver impairment should adhere to the maximum daily dosage, and caution is also needed for patients taking strong CYP3A4 inhibitors. In addition, patients taking medications that may exacerbate gastroesophageal reflux or esophagitis and those with autonomic neuropathy should be administered this medication with caution. Patients taking this medication may experience side effects such as dry mouth, constipation, blurred vision, urinary retention, dry eyes, nausea, indigestion, abdominal pain, vomiting, flu-like symptoms, pharyngitis, dizziness, depression, lower limb edema, fatigue, cough, hypertension, difficulty urinating, decreased urinary flow, bladder fullness, urinary tract infection, cystitis, post-nasal drip, vomiting, gastroesophageal reflux disease, headache, hallucinations, drowsiness, delirium, kidney impairment, itching, rash, erythema multiforme, exfoliative dermatitis, atrial fibrillation, palpitations, tachycardia, and ECG abnormalities. In severe cases, gastrointestinal adverse reactions such as fecal obstruction or intestinal obstruction may occur, requiring caution. This medication may induce serious arrhythmias in patients with cardiac issues such as QT prolongation syndrome or hyperkalemia. Severe allergic reactions like angioedema or anaphylaxis may occur; if these symptoms appear, administration should be stopped immediately, and treatment should be sought. Drowsiness, fatigue, and blurred vision may occur when driving or operating machinery, so caution is needed. This medication may enhance effects or worsen side effects when used in conjunction with other anticholinergic medications, so caution is advised if used together. Furthermore, it may reduce the efficacy of medications that increase gastrointestinal motility. As this medication is metabolized in the liver, taking it with a strong CYP3A4 inhibitor may increase the blood concentration, necessitating dose adjustment; patients with severe kidney or liver impairment should avoid such combinations. The safety for pregnant women has not been established, so caution should be exercised when used, and breastfeeding should be avoided as this medication may be excreted in breast milk and affect newborns. The safety and efficacy for children have not been established, so it should not be administered to pediatric patients. In case of overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may occur, with severe symptoms requiring appropriate treatment, and gastric lavage or administration of activated charcoal is recommended. This medication is known not to carry risks of genotoxicity or tumor formation and does not affect reproductive ability or fetal development.

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

This medication should be stored in a closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets/PTP, 30 tablets/bottle, 100 tablets/bottle