Medication info
Solinasin Tablet 5 mg (Solifenacin Succinate)

Solinasin Tablet 5 mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Chaeil Pharmaceutical Co., Ltd.
Appearance
Bright yellow round film-coated tablet
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201702068 · Approved 2017.04.24 · Insurance code 645404950

Summary

Main use
Treatment of overactive bladder symptoms (frequency, urinary urgency, etc.)
Who takes it
Adults
Adult dose
The usual recommended dose for adults (including older adults) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This medicine may be taken with or without food and should be swallowed whole with water. 1. Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Use with caution in patients with severe renal impairment (creatinine clearance≤30ml/min), and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is necessary in patients with mild hepatic impairment. Use with caution in patients with moderate hepatic impairment (Child-Pugh class B), and do not exceed 5mg once daily. 3. Patients taking a strong cytochrome P450 3A4(CYP3A4) inhibitor For patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Chaeil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (frequency, urinary urgency, etc.)

  • Urgency incontinence
  • frequent urination
  • urinary urgency
  • symptoms of overactive bladder
View approved original text

Overactive bladder includes symptoms such as urgency incontinence, frequent urination, and urinary urgency. This medication alleviates these symptoms and helps improve the patient's quality of life. Urgency incontinence is a situation where one suddenly and strongly cannot hold urine, and frequent urination is the symptom of urinating too often during the day. Urinary urgency refers to the state where there is a strong, sudden urge to urinate that is hard to control. This medication effectively improves these symptoms by relaxing the bladder muscle and is therefore used for symptoms of overactive bladder such as urgency incontinence, frequent urination, and urinary urgency.

How to take

Adult dose

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

Precautions

This medication is used to control hypersensitivity reactions of the bladder. This medication should not be administered to patients with urinary retention symptoms, serious gastrointestinal diseases, myasthenia gravis, or narrow-angle glaucoma. Additionally, it should not be given to patients with hypersensitivity to this medication or its ingredients, patients undergoing hemodialysis, or those with severe liver or kidney impairment. Caution should be exercised in patients at risk of urinary retention or those with gastrointestinal obstructive diseases or reduced gastrointestinal motility, patients with severe renal impairment or moderate liver impairment, and those using certain concomitant medications. Common side effects of this medication may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes; severe adverse reactions, such as gastrointestinal obstruction, may occur at high doses. Discontinuation of treatment due to side effects may occur, especially as dry mouth is the most common reason. This medication may rarely cause severe allergic reactions such as angioedema or anaphylaxis. If such symptoms occur, discontinue use immediately and seek appropriate medical treatment. Caution is advised when driving or operating machinery, as drowsiness, fatigue, and blurred vision may affect performance. When combined with other anticholinergic medications, this medication may increase effectiveness or exacerbate side effects, so consult a professional when co-administering. It may also reduce the effectiveness of medications that promote gastrointestinal motility. This medication is metabolized in the liver; therefore, dosage adjustments may be needed when administered to patients with impaired liver function or those taking strong liver enzyme inhibitors. The safety for pregnant women has not been established, so caution is advised when administering to pregnant women. During breastfeeding, it is advisable to avoid use, as this medication may pass into breast milk. The safety and efficacy in children have not been confirmed, so this medication should not be administered to children. In cases of overdose, central nervous system symptoms, blurred vision, and dizziness may occur, and gastric lavage and detoxification treatment may be necessary. Patients with QT prolongation syndrome or heart disease should exercise special caution as cardiac rhythm irregularities may occur with this medication.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
Show 47 more
  • dyspepsia
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower extremity edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow
  • bladder distension
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • hives
  • vascular edema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • prolonged QT interval on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech disturbance
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • headache
  • thirst
  • drowsiness

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and it is best to keep it at room temperature between 1 and 30 degrees Celsius. By storing it this way, the efficacy of the medication can be maintained and deterioration prevented.

Appearance and packaging

Appearance

Bright yellow round film-coated tablet

Package unit

30 tablets (10 tablets/PTP X 3)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.