Medication info

Boryung Solifenacin Tablet 5 mg (Solifenacin Succinate)

Prescription medicationTabletOralExpired
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Boryung Co., Ltd.
Appearance
Round film-coated tablets with a bright yellow color
Packaging
100 tablets (10 tablets/ PTP pack x 10), 30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201905367 · Approved 2019.07.29

This product's status changed to Expired on 2024.07.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder symptoms (e.g., urge urinary incontinence and frequent urination)
Who takes it
Adults
Adult dose
The 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; swallow it whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment No dose adjustment is required 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 required 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 potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients taking ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Boryung Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (e.g., urge urinary incontinence and frequent urination)

  • Urgent urinary incontinence
  • frequent urination
  • urinary urgency
View approved original text

This medicine is used to improve symptoms of overactive bladder such as urgent urinary incontinence, frequent urination, and urinary urgency.

How to take

Adult dose

The 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; swallow it whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment No dose adjustment is required 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 required 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 potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients taking ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This drug is used to manage bladder hyperactivity and should not be administered to patients with certain conditions. For example, it should not be used in patients with urinary retention symptoms or in those with severe gastrointestinal problems, myasthenia gravis, glaucoma, or those allergic to this drug or its ingredients. Additionally, patients undergoing hemodialysis or those with severe liver or kidney dysfunction should avoid this medication. In certain patients, caution is advised in cases where there is a risk of bladder outlet obstruction, reduced gastrointestinal motility, or moderate to severe impairment of liver or kidney function, where dosing limits or increased caution may be necessary. Side effects such as dry mouth, constipation, blurred vision, and urinary retention may occur, and these effects may be more frequent at high doses. In severe cases, intestinal obstruction, angioedema, or allergic reactions may occur, so contact a physician immediately if unusual symptoms arise. This drug can affect heart rhythm; therefore, patients with heart conditions or electrolyte imbalances should exercise caution. Moreover, the use of this drug in combination with other anticholinergic medications may enhance effectiveness or exacerbate side effects, so it is essential to inform your doctor about any other medications you are taking. Pregnant or breastfeeding women should consult with a healthcare professional before taking this medication, and it is not used in children as safety and efficacy have not been established. In case of overdose, do not induce vomiting and seek medical attention immediately.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
Show 69 more
  • dyspepsia
  • epigastric pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • urinary difficulty
  • decreased urinary flow
  • bladder overdistention
  • cystitis
  • nasopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • hives
  • angioedema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • electrocardiogram QT prolongation
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • voice disorders
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • facial edema
  • polyuria
  • urination disorders
  • urgency
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • abdominal distension
  • acute renal failure
  • nocturia
  • decreased urine output
  • sensory abnormalities
  • generalized edema
  • chest tightness
  • periorbital edema
  • edema
  • male perineal pain
  • benign prostatic hyperplasia
  • male genital itching
  • erectile dysfunction
  • insomnia
  • anxiety
  • headache
  • thirst
  • drowsiness

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

Storage

This medication may be sensitive to air and moisture, and should be stored in a tightly closed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius in a cool, dry place to safely preserve the drug's effectiveness.

Appearance and packaging

Appearance

Round film-coated tablets with a bright yellow color

Package unit

100 tablets (10 tablets/ PTP pack x 10), 30 tablets/bottle, 100 tablets/bottle

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.