Medication info
Urophenasin 10 mg (solifenacin succinate)

Urophenasin 10 mg (solifenacin succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
ShinPoong Pharmaceutical Co., Ltd.
Appearance
Bright pink round film-coated tablets
Packaging
100 tablets (10 tablets/PTP x 10)
Approval status
Active

MFDS item code 201501770 · Approved 2015.03.31 · Insurance code 648507370

Summary

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

Ingredients

Manufacturer
ShinPoong Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used to treat symptoms of overactive bladder such as urgency urinary incontinence, frequent urination, and urge incontinence.

How to take

Adult dose

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

Precautions

This medicine should not be used in patients with certain diseases. For example, patients with urinary retention who have difficulty urinating, those with serious gastrointestinal disorders, patients with myasthenia gravis, and those with glaucoma should not take this medication. Moreover, individuals allergic to this drug or its ingredients, patients undergoing hemodialysis, and those with severe liver or kidney dysfunction should not use this medication. This drug should be used cautiously in patients at risk of urinary retention due to bladder outlet obstruction, those with gastrointestinal obstruction diseases, or patients with impaired gastrointestinal motility. Especially, patients with moderate to severe impaired kidney or liver function should use a reduced dose, and caution is also required when taken with certain potent medications. The most common side effects of this medication include dry mouth and constipation. Additionally, blurred vision or dry eyes may occur, and in some patients, symptoms of urinary retention may be observed. In severe cases, serious side effects such as intestinal obstruction, angioedema, or allergic reactions can occur, so if any abnormal symptoms appear, immediate consultation with a healthcare professional is necessary. This medication may require caution when driving or operating machinery, as drowsiness, fatigue, or blurred vision may occur. Taking this drug with other anticholinergic medications may enhance effectiveness or increase side effects. Additionally, as this medicine is metabolized by certain liver enzymes, dosage adjustment is necessary when taken with drugs affecting liver metabolism. During pregnancy, the safety of this medication has not been sufficiently established, so caution is advised, and nursing women should avoid using this medication. It should not be used in children as safety and efficacy have not been established. In case of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, and in such cases, immediate medical treatment should be sought. Finally, this drug may pose risks for cardiac-related side effects in patients with heart disease or specific cardiac rhythm abnormalities, so caution is warranted.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colon obstruction
  • intestinal obstruction
  • vasogenic edema
  • nausea
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  • indigestion
  • epigastric pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower extremity edema
  • fatigue
  • cough
  • hypertension
  • difficulty urinating
  • decreased urinary flow
  • bladder hypertrophy
  • cystitis
  • nasopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • bowel obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • kidney impairment
  • itching
  • rash
  • hives
  • angioedema
  • erythema multiforme
  • exfoliative rhinitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • prolonged QT interval on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • voice disorders
  • anaphylaxis reaction
  • glaucoma
  • myopathy
  • facial edema
  • polyuria
  • bladder dysfunction
  • urgency
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • abdominal distension
  • acute kidney failure
  • nocturia
  • decreased urine volume
  • urinary stones
  • incontinence
  • sensory disturbances
  • difficulty walking
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male genital itching
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • hematuria
  • pneumonia
  • keratosis
  • hair loss
  • sinking feeling
  • anxiety
  • decreased sexual desire
  • back pain
  • vaginal bleeding
  • myocardial infarction
  • decreased cardiac output
  • syncope
  • hearing impairment
  • soft tissue inflammation
  • headache
  • thirst
  • drowsiness

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture, and it is best to keep it at room temperature between 1°C and 30°C. Storing it in this manner will help maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Bright pink round film-coated tablets

Package unit

100 tablets (10 tablets/PTP x 10)

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.