Medication info

Solifenacin Tablet 10 mg (Solifenacin Succinate)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Austin Pharmaceutical Co., Ltd.
Appearance
Bright pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201405583 · Approved 2014.11.27

This product's status changed to Approval withdrawn on 2024.04.15. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder symptoms (including urge urinary incontinence and urinary frequency)
Who takes it
Adults
Adult dose
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 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 for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Use 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 for patients with mild hepatic impairment. Use caution in patients with moderate hepatic impairment (Child-Pugh class B) and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors: For patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Austin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (including urge urinary incontinence and urinary frequency)

  • Urgency urinary incontinence
  • frequent urination
  • urge incontinence
View approved original text

This medication is used to treat symptoms of overactive bladder such as urgency urinary incontinence, frequent urination, and urge incontinence. It alleviates symptoms and improves bladder function to reduce discomfort in daily life.

How to take

Adult dose

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 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 for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Use 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 for patients with mild hepatic impairment. Use caution in patients with moderate hepatic impairment (Child-Pugh class B) and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors: For patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This medication should not be used by certain patients. For example, individuals who have trouble urinating, those with serious gastrointestinal issues, patients with severe muscle weakness, glaucoma patients with eye problems, anyone allergic to this medication or its components, patients undergoing hemodialysis, and those with very poor liver or kidney function should not use this medication. Also, caution should be taken when using this medication in patients with bladder outlet obstruction risk or gastrointestinal obstruction, those at risk for decreased gastrointestinal motility, patients with slightly poor liver or kidney function, and those taking certain other medications. Common side effects may include dry mouth, constipation, blurred vision, urinary retention, dry eyes, nausea, indigestion, upper abdominal pain, vomiting, urinary tract infections, influenza, pharyngitis, dizziness, depression, lower extremity edema, fatigue, cough, high blood pressure, difficulty urinating, reduced urinary flow, post-voiding sensation, cystitis, nasopharyngitis, vomiting, gastroesophageal reflux disease, headache, hallucination, drowsiness, delirium, kidney impairment, itching, rash, erythema multiforme, exfoliative dermatitis, atrial fibrillation, palpitations, tachycardia, and ECG changes. Caution is also needed in patients with arrhythmias or altered potassium levels as this medication may lead to cardiac rhythm issues. Additionally, care should be taken while driving or operating machinery during the course of treatment. While taking this medication alongside other anticholinergic drugs, effects may be heightened or side effects may worsen, so you must inform your doctor. Dosage adjustments may be necessary when used with certain antifungals or other medications. Pregnant women or breastfeeding mothers should consult with their doctor before taking this medication, and it is not to be used in children as safety has not been established. In the event of overdose, it is crucial to go to the hospital immediately for appropriate treatment, and do not induce vomiting. Finally, while this medication has been reported not to increase the risk of tumor formation with prolonged use, any abnormal symptoms during use should be discussed with a healthcare professional immediately.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
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  • indigestion
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow
  • bladder neck obstruction
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • bowel obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • urticaria
  • vascular edema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT prolongation on electrocardiogram
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech disorder
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • increased serum creatinine
  • perforated duodenal ulcer
  • urinary incontinence
  • acute renal failure
  • bladder neck obstruction
  • worsening renal function
  • pneumonia
  • increased prostate-specific antigen
  • ovarian carcinoma
  • biliary tract cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue inflammation
  • frequent urination
  • facial swelling
  • urinary disorders
  • urgency to urinate
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • bloating
  • nocturia
  • decreased urine volume
  • urinary stones
  • urinary incontinence
  • sensory disturbances
  • gait disturbances
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male genital itching
  • diminished erection
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen
  • keratosis
  • hair loss
  • feeling of heaviness
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • thirst
  • erectile dysfunction
  • headache
  • dry mouth
  • drowsiness

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Furthermore, it is advisable to keep the medication at room temperature between 1 to 30 degrees Celsius, avoiding extremely hot or cold places. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Bright pink round film-coated tablet

Package unit

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.