Medication info
Solifenacin Tablets 5mg (Solifenacin Succinate)

Solifenacin Tablets 5mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Austin Pharmaceutical Co., Ltd.
Appearance
Bright yellow circular film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201405582 · Approved 2014.11.27 · Insurance code 654305020

Summary

Main use
Treatment of overactive bladder symptoms (including urinary frequency and urgency)
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 urinary frequency and urgency)

  • Urgent urinary incontinence
  • frequent urination
  • bladder overactivity
View approved original text

This medication is used to treat symptoms of overactive bladder such as urgent urinary incontinence, frequent urination, and bladder overactivity. Overactive bladder is characterized by a sudden urge to urinate and frequent urination, and this medication alleviates excessive contractions of the bladder to improve symptoms. This helps patients reduce discomfort in daily life and live more comfortably.

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 in patients with urinary retention symptoms, severe gastrointestinal conditions, myasthenia gravis, or angle-closure glaucoma. Additionally, individuals allergic to this medication or its components, patients undergoing dialysis, and those with severe liver or kidney impairment should avoid administration. Patients at risk of urinary obstruction or gastrointestinal obstruction, as well as autonomic neuropathy patients, should use this medication cautiously, and dosage adjustment is necessary for those with kidney or liver dysfunction. When taking this medication, symptoms such as dry mouth, constipation, blurred vision, and urinary retention may occur, so these symptoms should be closely monitored. In particular, this medication can cause drowsiness or blurred vision that may require caution while driving or operating machinery. Severe allergic reactions, such as angioedema or anaphylaxis, may also occur; if any unusual symptoms arise, discontinue use immediately and consult a healthcare professional. This medication is metabolized in the liver, so dosage adjustment may be necessary when taken with certain antifungal or antiviral medications, and patients taking such medications must inform their physician. Women who are pregnant or breastfeeding should avoid use as the safety of this medication has not been established. This medication should not be administered to children, as the safety and efficacy have not been validated. In cases of overdose, inducing vomiting should be avoided, and appropriate emergency treatment such as gastric lavage or administration of activated charcoal should be received if necessary. Patients with heart disease or at risk of QT prolongation should be particularly cautious and should consult a healthcare professional prior to taking this medication.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
Show 97 more
  • indigestion
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • difficulty urinating
  • decreased urinary flow
  • bladder overflow
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • bowel 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
  • QT prolongation on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • voice disorders
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • inability to urinate
  • acute renal failure
  • bladder neck obstruction
  • worsening of renal function
  • pneumonia
  • increase in prostate-specific antigen
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue inflammation
  • increased serum creatinine
  • frequent urination
  • facial edema
  • urinary disorders
  • urgency
  • neurogenic bladder
  • skin numbness
  • diarrhea
  • bloating
  • nocturia
  • decreased urine volume
  • urinary stones
  • incontinence
  • sensory disturbances
  • gait difficulties
  • limb tremors
  • chest tension
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male genital itching
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen
  • keratosis
  • hair loss
  • sinking feeling
  • anxiety
  • decreased sexual desire
  • back pain
  • vaginal bleeding
  • fainting
  • hearing impairment
  • thirst
  • erectile dysfunction
  • headache
  • dry mouth
  • drowsiness

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or humidity. Additionally, it is best to store it at room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Bright yellow circular film-coated tablets

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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.