Medication info

Vesicare 5mg (Solifenacin Succinate)

Prescription medicationTabletOralExpired
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Korea Pharma Co., Ltd.
Appearance
Bright yellow round film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3), 100 tablets (10 tablets/PTP x 10)
Approval status
Expired

MFDS item code 201502487 · Approved 2015.04.27

This product's status changed to Expired on 2025.04.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder symptoms (frequent urination, urinary urgency, etc.)
Who takes it
Adults
Adult dose
The usual 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 drug may be taken regardless of 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 in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do not exceed 5mg once daily. 3. Patients taking strong cytochrome P450 3A4 (CYP3A4) inhibitors In patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Korea Pharma Co., Ltd.

Efficacy & effects

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

  • Urge incontinence
  • frequent urination
  • urgency
View approved original text

This medication is used to improve various symptoms of overactive bladder such as urge incontinence, frequent urination, and urgency. These symptoms refer to a sudden contraction of the bladder leading to an urgent need to urinate, which can cause significant discomfort in the patient's daily life. The medication helps to regulate excessive contractions of the bladder, alleviating symptoms and improving urinary control. As a result, patients can lead their daily lives more comfortably. This drug is used to improve symptoms of overactive bladder.

How to take

Adult dose

The usual 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 drug may be taken regardless of 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 in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do not exceed 5mg once daily. 3. Patients taking strong cytochrome P450 3A4 (CYP3A4) inhibitors In patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This medication should not be used in patients with symptoms of poor urine output. Patients with severe gastrointestinal problems or myasthenia gravis should also not take this medication. Patients with glaucoma or allergies to this medication should avoid administration, as well as patients undergoing dialysis and those with severely impaired liver or kidney function. Additionally, it is safe to avoid administering this medication to patients with certain genetic issues. Caution is advised for patients with a risk of urinary tract obstruction or slow gastrointestinal motility. Patients with moderate kidney or liver impairment should be careful not to exceed the maximum daily dose. Common side effects may include dry mouth, constipation, blurred vision, and dry eyes. Rarely, serious side effects, such as angioedema, allergic reactions, arrhythmias, and liver function abnormalities may occur, so immediate consultation with a healthcare professional is necessary if any unusual symptoms arise. While taking this medication, patients should be cautious of drowsiness or blurred vision that may pose risks during driving or operating machinery. Taking this drug in combination with other anticholinergic medications may enhance effects or increase side effects, so it is essential to inform healthcare providers before taking. When taking drugs that inhibit enzymes that metabolize this medication in the liver, the concentration of this medication may increase, necessitating dosage adjustment. Women who are pregnant or breastfeeding should consult carefully before use, as the safety of this medication has not been established. This medication is not recommended for children, as its safety and efficacy have not been confirmed in this population. In cases of overdose, patients should seek treatment at a hospital immediately, and inducing vomiting is not advisable. Overdose may lead to central nervous system symptoms, respiratory problems, and heart issues, necessitating professional treatment.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urine retention
  • dry eyes
  • nausea
  • dyspepsia
  • upper abdominal pain
  • vomiting
  • urinary tract infection
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  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • angioedema
  • fecal impaction
  • colonic obstruction
  • bowel obstruction
  • vascular edema
  • anaphylactic reaction
  • vomiting
  • gastroesophageal reflux disease
  • bowel blockade
  • 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
  • speech disorder
  • glaucoma
  • muscle weakness
  • dysuria
  • decreased urinary flow
  • bladder neck obstruction
  • cystitis
  • nasopharyngitis
  • increased serum creatinine
  • perforating duodenal ulcer
  • urinary incontinence
  • acute renal failure
  • bladder outlet obstruction
  • worsening of renal function
  • pneumonia
  • increased prostate-specific antigen
  • ovarian cancer
  • cholangiocarcinoma
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • increased urinary frequency
  • urinary disorders
  • urgency incontinence
  • neurogenic bladder
  • skin tingling
  • generalized edema
  • male perineal pain
  • insomnia
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • keratosis
  • hair loss
  • feeling of heaviness
  • facial edema
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood clots
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • male genital itching
  • headache
  • thirst
  • drowsiness
  • dilated pupils

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 moisture. It is recommended to maintain a storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Bright yellow round film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3), 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.