Medication info
Vesicore Tablet 10 mg (Solifenacin Succinate)

Vesicore Tablet 10 mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Genupharm Co., Ltd.
Appearance
Bright pink round film-coated tablet
Packaging
100 tablets (10 tablets/PTP x 10), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201701288 · Approved 2017.03.15

Summary

Main use
Treatment of overactive bladder symptoms (including urge urinary incontinence and frequent urination)
Who takes it
Adults
Adult dose
The usual recommended dose for adults (including older adults) is 5mg once daily. If needed, the dose may be increased to a maximum of 10mg once daily. This medicine may be taken with or without food and should be swallowed whole with water. The dosage and administration should be adjusted 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). 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 necessary 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 receiving strong cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or other strong CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Genupharm Co., Ltd.

Efficacy & effects

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

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

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

How to take

Adult dose

The usual recommended dose for adults (including older adults) is 5mg once daily. If needed, the dose may be increased to a maximum of 10mg once daily. This medicine may be taken with or without food and should be swallowed whole with water. The dosage and administration should be adjusted 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). 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 necessary 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 receiving strong cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or other strong CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This drug is used to relieve bladder hyperactivity and should not be used in patients with difficulty urinating, severe gastrointestinal disorders, myasthenia gravis, or eye diseases such as glaucoma. Patients with severely impaired liver or kidney function, those undergoing dialysis, or those allergic to this medication or its ingredients should also avoid using it. Caution should be exercised with patients who have gastrointestinal obstruction diseases or are at risk of blocking the bladder outlet, and the dosage should be reduced in patients with moderately impaired liver or kidney function. While taking this medication, side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur, especially with higher doses, these symptoms may occur more frequently. Rarely, angioedema or allergic reactions may occur, and if swelling of the face or neck or difficulty breathing occurs, discontinue the medication immediately and consult a healthcare professional. This drug is metabolized by specific enzymes in the liver, so if taken with strong enzyme inhibitors such as certain antifungal agents, the drug concentration may increase, requiring dosage adjustment. Safety during pregnancy has not been established, so caution is needed, and breastfeeding women should avoid using this medication as it may affect the baby through breast milk. The safety and efficacy in children have not been confirmed, and it should not be administered to them. In case of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision can occur, and appropriate treatment should be sought immediately. Finally, there is a risk of accidents while driving or operating machinery due to drowsiness or blurred vision while taking this medication, so caution is advised.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioneurotic edema
  • nausea
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  • dyspepsia
  • 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
  • intestinal 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 ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech disorder
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • increased serum creatinine
  • perforating duodenal ulcer
  • urinary incontinence
  • acute renal failure
  • bladder neck obstruction
  • worsened renal function
  • pneumonia
  • elevated prostate-specific antigen
  • ovarian cancer
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • frequent urination
  • urination disorders
  • urgency
  • 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 in semen
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male genital itching
  • headache
  • dry mouth
  • drowsiness
  • pupillary dilation

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius to ensure the efficacy and safety of the drug over time.

Appearance and packaging

Appearance

Bright pink round film-coated tablet

Package unit

100 tablets (10 tablets/PTP 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.