Medication info
Vesikyu Tablet 10 mg (Solifenacin Succinate)

Vesikyu Tablet 10 mg (Solifenacin Succinate)

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

MFDS item code 201500522 · Approved 2015.01.30 · Insurance code 657805500

Summary

Main use
Treatment of overactive bladder symptoms (urge urinary incontinence, frequency, etc.)
Who takes it
Adults
Adult dose
The recommended dose for adults (including elderly patients) is 5mg once daily. If necessary, 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. 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). 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: Limit the maximum daily dose to 5mg in patients receiving ketoconazole or other strong CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole).

Ingredients

Manufacturer
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (urge urinary incontinence, frequency, etc.)

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

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

How to take

Adult dose

The recommended dose for adults (including elderly patients) is 5mg once daily. If necessary, 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. 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). 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: Limit the maximum daily dose to 5mg in patients receiving ketoconazole or other strong CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole).

Precautions

This drug should not be used in patients with urinary retention or severe gastrointestinal disorders such as toxic megacolon. Additionally, it should not be administered to patients with myasthenia gravis, angle-closure glaucoma, known hypersensitivity to this medication, patients undergoing hemodialysis, and those with severe liver or kidney impairment. This drug contains lactose, so it should not be used in patients with lactose intolerance or related genetic issues. Caution should be exercised when administering to patients at risk of urinary retention, gastrointestinal obstruction, or those with severe renal impairment or moderate liver impairment. Dose adjustments may be necessary when co-administered with strong CYP3A4 inhibitors. Side effects may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes; rare but serious adverse reactions such as angioedema or severe gastrointestinal reactions can also occur. This medication may affect driving or operating machinery, so caution is advised, especially if drowsiness or blurred vision occurs. Additionally, using this drug with other anticholinergic medications may enhance effects or exacerbate side effects, so a consultation with a physician is recommended. The safety of this drug during pregnancy has not been established, and it should only be used cautiously when necessary; during breastfeeding, it is recommended to avoid use as it may be excreted in breast milk. Safety and efficacy in children have not been established, so it should not be administered to pediatric patients. In case of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, and immediate medical consultation is required for appropriate treatment. Special caution is necessary for patients with heart disease or those at risk of QT prolongation, and any adverse reactions during medication use should be immediately reported to a healthcare institution for treatment.

Side effects

  • dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • nausea
  • indigestion
  • upper abdominal pain
  • vomiting
  • urinary tract infection
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  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • angioneurotic edema
  • fecal impaction
  • colon obstruction
  • intestinal obstruction
  • vascular edema
  • anaphylactic reaction
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucination
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • hives
  • 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
  • glaucoma
  • muscle weakness
  • dysuria
  • decreased urine flow
  • bladder distension
  • cystitis
  • rhinopharyngitis
  • increased serum creatinine
  • perforating duodenal ulcer
  • urinary incontinence
  • acute renal failure
  • bladder neck obstruction
  • worsening of renal function
  • pneumonia
  • increased prostate-specific antigen
  • ovarian cancer
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue inflammation
  • increased urinary frequency
  • urination disorder
  • urgency in urination
  • neurogenic bladder
  • skin tingling
  • generalized edema
  • male perineal pain
  • insomnia
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • keratosis
  • hair loss
  • sinking sensation
  • facial swelling
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood-stained semen
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male genital itching
  • headache
  • dry mouth
  • drowsiness
  • pupil dilation

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 closed container. The recommended storage temperature is between 1°C and 30°C at room temperature. Proper storage will help maintain the drug's efficacy and safety over time.

Appearance and packaging

Appearance

Bright pink round 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

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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.