Medication info
Vesista Tablets 10 mg (Solifenacin Succinate)

Vesista Tablets 10 mg (Solifenacin Succinate)

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

MFDS item code 201605449 · Approved 2016.09.06 · Insurance code 640007080

Summary

Main use
Treatment of overactive bladder symptoms (such as urge urinary incontinence and urinary frequency)
Who takes it
Adults
Adult dose
The usual recommended dose for adults (including older adults) is 5 mg once daily. If necessary, the dose may be increased to a maximum of 10 mg 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 a strong cytochrome P450 3A4 (CYP3A4) inhibitor Limit the maximum daily dose to 5mg in patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole).

Ingredients

Manufacturer
HK inno.N Co., Ltd.

Efficacy & effects

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

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

Used to relieve symptoms such as urgency incontinence, frequent urination, and urinary urgency associated with overactive bladder.

How to take

Adult dose

The usual recommended dose for adults (including older adults) is 5 mg once daily. If necessary, the dose may be increased to a maximum of 10 mg 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 a strong cytochrome P450 3A4 (CYP3A4) inhibitor Limit the maximum daily dose to 5mg in patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole).

Precautions

This medication is used to alleviate symptoms of overactive bladder. However, it should not be used in individuals with urinary retention, severe gastrointestinal problems, myasthenia gravis, or narrow-angle glaucoma with high eye pressure. Furthermore, those with allergies to this medication or its components, patients undergoing hemodialysis, and those with severe liver or kidney dysfunction should avoid this medication. Caution is needed for those at risk of urinary retention, gastrointestinal obstruction, slow gastrointestinal motility, and patients with severe renal or liver impairment, as dose adjustments are necessary in conjunction with strong CYP3A4 inhibitors. When taking this medication, side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur, so if any unusual symptoms appear, consult with a doctor. In particular, dry mouth and constipation are common, and serious side effects such as gastrointestinal obstruction have been reported with high doses. Care should be taken when driving or operating machinery. Combining with other anticholinergic medications may increase effect or worsen side effects, so it is essential to consult with a doctor or pharmacist. Additionally, since this medication is metabolized in the liver, those with poor liver function or taking CYP3A4 inhibitors may require dose adjustments. Women who are pregnant or breastfeeding should consult healthcare professionals before using this medication, and safety in pediatric patients has not been established, so it is best avoided. In case of overdose, seek medical attention immediately for appropriate treatment, and it is crucial not to induce vomiting. This medication can rarely cause severe allergic reactions, angioedema, or anaphylaxis, so immediate treatment is necessary if unusual symptoms occur. Lastly, the effects of this medication typically appear after taking it for about 4 weeks, so consistent use is essential.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
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  • dyspepsia
  • abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • difficulty urinating
  • reduced urinary flow
  • post-void dribbling
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • altered taste
  • abdominal pain
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • confusion
  • renal impairment
  • itching
  • rash
  • hives
  • vascular edema
  • erythema multiforme
  • exfoliative dermatitis
  • dry skin
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • prolonged QT interval on ECG
  • abnormal liver function tests
  • reduced appetite
  • hyperkalemia
  • speech difficulties
  • nasal dryness
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • headache
  • thirst
  • drowsiness
  • blurred vision
  • increased serum creatinine
  • perforated duodenal ulcer
  • urinary retention
  • acute renal failure
  • bladder neck obstruction
  • worsening renal function
  • pneumonia
  • elevated prostate-specific antigen
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • increased frequency of urination
  • urination disorders
  • urgency to urinate
  • neurogenic bladder
  • skin paresthesia
  • diarrhea
  • bloating
  • nocturnal enuresis
  • decreased urine output
  • urinary stones
  • urinary incontinence
  • sensory disturbances
  • difficulty walking
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male perineal itching
  • reduced erectile function
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • hematuria
  • keratosis
  • hair loss
  • feeling of sinking
  • anxiety
  • reduced libido
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Bright pink round film-coated tablets

Package unit

100 tablets (10 tablets/PTP packaging x 10), 10 tablets (10 tablets/PTP packaging x 1)

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.