Medication info

Vesim Tablet 5mg (Solifenacin Succinate)

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

MFDS item code 201500443 · Approved 2015.01.28

This product's status changed to Expired on 2025.01.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder symptoms (frequency, urgency, etc.)
Who takes it
Adults
Adult dose
The usual recommended dose for adults (including older adults) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This drug 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 dosage adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Caution is required in patients with severe renal impairment (creatinine clearance≤30ml/min), and the dose should not exceed 5mg once daily. 2. Patients with hepatic impairment: No dosage adjustment is necessary for patients with mild hepatic impairment. Caution is required in patients with moderate hepatic impairment (Child-Pugh class B), and the dose should not exceed 5mg once daily. 3. Patients taking strong cytochrome P450 3A4 (CYP3A4) inhibitors: For patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Samchundang Pharm. Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (frequency, urgency, etc.)

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

This medication is used for the treatment of symptoms of overactive bladder such as urinary incontinence, frequent urination, and urgency.

How to take

Adult dose

The usual recommended dose for adults (including older adults) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This drug 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 dosage adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Caution is required in patients with severe renal impairment (creatinine clearance≤30ml/min), and the dose should not exceed 5mg once daily. 2. Patients with hepatic impairment: No dosage adjustment is necessary for patients with mild hepatic impairment. Caution is required in patients with moderate hepatic impairment (Child-Pugh class B), and the dose should not exceed 5mg once daily. 3. Patients taking strong cytochrome P450 3A4 (CYP3A4) inhibitors: For 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 by patients with urinary retention symptoms or certain serious conditions such as severe gastrointestinal disorders, myasthenia gravis, and narrow-angle glaucoma. Additionally, patients who are allergic to any component of this medication or those undergoing hemodialysis, as well as patients with severe liver or kidney impairment, should not receive this treatment. Caution should be exercised in patients at risk of urinary retention, those with gastrointestinal obstructive disease, severe kidney impairment, and moderate liver impairment. Dose adjustments are needed when taken in conjunction with strong CYP3A4 inhibitors. Side effects may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes, with dry mouth and constipation occurring more frequently at higher doses. Rarely, severe allergic reactions such as angioedema and anaphylaxis may occur; if such symptoms arise, discontinue use immediately and seek medical attention. This medication may cause drowsiness or blurred vision, caution is advised when driving or operating machinery. Concomitant use with other anticholinergic medications may intensify effects or exacerbate side effects, and the efficacy of gastrointestinal motility-promoting drugs may be reduced. As this medication is metabolized by certain enzymes (CYP3A4) in the liver, taking it with drugs that strongly inhibit this enzyme may raise blood levels, increasing the risk of side effects. Pregnant or breastfeeding women should consult a physician before using this medication, and it is particularly advisable to avoid use while breastfeeding. Safety and efficacy in pediatric patients have not been established; therefore, it should not be used in children. In cases of overdose, symptoms such as headaches, dizziness, drowsiness, and visual disturbances may occur, and severe cases may require professional treatment. Patients with heart disease or a risk of QT prolongation should be cautious as there may be cardiac side effects associated with this medication. Lastly, this medication is considered non-genotoxic and not likely to promote tumors, nor does it significantly affect reproductive capability.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • 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 distension
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • bowel 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
  • prolonged QT interval on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • dysphonia
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • facial edema
  • increased urinary frequency
  • urinary disorders
  • urgency
  • neurogenic bladder
  • paresthesia
  • diarrhea
  • abdominal bloating
  • acute renal failure
  • nocturnal enuresis
  • decreased urine volume
  • sensory disturbances
  • generalized edema
  • chest tension
  • periorbital edema
  • swelling
  • male perineal pain
  • benign prostatic hyperplasia
  • male genital itching
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen
  • pneumonia
  • keratosis
  • hair loss
  • feeling of heaviness
  • anxiety
  • decreased sexual desire
  • back pain
  • vaginal bleeding
  • myocardial infarction
  • decreased cardiac output
  • syncope
  • hearing impairment
  • soft tissue infection
  • headache
  • dry mouth
  • drowsiness

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

Storage

Store this medication in a tightly sealed container as it may be sensitive to air or moisture. The recommended storage temperature is room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy over time.

Appearance and packaging

Appearance

Bright yellow 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.