Medication info
Vesicore 5 mg (Solifenacin Succinate)

Vesicore 5 mg (Solifenacin Succinate)

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

MFDS item code 201701289 · Approved 2017.03.15 · Insurance code 698003460

Summary

Main use
Treatment of overactive bladder symptoms (including frequent urination and urinary urgency)
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. 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. 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. 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 frequent urination and urinary urgency)

  • Urgent urinary incontinence
  • increased frequency
  • urgency
View approved original text

This medication helps alleviate symptoms caused by overactive bladder such as urgent urinary incontinence, increased frequency, and urgency. Overactive bladder refers to the sudden urge to urinate that is difficult to defer; this medication improves symptoms by regulating excessive contractions of the bladder muscle. This helps patients reduce discomfort in their daily lives and lead to a more comfortable living. Therefore, it is used to treat symptoms of overactive bladder, such as urgent urinary incontinence and increased frequency.

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. 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. 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. For patients receiving ketoconazole or other strong CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This medication should not be used in patients with urinary retention symptoms or serious gastrointestinal issues such as toxic megacolon. Additionally, patients with myasthenia gravis, narrow-angle glaucoma, allergies to this medication or its components, those undergoing hemodialysis, or those with severe liver or kidney dysfunction should also avoid this medication. It is also not suitable for patients with genetic lactose intolerance. Caution is advised for patients at risk of urinary retention or those with gastrointestinal obstructive diseases or risk of decreased gastrointestinal motility. Patients with moderate to severe impairment of kidney or liver function should have their dosage limited, and careful monitoring is necessary when used with certain strong medications. Side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur, and these may be more frequent with higher doses. Serious side effects, though rare, include bowel obstruction, angioedema, and anaphylactic reactions; should symptoms appear, the use of the drug must be suspended immediately, and medical assistance sought. Caution is also advised when driving or operating machinery, as drowsiness or blurred vision may occur. Co-administration with other anticholinergic drugs may enhance effects or increase side effects; caution is warranted during combined use. Furthermore, this drug is metabolized by specific liver enzymes, so dosage adjustment is necessary when taken with strong CYP3A4 inhibitors. The safety for pregnant women has not been established; therefore, it should be used with caution during pregnancy. During breastfeeding, it is best to avoid this medication due to potential harm to the newborn through breast milk. The safety and efficacy for children have not been confirmed, so it should not be used in pediatric patients. In cases of overdose, central nervous system symptoms, cardiac problems, and urinary retention may occur, necessitating immediate medical treatment. Prior to taking this medication, it is essential to consult with healthcare professionals regarding existing conditions and medications for safe usage.

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 extremity edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow rate
  • bladder fullness
  • cystitis
  • rhinopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • 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
  • voice disturbances
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • increased blood creatinine
  • perforating duodenal ulcer
  • urinary retention
  • acute renal failure
  • bladder neck obstruction
  • worsening of renal impairment
  • pneumonia
  • increase in prostate specific antigen
  • ovarian cancer
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • reduced cardiac output
  • soft tissue infection
  • frequent urination
  • urination disorders
  • urgency in urination
  • neurogenic bladder
  • paresthesia
  • diarrhea
  • bloating
  • nocturia
  • decreased urine volume
  • urinary stones
  • incontinence
  • sensory disturbances
  • difficulty walking
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male perineal itching
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood-stained fluid
  • keratosis
  • hair loss
  • sinking feeling
  • anxiety
  • decreased sexual desire
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • thirst
  • erectile dysfunction
  • headache
  • dry mouth
  • drowsiness

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is best kept at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets (10 tablets/PTP packaging 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.