Medication info
Vesicalin 10 mg (Solifenacin Succinate)

Vesicalin 10 mg (Solifenacin Succinate)

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

MFDS item code 201604822 · Approved 2016.08.08 · Insurance code 645906110

Summary

Main use
Treatment of overactive bladder symptoms (urge incontinence, frequent urination, 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 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 dosage adjustment is necessary for 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 dosage adjustment is necessary for 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 taking potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients taking ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Dongkwang Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (urge incontinence, frequent urination, etc.)

  • Urgency urinary incontinence
  • frequency
  • urinary urgency
View approved original text

This medication is used to improve symptoms of overactive bladder, such as urgency urinary incontinence, frequency, and urinary 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 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 dosage adjustment is necessary for 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 dosage adjustment is necessary for 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 taking potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients taking ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This medication should not be used by patients with certain conditions. For example, patients with urinary retention, severe gastrointestinal diseases, myasthenia gravis, or glaucoma should not take this medication. Additionally, those with allergies to this medication or its components should avoid administration, as well as patients undergoing hemodialysis or with severe liver and kidney dysfunction. This medication should be used cautiously in patients at risk of urinary retention due to obstruction of the bladder outlet or those with gastrointestinal obstructive diseases or impaired gastrointestinal motility. In particular, patients with severe renal impairment or moderate hepatic impairment should limit the maximum daily dose, and dosage adjustments may be necessary when taken with certain potent medications. Common side effects of this medication include dry mouth, constipation, blurred vision, and indigestion; serious gastrointestinal problems or vascular edema, and allergic reactions may occur infrequently. If these symptoms appear, immediate consultation with a healthcare professional is recommended. Additionally, this medication may cause drowsiness or blurred vision when driving or operating machinery, so caution is required. Taking this medication concurrently with other anticholinergic drugs may enhance effects or exacerbate side effects, so any current medications must be disclosed. Since this medication is metabolized in the liver by certain enzymes, careful consideration is needed for dosage adjustments or potential interactions when administered with drugs that inhibit or induce these enzymes. Women who are pregnant or breastfeeding should consult a physician before using this medication, as its safety has not been fully established. It should not be used in children, as safety and efficacy have not been established. In the case of an overdose, patients should seek immediate medical attention for appropriate treatment, and inducing vomiting is not recommended. Finally, although this medication does not appear to increase tumor incidence or affect reproductive capabilities even with long-term use, it is advisable to consult a specialist if any adverse reactions occur during treatment.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
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  • dyspepsia
  • epigastric pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower extremity edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow
  • post-void residual
  • 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 disturbances
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • facial swelling
  • polyuria
  • urinary disorders
  • urgency
  • neurogenic bladder
  • skin numbness
  • diarrhea
  • bloating
  • acute renal failure
  • nocturia
  • decreased urine output
  • urolithiasis
  • urinary incontinence
  • sensory disturbances
  • gait difficulties
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male perineal pain
  • reduced libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen
  • pneumonia
  • keratosis
  • hair loss
  • sinking feeling
  • anxiety
  • decreased libido
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • back pain
  • vaginal bleeding
  • myocardial infarction
  • reduced cardiac output
  • syncope
  • hearing impairment
  • soft tissue infection
  • headache
  • thirst
  • drowsiness

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. Additionally, it is recommended to store the medication at room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold locations.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

100 tablets (10 tablets/PTP) x 10

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.