Medication info
Vesicare 5 mg (Solifenacin Succinate)

Vesicare 5 mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
Bright yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201500521 · Approved 2015.01.30 · Insurance code 657805510

Summary

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

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

This medication is used to treat the overactive bladder symptoms of urgency urinary incontinence, frequent urination, and urge incontinence. It helps to alleviate excessive contractions of the bladder, improving symptoms and reducing discomfort in patients' daily lives. Therefore, it is used to effectively manage overactive bladder symptoms and improve quality of life.

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 medication should not be used in patients with urinary retention, severe gastrointestinal problems, myasthenia gravis, or angle-closure glaucoma. Additionally, it should be avoided in patients with allergies to this medication or its components, those undergoing hemodialysis, and patients with severe liver or kidney impairment. It contains lactose, so individuals with genetic issues such as galactose intolerance should not take it. Patients at risk of urinary retention or with potential gastrointestinal obstruction or reduced gastrointestinal motility, as well as patients with severe kidney or liver impairment, should use this medication cautiously. When taken with strong CYP3A4 inhibitors, the maximum dosage must be limited, and caution is necessary for patients with certain gastrointestinal disorders or autonomic neuropathy. This medication can frequently cause side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes, with dry mouth and constipation being particularly common. In severe cases, serious gastrointestinal issues such as bowel occlusion or ileus may occur, so if any abnormal symptoms arise, medical advice should be sought immediately. Rarely, it can cause serious allergic reactions such as angioedema or anaphylaxis; in such cases, administration should be stopped immediately, and treatment should be sought. Caution is advised when driving or operating machinery, as drowsiness or blurred vision may occur. When used in conjunction with other anticholinergic medications, its effects may be potentiated or side effects may worsen, so consultation with a healthcare professional is necessary. This drug is mainly metabolized in the liver; therefore, dosage adjustments are needed in patients with compromised liver function or those taking strong CYP3A4 inhibitors. Women who are pregnant or breastfeeding should consult a doctor before using this medication, and especially during breastfeeding, use should be avoided. The safety and efficacy in children have not been established, therefore it is not administered to pediatric patients. In cases of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, and immediate medical attention should be sought for appropriate treatment. Special caution is needed for patients with heart disease or risk factors for QT prolongation.

Side effects

  • dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • nausea
  • dyspepsia
  • upper abdominal pain
  • vomiting
  • urinary tract infection
Show 94 more
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • angioedema
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • elevated serum creatinine
  • perforating duodenal ulcer
  • urinary incontinence
  • acute renal failure
  • bladder neck obstruction
  • worsening of renal dysfunction
  • pneumonia
  • elevated prostate-specific antigen
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • 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 electrocardiogram
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech impairment
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • dysuria
  • decreased urinary flow
  • post-void residual
  • cystitis
  • nasopharyngitis
  • frequent urination
  • urinary disorders
  • urgency
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • abdominal bloating
  • nocturia
  • decreased urinary volume
  • urinary stones
  • incontinence
  • sensory disturbance
  • gait difficulties
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male perineal itching
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • keratosis
  • hair loss
  • sensation of heaviness
  • anxiety
  • decreased sexual desire
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • thirst
  • erectile dysfunction
  • headache
  • dry mouth
  • drowsiness
  • mydriasis

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is best stored at room temperature between 1 and 30 degrees Celsius to maintain the medication's efficacy and prevent deterioration.

Appearance and packaging

Appearance

Bright yellow round film-coated tablet

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.

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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.