Medication info
Solnashinjung 10mg (Solifenacin succinate)

Solnashinjung 10mg (Solifenacin succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Hyubist Pharmaceutical Co., Ltd.
Appearance
Light pink round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle, 100 tablets/PTP [(10 tablets/PTP X 10)]
Approval status
Active

MFDS item code 201901225 · Approved 2019.02.26

Summary

Main use
Treatment of symptoms of overactive bladder (such as urge incontinence and urinary frequency)
Who takes it
Adults
Adult dose
The 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. Dosage adjustment is required for the following patients. 1. Patients with renal impairment: No dosage adjustment is needed 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 dosage adjustment is needed 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
Hyubist Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used to effectively relieve symptoms of overactive bladder such as urgency incontinence, frequency, and urinary urgency.

How to take

Adult dose

The 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. Dosage adjustment is required for the following patients. 1. Patients with renal impairment: No dosage adjustment is needed 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 dosage adjustment is needed 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 relieve bladder hyperactivity. It should not be administered to individuals with certain conditions such as urinary retention, severe gastrointestinal disorders, myasthenia gravis, or angle-closure glaucoma. Additionally, individuals with allergic reactions to this medication, patients on dialysis, those with severe liver or kidney impairment, and patients with specific genetic metabolic disorders should avoid use. Individuals at risk of urinary retention or gastrointestinal obstruction, or those at risk of decreased gastrointestinal motility should use this medication with caution, and patients with severe renal impairment or moderate liver impairment, as well as those taking strong CYP3A4 inhibitors, may need dosage adjustments. Side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur while taking this medication, so caution is advised. Dry mouth and constipation are relatively common, while serious side effects such as gastrointestinal obstruction or angioedema have been reported rarely. Caution is also required when driving or operating machinery, as this medication may induce drowsiness or fatigue. Furthermore, combining this medication with other anticholinergic drugs may enhance effects or exacerbate side effects, so consultation with a physician is necessary. Since this medication is metabolized in the liver, dose adjustments are required for patients with impaired liver function or those taking CYP3A4 inhibitors. Pregnant or breastfeeding women should consult a physician before using this medication, and it is advisable to avoid use while breastfeeding. The safety and efficacy in pediatric patients have not been established, therefore it should not be administered to children. In the case of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, and appropriate treatment is required for severe symptoms. While using this medication, sufficient attention to adverse effects and interactions is necessary, and it should be taken according to a physician's instructions.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • bowel obstruction
  • vascular neurosis
  • nausea
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  • indigestion
  • abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urine flow
  • bladder distension
  • cystitis
  • rhinopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • bowel obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • urticaria
  • angioedema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT prolongation on ECG
  • abnormal liver function tests
  • loss of appetite
  • hyperkalemia
  • speech disturbances
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • frequency of urination
  • urinary disorders
  • urgency to urinate
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • bloating
  • acute kidney failure
  • nocturnal enuresis
  • decreased urine output
  • sensory disturbances
  • difficulty walking
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male perineal pruritus
  • reduced libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen
  • pneumonia
  • keratosis
  • hair loss
  • feeling of sinking
  • anxiety
  • decreased libido
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • 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

This medication should be stored in a sealed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius at room temperature to preserve the drug's effectiveness and safety.

Appearance and packaging

Appearance

Light pink round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle, 100 tablets/PTP [(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.