Medication info

Quranashinjung 10mg (Solifenacin Succinate)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
JW Pharmaceutical Co., Ltd.
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201501853 · Approved 2015.04.06

This product's status changed to Approval withdrawn on 2023.12.07. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder symptoms (urge incontinence, frequency, 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 receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
JW Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

Used to treat symptoms of overactive bladder, such as urge urinary incontinence, frequent urination, and urge.

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 receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This medicine should not be used in patients with urinary retention or serious gastrointestinal diseases, including toxic megacolon. It should also not be administered to patients with myasthenia gravis, angle-closure glaucoma, or those allergic to this medication or its components. It should not be given to patients on hemodialysis or those with severe liver or kidney dysfunction. Patients with lactose intolerance or certain genetic lactose metabolism issues should not take this medication. Use this medicine with caution in patients at risk of bladder outlet obstruction or those with gastrointestinal obstructive diseases or reduced gastrointestinal motility. Dose adjustment is needed in patients with moderate or severe renal or hepatic impairment and those taking strong CYP3A4 inhibitors. Special caution is necessary for patients taking medications that can induce gastroesophageal reflux disease or esophagitis. When taking this medication, common side effects may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Serious gastrointestinal issues may arise in some patients, and if symptoms become severe, medical consultation should be sought immediately. Severe allergic reactions such as angioedema or anaphylaxis have been reported infrequently, and if these symptoms occur, medication should be discontinued immediately and treatment sought. Caution is necessary while driving or operating machinery, as blurred vision, drowsiness, and fatigue may occur. This medicine may enhance effects or increase side effects when taken with other anticholinergic drugs, so caution is advised when used in combination. It may also reduce the effectiveness of drugs that promote gastrointestinal motility. This medicine is primarily metabolized in the liver; therefore, adjustments are needed for patients with impaired liver function or those taking CYP3A4 inhibitors. Women who are pregnant or breastfeeding should consult a physician before use, as the safety of this drug has not been established. Safety in children has not been confirmed, so it should not be used in pediatric patients. Overdose may cause symptoms such as headache, dizziness, drowsiness, and blurred vision, and in such cases, immediate medical attention should be sought for appropriate treatment. Long-term use of this medication is not known to affect fertility or tumor formation, but as with all medications, it is important to adhere to the prescribed dosage and usage.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • nausea
  • dyspepsia
  • upper abdominal pain
  • vomiting
  • urinary tract infection
Show 96 more
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • angioedema
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • vascular edema
  • anaphylactic reaction
  • vomiting
  • gastroesophageal reflux disease
  • bowel obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • hives
  • angioedema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • prolonged QT interval on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech disorder
  • glaucoma
  • myopathy
  • dysuria
  • decreased urinary flow
  • bladder overdistension
  • cystitis
  • nasopharyngitis
  • increased serum creatinine
  • perforated duodenal ulcer
  • urinary incontinence
  • acute renal failure
  • bladder neck obstruction
  • worsening renal function
  • pneumonia
  • increased prostate-specific antigen
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • frequent urination
  • urinary disorder
  • urgency
  • neurogenic bladder
  • skin tingling
  • generalized edema
  • male perineal pain
  • insomnia
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • keratosis
  • hair loss
  • feeling of heaviness
  • facial edema
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen
  • chest tension
  • chest pain
  • periorbital edema
  • edema
  • male genital itching
  • headache
  • thirst
  • drowsiness
  • blurred vision
  • hallucinations
  • excessive excitement
  • convulsions
  • respiratory failure
  • tachycardia
  • mydriasis

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

Storage

This medicine should be stored in a tightly sealed container to prevent exposure to air or moisture and is safely stored at room temperature between 1 to 30 degrees Celsius. Proper storage can help maintain the drug's efficacy for a long time.

Appearance and packaging

Appearance

Pink round film-coated tablets

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.

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.