Medication info

Hyundai Solifenacin Succinate Tablet 10 mg

Prescription medicationTabletOralExpired
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Hyundai Pharmaceutical Co., Ltd.
Appearance
Light pink round film-coated tablets
Packaging
100 tablets/PTP [10 tablets/PTP X 10]
Approval status
Expired

MFDS item code 202002516 · Approved 2020.04.09

This product's status changed to Expired on 2025.04.09. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder symptoms (urge urinary incontinence, urinary frequency, etc.)
Who takes it
Adults
Adult dose
The usual recommended dose for adults (including the elderly) 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. No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5mg once daily. No dose adjustment is necessary for patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh Class B), administer with caution and do not exceed 5mg once daily. For patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Hyundai Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Urinary urgency
  • frequent urination
  • urge incontinence
  • symptoms of overactive bladder
View approved original text

This medication is used to treat symptoms of overactive bladder such as urinary urgency, frequent urination, and urge incontinence.

How to take

Adult dose

The usual recommended dose for adults (including the elderly) 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. No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5mg once daily. No dose adjustment is necessary for patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh Class B), administer with caution and do not exceed 5mg once daily. For patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This medication should not be used in patients with certain diseases or conditions. For example, it should not be taken by patients with urinary retention symptoms or serious gastrointestinal problems, those with severe myasthenia gravis, glaucoma, those allergic to this medication, patients undergoing hemodialysis, and those with severe liver or kidney dysfunction. Additionally, it should be used with caution in patients at risk of urinary retention, those with a risk of gastrointestinal obstruction or decreased gastrointestinal motility, those with severe kidney or liver dysfunction, and patients who are on specific concurrent medications. Particularly, dosages should be limited in patients with impaired liver and kidney function, and caution should be exercised when taken with certain drugs. While taking this medication, side effects such as dry mouth, constipation, blurred vision, dyspepsia, urinary tract infection, dizziness, and fatigue may occur. In some patients, serious allergic reactions such as severe bowel obstruction or angioedema and anaphylaxis may occur, so any unusual symptoms should be reported to a healthcare professional immediately. This medication may cause heart rhythm problems in patients with arrhythmias or abnormal potassium levels, so patients at risk should be especially cautious. The effectiveness may be enhanced or side effects may increase when taken with other anticholinergic medications, and it may reduce the efficacy of medications that promote gastrointestinal motility. It can also interact with enzymes that metabolize drugs in the liver, requiring dose adjustments when taken with certain medications. Women who are pregnant or breastfeeding should be cautious when taking this medication, especially breastfeeding mothers, as it can be passed to breast milk and may affect the baby, so it is advisable to avoid its use. Safety and effectiveness have not been established in pediatric patients, so it should not be administered to them. In case of overdose, symptoms such as headaches, dry mouth, dizziness, drowsiness, and blurred vision may occur, and in severe cases, specific treatments may be required. If an overdose is suspected, it is essential to visit a medical institution immediately for appropriate treatment. During the use of this medication, driving or operating machinery may increase the risk of accidents due to symptoms such as drowsiness and blurred vision, so caution is advised.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • nausea
  • dyspepsia
  • abdominal pain
  • vomiting
  • urinary tract infection
Show 94 more
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • 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
  • urticaria
  • angioedema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT prolongation on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech disorder
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • dysuria
  • decreased urinary flow
  • post-void residual
  • cystitis
  • nasopharyngitis
  • increased serum creatinine
  • perforated duodenal ulcer
  • urinary incontinence
  • acute renal failure
  • bladder outlet obstruction
  • worsening renal function
  • pneumonia
  • increased prostate-specific antigen
  • ovarian cancer
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • frequent urination
  • urinary disorders
  • urgency to urinate
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • abdominal distension
  • nocturia
  • decreased urine volume
  • urinary stones
  • urinary incontinence
  • sensory abnormalities
  • 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 in semen
  • keratosis
  • hair loss
  • sinking feeling
  • anxiety
  • decreased sexual desire
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment

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. Additionally, it is best to store the medication at room temperature, not too hot or too cold, specifically between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Light pink round film-coated tablets

Package unit

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.