Medication info

Solicon Tablet 10mg (Solfenacin Succinate)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Bionex Co., Ltd.
Appearance
Pale pink round film-coated tablet
Packaging
100 tablets (10 tablets/PTP×10)
Approval status
Approval withdrawn

MFDS item code 201604009 · Approved 2016.06.28

This product's status changed to Approval withdrawn on 2024.12.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder symptoms (e.g., urinary frequency and urgency)
Who takes it
Adults
Adult dose
The usual recommended dose for adults (including older adults) is 5 mg once daily. If necessary, the dose may be increased to a maximum of 10 mg once daily. This medicine may be taken with or without food and should be swallowed whole with water. 1. Patients with renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance>30 ml/min). Caution is required in patients with severe renal impairment (creatinine clearance≤30 ml/min), and the dose should not exceed 5 mg once daily. 2. Patients with hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment. Caution is required in patients with moderate hepatic impairment (Child-Pugh class B), and the dose should not exceed 5 mg once daily. 3. Patients receiving a strong cytochrome P450 3A4 (CYP3A4) inhibitor For patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5 mg.

Ingredients

Manufacturer
Bionex Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (e.g., urinary frequency and urgency)

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

This medication is used to treat 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 5 mg once daily. If necessary, the dose may be increased to a maximum of 10 mg once daily. This medicine may be taken with or without food and should be swallowed whole with water. 1. Patients with renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance>30 ml/min). Caution is required in patients with severe renal impairment (creatinine clearance≤30 ml/min), and the dose should not exceed 5 mg once daily. 2. Patients with hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment. Caution is required in patients with moderate hepatic impairment (Child-Pugh class B), and the dose should not exceed 5 mg once daily. 3. Patients receiving a strong cytochrome P450 3A4 (CYP3A4) inhibitor For patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5 mg.

Precautions

This medication should not be used in patients with urinary retention symptoms, severe gastrointestinal disorders, myasthenia gravis, narrow-angle glaucoma, patients allergic to this medication or its ingredients, patients undergoing hemodialysis, or patients with severe liver or kidney impairment. Caution is advised in patients at risk for urinary retention or gastrointestinal obstruction, those at risk for decreased gastrointestinal motility, patients with severe renal impairment, moderate liver dysfunction, or in patients taking potent CYP3A4 inhibitors, as well as in those with gastroesophageal reflux disease or autonomic neuropathy. Common side effects include dry mouth, constipation, blurred vision, urinary retention, and dry eyes, particularly at higher doses, where side effects may occur more frequently. Severe allergic reactions such as angioedema or anaphylaxis may occur; medication use should be stopped immediately, and appropriate treatment sought if symptoms arise. Caution is needed while driving or operating machinery, as blurred vision, drowsiness, and fatigue may occur. When taken with other anticholinergic medications, the effects may be enhanced or side effects may worsen, so caution is required when co-administering. When taken with strong CYP3A4 inhibitors, drug concentration may increase, heightening the risk of side effects, necessitating dosage adjustment. Safety during pregnancy has not been established, so caution is advised when using in pregnant women, and nursing mothers should avoid use due to potential transfer of the drug through breast milk. Safety and efficacy in pediatric patients have not been established, thus use in children should be avoided. In cases of overdose, symptoms such as headache, dry mouth, dizziness, drowsiness, and blurred vision may occur, and appropriate emergency treatment may be needed. This medication is known to have no genotoxicity or tumor development risk and does not affect reproductive capacity or early embryonic development.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • nausea
  • indigestion
  • abdominal pain
  • vomiting
  • urinary tract infection
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  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • angioedema
  • fecal impaction
  • colon obstruction
  • bowel obstruction
  • vascular edema
  • anaphylactic reaction
  • vomiting
  • gastroesophageal reflux disease
  • bowel obstruction
  • peripheral edema
  • headache
  • hallucination
  • 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
  • voice disorder
  • glaucoma
  • muscle weakness
  • dysuria
  • decreased urinary flow rate
  • bladder overflow
  • cystitis
  • rhinopharyngitis
  • increased serum creatinine
  • perforating duodenal ulcer
  • urinary retention
  • 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
  • increased urinary frequency
  • urination disorder
  • urgency
  • neurogenic bladder
  • skin tingling
  • generalized edema
  • male perineal pain
  • insomnia
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • facial edema
  • thirst
  • erectile dysfunction
  • headache
  • dry mouth
  • drowsiness

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture. Additionally, it is advisable to store it at room temperature between 1 to 30 degrees Celsius to maintain efficacy.

Appearance and packaging

Appearance

Pale pink round film-coated tablet

Package unit

100 tablets (10 tablets/PTP×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.