Medication info
Becystar Tablet 5 mg (Solu Fenacine Succinate)

Becystar Tablet 5 mg (Solu Fenacine Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
HK INNO.N Corp.
Appearance
Light yellow round film-coated tablet
Packaging
100 tablets (10 tablets/PTP packaging x 10), 10 tablets (10 tablets/PTP packaging x 1)
Approval status
Active

MFDS item code 201701572 · Approved 2017.03.31 · Insurance code 640007110

Summary

Main use
Treatment of overactive bladder symptoms (frequent urination, urinary urgency, 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 drug 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 in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Caution is required in patients with severe renal impairment (creatinine clearance≤30ml/min), and the dose should not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is necessary in patients with mild hepatic impairment. Caution is required in patients with moderate hepatic impairment (Child-Pugh class B), and the dose should not exceed 5mg 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 5mg.

Ingredients

Manufacturer
HK INNO.N Corp.

Efficacy & effects

Treatment of overactive bladder symptoms (frequent urination, urinary urgency, etc.)

  • Urgency urinary incontinence
  • frequent urination
  • bladder urgency
  • symptoms of overactive bladder
View approved original text

This medicine is used to treat symptoms of overactive bladder such as urgency urinary incontinence, frequent urination, and bladder urgency. It helps alleviate the patient's symptoms of overactive bladder and reduces discomfort in daily life, improving quality of life.

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 drug 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 in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Caution is required in patients with severe renal impairment (creatinine clearance≤30ml/min), and the dose should not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is necessary in patients with mild hepatic impairment. Caution is required in patients with moderate hepatic impairment (Child-Pugh class B), and the dose should not exceed 5mg 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 5mg.

Precautions

This medication is used to relieve bladder hyperactivity and should not be used in patients with certain conditions. For example, it should not be administered to individuals with urinary retention symptoms or significant gastrointestinal problems, myasthenia gravis patients, and glaucoma patients. Additionally, those allergic to this drug, patients undergoing hemodialysis, and patients with severe liver or kidney disorders should not use it. The use of this drug should also be avoided in patients with specific genetic metabolic disorders. This medication should be used cautiously in patients at risk of urinary retention due to bladder outlet obstruction or in those with gastrointestinal obstruction or decreased mobility. Patients with severe kidney and liver disorders require dose adjustment and must be cautious when combined with certain strong medications. Patients taking medications that may cause gastroesophageal reflux disease or esophagitis, as well as those with autonomic nervous system disorders, should also exercise caution. Common side effects upon administration may include dry mouth, constipation, blurred vision, urinary retention, dry eyes, etc., especially at higher doses where these side effects may occur more frequently. In severe cases, significant adverse reactions such as bowel obstruction or angioedema may occur, so if symptoms arise, immediate consultation with medical personnel is required. This drug may cause serious allergic reactions such as angioedema or anaphylaxis in some patients, so if such symptoms occur, discontinuation and treatment should be sought immediately. Additionally, before taking this drug, it is crucial to confirm the absence of urinary problems due to other causes or urinary tract infections and to conduct appropriate treatment concurrently. It may take about 4 weeks for this drug to show effects, and symptoms such as drowsiness, fatigue, and blurred vision may rarely occur, requiring caution when driving or operating machinery. Combining this drug with other anticholinergic medications may enhance the effect or worsen side effects, so caution is required during concomitant use, and a one-week washout period is recommended before starting another anticholinergic after discontinuation of this medication. This drug is metabolized by specific enzymes (CYP3A4) in the liver, so taking strong CYP3A4 inhibitors concurrently may increase the blood concentration of this medication, raising the risk of side effects. In such cases, dose adjustments or avoidance of combination therapy are necessary. The safety of this drug during pregnancy has not been established, so it should be used cautiously in pregnant women, and breastfeeding women are advised to avoid it as it may be excreted in breast milk and affect the baby. The safety and efficacy in pediatric patients have not been confirmed, so it should not be administered to children. Overdosage may lead to symptoms such as headache, dry mouth, dizziness, drowsiness, blurred vision, and in severe cases, may require professional treatment. This drug has been reported to not affect cancer risk or reproductive function even with long-term use, but if any unusual symptoms appear during use, immediate consultation with medical personnel is advised.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • vascular neurogenic edema
  • nausea
Show 52 more
  • dyspepsia
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • peripheral edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • reduced urinary flow
  • post-voiding bladder sensation
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • bowel obstruction
  • taste disturbance
  • abdominal pain
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • confusion
  • renal impairment
  • itching
  • rash
  • urticaria
  • angioedema
  • erythema multiforme
  • exfoliative dermatitis
  • dry skin
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • prolonged QT interval on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • dysphonia
  • nasal dryness
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • headache
  • thirst
  • drowsiness

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius to keep the medication effective for a longer period.

Appearance and packaging

Appearance

Light yellow round film-coated tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10), 10 tablets (10 tablets/PTP packaging x 1)

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.