Medication info

Megasulfena Tablet 10mg (Solefenacin Succinate)

Prescription medicationTabletOralApproval withdrawn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Approval withdrawn

MFDS item code 202003533 · Approved 2020.05.15

This product's status changed to Approval withdrawn on 2024.09.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder symptoms (such as frequent urination and urinary urgency)
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 for 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 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 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), the maximum daily dose should be limited to 5mg.

Ingredients

Manufacturer
LNC Bio Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (such as frequent urination and urinary urgency)

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

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

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 for 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 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 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), the maximum daily dose should be limited to 5mg.

Precautions

This medication should not be used by patients with symptoms of urinary retention. Patients with severe gastrointestinal diseases, myasthenia gravis, or narrow-angle glaucoma should also not take this medication. Additionally, patients with allergies to this medication or its ingredients, patients undergoing dialysis, and those with severe liver or kidney dysfunction should not be administered this medication. Patients with genetic issues such as lactose intolerance should also avoid this medication. Caution is advised when using this medication in patients at risk of urinary tract obstruction or suspected gastrointestinal obstruction, as well as in those at risk of decreased gastrointestinal motility. Patients with severe renal or liver dysfunction should have their dosage limited, and caution should be exercised when taken with specific medications. Those with gastroesophageal reflux disease, esophagitis, or autonomic neuropathy should also be administered this medication carefully. This medication may cause dry mouth, constipation, blurred vision, and other symptoms. In severe cases, gastrointestinal issues such as bowel obstruction may occur, so consult a physician immediately if any abnormal symptoms arise. Moreover, serious allergic reactions such as angioedema or anaphylaxis have been reported rarely; if such symptoms occur, cease taking the medication immediately and seek treatment. This medication may cause drowsiness, blurred vision, and fatigue when driving or operating machinery, so caution is needed. Taking this medication with other anticholinergic medications may enhance its effects or increase side effects and may reduce the effectiveness of gastrointestinal motility-promoting drugs. Furthermore, this medication is metabolized by specific hepatic enzymes, so dosage adjustments may be needed when taken with strong CYP3A4 inhibitors. The safety of this medication in pregnant women has not been established, so caution is necessary. Nursing mothers are advised to avoid this medication. The safety and efficacy of this medication in children have not been established, so it should not be used in this population. In the case of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, and in severe cases, specialized treatment may be required. If an overdose is suspected, seek medical attention immediately.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • nausea
  • indigestion
  • upper abdominal pain
  • vomiting
  • urinary tract infection
Show 88 more
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower extremity 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
  • QT prolongation on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech disorder
  • glaucoma
  • myopathy
  • dysuria
  • decreased urinary flow
  • bladder distension
  • cystitis
  • rhinitis
  • increased serum creatinine
  • perforated duodenal ulcer
  • urinary retention
  • acute renal failure
  • bladder neck obstruction
  • worsening of renal function
  • pneumonia
  • elevated prostate-specific antigen
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • increased urinary frequency
  • urinary dysfunction
  • urgency
  • neurogenic bladder
  • skin tingling
  • generalized edema
  • male perineal pain
  • insomnia
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • keratosis
  • alopecia
  • feeling of sinking
  • male genital itching
  • decreased erection
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • thirst

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is best to store it at a temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a long time.

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.