Medication info
Solferak Tablet 10 mg (Solifenacin Succinate)

Solferak Tablet 10 mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Alrico Pharmaceuticals Co., Ltd.
Appearance
Bright pink round film-coated tablet
Packaging
100 tablets (10 tablets/PTP x 10), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201505093 · Approved 2015.07.27 · Insurance code 656004480

Summary

Main use
Treatment of overactive bladder symptoms (urgency urinary incontinence, frequency, etc.)
Who takes it
Adults
Adult dose
The 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 medication 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). For patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is necessary for patients with mild hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do 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
Alrico Pharmaceuticals Co., Ltd.

Efficacy & effects

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

  • Urinary urgency
  • frequency
  • urge incontinence
View approved original text

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

How to take

Adult dose

The 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 medication 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). For patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is necessary for patients with mild hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do 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 drug should not be used in patients with urinary retention symptoms. Patients with serious gastrointestinal diseases such as toxic megacolon should also avoid this medication. It is also not safe for patients with myasthenia gravis or angle-closure glaucoma. Avoid this drug if you are allergic to it or any of its components. Patients undergoing hemodialysis or with severe liver or kidney dysfunction should not use this drug. Furthermore, patients with lactose intolerance or certain genetic metabolic disorders are advised against using this medication. Use with caution in patients at risk of urinary retention or with gastrointestinal obstructive diseases, or those at risk of decreased gastrointestinal motility. Patients with severe kidney impairment or decreased liver function should use with restricted dosage, and those taking strong CYP3A4 inhibitors should also be cautious. Patients with gastroesophageal reflux disease or autonomic neuropathy should be careful when using this medication. The most common side effects of this medication include dry mouth and constipation. Blurred vision or dry eyes may occur, and rarely, serious side effects such as urinary retention or bowel obstruction have been reported. If side effects occur, it is important to consult a doctor regarding discontinuation of the medication. This drug can cause severe allergic reactions such as cardiac arrhythmias, angioedema, or anaphylaxis, and if these symptoms appear, it should be discontinued immediately and you should seek treatment. Additionally, prior to taking this medication, other causes of urinary frequency or urinary tract infections should be evaluated. Caution should be exercised when taking this drug with other anticholinergic medications as effects may be enhanced or side effects may worsen. The effectiveness may be reduced when used with drugs that promote gastrointestinal motility. Since this medication is metabolized in the liver, there may be interactions with drugs that inhibit or induce certain liver enzymes, so you must inform your doctor about your current medications. The safety of this drug in pregnant women has not been established, so it should be used cautiously during pregnancy. During breastfeeding, it is advisable to avoid use as this drug may be secreted into breast milk. The safety and efficacy in pediatric patients have not been confirmed, so it should not be used in this population. In cases of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, and appropriate emergency measures such as gastric lavage or administration of activated charcoal may be necessary. Severe central nervous system symptoms, heart problems, or urinary retention may require professional treatment. This medication may require caution when driving or operating machinery due to drowsiness or blurred vision, so be mindful of symptoms.

Side effects

  • dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
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  • dyspepsia
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • leg swelling
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urine flow
  • post-void residual
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • bowel obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • urticaria
  • vascular edema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT prolongation on electrocardiogram
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • dysphonia
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • frequent urination
  • urination disorders
  • urgency
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • abdominal bloating
  • acute renal failure
  • nocturia
  • decreased urine volume
  • sensory disturbances
  • generalized edema
  • chest tightness
  • periorbital edema
  • edema
  • male perineal pain
  • benign prostatic hyperplasia
  • male genital itching
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • hematospermia
  • pneumonia
  • keratosis
  • hair loss
  • feeling of heaviness
  • anxiety
  • decreased sexual desire
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • back pain
  • vaginal bleeding
  • myocardial infarction
  • decreased cardiac output
  • syncope
  • hearing impairment
  • soft tissue infection
  • headache
  • thirst
  • drowsiness

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 recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Bright pink round film-coated tablet

Package unit

100 tablets (10 tablets/PTP x 10), 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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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.