Medication info

Solafesin 10 mg (Solfenacin Succinate)

Prescription medicationTabletOralExpired
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Korea Pavis Pharmaceutical Co., Ltd.
Appearance
Round film-coated tablets in light pink color
Packaging
100 tablets/box [(10 tablets/PTP*10)]
Approval status
Expired

MFDS item code 202002959 · Approved 2020.04.24

This product's status changed to Expired on 2025.04.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder symptoms (urgency urinary incontinence, frequent urination, etc.)
Who takes it
Adults
Adult dose
The usual recommended dose for adults, including older adults, is 5mg once daily. If needed, 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. The dosage must be adjusted for the following patients. 1. Patients with renal impairment No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance>30ml/min). Use with caution in patients with severe renal impairment (creatinine clearance≤30ml/min), and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is necessary in patients with mild hepatic impairment. Use with caution in patients with moderate hepatic impairment (Child-Pugh class B), and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Korea Pavis Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication effectively treats symptoms of overactive bladder, including urgency urinary incontinence, frequency, and urgency. It helps alleviate these symptoms, improving the quality of life for patients. It is used to reduce uncomfortable urination symptoms and maintain normal bladder function.

How to take

Adult dose

The usual recommended dose for adults, including older adults, is 5mg once daily. If needed, 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. The dosage must be adjusted for the following patients. 1. Patients with renal impairment No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance>30ml/min). Use with caution in patients with severe renal impairment (creatinine clearance≤30ml/min), and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is necessary in patients with mild hepatic impairment. Use with caution in patients with moderate hepatic impairment (Child-Pugh class B), and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This drug is used to alleviate bladder hyperactivity. However, it should not be administered to certain patients. For example, patients with urinary retention symptoms, severe gastrointestinal diseases, severe myasthenia gravis, closed-angle glaucoma, allergies to this drug or its components, patients undergoing dialysis, and those with severe liver or kidney impairment should not be given this medication. Additionally, patients at risk of urinary retention or those with gastrointestinal obstructive disease, and some with severe renal impairment or moderate liver impairment should use this medication with caution and may need to limit the maximum dosage. Caution is also required when used in combination with strong CYP3A4 inhibitors. Common side effects of this medication include dry mouth and constipation, and may cause blurred vision or dry eyes. Rarely, urinary retention, angioedema, allergic reactions, and heart arrhythmias may occur, so it is essential to consult a healthcare professional if any unusual symptoms arise. This medication may require caution when driving or operating machinery due to drowsiness or blurred vision. Furthermore, when used in conjunction with other anticholinergic drugs, effects may be enhanced or side effects may worsen, necessitating careful monitoring. Pregnant or nursing women are advised to avoid this medication as its safety has not been established. It is also not recommended for children due to insufficient evidence of safety and efficacy. In case of overdose, central nervous system symptoms, blurred vision, or dizziness may occur, necessitating appropriate emergency care. Special caution should be taken for patients with a history of heart disease or those at risk of QT prolongation.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • nausea
  • dyspepsia
  • upper abdominal pain
  • vomiting
  • urinary tract infection
Show 112 more
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • angioedema
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • anaphylactic reaction
  • vomiting
  • gastroesophageal reflux disease
  • intestinal blockage
  • 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
  • voice disorders
  • glaucoma
  • muscular weakness
  • dysuria
  • decreased urinary flow rate
  • bladder fullness
  • cystitis
  • rhinitis
  • peripheral edema
  • headache
  • hallucinations
  • dizziness
  • drowsiness
  • delirium
  • urinary retention
  • 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 disorders
  • anaphylactic reaction
  • facial edema
  • frequent urination
  • urination disorders
  • urgency
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • bloating
  • acute renal failure
  • nocturia
  • reduced urine output
  • sensory abnormalities
  • generalized edema
  • chest tightness
  • periorbital edema
  • edema
  • male perineal pain
  • benign prostatic hyperplasia
  • male genital itching
  • erectile dysfunction
  • insomnia
  • anxiety
  • increased serum creatinine
  • perforated duodenal ulcer
  • urinary retention
  • pneumonia
  • increased prostate-specific antigen
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • headache
  • thirst
  • drowsiness
  • blurred vision
  • hallucinations
  • excessive excitement
  • seizures
  • respiratory failure
  • tachycardia
  • mydriasis

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

Storage

This medication should be stored in a tightly sealed container to protect it from exposure to air or moisture. It is best to store it at room temperature between 1 degree and 30 degrees Celsius, avoiding excessively hot or cold conditions.

Appearance and packaging

Appearance

Round film-coated tablets in light pink color

Package unit

100 tablets/box [(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.