Medication info
Solinasin Tablet 10 mg (Solifenacin Succinate)

Solinasin Tablet 10 mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Jeil Pharmaceutical Co., Ltd.
Appearance
Bright pink round film-coated tablet
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201702069 · Approved 2017.04.24 · Insurance code 645404960

Summary

Main use
Treatment of overactive bladder symptoms (frequency, 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 medicine may be taken with or without food and should be swallowed whole with water. The dosage regimen must be adjusted for the following patients. 1. Patients with renal impairment No dose adjustment is necessary in patients with mild or 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 taking a strong cytochrome P450 3A4(CYP3A4) inhibitor For patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Jeil Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used to treat symptoms such as urge urinary incontinence, frequency, and urgency caused by overactive bladder. These symptoms arise from excessive contraction of the bladder, and the medication helps stabilize the bladder muscles, alleviating symptoms. This can enhance the patient's quality of life and reduce discomfort from frequent trips to the bathroom. Therefore, it is effectively used to improve symptoms of overactive bladder.

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 medicine may be taken with or without food and should be swallowed whole with water. The dosage regimen must be adjusted for the following patients. 1. Patients with renal impairment No dose adjustment is necessary in patients with mild or 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 taking a strong cytochrome P450 3A4(CYP3A4) inhibitor For patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This medication should not be administered to patients with urinary retention, severe gastrointestinal disorders, myasthenia gravis, or angle-closure glaucoma. Additionally, it should be avoided in individuals who have a hypersensitivity to this medication or its components, patients undergoing hemodialysis, patients with severe liver impairment, severe renal impairment, and those taking strong CYP3A4 inhibitors. Patients at risk for urinary retention or with gastrointestinal obstruction, reduced gastrointestinal motility, severe renal impairment, or moderate liver impairment should be given this medication with caution. This medication may commonly cause side effects such as dry mouth, constipation, blurred vision, urinary retention, dry eyes, etc., with an increased incidence of side effects particularly at higher doses. Severe allergic reactions such as angioedema or anaphylaxis may occur, so if symptoms arise, administration should be immediately stopped and medical attention sought. Caution is needed when driving or operating machinery due to the possibility of drowsiness, blurred vision, and fatigue. This medication may enhance the effects or side effects of other anticholinergic drugs when used together and may reduce the effectiveness of prokinetic agents. Moreover, since this medication is metabolized by CYP3A4 enzymes, dose adjustments may be necessary when taken with strong CYP3A4 inhibitors. Women who are pregnant or breastfeeding must consult a specialist before using this medication, and safety in pediatric patients has not been established, so use is generally not recommended. In case of overdose, it is important to visit a medical facility promptly for appropriate treatment, as severe central nervous system symptoms or cardiac irregularities may occur, requiring caution. Although this medication is known not to increase the risk of tumor development with long-term use, careful evaluation of the patient's condition and thorough monitoring is necessary before administration.

Side effects

  • dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
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  • indigestion
  • epigastric pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • urinary difficulty
  • reduced urinary flow
  • post-voiding dribbling
  • cystitis
  • nasopharyngitis
  • 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
  • speech disturbance
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • headache
  • thirst
  • drowsiness
  • hallucination
  • excessive excitement
  • convulsions
  • respiratory failure
  • tachycardia
  • pupillary dilation
  • thirst
  • erectile dysfunction
  • facial edema
  • frequent urination
  • urinary disorders
  • urgency
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • abdominal fullness
  • acute renal failure
  • nocturia
  • reduced urine volume
  • sensory abnormalities
  • generalized edema
  • chest tightness
  • periorbital edema
  • edema
  • male perineal pain
  • benign prostatic hyperplasia
  • male genital itching
  • erectile dysfunction
  • insomnia
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • myocardial infarction
  • decreased cardiac output
  • syncope
  • hearing impairment
  • soft tissue infection

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture, preferably at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer duration.

Appearance and packaging

Appearance

Bright pink round film-coated tablet

Package unit

30 tablets (10 tablets/PTP X 3)

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.