Medication info
Syscare 10 mg (Solifenacin Succinate)

Syscare 10 mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
KS Pharm Co., Ltd.
Appearance
Light pink round film-coated tablet
Packaging
10 tablets/box [100 tablets (10 tablets/PTPX10)]
Approval status
Active

MFDS item code 202000291 · Approved 2020.01.20 · Insurance code 059000560

Summary

Main use
Treatment of overactive bladder symptoms (including frequent urination and urinary urgency)
Who takes it
Adults
Adult dose
For adults (including elderly patients), the recommended dose 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. Dose adjustment is required for the following patients. 1. Patients with renal impairment: No dose 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 dose 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 strong cytochrome P450 3A4 (CYP3A4) inhibitors: For patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
KS Pharm Co., Ltd.

Efficacy & effects

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

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

This medication is used for the treatment of symptoms of overactive bladder, such as urinary urgency incontinence, frequency, and urgency.

How to take

Adult dose

For adults (including elderly patients), the recommended dose 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. Dose adjustment is required for the following patients. 1. Patients with renal impairment: No dose 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 dose 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 strong cytochrome P450 3A4 (CYP3A4) inhibitors: For patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This medication should not be used in certain patients. For example, patients with urinary retention who have difficulty urinating or severe gastrointestinal diseases should not take this medication. Additionally, patients with severe myasthenia gravis, glaucoma, or allergies to this medication or its ingredients may also be at risk if they take it. Patients undergoing hemodialysis or with severely impaired liver and kidney function should avoid this medication. Caution is required when administering this medication to some patients. Dose adjustment may be needed for patients at risk of bladder outlet obstruction or with gastrointestinal obstruction, and those with moderate to severe impairment of kidney or liver function. Furthermore, caution is necessary when taken with certain medications, and patients with autonomic nervous system issues should be careful. Side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur while taking this medication. In particular, dry mouth and constipation are reported frequently, and the incidence of these side effects increases with higher doses. Serious gastrointestinal issues, angioedema, or allergic reactions can occur infrequently, so consult a doctor immediately if unusual symptoms appear. This medication may cause drowsiness or blurred vision when driving or operating machinery, so caution is necessary. Patients with cardiac issues such as QT prolongation syndrome or hyperkalemia should be especially careful due to the risk of cardiac arrhythmias. Taking this medication with other anticholinergic drugs may enhance its effects or exacerbate side effects, and can decrease the effectiveness of medications that promote gastrointestinal motility. As this medication is metabolized in the liver, dose adjustments may be needed when taken with drugs that inhibit certain hepatic metabolic enzymes. Safety during pregnancy has not been established, so it should be used cautiously if pregnant, and nursing mothers are advised to avoid use as it may be excreted in breast milk and affect the baby. Its safety and efficacy in children have not been proven, so it should not be used in pediatric patients. In the case of overdose, immediate medical attention is required; induce vomiting should be avoided, and appropriate measures such as administration of activated charcoal should be taken. Overdose may result in central nervous system symptoms, heart problems, and urinary elimination issues, necessitating prompt action.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
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  • dyspepsia
  • abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urine flow
  • post-void residual
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • 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 electrocardiogram
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech disturbance
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • increased serum creatinine
  • perforating duodenal ulcer
  • urinary incontinence
  • acute renal failure
  • bladder neck obstruction
  • worsened renal function
  • pneumonia
  • elevated prostate-specific antigen
  • ovarian carcinoma
  • biliary tract cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • frequent urination
  • facial edema
  • urinary disorder
  • urgency
  • neurogenic bladder
  • skin paresthesia
  • diarrhea
  • bloating
  • nocturnal enuresis
  • decreased urine output
  • urinary stones
  • urinary incontinence
  • sensory disturbances
  • difficulty walking
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male perineal pain
  • reduced erection
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen
  • keratosis
  • hair loss
  • sinking sensation
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • thirst
  • erectile dysfunction
  • headache
  • dry mouth
  • 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. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature to ensure the safety of the medication's efficacy.

Appearance and packaging

Appearance

Light pink round film-coated tablet

Package unit

10 tablets/box [100 tablets (10 tablets/PTPX10)]

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.