Medication info

Caresil 5mg (Solifenacin Succinate)

Prescription medicationTabletOralExpired
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Hawon Pharmaceutical Co., Ltd.
Appearance
Bright yellow round film-coated tablet
Packaging
100 tablets (10 tablets/PTP×10)
Approval status
Expired

MFDS item code 201502465 · Approved 2015.04.27

This product's status changed to Expired on 2025.04.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder symptoms (urge urinary incontinence, frequent urination, etc.)
Who takes it
Adults
Adult dose
The usual 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 drug may be taken regardless of meals and should be swallowed whole with water. Dosage adjustment is required 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). In 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 in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do not exceed 5mg once daily. 3. Patients taking strong cytochrome P450 3A4 (CYP3A4) inhibitors In patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Hawon Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Urgent urinary incontinence
  • frequent urination
  • urgency
View approved original text

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

How to take

Adult dose

The usual 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 drug may be taken regardless of meals and should be swallowed whole with water. Dosage adjustment is required 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). In 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 in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do not exceed 5mg once daily. 3. Patients taking strong cytochrome P450 3A4 (CYP3A4) inhibitors In patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This medication is used to relieve the symptoms of overactive bladder by controlling bladder muscles. It should not be used in patients with urinary retention symptoms where urine cannot be discharged well. Patients with severe gastrointestinal problems, myasthenia gravis, or angle-closure glaucoma should also not take this medication. Patients with allergies to this medication or those undergoing dialysis, as well as those with severe liver or kidney dysfunction, should use caution. Patients who are at risk for urinary retention or have gastrointestinal obstruction or decreased gastrointestinal motility should be prescribed this medication with care. Patients with moderate to severe liver or kidney dysfunction should have their maximum dosage of this medication limited. Particularly when taken in conjunction with strong CYP3A4 inhibitors, dosage adjustments may be necessary, and it should be avoided in patients with certain metabolic disorders. Side effects such as dry mouth, constipation, blurred vision, urinary retention, dry eyes, etc., may occur with this medication. In severe cases, symptoms like bowel obstruction, angioedema, or anaphylactic reactions may occur, and if any unusual symptoms appear, medical consultation should be sought immediately. This medication may cause drowsiness or fatigue, so caution is needed when driving or operating machinery. Taking it with other anticholinergic medications may enhance effects or increase side effects, so care should be taken when combining therapies. Additionally, it may reduce the effectiveness of drugs that promote gastrointestinal motility. Since this medication is primarily metabolized in the liver, patients with liver dysfunction or those taking CYP3A4 inhibitors may experience increased drug concentrations, necessitating dosage adjustments. The safety during pregnancy has not been established, so special precautions are needed; nursing women are advised to avoid using this medication. The safety and effectiveness in pediatric patients have also not been adequately established, so its use is not recommended. In cases of overdose, central nervous system symptoms, blurred vision, dizziness, etc., may occur, and appropriate treatment should be sought immediately. Patients with a history of heart disease or those at risk for QT prolongation should take caution as there is a risk of cardiac side effects in the event of an overdose.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • nausea
  • indigestion
  • abdominal pain
  • vomiting
  • urinary tract infection
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  • influenza
  • pharyngitis
  • dizziness
  • depression
  • leg edema
  • fatigue
  • cough
  • hypertension
  • angioedema
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • vascular edema
  • anaphylaxis reaction
  • vomiting
  • gastroesophageal reflux disease
  • bowel 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 ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech disorders
  • glaucoma
  • muscle weakness
  • dysuria
  • decreased urinary flow
  • bladder outlet obstruction
  • cystitis
  • rhinitis
  • increased blood creatinine
  • perforated duodenal ulcer
  • urinary retention
  • acute renal failure
  • bladder neck obstruction
  • worsening of renal function
  • pneumonia
  • elevated prostate-specific antigen
  • ovarian cancer
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • frequent urination
  • urination disorders
  • urgent urination
  • neurogenic bladder
  • skin tingling
  • generalized edema
  • male perineal pain
  • insomnia
  • anxiety
  • facial edema
  • diarrhea
  • bloating
  • nocturia
  • decreased urine volume
  • urinary stones
  • urinary incontinence
  • sensory disturbances
  • difficulty walking
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male genital itching
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • hematuria
  • keratosis
  • hair loss
  • feeling of heaviness
  • decreased sexual desire
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • headache
  • thirst
  • drowsiness

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is best to store it at room temperature between 1 and 30 degrees Celsius. This way, the efficacy of the medication can be maintained for a long time.

Appearance and packaging

Appearance

Bright yellow 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.