Medication info
Medifenacin Tablet 5mg (Solifenacin Succinate)

Medifenacin Tablet 5mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
KooJoo Pharmaceutical Co., Ltd.
Appearance
Bright yellow round film-coated tablets
Packaging
100 tablets (10 tablets/Blister*10)
Approval status
Active

MFDS item code 201501327 · Approved 2015.03.13 · Insurance code 669804670

Summary

Main use
Treatment of overactive bladder symptoms (e.g., urge urinary incontinence and urinary frequency)
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 drug may be taken with or without food and should be swallowed whole with water. Dosage adjustment is required in the following patients. 1. Patients with renal impairment No dosage 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 dosage 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 receiving potent cytochrome P450 3A4(CYP3A4) inhibitors In patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
KooJoo Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (e.g., urge urinary incontinence and urinary frequency)

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

This medication is used to treat the main symptoms of overactive bladder including urgency urinary incontinence, frequent urination, and urgency. Patients can receive relief from sudden urges to urinate and frequent urination. This improves these symptoms and reduces discomfort in daily life. It is effective in managing the symptoms of overactive bladder and is used to enhance the quality of life of patients.

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 drug may be taken with or without food and should be swallowed whole with water. Dosage adjustment is required in the following patients. 1. Patients with renal impairment No dosage 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 dosage 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 receiving potent cytochrome P450 3A4(CYP3A4) inhibitors In patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This medication should not be used in patients with urinary retention symptoms or severe gastrointestinal disorders. Patients with myasthenia gravis, angle-closure glaucoma, or those with hypersensitivity to this medication should also refrain from taking it. Avoid administration to patients receiving dialysis or with severe liver or kidney dysfunction. Patients with inherited galactose intolerance and other related issues should not take this medication. Patients at high risk for urinary retention, or with gastrointestinal obstructive diseases or decreased gastrointestinal motility, should use this medication cautiously. Patients with severe renal impairment or moderate hepatic impairment should limit the maximum daily dose. Dosage adjustment may be required when used in combination with strong CYP3A4 inhibitors. Patients with gastroesophageal reflux or autonomic neuropathy should also use this medication with caution. Common side effects of this medication may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Particularly at the 10mg dosage, the incidence of side effects is higher, so caution is necessary. Severe adverse reactions such as bowel obstruction or angioedema may occur, so if symptoms occur, immediate consultation with a doctor is necessary. This medication may increase the risk of cardiac arrhythmias in patients with QT prolongation syndrome or hyperkalemia, so caution is warranted. If symptoms of angioedema or anaphylaxis occur, administration should be stopped immediately and treatment sought. Care should also be taken when driving or operating machinery due to risks associated with drowsiness or blurred vision. Using this medication with other anticholinergic medications may enhance effects or worsen side effects. It may reduce the effect of medications that increase gastrointestinal motility, so it is necessary to consult a doctor when using in combination. When taken with strong CYP3A4 inhibitors, the blood concentration of this medication can significantly increase, dictating dosage adjustment. There is insufficient safety established during pregnancy, so caution is necessary when used, and during lactation, this medication may pass into breast milk and harm the newborn, thus it should be avoided. Safety and effectiveness in pediatric patients have not been established, so this medication should not be administered to children. In case of overdose, symptoms may include headache, dizziness, drowsiness, and blurred vision, and appropriate emergency measures should be taken if necessary. This medication has not shown genotoxicity, and there have been reports of no increased risk of tumor development or effects on reproductive capacity with prolonged use.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • nausea
  • indigestion
  • upper abdominal pain
  • vomiting
  • urinary tract infection
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  • influenza
  • pharyngitis
  • dizziness
  • depression
  • leg edema
  • fatigue
  • cough
  • hypertension
  • angioneurotic edema
  • 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
  • vascular edema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT prolongation on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • voice disorder
  • anaphylaxis reaction
  • glaucoma
  • muscle weakness
  • dysuria
  • decreased urinary flow
  • post-void residual
  • cystitis
  • nasopharyngitis
  • increased serum creatinine
  • perforating duodenal ulcer
  • urinary incontinence
  • acute renal failure
  • bladder neck obstruction
  • worsening renal function
  • pneumonia
  • increased prostate-specific antigen
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • frequent urination
  • urinary disturbance
  • urgency
  • neurogenic bladder
  • skin numbness
  • generalized edema
  • male perineal pain
  • insomnia
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • keratosis
  • hair loss
  • feeling of heaviness
  • facial edema
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood-tinged fluid
  • chest tension
  • chest pain
  • periorbital edema
  • edema
  • male genital itching
  • headache
  • thirst
  • drowsiness

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained between 1 degrees Celsius and 30 degrees Celsius to safely preserve the efficacy of the medication.

Appearance and packaging

Appearance

Bright yellow round film-coated tablets

Package unit

100 tablets (10 tablets/Blister*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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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.