Medication info
Medifenacin Tablet 10mg (Solifenacin Succinate)

Medifenacin Tablet 10mg (Solifenacin Succinate)

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

MFDS item code 201501328 · Approved 2015.03.13 · Insurance code 669804660

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
Kujoo 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 improve symptoms of overactive bladder such as urgency urinary incontinence, frequent urination, and urgency.

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, severe gastrointestinal disorders, myasthenia gravis, or narrow-angle glaucoma. Additionally, it should not be administered to those with a hypersensitivity to this drug or its ingredients, patients undergoing hemodialysis, patients with severe liver dysfunction, or moderate liver dysfunction patients taking strong CYP3A4 inhibitors. This drug should be used cautiously in patients at risk of urinary retention or with gastrointestinal obstructive disease or reduced gastrointestinal motility. Patients with severe renal impairment or moderate liver impairment should have a maximum daily dose limited, and caution is warranted in those taking strong CYP3A4 inhibitors concurrently. This medication may cause side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes; therefore, if any abnormal symptoms occur, consult a healthcare professional. In particular, if serious allergic reactions such as angioedema or anaphylaxis occur, immediately discontinue use and seek appropriate treatment. Caution should be taken due to the risk of accidents resulting from drowsiness or blurred vision while driving or operating machinery. This medication may enhance effects or worsen side effects when used with other anticholinergic drugs, so inform healthcare providers about any medications being taken. Safety during pregnancy or lactation has not been established, so consultation with a physician is necessary before use. It is advisable not to use in children as safety and efficacy have not been confirmed. In case of overdose, seek appropriate treatment immediately at a hospital, and special treatment may be required if severe symptoms occur. Patients with heart disease or at risk of QT prolongation should exercise special caution when using this medication.

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
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • angioedema
  • fecal impaction
  • colon obstruction
  • intestinal obstruction
  • vascular edema
  • anaphylactic reaction
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • hives
  • angioedema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT prolongation on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • dysphonia
  • glaucoma
  • muscular weakness
  • dysuria
  • decreased urinary flow
  • bladder prolapse
  • cystitis
  • nasopharyngitis
  • urinary retention
  • increased serum creatinine
  • perforated duodenal ulcer
  • urinary incontinence
  • acute renal failure
  • bladder neck obstruction
  • exacerbation of renal dysfunction
  • pneumonia
  • increased prostate-specific antigen
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • frequency of urination
  • urination disorders
  • urgency in urination
  • neurogenic bladder
  • skin tingling
  • general edema
  • male perineal pain
  • insomnia
  • anxiety
  • facial swelling
  • diarrhea
  • abdominal bloating
  • nocturia
  • decreased urine volume
  • sensory abnormalities
  • gait difficulties
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male genital itching
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • hematocele
  • keratosis
  • hair loss
  • sinking feeling
  • decreased sexual desire
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • thirst
  • erectile dysfunction
  • headache
  • xerostomia
  • drowsiness

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Bright pink 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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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.