Medication info
Europhenazin Tablet 5 mg (Solifenacin Succinate)

Europhenazin Tablet 5 mg (Solifenacin Succinate)

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

MFDS item code 201502378 · Approved 2015.04.20 · Insurance code 648507380

Summary

Main use
Treatment of overactive bladder symptoms (urge incontinence, urinary frequency, etc.)
Who takes it
Adults
Adult dose
The usual recommended dose for adults (including older adults) is 5 mg once daily. If necessary, the dose may be increased to a maximum of 10 mg once daily. This medicine may be taken with or without food and should be swallowed whole with water. No dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance>30 ml/min). In patients with severe renal impairment (creatinine clearance≤30 ml/min), administer with caution and do not exceed 5 mg once daily. 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 5 mg once daily. For patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5 mg.

Ingredients

Manufacturer
Shinpoong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (urge incontinence, urinary frequency, 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 older adults) is 5 mg once daily. If necessary, the dose may be increased to a maximum of 10 mg once daily. This medicine may be taken with or without food and should be swallowed whole with water. No dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance>30 ml/min). In patients with severe renal impairment (creatinine clearance≤30 ml/min), administer with caution and do not exceed 5 mg once daily. 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 5 mg once daily. For patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5 mg.

Precautions

This medication should not be used in patients with certain conditions. For example, it should not be administered to patients with urinary retention symptoms, severe gastrointestinal problems, severe myasthenia gravis, glaucoma, allergies to the components of this drug, patients undergoing hemodialysis, and patients with severe liver or kidney dysfunction. Additionally, patients with bladder outlet issues or impaired gastrointestinal motility, severe kidney or liver dysfunction, and those taking specific strong medications should exercise caution when using this drug. In such cases, dosage should be limited or used carefully in consultation with a physician. When taking this drug, symptoms such as dry mouth, constipation, blurred vision, and urinary retention may occur. These side effects are more common at higher doses, so caution is advised. Rarely, angioedema or allergic reactions may occur, so if symptoms such as swelling of the face or neck, or difficulty breathing appear, immediately stop taking the medication and visit a hospital. This medication may require caution when driving or operating machinery, as drowsiness or dizziness may occur. Furthermore, taking this drug with other anticholinergic medications may increase efficacy or intensify side effects, so it is essential to discuss any combination with a physician or pharmacist. Women who are pregnant or breastfeeding should exercise caution when using this medication, especially during breastfeeding, as it can transfer into breast milk and affect the baby, so it is advisable to avoid use. Safety and efficacy in children have not been established, thus it should not be used in this population. In case of overdose, immediately visit a medical institution for appropriate treatment, and do not induce vomiting. Symptoms that may occur due to overdose include headache, dizziness, drowsiness, and blurred vision, so caution is advised. Finally, this medication is known not to increase the risk of cancer with long-term use, but it is important to consult a specialist if any discomfort occurs during use.

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 extremity edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow
  • bladder distension
  • cystitis
  • nasopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • pruritus
  • 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
  • increased serum creatinine
  • perforating duodenal ulcer
  • urinary retention
  • acute renal failure
  • bladder neck obstruction
  • worsening renal function
  • pneumonia
  • elevated prostate-specific antigen
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • frequent urination
  • urinary disorders
  • urgency
  • neurogenic bladder
  • paresthesia
  • generalized edema
  • male perineal pain
  • insomnia
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • keratosis
  • hair loss
  • sinking feeling
  • facial edema
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. The appropriate storage temperature is room temperature between 1 and 30 degrees Celsius, and it is advisable to avoid extremely hot or cold places.

Appearance and packaging

Appearance

Bright yellow round film-coated tablets

Package unit

100 tablets (10 tablets/PTP x 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.