Medication info
Eurothera Tablet 10mg (Solifenacin Succinate)

Eurothera Tablet 10mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Medica Korea Co., Ltd.
Appearance
Bright pink, round, film-coated tablets
Packaging
100 tablets/box [10 tablets/PTP×10], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201500977 · Approved 2015.02.25 · Insurance code 646003920

Summary

Main use
Treatment of symptoms of overactive bladder (such as urinary frequency and urgency)
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 medicine may be taken with or without food. Swallow it whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment No dosage adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Use with caution in patients with severe renal impairment (creatinine clearance≤30ml/min), and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is necessary for patients with mild hepatic impairment. Use with caution in patients with moderate hepatic impairment (Child-Pugh Class B), and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4(CYP3A4) inhibitors For patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Medica Korea Co., Ltd.

Efficacy & effects

Treatment of symptoms of overactive bladder (such as urinary frequency and urgency)

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

This medication is used to treat symptoms of overactive bladder, such as urgency urinary incontinence, frequency, and urinary 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 medicine may be taken with or without food. Swallow it whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment No dosage adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Use with caution in patients with severe renal impairment (creatinine clearance≤30ml/min), and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is necessary for patients with mild hepatic impairment. Use with caution in patients with moderate hepatic impairment (Child-Pugh Class B), and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4(CYP3A4) inhibitors For 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, severe gastrointestinal disorders, severe myasthenia gravis, or angle-closure glaucoma. Additionally, it should not be administered to those with allergies to this drug or its components, patients undergoing hemodialysis, severe liver impairment, and certain patients with severe kidney impairment taking specific medications. As it contains lactose, patients with lactose intolerance or related genetic disorders should not take it. Caution is advised when used in patients at risk of urinary retention, gastrointestinal obstruction, or reduced motility, and dosage should be limited in patients with impaired kidney or liver function. Common side effects of this medication may include dry mouth, constipation, blurred vision, urinary retention, and dry eyes; particularly, adverse reactions may be more frequent at high doses. If serious allergic reactions such as angioedema or anaphylaxis occur, administration should be stopped immediately, and appropriate treatment should be provided. This medication may cause blurred vision, drowsiness, and fatigue, so caution is needed when driving or operating machinery. Furthermore, when used with other anticholinergic medications, effects may be enhanced or side effects may worsen, so care should be taken during co-administration. As this drug is metabolized by specific liver enzymes (CYP3A4), dosage adjustments may be necessary when taken with drugs that strongly inhibit or induce this enzyme. The safety for pregnant women is not certain, so pregnant individuals should use it cautiously, and breastfeeding women are advised to avoid using this medication. Safety in children has not been established, so it should not be administered to children. In case of overdose, appropriate measures such as administering activated charcoal should be taken, and if severe central nervous system symptoms, heart issues, or urinary retention occur, immediate medical attention should be sought.

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
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • anaphylactic reaction
  • vomiting
  • gastroesophageal reflux disease
  • bowel obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • kidney impairment
  • pruritus
  • 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
  • dysuria
  • decreased urinary flow
  • bladder outlet obstruction
  • cystitis
  • nasopharyngitis
  • increased serum creatinine
  • perforated duodenal ulcer
  • inability to urinate
  • acute renal failure
  • bladder neck obstruction
  • worsening of renal function
  • pneumonia
  • increased prostate-specific antigen
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • frequent urination
  • urination disorders
  • urgency
  • neurogenic bladder
  • skin paresthesia
  • generalized edema
  • male perineal pain
  • insomnia
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • keratosis
  • hair loss
  • feeling of heaviness
  • male genital pruritus
  • decreased erection
  • abnormal orgasm
  • retrograde ejaculation
  • blood-stained fluid
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • facial edema
  • headache
  • thirst
  • drowsiness
  • pupillary dilatation

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 sealed container. It is advisable to maintain an ambient temperature between 1 to 30 degrees Celsius. This will help to preserve the medication's efficacy for a longer time.

Appearance and packaging

Appearance

Bright pink, round, film-coated tablets

Package unit

100 tablets/box [10 tablets/PTP×10], 30 tablets/bottle, 100 tablets/bottle

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.