Medication info

UnaCare Tablet 5mg (Solifenacin Succinate)

Prescription medicationTabletOralExpired
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Mirae Biopharmaceuticals Co., Ltd.
Appearance
Bright yellow round film-coated tablet
Packaging
100 tablets/box [(10 tablets/PTPX10)]
Approval status
Expired

MFDS item code 201406094 · Approved 2014.12.29

This product's status changed to Expired on 2024.12.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of symptoms of overactive bladder (frequency, urinary urgency, etc.)
Who takes it
Adults
Adult dose
The usual adult dose (including elderly patients) is 5mg once daily as the recommended dose. If necessary, the dose may be increased to a maximum of 10mg once daily. This medicine may be taken with or without food and should be swallowed 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 a strong cytochrome P450 3A4 (CYP3A4) inhibitor: For patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Mirae Biopharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of symptoms of overactive bladder (frequency, urinary urgency, etc.)

  • Urge incontinence
  • urinary frequency
  • urinary urgency
View approved original text

This medication is used to effectively treat symptoms of overactive bladder such as urge incontinence, urinary frequency, and urinary urgency.

How to take

Adult dose

The usual adult dose (including elderly patients) is 5mg once daily as the recommended dose. If necessary, the dose may be increased to a maximum of 10mg once daily. This medicine may be taken with or without food and should be swallowed 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 a strong cytochrome P450 3A4 (CYP3A4) inhibitor: For patients receiving ketoconazole or another strong 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 diseases, myasthenia gravis, or angle-closure glaucoma. Additionally, patients undergoing dialysis, those with severe liver or kidney disease, and anyone allergic to this medication or its ingredients should not receive it. Patients at risk for urinary retention or with obstructive gastrointestinal diseases or decreased gastrointestinal motility should use this medication with caution. Patients with severe kidney or liver impairment should take care not to exceed the maximum daily dose, and dosage adjustments may be necessary when used in conjunction with certain potent medications. When using this medication, side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may frequently occur, so if symptoms are severe, consult a physician. Severe allergic reactions such as angioedema or anaphylaxis may occur, so if these symptoms appear, discontinue use immediately and seek appropriate treatment. Caution is needed when driving or operating machinery due to the risk of drowsiness or blurred vision. Using this medication with other anticholinergic drugs may enhance effects or exacerbate side effects, so caution is advised when combining these medications. Since this drug is metabolized in the liver, dosage adjustments may be necessary in patients with reduced liver function or when taken with certain medications. Pregnant or nursing women should consult a physician before using this medication, and it is especially advisable to avoid it during breastfeeding. Safety and efficacy in pediatric patients have not been established, so it should not be administered to children. In cases of overdose, central nervous system symptoms, blurred vision, dry mouth, and dizziness may occur, and emergency treatment should be obtained immediately. Patients with heart disease or QT prolongation syndrome should consult a physician before use.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
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  • dyspepsia
  • epigastric pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower leg edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow
  • post-void residual
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucination
  • 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 test
  • decreased appetite
  • hyperkalemia
  • voice disorder
  • anaphylaxis
  • glaucoma
  • muscle weakness
  • frequent urination
  • facial edema
  • urination disorders
  • urgency
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • bloating
  • acute renal failure
  • nocturia
  • decreased urine output
  • urinary stones
  • incontinence
  • sensory disturbances
  • walking difficulties
  • limb tremors
  • chest tension
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male perineal pruritus
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • hematochezia
  • pneumonia
  • keratosis
  • hair loss
  • sinking sensation
  • anxiety
  • decreased libido
  • ovarian carcinoma
  • bile duct cancer
  • cervical cancer
  • back pain
  • vaginal bleeding
  • myocardial infarction
  • decreased cardiac output
  • syncope
  • hearing impairment
  • soft tissue inflammation
  • headache
  • thirst
  • drowsiness

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

Storage

This medication may be sensitive to air or humidity, so it must be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to preserve the medication's effectiveness and safety for a long time.

Appearance and packaging

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets/box [(10 tablets/PTPX10)]

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.