Medication info
Soli-Pair Tablet 5 mg (Solenfenacin Succinate)

Soli-Pair Tablet 5 mg (Solenfenacin Succinate)

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

MFDS item code 201502574 · Approved 2015.04.29 · Insurance code 658603250

Summary

Main use
Treatment of overactive bladder symptoms (urge urinary incontinence, frequency, etc.)
Who takes it
Adults
Adult dose
The usual recommended dose for adults (including elderly patients) 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 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 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
IYON Pharm Co., Ltd.

Efficacy & effects

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

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

This medication is used to effectively improve symptoms of overactive bladder such as urgency incontinence, frequent urination, and urinary urgency. These symptoms indicate that the bladder contracts frequently, resulting in an urgent need to urinate, which can cause discomfort in the patient's daily life. This medication alleviates symptoms by inhibiting excessive contractions of the bladder muscles, improving the ability to hold urine and enhancing the quality of daily life. Therefore, it helps in the stable management of overactive bladder symptoms, thereby improving the patient's quality of life.

How to take

Adult dose

The usual recommended dose for adults (including elderly patients) 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 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 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 or serious gastrointestinal problems such as toxic megacolon. Additionally, patients with severe myasthenia gravis or angle-closure glaucoma should not take this medication. It should also be avoided in patients with hypersensitivity to this drug or those undergoing hemodialysis, and in patients with severe liver or kidney dysfunction. Patients with certain genetic metabolic disorders should also avoid this medication. Those at risk of urinary retention or with gastrointestinal obstruction should use this medication cautiously, especially patients with poor kidney or liver function who may require dosage adjustments. Common side effects include dry mouth, constipation, blurred vision, urinary retention, and dry eyes, and if symptoms are severe, consultation with a doctor is advised. Rarely, serious allergic reactions such as angioedema or anaphylaxis may occur, so immediate treatment is required if abnormal symptoms appear. Caution is needed when driving or operating machinery due to potential drowsiness or blurred vision. Taking this medication with other anticholinergic drugs may enhance effects or exacerbate side effects, so it should be reported to a doctor before use. If taking drugs that inhibit the enzymes that metabolize this medication in the liver, the dosage should be reduced, and patients with severe kidney or liver disorders should not combine them with these medications. Pregnant women need to be cautious as the safety of this medication is not established, and breastfeeding mothers are advised to avoid this medication. Safety and efficacy in children have not been confirmed, so it should not be used in this population. In cases of overdose, appropriate emergency treatment such as administering activated charcoal is necessary instead of inducing vomiting, and professional treatment is required for severe symptoms.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • vascular neurosis
  • nausea
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  • dyspepsia
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower leg edema
  • fatigue
  • cough
  • hypertension
  • difficulty urinating
  • decreased urinary flow
  • bladder distention
  • cystitis
  • nasopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • 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 impairment
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • frequent urination
  • facial edema
  • urinary difficulty
  • urgency in urination
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • bloating
  • acute renal failure
  • nocturia
  • decreased urine output
  • urinary calculi
  • incontinence
  • sensory disturbances
  • gait difficulties
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male perineal itching
  • reduced erection
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • hematuria
  • pneumonia
  • keratosis
  • hair loss
  • sinking sensation
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • myocardial infarction
  • decreased cardiac output
  • syncope
  • hearing impairment
  • soft tissue infection
  • headache
  • thirst
  • drowsiness

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should be maintained between 1 degree and 30 degrees Celsius to preserve the drug's efficacy and safety for a longer duration.

Appearance and packaging

Appearance

Bright yellow, round film-coated tablets

Package unit

100 tablets (10 tablets/PTP × 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.