Medication info
Soul-Q 5 mg tablets (Solifenacin Succinate)

Soul-Q 5 mg tablets (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
DaeHwa Pharmaceutical Co., Ltd.
Appearance
Bright yellow round film-coated tablets
Packaging
100 tablets/box [10 tablets/PTP X 10]
Approval status
Active

MFDS item code 201702201 · Approved 2017.04.28 · Insurance code 645604840

Summary

Main use
Treatment of overactive bladder symptoms (e.g., frequent urination, urinary urgency)
Who takes it
Adults
Adult dose
For adults (including the elderly), the recommended dose 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. 1. Patients with renal impairment No dose adjustment is necessary in 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 dose adjustment is necessary in 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 taking potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients taking ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
DaeHwa Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (e.g., frequent urination, urinary urgency)

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

This medication is used to treat symptoms of overactive bladder such as urge incontinence, frequent urination, and urinary urgency. It helps reduce the occurrence of sudden and uncontrollable urges felt by patients, improving their daily life. Additionally, it aids in regulating the frequency of urination to normal levels, stabilizing bladder function, which may enhance the quality of life for patients. It is effectively used for the relief of overactive bladder symptoms.

How to take

Adult dose

For adults (including the elderly), the recommended dose 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. 1. Patients with renal impairment No dose adjustment is necessary in 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 dose adjustment is necessary in 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 taking potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients taking 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 certain diseases or conditions. For example, patients with urinary retention or severe gastrointestinal issues, myasthenia gravis, closed-angle glaucoma, those having hypersensitivity to this medication, patients undergoing dialysis, and those with severe liver or kidney disorders may be at risk if they take this medication. Moreover, caution should be exercised in patients with a narrow bladder outlet leading to urinary retention, those with gastrointestinal obstruction or risk of reduced gastrointestinal motility, severe kidney impairment, moderate liver impairment, and patients taking certain strong medications. Common side effects of this medication may include dry mouth, constipation, blurred vision, urinary retention, dry eyes, etc. The incidence of side effects may increase with high dosages, so be careful. Rarely, serious allergic reactions such as angioedema and anaphylaxis have been reported, necessitating immediate discontinuation of the drug and consultation with healthcare professionals. Special attention is needed in patients with cardiac arrhythmias or specific electrolyte imbalances as heart rhythm disorders may occur. Additionally, there is a risk of accidents due to drowsiness or blurry vision when driving or operating machinery, so caution is advised. Potential interactions with other anticholinergic drugs may increase the effectiveness or worsen side effects, while the effect of drugs promoting gastrointestinal motility may be reduced. This medication is metabolized by certain enzymes in the liver (CYP3A4), so taking it with drugs that strongly inhibit this enzyme may increase drug concentration and the risk of side effects. Women who are pregnant or breastfeeding should use this medication with caution, particularly during breastfeeding, as it may be passed into breast milk and affect the infant. The safety and efficacy in children have not been established, and this medication should not be administered to children. In case of overdose, symptoms may include headache, dizziness, drowsiness, and blurred vision, and in severe cases, professional treatment may be required. In the event of an overdose, immediate consultation with a healthcare institution for appropriate treatment is necessary.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • vascular neurogenic edema
  • nausea
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  • indigestion
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower extremity edema
  • fatigue
  • cough
  • hypertension
  • difficulty urinating
  • decreased urinary flow
  • post-voiding residual
  • cystitis
  • rhinosinusitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal occlusion
  • peripheral edema
  • headache
  • hallucination
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • hives
  • angioedema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT prolongation on electrocardiogram
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • vocal cord dysfunction
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • facial edema
  • frequent urination
  • urination disorders
  • urgency
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • bloating
  • acute kidney failure
  • nocturia
  • decreased urine output
  • sensory disturbances
  • generalized edema
  • chest tightness
  • periorbital edema
  • edema
  • male perineal pain
  • benign prostatic hyperplasia
  • male genital itching
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen
  • pneumonia
  • keratosis
  • hair loss
  • sinking feeling
  • anxiety
  • decreased sexual desire
  • ovarian cancer
  • bile duct cancer
  • uterine cancer
  • 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 may be sensitive to air or moisture, thus it should be stored in a tightly closed container. Additionally, avoid places that are too hot or too cold, and it is advisable to store it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Bright yellow round film-coated tablets

Package unit

100 tablets/box [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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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.