Medication info
Soul Q Tablet 10 mg (Solfenacin Succinate)

Soul Q Tablet 10 mg (Solfenacin Succinate)

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

MFDS item code 201702204 · Approved 2017.04.28 · Insurance code 645604850

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
Dae Hwa Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used for the treatment of symptoms of overactive bladder such as urgency urinary incontinence, frequent urination, and urgency.

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 administered to certain patients. For example, patients with urinary retention, severe gastrointestinal disorders, severe myasthenia gravis, patients with angle-closure glaucoma with high pressure in the eye, patients allergic to this medication or its components, patients undergoing hemodialysis, and patients with severe liver or kidney dysfunction should not take this medication. Additionally, patients at risk of urinary retention or with bladder outlet obstruction, patients with gastrointestinal obstruction symptoms, patients with impaired gastrointestinal motility, patients with severe kidney or liver dysfunction, and patients simultaneously taking certain medications should take this medication with caution and may require dosage adjustment. Possible side effects include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. The incidence of side effects may increase, particularly when taking high doses. Rarely, serious side effects such as angioedema, allergic reactions, arrhythmias, and liver dysfunction have been reported, so any unusual symptoms should be immediately discussed with a physician. Caution is needed when driving or operating machinery as drowsiness or blurred vision may occur. Taking this medication with other anticholinergic drugs may increase the effectiveness or worsen side effects, so caution should be exercised in concurrent administration. Furthermore, it may reduce the effectiveness of medications that enhance gastrointestinal motility. If taken with certain drugs that inhibit enzymes in the liver that break down this medication, the concentration of this medication in the blood may increase, necessitating dosage adjustment. Women who are pregnant should consult a physician before taking this medication since its safety has not been established, and breastfeeding is generally discouraged as this medication may be excreted in breast milk. Safety and efficacy in children have not been established, so this medication should not be administered to children. In case of overdose, immediate medical intervention should be sought, and inducing vomiting is not recommended. Symptoms of overdose may include central nervous system symptoms, arrhythmias, and respiratory distress, requiring prompt treatment.

Side effects

  • dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
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  • indigestion
  • abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower extremity edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urine flow
  • post-void dribbling
  • cystitis
  • nasopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • bowel obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • hives
  • vascular edema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • ECG QT prolongation
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • voice disorders
  • anaphylactic reaction
  • glaucoma
  • myopathy
  • facial edema
  • increased urination
  • urination disorders
  • urgency
  • neurogenic bladder
  • paresthesia
  • diarrhea
  • bloating
  • acute renal failure
  • nocturia
  • decreased urine volume
  • sensory disturbances
  • generalized edema
  • chest tightness
  • periorbital edema
  • edema
  • male perineal pain
  • benign prostatic hyperplasia
  • male genital itching
  • erectile dysfunction
  • insomnia
  • 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 may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to maintain a room temperature between 1 to 30 degrees Celsius to preserve the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Bright pink round film-coated tablet

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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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.