Medication info
Solistop Tablet 10 Milligrams (Solifenacin Succinate)

Solistop Tablet 10 Milligrams (Solifenacin Succinate)

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

MFDS item code 201705756 · Approved 2017.07.19

Summary

Main use
Treatment of overactive bladder symptoms (frequency, urinary urgency, etc.)
Who takes it
Adults
Adult dose
The recommended dose for adults (including the elderly) 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 dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment: No dose adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do not exceed 5mg once daily. 3. Patients receiving a strong cytochrome P450 3A4 (CYP3A4) inhibitor : In patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Korea United Pharm (Co., Ltd.)

Efficacy & effects

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

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

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

How to take

Adult dose

The recommended dose for adults (including the elderly) 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 dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), administer with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment: No dose adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do not exceed 5mg once daily. 3. Patients receiving a strong cytochrome P450 3A4 (CYP3A4) inhibitor : In patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This medication is used for regulating bladder function and should not be administered to patients with certain diseases or conditions. For example, patients with urinary retention symptoms, severe gastrointestinal disorders, myasthenia gravis, and glaucoma with high intraocular pressure should not use this medication. Additionally, patients undergoing hemodialysis or those with severely impaired liver and kidney function, as well as patients with certain genetic metabolic disorders, should also avoid this medication. There may be patients for whom this medication requires careful usage. For example, patients at risk of bladder outlet obstruction or reduced gastrointestinal motility, those with severe kidney or liver dysfunction, and patients taking specific strong medications should take this medication under close medical supervision. Side effects such as dry mouth, constipation, and blurred vision may occur due to this medication, and these side effects are more frequent with higher doses. Rarely, angioedema, allergic reactions, and serious gastrointestinal problems have been reported; thus, if unusual symptoms occur, medical consultation should be sought immediately. Care must be taken when driving or operating machinery, as drowsiness or blurred vision may occur. Taking other anticholinergic medications may enhance the effects or worsen side effects; therefore, it is essential to consult a doctor or pharmacist before taking any medications. In particular, if taken with certain medications that inhibit the enzymes that metabolize this medication in the liver, the blood concentration of this medication may increase, raising the risk of side effects and necessitating dosage adjustments. Pregnant women must be cautious as the safety of this drug has not been established, and nursing mothers should avoid its use, as it can be transmitted through breast milk and affect the baby. This medication should not be administered to children as its safety and efficacy have not been confirmed. In case of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may appear, and it is crucial to visit a medical institution for appropriate treatment. Emergency treatments such as activated charcoal or other interventions may be necessary in case of overdose, and professional treatment may be required for severe symptoms.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • bowel obstruction
  • angioedema
  • nausea
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  • indigestion
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower extremity edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow
  • post-voiding dribbling
  • cystitis
  • rhinopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • urticaria
  • angioedema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitation
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT prolongation on electrocardiogram
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • voice disorders
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • polyuria
  • facial edema
  • urination disorders
  • urgency
  • neurogenic bladder
  • paresthesia
  • diarrhea
  • bloating
  • acute renal failure
  • enuresis
  • decreased urine output
  • urinary stones
  • urinary incontinence
  • sensory abnormalities
  • gait difficulties
  • limb tremor
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male genital itching
  • decreased erectile function
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen
  • pneumonia
  • keratosis
  • hair loss
  • feeling of sinking
  • anxiety
  • decreased libido
  • ovarian carcinoma
  • 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 should be stored in a tightly closed container to protect it from air and moisture, and it is safely stored at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Bright pink round film-coated tablet

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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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.