Medication info

Solive Tablet 5 mg (Solifenacin Succinate)

Prescription medicationTabletOralExpired
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Hanpung Pharmaceutical Co., Ltd.
Appearance
Bright yellow round film-coated tablet
Packaging
100 tablets/PTP [10 tablets/PTP packaging x 10], 30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201905901 · Approved 2019.08.21

This product's status changed to Expired on 2024.08.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder symptoms (such as frequent urination and urinary urgency)
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 up to 10mg once daily. This drug may be taken irrespective of meals and should be swallowed whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment: No dose adjustment is required for 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 required for 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: For patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Hanpung Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (such as frequent urination and urinary urgency)

  • Urgent urinary incontinence
  • increased urinary frequency
  • urgency
View approved original text

This medication is used for the treatment of symptoms of overactive bladder such as urgent urinary incontinence, increased urinary frequency, and urgency.

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 up to 10mg once daily. This drug may be taken irrespective of meals and should be swallowed whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment: No dose adjustment is required for 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 required for 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: 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 symptoms, severe gastrointestinal problems, myasthenia gravis patients, and patients with narrow-angle glaucoma. Additionally, it should not be administered to patients with known hypersensitivity to this drug or its components, patients undergoing hemodialysis, patients with severe liver dysfunction, patients with severe renal dysfunction or moderate liver dysfunction who are taking potent CYP3A4 inhibitors, and patients with certain genetic issues. This drug should be used with caution in patients at risk of urinary retention or gastrointestinal obstructive diseases, reduced gastrointestinal motility, severe renal dysfunction, or moderate liver dysfunction. Also, it should be carefully administered in patients taking strong CYP3A4 inhibitors, those with hyperdynamic personality, gastroesophageal reflux patients, and autonomic neuropathy patients. While taking this drug, side effects may include dry mouth, constipation, blurred vision, urinary retention, dry eyes, and more, with dry mouth and constipation being the most commonly reported. In severe cases, significant gastrointestinal adverse reactions may occur, and if symptoms are severe, immediate consultation with a physician is advised. This drug may cause drowsiness or blurred vision affecting driving or machinery operation, requiring caution. When taken with other anticholinergic drugs, effects or side effects may be amplified, therefore it is necessary to inform healthcare providers of any other medications being taken. Particularly, when combined with potent CYP3A4 inhibitors, the dosage should be limited, and patients with severe renal dysfunction or moderate liver dysfunction should avoid this combination. Safety during pregnancy has not been established and caution is necessary; during breastfeeding, it is advisable not to use this drug as it may be excreted in breast milk. Safety and efficacy in pediatric populations have not been established, therefore it should not be administered to children. In the case of overdose, appropriate treatment is required based on symptoms, and in severe cases, professional emergency care may be necessary. Prior to taking this drug, consult with a physician or pharmacist to ensure safe usage based on individual health status and history.

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 limb edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow rate
  • bladder pressure sensation
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucinations
  • 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
  • speech disorder
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • increased frequency of urination
  • facial edema
  • urination disorder
  • urgency
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • bloating
  • acute renal failure
  • nocturia
  • decreased urine volume
  • urinary stones
  • urinary incontinence
  • sensory disturbances
  • difficulty walking
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male perineal itching
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen
  • pneumonia
  • keratosis
  • hair loss
  • feeling of heaviness
  • anxiety
  • decreased sexual desire
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • back pain
  • vaginal bleeding
  • myocardial infarction
  • decreased cardiac output
  • syncope
  • hearing impairment
  • soft tissue infection
  • headache
  • dry mouth
  • 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 best stored at room temperature between 1°C and 30°C. Storing it this way helps maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets/PTP [10 tablets/PTP packaging x 10], 30 tablets/bottle, 100 tablets/bottle

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.