Medication info
Solysine Tablet 10mg (Solfenacin Succinate)

Solysine Tablet 10mg (Solfenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Withus Pharmaceutical Co., Ltd.
Appearance
Bright pink round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201403051 · Approved 2014.07.10 · Insurance code 660702710

Summary

Main use
Treatment of symptoms of overactive bladder (urgency urinary incontinence, urinary frequency, etc.)
Who takes it
Adults
Adult dose
The usual recommended dose for adults (including older adults) 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 taking strong cytochrome P450 3A4 (CYP3A4) inhibitors: Limit the maximum daily dose to 5mg in patients taking ketoconazole or other strong CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole).

Ingredients

Manufacturer
Withus Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Urinary urgency
  • frequent urination
  • urge incontinence
View approved original text

Used to treat typical symptoms of overactive bladder, including urinary urgency, frequent urination, and urge incontinence.

How to take

Adult dose

The usual recommended dose for adults (including older adults) 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 taking strong cytochrome P450 3A4 (CYP3A4) inhibitors: Limit the maximum daily dose to 5mg in patients taking ketoconazole or other strong CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole).

Precautions

This medication is used to improve bladder function, and should not be used in patients with urinary retention or severe gastrointestinal problems. Furthermore, it should not be administered to patients with myasthenia gravis, angle-closure glaucoma, those allergic to this drug or its components, patients undergoing dialysis, or those with severe liver or kidney dysfunction. Patients with certain metabolic disorders such as congenital lactose deficiency or galactose intolerance should also avoid using this drug. In patients at risk of urinary retention, gastrointestinal obstruction, or those with severe kidney disorders or moderate liver dysfunction, dosage should be limited and administered with caution. Caution is also necessary when used with strong CYP3A4 inhibitors, and in patients taking medications that may exacerbate gastroesophageal reflux or esophagitis, as well as in those with autonomic neuropathy. Common side effects of this medication include dry mouth, constipation, blurred vision, urinary retention, and dry eyes. Notably, the incidence of dry mouth and constipation increases with higher doses. Rarely, serious side effects such as angioedema, headache, dizziness, drowsiness, hallucinations, skin rashes, abnormal heart rhythms, and liver function abnormalities have been reported. Patients with heart conditions or those with prolonged QT syndrome, hyperkalemia are at risk of developing cardiac rhythm abnormalities when taking this drug, thus caution is advised. If symptoms of angioedema or anaphylaxis occur, discontinue the medication immediately and seek appropriate treatment. This medication may require caution when driving or operating machinery due to the potential for rare symptoms such as blurred vision, drowsiness, and fatigue. When used in conjunction with other anticholinergic drugs, the effects may be enhanced or side effects may worsen, thus caution is advised. This drug is metabolized by CYP3A4; therefore, careful consideration of dosage adjustments or the need for co-administration with drugs that inhibit or induce this enzyme is essential. The safety of this drug during pregnancy has not been established, therefore pregnant women should use caution. Breastfeeding women should avoid using this medication as it may be excreted in breast milk and potentially harm the infant. The safety and efficacy for pediatric patients have not been established, thus it should not be administered to children. In cases of overdose, central nervous system symptoms, blurred vision, dizziness may occur, and appropriate emergency measures such as gastric lavage or activated charcoal may be needed. Before taking this medication, patients should consult with healthcare providers about their health status and any other drugs they are taking, and report any adverse reactions immediately.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • bowel obstruction
  • vascular neurogenic edema
  • nausea
Show 64 more
  • indigestion
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow
  • post-vaccination bladder fullness
  • cystitis
  • nasopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • bowel 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 disturbance
  • anaphylaxis
  • glaucoma
  • muscle weakness
  • frequent urination
  • urination disorders
  • urgency
  • neurogenic bladder
  • skin paresthesia
  • generalized edema
  • male perineal pain
  • 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 should be stored in a tightly sealed container to prevent air and moisture infiltration. It is recommended to store it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug’s effectiveness.

Appearance and packaging

Appearance

Bright pink round film-coated tablets

Package unit

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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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.