Medication info
Solitaire Tablet 10mg (Solifenacin Succinate)

Solitaire Tablet 10mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Myeongmun Pharmaceutical Co., Ltd.
Appearance
Light pink, round film-coated tablet
Packaging
100 tablets (10 tablets/PTPX10)
Approval status
Active

MFDS item code 201603491 · Approved 2016.06.15 · Insurance code 649807260

Summary

Main use
Treatment of overactive bladder symptoms (e.g., urinary frequency and 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 to a maximum of 10mg once daily. This drug 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). 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 receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Myeongmun Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (e.g., urinary frequency and urgency)

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

This medication is used to treat symptoms of overactive bladder such as urgency incontinence, frequent urination, and urinary 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 to a maximum of 10mg once daily. This drug 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). 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 receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This medication is used to treat various symptoms related to the bladder. However, it should not be used in patients with urinary retention who have difficulty emptying the bladder, serious gastrointestinal problems, myasthenia gravis with muscle weakness, or angle-closure glaucoma with high eye pressure. Additionally, it should not be administered to patients with allergies to this medication or its ingredients, those undergoing dialysis, or those with severe liver or kidney dysfunction. Patients with genetic disorders that hinder lactose breakdown should also avoid this medication. Patients with issues concerning urinary voiding or those at risk for gastrointestinal blockage or reduced gastrointestinal motility, moderate liver or kidney dysfunction, or who are taking strong medications like certain antifungals should exercise caution. Moreover, patients with esophageal disorders or autonomic nervous system issues should use this medication with care. This medication may cause dry mouth, constipation, blurred vision, difficulty urinating, or dry eyes. Dry mouth and constipation tend to occur more frequently with higher doses. In rare cases, serious gastrointestinal side effects such as intestinal obstruction or fecal impaction have been reported. This medication can cause serious side effects such as cardiac arrhythmias, angioedema, or severe allergic reactions, necessitating immediate discontinuation and treatment upon their occurrence. Before taking this medication, urinary problems from other causes or urinary tract infections should be ruled out, and safety for patients with neurogenic bladder is not yet confirmed. The maximum effect of this medication may take about four weeks to manifest. Additionally, side effects such as drowsiness, blurred vision, or fatigue may necessitate caution when driving or operating machinery. Caution must be exercised when taking this medication with other anticholinergic drugs, as their effects might be enhanced or side effects increased. Furthermore, it may reduce the efficacy of drugs that promote gastrointestinal motility. Since this medication is metabolized by specific enzymes in the liver, taking it with medications that strongly inhibit these enzymes may lead to increased drug concentration and a heightened risk of side effects. In such cases, the dosage should be lowered, and patients with severe liver or kidney dysfunction should not take such medications with this one. The safety of this drug during pregnancy has not been established, so pregnant women should exercise caution, while breastfeeding women should avoid it as it may be excreted in breast milk and could harm the baby. Safety and efficacy in children have not been confirmed, so it is advisable not to use it in that demographic. In case of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, requiring appropriate treatment along with gastric lavage or antidotes. Severe side effects may require professional medical intervention. Finally, this medication is reported to pose no genotoxicity or tumorigenicity risk and has no direct effect on reproductive ability or fetal development.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colon obstruction
  • intestinal obstruction
  • vasomotor 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
  • bladder post-void residual
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • urticaria
  • 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
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • facial edema
  • frequent urination
  • voiding difficulties
  • urgency
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • bloating
  • acute renal failure
  • enuresis
  • decreased urine volume
  • sensory disturbance
  • gait difficulties
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male perineal itching
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • hematuria
  • pneumonia
  • keratosis
  • hair loss
  • feeling of heaviness
  • anxiety
  • decreased sexual desire
  • back pain
  • vaginal bleeding
  • myocardial infarction
  • decreased cardiac output
  • syncope
  • hearing impairment
  • soft tissue infection
  • headache
  • thirst
  • drowsiness
  • pupil dilation

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 or moisture penetration. Maintaining a storage temperature between 1 and 30 degrees Celsius at room temperature is essential for preserving the drug's efficacy and safety.

Appearance and packaging

Appearance

Light pink, round film-coated tablet

Package unit

100 tablets (10 tablets/PTPX10)

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.