Medication info
Solitaire Tablet 10 mg (Solefenacin Succinate)

Solitaire Tablet 10 mg (Solefenacin Succinate)

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

MFDS item code 201604148 · Approved 2016.07.04 · Insurance code 644003750

Summary

Main use
Treatment of overactive bladder symptoms (urinary frequency, urinary urgency, etc.)
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 medicine may be taken with or without food and should be swallowed whole with water. Patients with renal impairment No dosage 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. Patients with hepatic impairment No dosage 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. Patients taking a strong cytochrome P450 3A4 (CYP3A4) inhibitor For patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Samik Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

Used to treat the symptoms of overactive bladder, including urgency urinary incontinence, frequent urination, 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 to a maximum of 10mg once daily. This medicine may be taken with or without food and should be swallowed whole with water. Patients with renal impairment No dosage 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. Patients with hepatic impairment No dosage 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. Patients taking a strong cytochrome P450 3A4 (CYP3A4) inhibitor For patients taking 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 symptoms of urinary retention. Patients with severe gastrointestinal disorders or myasthenia gravis should also avoid this medication. Patients with glaucoma, who have high eye pressure, or those allergic to any of the ingredients should not use it. Additionally, patients who are undergoing dialysis or have severely impaired liver or kidney function should avoid this medication. It is also unsuitable for patients with genetic issues such as lactose intolerance. This medication should be used cautiously in patients at risk of urinary obstruction, those with gastrointestinal obstruction diseases, and those at risk of slowed gastrointestinal motility. Patients with moderately impaired kidney or liver function should limit the maximum daily dose, and caution is also necessary when taking it with certain potent medications. Patients taking medications that can induce or worsen gastroesophageal reflux or esophagitis should exercise caution. Patients with autonomic nervous system disorders should also be cautious when using this medication. This medication may cause dry mouth, constipation, and blurred vision. In rare cases, serious gastrointestinal issues may arise, so any unusual symptoms should be reported immediately. The degree of adverse reactions does not significantly change even with prolonged use, and dry mouth is a common reason for discontinuation. This medication can cause drowsiness or fatigue and blurred vision, so caution is advised when driving or operating machinery. In case of severe allergic reactions like angioedema or anaphylaxis, discontinue the medication immediately and seek treatment. This medication can enhance the effects or increase side effects when used with other anticholinergic drugs, so caution is warranted. It may also reduce the effectiveness of gastrointestinal motility-promoting medications. The medication is metabolized in the liver, so using it in patients with poor liver function or with certain strong liver enzyme inhibitors may result in elevated drug levels. In such cases, the dosage should be reduced, and patients with severe liver or kidney disease should preferably avoid concurrent use. The safety of this medication during pregnancy has not been established, so caution is necessary when taking it. Breastfeeding mothers should avoid this medication as it may pass into breast milk and affect the baby. This medication has not been confirmed for safety and efficacy in pediatric patients, so it should not be administered to them. Overdose may result in symptoms such as headache, dizziness, drowsiness, and blurred vision, and severe cases may require professional treatment. In cases of overdose, gastric lavage or inducing vomiting is not performed, and treatment may involve antidotes or symptomatic care as needed. This medication is known not to increase the risks of genotoxicity or cancer development even with long-term use. It has been shown in animal studies not to affect reproductive ability or fetal development.

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
  • bladder overdistension
  • 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 impairment
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • facial edema
  • frequent urination
  • urination disorders
  • urgency
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • bloating
  • acute renal failure
  • nocturia
  • decreased urine volume
  • sensory abnormalities
  • gait difficulties
  • limb tremors
  • chest tension
  • 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
  • sensation of sinking
  • anxiety
  • decreased sexual desire
  • back pain
  • vaginal bleeding
  • myocardial infarction
  • decreased cardiac output
  • fainting
  • hearing impairment
  • soft tissue infection
  • headache
  • dry mouth
  • drowsiness

Not everyone experiences these, and they can vary from person to person.

Storage

Store this medication in a tightly sealed container, avoiding exposure to air or moisture. It is best to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and ensure safe use.

Appearance and packaging

Appearance

Light pink round film-coated tablet

Package unit

100 tablets/PTP (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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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.