Medication info
Solipro Tablet 10mg (Solyfenacin Succinate)

Solipro Tablet 10mg (Solyfenacin Succinate)

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

MFDS item code 201504249 · Approved 2015.06.30 · Insurance code 671805980

Summary

Main use
Treatment of overactive bladder symptoms (e.g., urge urinary incontinence and urinary frequency)
Who takes it
Adults
Adult dose
The usual recommended dose in adults (including older adults) 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 required in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), use cautiously and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is required in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), use cautiously 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
Daewon Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used to treat symptoms of overactive bladder such as urgent urinary incontinence, frequent urination, and urinary urgency. Overactive bladder is characterized by sudden urges to urinate and increased frequency of urination, which can reduce the quality of life of patients. This medication helps to control excessive contractions of the bladder, alleviating symptoms and improving the comfort of urination, thus reducing the discomfort experienced in daily life.

How to take

Adult dose

The usual recommended dose in adults (including older adults) 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 required in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In patients with severe renal impairment (creatinine clearance≤30ml/min), use cautiously and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is required in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), use cautiously 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 should not be used in patients with symptoms of urinary retention or significant gastrointestinal disorders such as toxic megacolon. Patients with myasthenia gravis or angle-closure glaucoma should also not take this medication. Patients who are allergic to any ingredients in this product, patients undergoing hemodialysis, those with severe liver impairment, and those with severe kidney impairment who are taking strong CYP3A4 inhibitors should also avoid this medication. Additionally, patients with lactose intolerance or genetic lactose degradation disorders should steer clear of this medication. It should be used with caution in patients with the risk of urinary retention or bladder outlet obstruction, gastrointestinal obstructive diseases, or decreased gastrointestinal motility. Patients with severe kidney impairment, moderate liver impairment, or those taking strong CYP3A4 inhibitors should restrict dosages or use the medication with caution. Patients currently taking medications that may induce or exacerbate gastroesophageal reflux disease or esophagitis should also be cautious. Patients with autonomic neuropathy should be cautious when using this medication. Taking this medication may result in side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes. In particular, dry mouth and constipation occur frequently, and higher doses may increase the frequency of side effects. In severe cases, serious adverse reactions such as gastrointestinal obstruction or angioedema may occur, so if symptoms are severe, consult a doctor immediately. This medication carries a risk of cardiac side effects associated with QT interval prolongation, so patients with heart disease or electrolyte abnormalities should be particularly cautious. Serious allergic reactions such as angioedema or anaphylaxis may occur, so if these symptoms arise, stop taking the medication immediately and seek treatment. When driving or operating machinery, symptoms such as blurred vision, drowsiness, or fatigue may occur, so caution is warranted. When taken with other anticholinergic medications, this medication may enhance effects or increase side effects, therefore, consult a professional before concurrent use. Additionally, it may reduce the effectiveness of medications that promote gastrointestinal motility. This medication is metabolized by CYP3A4 enzyme; therefore, taking it with strong CYP3A4 inhibitors may increase its blood concentration. In this case, dosage adjustments may be necessary, and patients with severe kidney or liver impairment should avoid concurrent use with strong CYP3A4 inhibitors. The safety of this medication during pregnancy has not been established, so it should be used cautiously after consulting a doctor if necessary. Nursing mothers are advised to avoid using this medication as it may be excreted in breast milk and affect the infant. The safety and efficacy in pediatric patients have not been established, so it should not be used in children. In the case of overdose, symptoms may include headache, thirst, dizziness, drowsiness, and blurred vision, and severe cases may require professional treatment. If an overdose is suspected, seek appropriate medical care immediately.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
Show 84 more
  • dyspepsia
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower extremity edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow
  • post-void residual
  • cystitis
  • nasopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • urticaria
  • vascular edema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT prolongation on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech disorder
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • urinary incontinence
  • acute renal failure
  • bladder neck obstruction
  • worsening of renal function
  • pneumonia
  • elevated prostate-specific antigen
  • ovarian cancer
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • increased serum creatinine
  • frequent urination
  • facial edema
  • urination disorders
  • urgency
  • neurogenic bladder
  • skin tingling
  • generalized edema
  • male perineal pain
  • insomnia
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • keratosis
  • hair loss
  • feeling of sedation
  • male genital itching
  • decreased erection
  • abnormal orgasm
  • retrograde ejaculation
  • blood-stained fluid
  • chest stiffness
  • chest pain
  • periorbital edema
  • edema

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to maintain the storage temperature between 1 and 30 degrees Celsius. Storing the medication this way helps to safely maintain its efficacy.

Appearance and packaging

Appearance

Light pink round film-coated tablet

Package unit

100 tablets (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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.