Medication info
Solipro 5 mg (Solfenacin Succinate)

Solipro 5 mg (Solfenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›5mg / 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 201504859 · Approved 2015.07.15 · Insurance code 671805970

Summary

Main use
Treatment of symptoms of overactive bladder (e.g., urge urinary incontinence, frequent urination)
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 required 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 required 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 potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients taking 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 symptoms of overactive bladder (e.g., urge urinary incontinence, frequent urination)

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

Used to treat symptoms of overactive bladder such as urgent urinary incontinence, frequent urination, and urinary urgency.

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 required 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 required 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 potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients taking 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 individuals with urinary retention symptoms. Additionally, it should not be administered to patients with severe gastrointestinal problems, myasthenia gravis, or certain glaucoma patients. Individuals with hypersensitivity to this medication or who are undergoing hemodialysis, as well as those with severe liver or kidney dysfunction, should also avoid using this medication. This medication contains lactose, so those with lactose intolerance or related genetic disorders should not take it. Caution should be exercised when administering this medication to individuals with a risk of urinary blockage or gastrointestinal obstructive diseases. Patients with moderate to severe impairment of kidney and liver function should also be carefully dosed with restrictions. Particularly, caution is required when taken with certain medications due to potential interactions. Taking this medication may cause side effects such as dry mouth, constipation, and blurred vision. Higher doses may increase the frequency of these symptoms, making dosage adjustment important. In severe cases, gastrointestinal issues such as bowel obstruction may arise, so immediate consultation with healthcare professionals is necessary if unusual symptoms occur. This medication can cause serious allergic reactions such as irregular heartbeat, vascular angioedema, and anaphylaxis, requiring immediate cessation of use and medical treatment if such symptoms occur. Caution is also needed when driving or operating machinery due to risks of drowsiness or blurred vision. Taking this medication along with other anticholinergic drugs can enhance its effects or worsen side effects. Moreover, it may reduce the effectiveness of medications that increase gastrointestinal motility, so consultation with professionals is advised. The safety of this medication has not been established for pregnant women, so caution is needed during usage, and breastfeeding women are advised to avoid it due to potential effects on infants. Safety and efficacy have not been confirmed for children, so it should not be used in this population. Overdose may cause symptoms such as headache, dizziness, drowsiness, and blurred vision; in severe cases, proper medical treatment at healthcare facilities may be necessary. This medication is reported to have no genetic toxicity or tumorigenic risk, and no special effects on reproductive ability or fetal development have been observed.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • nausea
  • indigestion
  • upper abdominal pain
  • vomiting
  • urinary tract infection
Show 92 more
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • angioedema
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • vascular edema
  • anaphylactic reaction
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucination
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • urticaria
  • angioedema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • prolongation of QT interval on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech disorders
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • dysuria
  • decreased urinary flow
  • post-void residual
  • cystitis
  • nasopharyngitis
  • increased serum creatinine
  • perforating duodenal ulcer
  • urinary retention
  • acute renal failure
  • bladder neck obstruction
  • worsening of renal function impairment
  • pneumonia
  • increased prostate-specific antigen
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • frequent urination
  • urinary dysfunction
  • 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 heaviness
  • male genital itching
  • reduced erection
  • abnormal orgasm
  • retrograde ejaculation
  • hematospermia
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • erectile dysfunction
  • thirst
  • 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 as it is sensitive to air and moisture. It is recommended to keep the storage temperature between 1°C and 30°C.

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

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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.