Medication info
Solshin 5 mg (Solipecan Sodium Succinate)

Solshin 5 mg (Solipecan Sodium Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Aju Pharmaceuticals Co., Ltd.
Appearance
Bright yellow round film-coated tablet
Packaging
100 tablets (10 tablets/PTP*10)
Approval status
Active

MFDS item code 201405464 · Approved 2014.11.24 · Insurance code 654004580

Summary

Main use
Treatment of symptoms of overactive bladder (urgency urinary incontinence, frequent urination, 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 potent cytochrome P450 3A4 (CYP3A4) inhibitors: Limit the maximum daily dose to 5mg in patients taking ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole).

Ingredients

Manufacturer
Aju Pharmaceuticals Co., Ltd.

Efficacy & effects

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

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

This medication is used for the treatment of symptoms of overactive bladder such as urgent urinary incontinence, frequent urination, and 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 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 potent cytochrome P450 3A4 (CYP3A4) inhibitors: Limit the maximum daily dose to 5mg in patients taking ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole).

Precautions

This medication is used to manage the overactive response of the bladder. It should not be used in patients with symptoms of urinary retention, severe gastrointestinal disorders, myasthenia gravis, glaucoma, or known allergies to the medication. Patients undergoing hemodialysis or those with severe liver or kidney dysfunction should also avoid this medication. It should be used with caution in individuals with urinary outlet obstruction, reduced gastrointestinal motility, moderate liver or kidney dysfunction, or those taking certain other medications. Side effects may include dry mouth, constipation, blurred vision, urinary retention, dry eyes, lower limb edema, fatigue, cough, hypertension, nausea, dyspepsia, abdominal pain, vomiting, influenza, pharyngitis, dizziness, depression, difficulty urinating, decreased urinary flow rate, bladder grip, urinary tract infection, cystitis, nasopharyngitis, vomiting, gastroesophageal reflux disease, intestinal obstruction, peripheral edema, headache, hallucinations, drowsiness, delirium, renal dysfunction, itching, rash, angioedema, erythema multiforme, exfoliative dermatitis, and heart symptoms. Serious side effects such as gastrointestinal obstruction have been rarely reported, especially at high doses. If severe allergic reactions such as angioedema or anaphylaxis occur, the medication should be discontinued immediately and medical attention sought. This medication can occasionally cause drowsiness, fatigue, or blurred vision, so caution is advised when driving or operating machinery. Additionally, this medication is metabolized in the liver by a specific enzyme (CYP3A4); concomitant use with drugs that strongly inhibit this enzyme may increase drug concentration and the risk of side effects. Pregnant or nursing women should consult a doctor before taking this medication, and it should not be used in children as safety and effectiveness have not been established. In cases of overdose, symptoms may include headache, dizziness, drowsiness, and blurred vision, and gastric lavage or detoxification treatment may be needed. Before taking this medication, inform your doctor of any other diseases or medications you are taking, and ensure regular check-ups for safe use.

Side effects

  • dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • vascular allergic edema
  • nausea
Show 96 more
  • dyspepsia
  • epigastric pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • peripheral edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow
  • bladder fullness
  • 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 ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech disturbance
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • increased serum creatinine
  • perforated duodenal ulcer
  • urinary incontinence
  • acute renal failure
  • bladder neck obstruction
  • worsening renal function
  • pneumonia
  • increased prostate-specific antigen
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • frequent urination
  • urination disorders
  • urgent urination
  • neurogenic bladder
  • paresthesia
  • generalized edema
  • male perineal pain
  • insomnia
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • syncope
  • hearing impairment
  • keratosis
  • hair loss
  • feeling of heaviness
  • facial edema
  • blood clots
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male genital itching
  • decreased erection
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • diarrhea
  • bloating
  • nocturia
  • decreased urinary volume
  • urinary stones
  • urinary incontinence
  • sensory disturbances
  • difficulty walking
  • limb tremors

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets (10 tablets/PTP*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.