Medication info

Beshina Tablet 5 mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Korea Prime Pharmaceutical Co., Ltd.
Appearance
Bright yellow round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201604103 · Approved 2016.06.30 · Insurance code 663607040

Summary

Main use
Treatment of overactive bladder symptoms (e.g., urinary frequency and urgency)
Who takes it
Adults
Adult dose
For adults (including elderly patients), the recommended dose is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This drug may be taken regardless of meals 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 for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). For patients with severe renal impairment (creatinine clearance≤30ml/min), use with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is required for patients with mild hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh class B), use with caution 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
Korea Prime Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Urgency incontinence
  • frequency
  • urgency
View approved original text

This medication is used to alleviate symptoms of overactive bladder, including urge incontinence, frequency, and urgency. These symptoms can include a sudden urge to urinate that is difficult to resist, causing significant inconvenience in daily life. This medication improves symptoms by controlling bladder muscle tension and reduces frequent urination and urgency, thereby enhancing the quality of life. Hence, it is effectively used for symptoms of overactive bladder.

How to take

Adult dose

For adults (including elderly patients), the recommended dose is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This drug may be taken regardless of meals 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 for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). For patients with severe renal impairment (creatinine clearance≤30ml/min), use with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dose adjustment is required for patients with mild hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh class B), use with caution 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 certain conditions. For example, it should not be administered to patients with urinary retention symptoms, severe gastrointestinal conditions, myasthenia gravis, or narrow-angle glaucoma. Additionally, it should be avoided by individuals who have allergic reactions to this medication, patients undergoing dialysis, and those with severe liver or kidney dysfunction. There are also patients for whom careful administration is required. Patients at risk of urinary blockage or decreased gastrointestinal motility, as well as those with severe renal and liver impairment, may need dose adjustments. Care should also be taken when used in combination with certain medications, and patients with autonomic nervous system problems should be cautious. When taking this medication, be aware that side effects such as dry mouth, constipation, blurred vision, dry eyes, nausea, indigestion, abdominal pain, vomiting, urinary tract infections, influenza, pharyngitis, dizziness, depression, lower limb edema, fatigue, cough, hypertension, difficulty urinating, decreased urinary flow, post-void residual volume, cystitis, rhinitis, vomiting, gastroesophageal reflux disease, peripheral edema, headaches, hallucinations, drowsiness, delirium, renal impairment, itching, rash, erythema multiforme, exfoliative dermatitis, atrial fibrillation, palpitations, and tachycardia may occur. Severe allergic reactions, including hives, severe swelling, angioedema, chest tightness, difficulty breathing, anaphylaxis, vascular edema, severe rash, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice of the skin or eyes, severe lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, and drastically reduced urine output are also noted. This medication can affect driving or operating machinery, so caution is advised during use. When used in conjunction with other anticholinergic medications, the effects may be enhanced or side effects may be worsened, so be sure to inform the healthcare provider. The drug is metabolized in the liver, so in patients with reduced liver function or when used with certain strong hepatic enzyme inhibitors, the dosage should be reduced. Pregnant or nursing women should consult a physician before using this medication, and particularly during breastfeeding, it is advisable to avoid use. It is not recommended for children, as safety and effectiveness have not been established. In case of overdose, immediate medical attention should be sought, and appropriate treatment should be administered according to the symptoms. Before taking this medication, inform the healthcare provider of any existing conditions or medications being taken, and seek expert assistance if any abnormal reactions or uncomfortable symptoms occur.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
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  • dyspepsia
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • urination difficulties
  • decreased urinary flow
  • post-void dribbling
  • cystitis
  • rhinopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • bowel 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 electrocardiogram
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech disturbance
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • increased serum creatinine
  • perforated duodenal ulcer
  • urinary retention
  • acute renal failure
  • bladder neck obstruction
  • worsening renal function
  • pneumonia
  • elevated prostate-specific antigen
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • myocardial infarction
  • decreased cardiac output
  • soft tissue infection
  • frequent urination
  • urination disorders
  • urgency
  • neurogenic bladder
  • skin paresthesia
  • generalized edema
  • male perineal pain
  • insomnia
  • anxiety
  • erectile dysfunction
  • hematoma
  • keratosis
  • hair loss
  • feeling of sinking
  • syncope
  • hearing impairment
  • nocturia
  • decreased urine volume
  • urinary stones
  • urinary incontinence
  • sensory disturbances
  • gait difficulties
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male genital itching
  • abnormal orgasm
  • retrograde ejaculation
  • decreased appetite
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • thirst
  • dizziness
  • drowsiness
  • blurred vision

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 exposure to air and moisture. It is best to keep the medication at room temperature between 1 to 30 degrees Celsius, avoiding extreme temperatures.

Appearance and packaging

Appearance

Bright yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle

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.