Medication info

Allfenacin Tablets 5mg (Solifenacin Succinate)

Prescription medicationTabletOralApproval withdrawn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Approval withdrawn

MFDS item code 202001666 · Approved 2020.03.11

This product's status changed to Approval withdrawn on 2025.01.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of symptoms of overactive bladder (such as urge incontinence and urinary frequency)
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 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 dosage 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), administer with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is required for patients with mild hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh class B), administer 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
Dasan Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of overactive bladder (such as urge incontinence and urinary frequency)

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

This medication is used for the treatment of symptoms of overactive bladder, such as urge urinary incontinence, frequent urination, and urinary 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 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 dosage 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), administer with caution and do not exceed 5mg once daily. 2. Patients with hepatic impairment No dosage adjustment is required for patients with mild hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh class B), administer 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 diseases or conditions. For example, it should not be administered to patients who have difficulty urinating, severe gastrointestinal diseases, myasthenia gravis, glaucoma, patients allergic to this medication, patients undergoing dialysis, and patients with severe liver or kidney dysfunction. Additionally, caution should be exercised when administering this medication to patients at risk of urinary retention, with a risk of gastrointestinal obstruction or decreased gastrointestinal motility, those with severe kidney or liver dysfunction, and those taking specific medications concomitantly. While taking this medication, side effects such as dry mouth, constipation, blurred vision, urinary retention may occur, and some patients may experience severe gastrointestinal issues. In case of severe symptoms due to side effects, patients are advised to consult their healthcare provider. This medication may cause serious allergic reactions such as arrhythmias or angioedema, or anaphylaxis, and should be discontinued immediately and treated if these symptoms occur. This medication may have increased effects or aggravated side effects when taken with other anticholinergic medications, so patients should inform their healthcare provider of all medications currently being taken. Also, as this medication is metabolized in the liver, dose adjustments may be necessary for patients with impaired liver function or those taking specific medications. Women who are pregnant or breastfeeding should use caution with this medication, as its safety has not been established, and especially during breastfeeding, it is recommended to avoid use. The safety and efficacy of this medication have not been confirmed in children, hence it should not be used in this population. In case of an overdose, patients should visit a medical facility immediately for appropriate treatment, and it is advised to administer activated charcoal and treat symptoms rather than inducing vomiting. During treatment with this medication, patients should be careful while driving or operating machinery, as drowsiness or blurred vision may occur.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colon obstruction
  • intestinal obstruction
  • vascular neurogenic edema
  • nausea
Show 88 more
  • dyspepsia
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urinary flow
  • bladder distension
  • cystitis
  • nasopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucination
  • drowsiness
  • delirium
  • kidney impairment
  • itching
  • rash
  • hives
  • 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
  • facial edema
  • polyuria
  • urination disorder
  • urgency
  • neurogenic bladder
  • skin prickling
  • diarrhea
  • abdominal bloating
  • acute kidney failure
  • nocturia
  • reduced urine output
  • urinary calculi
  • urinary incontinence
  • sensory disturbances
  • difficulty walking
  • limb tremors
  • chest tension
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male perineal pain
  • male genital itching
  • reduced erection
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • hematuria
  • pneumonia
  • keratosis
  • hair loss
  • sinking feeling
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • myocardial infarction
  • decreased cardiac output
  • syncope
  • hearing impairment
  • soft tissue infection
  • headache
  • thirst
  • drowsiness

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

Storage

This medication should be stored in a sealed container to prevent exposure to air, and the storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature. This will help maintain the medication's efficacy and safety for a longer duration.

Appearance and packaging

Appearance

Bright yellow round film-coated tablets

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

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.