Medication info
Solifenacin Tablets 5mg (Solifenacin Succinate)

Solifenacin Tablets 5mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›5mg / 1 tablet
Manufacturer / importer
Alvogen Korea Co., Ltd.
Appearance
Light pink round film-coated tablet
Packaging
100 tablets (10 tablets/PTP packaging x 10)
Approval status
Active

MFDS item code 201603455 · Approved 2016.06.14 · Insurance code 652606250

Summary

Main use
Treatment of overactive bladder symptoms (such as frequent urination and urinary urgency)
Who takes it
Adults
Adult dose
The usual recommended dose for adults (including the elderly) 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 receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or other potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Alvogen Korea Co., Ltd.

Efficacy & effects

Treatment of overactive bladder symptoms (such as frequent urination and urinary urgency)

  • Urinary urgency incontinence
  • frequent urination
  • urge incontinence
  • symptoms of overactive bladder
View approved original text

This medication is used to improve symptoms of overactive bladder such as urinary urgency incontinence, frequent urination, and urge incontinence. It aids those suffering from discomfort due to overactive bladder and improves quality of life by facilitating control over the urge to urinate. It alleviates these symptoms to reduce discomfort in daily life. This drug is effective for treating symptoms of overactive bladder.

How to take

Adult dose

The usual recommended dose for adults (including the elderly) 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 receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors For patients receiving ketoconazole or other potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This drug should not be used in patients with certain conditions. For example, it should not be administered to those with urinary retention, severe gastrointestinal disorders, myasthenia gravis, glaucoma, or those who are allergic to this medication or its ingredients. Patients on dialysis or with severe liver or kidney dysfunction should also avoid using this drug. This medication contains lactose, so patients with lactose intolerance or related genetic disorders need to take caution. Patients with urinary obstruction, gastrointestinal obstruction, or gastrointestinal motility disorders, as well as those with severe renal or liver dysfunction should be administered this drug with caution, and the dosage may need to be restricted. Caution is also necessary when taken with certain other medications. While using this medication, side effects such as dry mouth, constipation, blurred vision, urinary retention, and dry eyes may occur, so if symptoms are severe, consult with a doctor. Rarely, severe allergic reactions such as angioedema or anaphylaxis may occur, so if these symptoms arise, discontinue use immediately and seek treatment. Caution should be exercised in situations requiring driving or operation of machinery as drowsiness or blurred vision may occur. This drug may enhance effects or increase side effects when used with other anticholinergic drugs, so consultation with a specialist is necessary in such cases. Women who are pregnant or breastfeeding should avoid using this drug as its safety has not been established. Safety in pediatric patients has not been confirmed, so it should not be used in children. In the case of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may appear, and appropriate emergency care is necessary. Finally, this medication is known not to influence tumor development or reproductive function even with long-term use, but it should always be taken as directed by healthcare providers.

Side effects

  • dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • vascular neurogenic edema
  • nausea
Show 87 more
  • indigestion
  • upper abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • difficulty urinating
  • decreased urinary flow
  • post-void residual
  • cystitis
  • rhinitis
  • vomiting
  • gastroesophageal reflux disease
  • bowel obstruction
  • peripheral edema
  • headache
  • hallucination
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • hives
  • angioedema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT prolongation on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech impairment
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • facial edema
  • frequent urination
  • urinary dysfunction
  • urgency
  • neurogenic bladder
  • skin tingling
  • diarrhea
  • bloating
  • acute renal failure
  • nocturia
  • decreased urine output
  • urinary stone
  • incontinence
  • sensory disturbance
  • difficulty walking
  • limb tremors
  • chest tightness
  • chest pain
  • periorbital edema
  • edema
  • benign prostatic hyperplasia
  • male perineal pain
  • decreased libido
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen
  • pneumonia
  • keratosis
  • hair loss
  • sensation of sinking
  • 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 can degrade due to air or moisture, so it must be stored in a tightly closed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature to ensure the drug's efficacy.

Appearance and packaging

Appearance

Light pink round film-coated tablet

Package unit

100 tablets (10 tablets/PTP packaging 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.