Medication info

Solica 10mg (Solifenacin succinate)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Hanwha Pharmaceutical Co., Ltd.
Appearance
Light pink round film-coated tablet
Packaging
100 tablets (10 tablets/PTP x 10)
Approval status
Approval withdrawn

MFDS item code 201603893 · Approved 2016.06.24

This product's status changed to Approval withdrawn on 2025.12.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of overactive bladder symptoms (e.g., urge urinary incontinence and urinary frequency)
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 necessary in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In 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 necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do not exceed 5mg once daily. 3. Patients receiving a strong cytochrome P450 3A4 (CYP3A4) inhibitor For patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
Hanwha Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Urgent urinary incontinence
  • frequency
  • urinary urgency
View approved original text

Used to treat symptoms such as urgent urinary incontinence, frequency, and urinary urgency caused by 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 necessary in patients with mild or moderate renal impairment (creatinine clearance>30ml/min). In 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 necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), administer with caution and do not exceed 5mg once daily. 3. Patients receiving a strong cytochrome P450 3A4 (CYP3A4) inhibitor For patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Precautions

This medication should not be used in patients with urinary retention or severe gastrointestinal diseases. It should also not be administered to patients with myasthenia gravis or angle-closure glaucoma, and those allergic to this drug or its components should avoid it. The use of this medication is prohibited in patients undergoing hemodialysis or those with severe liver or kidney dysfunction. Caution should be exercised when using this drug in patients with bladder outlet obstruction or reduced gastrointestinal motility. Patients with severe renal or hepatic impairment should have their dose reduced, and caution is advised when taking with strong CYP3A4 inhibitors such as certain antifungals. Common side effects of this medication may include dry mouth, constipation, blurred vision, urinary retention, dry eyes, peripheral edema, fatigue, cough, hypertension, nausea, dyspepsia, abdominal pain, vomiting, urinary tract infection, influenza, pharyngitis, dizziness, depression, urination difficulties, decreased urinary flow, post-void residual, cystitis, rhinitis, vomiting, gastroesophageal reflux disease, headache, hallucinations, drowsiness, delirium, renal impairment, itching, rash, angioedema, erythema multiforme, exfoliative dermatitis, atrial fibrillation, tachycardia. Serious adverse reactions such as anaphylaxis, angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with fever, blistering, skin peeling, mucosal pain, severe skin reactions, respiratory difficulties, asthma attacks, respiratory problems with cough and fever, jaundice (yellowing of skin or eyes), severe lethargy, liver problems (jaundice), sudden reactions should be closely monitored. Patients with QT prolongation syndrome or hyperkalemia should be cautious due to the risk of cardiac arrhythmias. If angioedema or anaphylactic reactions occur, administration should be stopped immediately, and appropriate treatment should be sought. This medication may enhance the effects or side effects when taken in combination with other anticholinergic drugs, so caution is needed when used together. Additionally, it may reduce the effectiveness of medications that promote gastrointestinal motility, so consultation with a healthcare provider is recommended. Safety has not been established for pregnant women; caution is required, and breastfeeding mothers should avoid using this product as it may be excreted in breast milk. Safety and efficacy in children have not been confirmed, so it should not be administered to pediatric patients. In case of overdose, inducing vomiting should be avoided, and appropriate emergency treatment such as administering activated charcoal is necessary. Specialized treatment may be required depending on the severity of symptoms. Caution is required when driving or operating machinery, as drowsiness or blurred vision may occur.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
Show 87 more
  • indigestion
  • abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • lower limb edema
  • fatigue
  • cough
  • hypertension
  • dysuria
  • decreased urine flow
  • post-voiding urinary residual
  • cystitis
  • nasopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal occlusion
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • renal impairment
  • itching
  • rash
  • urticaria
  • angioedema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT interval prolongation on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech disturbances
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • facial edema
  • increased urinary frequency
  • urinary disorders
  • urgency
  • neurogenic bladder
  • skin paresthesia
  • diarrhea
  • abdominal bloating
  • acute renal failure
  • enuresis
  • decreased urine volume
  • sensory disturbances
  • generalized edema
  • chest tightness
  • periorbital edema
  • edema
  • male perineal pain
  • benign prostatic hyperplasia
  • male genital itching
  • decreased erection
  • erectile dysfunction
  • abnormal orgasm
  • retrograde ejaculation
  • blood in semen
  • pneumonia
  • keratosis
  • hair loss
  • sinking sensation
  • anxiety
  • decreased libido
  • ovarian carcinoma
  • bile duct cancer
  • uterine cancer
  • 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 tightly closed container to prevent air or moisture ingress. Additionally, it is recommended to store the drug at a cool and temperate room temperature between 1 to 30 degrees Celsius.

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.