Medication info
Solifenacin Tablets 10mg (Solifenacin Succinate)

Solifenacin Tablets 10mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
PharmGen Science Co., Ltd.
Appearance
Light pink round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201500233 · Approved 2015.01.16 · Insurance code 670104110

Summary

Main use
Treatment of symptoms of overactive bladder (e.g., urinary frequency and urgency)
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 in the following patients. 1. Patients with renal impairment: No dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance>30ml/min). In 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 dosage adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), use with caution and do not exceed 5mg once daily. 3. Patients receiving a strong cytochrome P450 3A4 (CYP3A4) inhibitor: In patients receiving ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 5mg.

Ingredients

Manufacturer
PharmGen Science Co., Ltd.

Efficacy & effects

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

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

This medication is used to improve symptoms of overactive bladder such as urgency 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 in the following patients. 1. Patients with renal impairment: No dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance>30ml/min). In 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 dosage adjustment is necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment (Child-Pugh class B), use with caution and do not exceed 5mg once daily. 3. Patients receiving a strong cytochrome P450 3A4 (CYP3A4) inhibitor: In 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 certain diseases or conditions. For example, it should not be administered to patients with urinary retention symptoms where urination is difficult, severe gastrointestinal issues, myasthenia gravis, glaucoma, or a known allergy to this medication or its components. Patients undergoing hemodialysis or with severe liver or kidney dysfunction also need to be cautious. Special care is needed for patients with moderate to severe liver or kidney function impairment who are taking certain medications together. This medication should also be used with caution in patients at risk of blocked bladder outlet where urination is difficult, patients with gastrointestinal obstruction, or patients with decreased gastrointestinal motility. Patients with liver and kidney impairment should have their dosage limited, and caution is needed when taken with certain medications. The most commonly reported side effects during the use of this medication include dry mouth and constipation. Blurred vision or dry eyes may occur, and in rare cases, severe gastrointestinal problems may also arise. If these symptoms occur, immediate consultation with a healthcare professional is necessary. Additionally, this medication may rarely cause angioedema or allergic reactions (anaphylaxis), so if such symptoms occur, it should be discontinued immediately and treatment should be sought. Caution is advised when driving or operating machinery, as drowsiness, blurred vision, or fatigue may occur. When used with other anticholinergic medications, the effects may be enhanced or side effects increased. Conversely, the effects of medications that promote gastrointestinal motility may be reduced. Since this medication is metabolized in the liver, taking it with substances that inhibit certain liver metabolic enzymes may increase its concentration and the risk of side effects. In such cases, the dosage should be reduced, and patients with severe liver or kidney dysfunction should avoid using such medications together. The safety of this medication during pregnancy has not been established, so caution is advised, and breastfeeding women should avoid its use due to potential transmission through breast milk. The safety and efficacy in children have not been confirmed, so it should not be administered to children. If this medication is overdosed, contact medical personnel immediately and receive appropriate treatment based on symptoms. Symptoms of overdose may include headache, dizziness, drowsiness, and blurred vision. This medication is known to not increase the risk of tumor formation or affect reproductive function, even with long-term use, but if unusual symptoms occur during use, consult a healthcare professional.

Side effects

Dry mouth, constipation, blurred vision, urinary retention, dry eyes, fecal impaction, colonic obstruction, intestinal obstruction, vascular angioedema, nausea, dyspepsia, upper abdominal pain, vomiting, urinary tract infection, influenza, pharyngitis, dizziness, depression, lower limb edema, fatigue, cough, hypertension, dysuria, decreased urinary flow, post-void residual, 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, prolonged QT interval on electrocardiogram, abnormal liver function tests, decreased appetite, hyperkalemia, speech disturbance, anaphylactic reaction, glaucoma, muscle weakness, increased serum creatinine, perforating duodenal ulcer, urinary incontinence, acute renal failure, bladder neck obstruction, worsening renal function, pneumonia, prostate-specific antigen increase, ovarian carcinoma, bile duct cancer, uterine cancer, myocardial infarction, decreased cardiac output, soft tissue infection, frequency of urination, urinary disorders, urgency, neurogenic bladder, skin paresthesia, generalized edema, male perineal pain, insomnia, anxiety, decreased libido, back pain, vaginal bleeding, syncope, hearing impairment, keratosis, hair loss, sensation of sinking, facial edema, erectile dysfunction, abnormal orgasm, retrograde ejaculation, blood in semen, chest tightness, chest pain, periorbital edema, edema, benign prostatic hyperplasia, male genital itching, 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 protect from air and moisture, and it is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Light pink 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.