Tobias Extended-Release Tablets 8 mg (Fesoterodine Fumarate)

Adult dose

The usual recommended dose for adults (including elderly patients) is 4 mg once daily. Depending on the patient's condition, the dose may be increased to 8 mg once daily. The maximum daily dose is 8 mg. This medicine may be taken with or without food. Swallow whole with water; do not chew. Because the therapeutic effect appears within 2 to 8 weeks, it is recommended that the patient's response be reassessed after 8 weeks of treatment. Dose adjustment is required for the following patients. 1. Patients taking moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors: For patients taking ketoconazole or another strong CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole), limit the maximum daily dose to 4 mg. For patients taking a moderate CYP3A4 inhibitor, increase the dose cautiously to 8 mg once daily only after assessing the patient's response and tolerability. 2. Patients with renal or hepatic impairment: For patients with renal or hepatic impairment, administer the recommended daily dose shown below, regardless of concomitant use of moderate or strong CYP3A4 inhibitors. If an increase to 8 mg once daily is needed, increase the dose cautiously after assessing the patient's response and tolerability. Mild renal impairment: No concomitant inhibitor, 4→8 mg; with a moderate inhibitor, 4 mg; with a strong inhibitor, avoid concomitant use Moderate renal impairment: No concomitant inhibitor, 4→8 mg; with a moderate inhibitor, 4 mg; with a strong inhibitor, contraindicated Severe renal impairment: No concomitant inhibitor, 4 mg; with a moderate inhibitor, avoid concomitant use; with a strong inhibitor, contraindicated Mild hepatic impairment: No concomitant inhibitor, 4→8 mg; with a moderate inhibitor, 4 mg; with a strong inhibitor, avoid concomitant use Moderate hepatic impairment: No concomitant inhibitor, 4 mg; with a moderate inhibitor, avoid concomitant use; with a strong inhibitor, contraindicated (1) Creatinine clearance (CLcr): mild, ≥50 ~ <80 mL/min; moderate, ≥30 ~ <50 mL/min; severe, <30 mL/min.

This medication may cause a serious allergic reaction known as angioedema; if symptoms such as swelling of the face, neck, or lips occur after taking this medication, you must stop taking it immediately and seek treatment at a hospital. Those who are allergic to any ingredients in this medication or to peanuts, soybeans, etc., those with urinary retention, obstructed gastrointestinal tract, uncontrolled glaucoma, severe myasthenia gravis, or severe liver or kidney impairment should not take this medication. Furthermore, patients with severe ulcerative colitis, toxic megacolon, or genetic lactose intolerance should not use this medication. Patients at risk of urinary obstruction or with gastrointestinal obstruction diseases, gastroesophageal reflux, autonomic neuropathy, or controlled glaucoma should take this medication with caution, and care should be taken when combined with certain drugs as side effects may be heightened in those with impaired liver or kidney function. During use, dry mouth, dry eyes, dyspepsia, constipation, and rarely, urinary retention may occur, particularly among elderly males, who are at higher risk for urinary retention. Pregnant women should avoid this medication as it may pose risks to the fetus, and breastfeeding mothers are also advised to avoid using this medication. Children and adolescents under 18 years old should not use this medication as its safety and efficacy have not been established for this age group. In case of overdose, severe side effects may occur, and you must go to a hospital immediately for appropriate treatment, which may include cardiac monitoring and treatment according to symptoms. This medication may cause dizziness or drowsiness while driving or operating machinery, so caution is advised, and side effects may be aggravated when used together with other antimuscarinic medications or certain drugs, so consultation with a physician is required. Finally, keep this medication out of reach of children, and avoid transferring it to another container as it may lead to accidents or deterioration in quality.

• Angioedema
• dry mouth
• dry eyes
• dyspepsia
• constipation
• urinary retention
• tachycardia
• palpitations
• insomnia
• confusion

Store this medication in a tightly closed container to protect it from air or moisture, and keep it in a cool place below 25 degrees Celsius. This is to maintain the medication's effectiveness and prevent degradation.

Appearance

Blue, oval-shaped, double convex, film-coated tablets

Package unit

28 tablets (7 tablets/blister x 4)