Tobias Extended Release Tablet 4 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. 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. 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 moderate or strong CYP3A4 inhibitor, 4→8 mg; with a moderate inhibitor, 4 mg; with a strong inhibitor, avoid concomitant use Moderate renal impairment: No concomitant moderate or strong CYP3A4 inhibitor, 4→8 mg; with a moderate inhibitor, 4 mg; with a strong inhibitor, contraindicated Severe renal impairment: No concomitant moderate or strong CYP3A4 inhibitor, 4 mg; with a moderate inhibitor, avoid concomitant use; with a strong inhibitor, contraindicated Mild hepatic impairment: No concomitant moderate or strong CYP3A4 inhibitor, 4→8 mg; with a moderate inhibitor, 4 mg; with a strong inhibitor, avoid concomitant use Moderate hepatic impairment: No concomitant moderate or strong CYP3A4 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 serious allergic reactions such as angioedema, so if symptoms appear, discontinue use immediately and visit a hospital. Patients allergic to the ingredients in this medication or to peanuts, soybeans, or similar substances should not take it. Patients with urinary obstruction, gastrointestinal stasis, uncontrollable glaucoma, severe myasthenia gravis, or severe liver or kidney impairment should also avoid this medication. Additionally, patients with certain genetic disorders such as severe ulcerative colitis, toxic megacolon, or lactose intolerance should not take this medication. Patients at risk of urinary retention or with gastrointestinal obstruction, gastroesophageal reflux, or autonomic neuropathy should consult a doctor before taking this medication and should administer it with caution. Patients with reduced liver or kidney function should be careful as adverse reactions may increase when taken with certain drugs. This medication may cause a variety of side effects such as dry mouth, dry eyes, indigestion, constipation, headache, dizziness, and insomnia, particularly with a risk of urinary retention that should be monitored. Pregnant or breastfeeding women are advised not to take this medication, and it should not be administered to adolescents or children under 18 years of age. In case of overdose, serious side effects may occur, and immediate medical attention should be sought. Caution is advised as dizziness or drowsiness may occur when driving or operating machinery. Interactions may occur if taken with other antimuscarinic medications, certain antibiotics, antifungals, etc., so it is important to inform the doctor about any other medicines being taken. Store in a tightly closed container to prevent air or moisture from entering, and keep in a cool place below 25 degrees Celsius for optimal effect retention.

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

Store this medication in a tightly closed container to prevent air or moisture from entering, and it's best kept in a cool place below 25 degrees Celsius. This way, the effectiveness of the medication can be maintained for a longer period.

Appearance

Light blue, bilaterally convex elliptical film-coated tablet

Package unit

28 tablets (7 tablets/blister x 4)