Sedatol SR Tablet 4 mg (Tolterodine L-Tartrate)

Adult dose

(Tablets) Adults : Administer tolterodine L-tartrate 2 mg orally twice daily. However, based on the patient's response and tolerability, the dose may be reduced from 2 mg to 1 mg per dose and administered twice daily. Patients with renal impairment, hepatic impairment, or receiving ketoconazole or another potent CYP3A4 inhibitor: The recommended dose of this drug is 1 mg twice daily. (Extended-release tablets)(Extended-release capsules) Adults : Administer tolterodine L-tartrate 4 mg orally once daily. Patients with renal impairment, hepatic impairment, or receiving ketoconazole or another potent CYP3A4 inhibitor: Administer 2 mg of this drug once daily. If adverse reactions occur, the dose may be reduced from 4 mg to 2 mg once daily. This drug may be taken with or without food. Swallow the dosage form whole; do not crush or split it.

This medication should not be used in patients with specific symptoms. For example, patients with urinary retention symptoms or gastric retention symptoms, patients with uncontrolled glaucoma, patients who have allergic reactions to this medication or its ingredients, patients with severe muscle weakness such as myasthenia gravis, patients with severe ulcerative colitis or toxic megacolon should not take this medication. Additionally, this medication contains lactose and should not be administered to patients with genetic issues such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. When using this medication, caution should be exercised in patients with bladder outlet obstruction at risk of urinary retention, patients with controlled glaucoma, patients with gastrointestinal obstruction diseases, patients with poor renal or hepatic function, patients taking certain antibiotics, antifungals, immunosuppressants, etc., patients with autonomic neuropathy, patients with hiatal hernia, and patients at risk of decreased gastrointestinal motility. Common side effects of this medication include dry mouth, dyspepsia, decreased tear production, confusion, drowsiness, dizziness, headache, anxiety, constipation, abdominal pain, vomiting, urinary difficulties and pain, chest pain, weight gain, fatigue, visual disturbances, skin flushing, and skin dryness. Particularly, this medication may affect the QT interval related to heart rhythm, so patients with heart disease or those taking other medications that prolong the QT interval, electrolyte imbalances, or bradycardia should be monitored closely. Co-administration with strong CYP3A4 inhibitors should be avoided. This medication may cause drowsiness or reduced reaction speed, so caution is advised when driving or operating machinery, and the cause of bladder issues should be adequately evaluated before treatment. Co-administration with other anticholinergic medications may increase effectiveness, and there may be interactions with some metabolic enzymes, so discuss concomitant medications with healthcare professionals. Safety during pregnancy has not been established, so it should not be used, and women of childbearing age should ensure proper contraception. Use during breastfeeding should also be avoided. Safety and efficacy in children have not been sufficiently established. In case of overdose, serious symptoms such as visual disturbances and urinary difficulties may occur, and immediate medical treatment should be sought. Gastric lavage, activated charcoal administration, and symptomatic medication may be necessary as supportive treatment. Finally, this medication should be kept out of reach of children, and care must be taken not to transfer it to other containers as it may negatively affect quality and safety.

• Dry mouth
• dyspepsia
• decreased tear production
• bronchitis
• allergic reactions
• confusion
• drowsiness
• dizziness
• headache
• nervous excitability

This medication should be stored in a tightly sealed container to avoid exposure to air or light. Additionally, it is important to maintain a cool temperature below 25 degrees Celsius when storing the medication. This will help preserve the medication's effectiveness and safety for a longer period.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle