Setelaxal Plus Ear Drops

Adult use

For children aged 7 years and older and adults, 4 to 6 drops of this medication should be applied to the infected ear canal every 8 hours. The treatment duration is 7 to 8 days. If the temperature of the solution is low, it may cause dizziness, so warm the container in hand for about 1–2 minutes before application. Tilt the head to the side so that the infected ear is facing upwards and apply the drops, maintaining the position for about 30 seconds to ensure the medication enters the ear canal.

Child use

For children aged 7 years and older and adults, 4 to 6 drops of this medication should be applied to the infected ear canal every 8 hours. The treatment duration is 7 to 8 days. If the temperature of the solution is low, it may cause dizziness, so warm the container in hand for about 1–2 minutes before application.

This medication is a solution that contains specific antibiotic ingredients and corticosteroids. It should not be used in patients who are allergic to fluocinolone, ciprofloxacin, or other quinolone antibiotics, or in patients with viral external ear infections such as chickenpox and herpes simplex. It should be used with caution in patients with suspected or confirmed perforation of the tympanic membrane, as safety and efficacy have not been sufficiently verified. During the use of this medication, side effects such as headache, tinnitus, itching, and hypersensitivity may occur rarely; if symptoms persist or worsen, consult a physician. The safety and efficacy of this medication have not been established in patients with otitis media, and if urticaria or allergic reactions occur, use should be discontinued immediately. This medication should not be ingested or injected; during application, care should be taken to avoid contamination by preventing the dropper from touching the ear or fingers. Do not use in conjunction with other otic solutions; prolonged use may exacerbate fungal infections, so further examination is required if symptoms do not improve after one week. Quinolone ingredients have been shown to cause joint damage in animals, so use in children is recommended only for those 7 years of age and older, and pregnant or lactating women should use it cautiously under a physician's direction. During the use of this medication, avoid exposure to ultraviolet light or strong light, and if vision becomes blurred or eye problems occur, seek ophthalmic treatment immediately. Due to the presence of preservative para-oxybenzoate, allergic reactions may occur, so caution is necessary. This medication is known not to affect driving or operating machinery, but individual variations may occur, so observe your condition. If this medication is accidentally swallowed, emergency measures such as vomiting, gastric lavage, or administration of activated charcoal may be necessary. Contact a medical institution immediately. This medication should not be used for ophthalmic or parenteral administration; before use, it is advisable to warm the container in hands and shake well before application. Store away from direct sunlight and avoid freezing; use within 30 days after opening.

Serious side effects

Urticaria

Mild side effects

• Headache
• tinnitus
• local itching
• hypersensitivity
• blurred vision

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius (room temperature) to preserve the effectiveness of the medication.

Appearance

A colorless to pale yellow transparent liquid contained in an opaque white plastic container

Package unit

10 mL/bottle