The combination of Dexamethasone + Neomycin + Glacial Acetic Acid ear spray is indicated for the treatment of Otitis Externa (infection of the outer ear canal).

Neomycin is a well-known antibiotic with a broad spectrum of antibacterial activity. Dexamethasone is a topical corticosteroid that helps reduce inflammation, redness, and swelling. Glacial Acetic Acid works by lowering the pH of the ear canal, which helps inhibit bacterial growth and supports the control of infection.

Adults (including the elderly) and children 2 years of age and over: One metered dose (60 mg) to be administered directly into each affected ear three times daily. Treatment should be continued until two days after symptoms have disappeared. Discontinue treatment if there is no clinical improvement after 7 days.

Infants and neonates (under 2 years of age): This ear spray is not suitable for infants and neonates.

Shake the bottle well before use. Before first use, press actuator down several times to obtain a fine spray. Each press then delivers one metered dose. Do not inhale the spray. Administer spray directly by gently placing nozzle tip into ear opening and pressing down once on the actuator. Use within one month of first use. If there is a period of more than one week since last use, press actuator down a few times before using again.

Hypersensitivity to the active ingredients or any of the excipients of this ear drop. The product should not be used in patients with a known or suspected perforated tympanic membrane or in those with a tympanostomy tube (grommet) in place. It is also contraindicated in infants and neonates under 2 years of age.

Eye disorders: Blurred vision has been reported with the use of corticosteroids; for dexamethasone, the frequency is not known.

Skin and subcutaneous tissue disorders: Some patients may experience temporary stinging or burning sensations during the initial days of treatment. Hypersensitivity reactions of the skin (both immediate and delayed) may occur, leading to irritation, burning, stinging, itching, and dermatitis.

Reporting of suspected adverse reactions: Reporting any suspected adverse reactions after the product has been authorised is important, as it supports ongoing monitoring of the benefit–risk balance of the medicine.

Pregnancy: There are no adequate data on the use of Dexamethasone + Neomycin + Glacial Acetic Acid ear spray in pregnant women. Animal studies suggest that topical corticosteroids may cause reproductive toxicity. Administration of aminoglycoside antibiotics during pregnancy may increase the risk of foetal ototoxicity. Therefore, this ear spray is not recommended during pregnancy.

Lactation: There are no reports on the use of Neomycin or Dexamethasone in breastfeeding women, and the effects on a nursing infant are unknown. Topical use in mothers generally carries less risk than systemic administration, but a potential risk to the breastfed child cannot be excluded. A decision must be made whether to stop breastfeeding or discontinue this ear spray, considering the benefits of breastfeeding for the child and therapy for the mother.

Use of the product should be discontinued and medical advice sought if irritation or rash develops, or if the condition worsens or fails to improve within 7 days.

When treating otitis externa with topical preparations containing aminoglycosides, patients with a perforated tympanic membrane are at increased risk of drug-induced hearing loss. Therefore, it is essential to confirm that the tympanic membrane is intact before use.

Chronic alternative diagnoses, including chronic otitis media, should be ruled out prior to initiating treatment.

Treatment with corticosteroid/antibiotic combinations should not be continued beyond 7 days in the absence of clinical improvement, as prolonged use may mask symptoms and allow hidden spread of infection.

In children, there is a theoretical risk of systemic absorption of corticosteroids leading to adrenal suppression, particularly with prolonged use.

Extended use may also result in skin sensitisation and the development of resistant organisms.

Due to potentially immature renal function in children, there is a risk of toxicity; therefore, caution is advised when administering neomycin in this population.

Aminoglycoside antibiotics may cause irreversible partial or complete hearing loss when administered systemically or applied topically to damaged skin or open wounds. This risk is dose-related and may be increased in patients with renal or hepatic impairment. Special consideration is required when high doses or prolonged therapy are used in young children.

Ear anti-infective and antiseptic agents.

Store below 25°C. Do not freeze. Keep the container upright in the outer carton. Use within one month after first opening.