4.1. Therapeutic indications

For the treatment of otitis externa.

4.2. Posology and method of administration

Posology

Adults (including the elderly) and children 2 years of age and over:

Discontinue treatment if there is no clinical improvement after 7 days (see section 4.4).

One metered dose (60mg) to be administered directly into each affected ear three times daily.

Treatment should be continued until two days after symptoms have disappeared.

Infants and neonates (under 2 years of age):

Dexamethasone/ Neomycin sulfate/ Acetic acid (Otomize) ear spray is not suitable for infants and neonates (see section 4.3).

Method of administration

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.

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

The product should not be used in patients where a perforated tympanic membrane has been diagnosed or is suspected or where a tympanostomy tube (grommet) is in situ.

The product should not be used in infants and neonates under 2 years of age.

4.4. Special warnings and precautions for use

Product use should be discontinued, and medical advice sought where appropriate, if irritation or rash occurs, or if the condition worsens or does not improve within 7 days.

When otitis externa is treated topically with preparations containing aminoglycosides, in patients who have a perforation of the tympanic membrane, there is an increased risk of drug induced deafness. It is therefore important to ensure that there is no perforation in such patients (see section 4.3).

It is important to exclude chronic alternate diagnoses, including chronic otitis media, before treatment is commenced.

Treatment with corticosteroid/antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement, since prolonged use may lead to occult extension of infections due to the masking effect of the steroid.

In children there is a theoretical risk that sufficient steroid may be absorbed to cause adrenal suppression, with prolonged use increasing this risk of adrenal suppression in children.

Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms.

Due to potentially immature renal function in children toxicity may develop, thus caution is warranted when administering neomycin in this age group.

Aminoglycoside antibiotics may cause irreversible, partial or total deafness when given systemically or when applied topically to open wounds or damaged skin. This effect is dose related and is enhanced by renal or hepatic impairment. This possibility should be considered when high doses or prolonged treatment is given to small children.

There have been observed cases of an increased risk of ototoxicity with aminoglycosides administered to patients with mitochondrial mutations, particularly the m.1555A>G mutation, including cases where the patient's aminoglycoside serum levels were within the recommended range. Some cases were associated with a maternal history of deafness and/or mitochondrial mutation. While no cases were identified with neomycin, based on a shared mechanism of action there is the potential for a similar effect with neomycin. These mitochondrial mutations are rare, and the penetrance of this observed effect is unknown.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids

Contains methyl and propyl hydroxybenzoates (E218 and E216) which may cause allergic reactions (possibly delayed).

Contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

4.5. Interaction with other medicinal products and other forms of interaction

None known

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no adequate data on the use of dexamethasone in pregnant women. Studies in animals have shown topical administration of corticosteroids to cause reproductive toxicity.

There is a risk of foetal ototoxicity if aminoglycoside antibiotics preparations are administrated during pregnancy.

Dexamethasone/ Neomycin sulfate/ Acetic acid (Otomize) ear spray is not recommended during pregnancy.

Lactation

No reports describing the use of neomycin or dexamethasone during human lactation are available and the effects on the nursing infant from exposure to the drug in milk are unknown. Maternal use of topical preparations generally carries less risk than a systemically administered drug.

A risk to the breast-fed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Dexamethasone/ Neomycin sulfate/ Acetic acid (Otomize) ear spray therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

4.7. Effects on ability to drive and use machines

Unresolved ear problems could themselves affect driving ability.

4.8. Undesirable effects

Eye disorders

Blurred vision has been reported with corticosteroid use; for dexamethasone, the frequency is not known (see also section 4.4)

Skin and subcutaneous tissue disorders

Some patients may experience a transient stinging or burning sensation for the first few days of treatment.

Skin sensitisation / hypersensitivity reactions (immediate and delayed) leading to irritation, burning, stinging, itching and dermatitis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Overdosage by this route is extremely unlikely.