GENTISONE HC

Posology Adults, the elderly and the paediatric population The area should be cleaned and 2 - 4 drops instilled in the affected ear three to four times a day and at night. Alternatively, wicks medicated with this medicine may be placed in the external ear or mastoid cavity.

Method of administration Auricular use only.

In the event of irritation, sensitisation or super-infection, treatment with Gentisone HC Ear drops should be discontinued and appropriate therapy instituted. The undesirable effects listed below have been reported at the following frequency: Not known (cannot be estimated from available data) System organ class Frequency Undesirable effects Ear and labyrinth disorders Not known - Local sensitivity - Ototoxicity - Vestibular disorder: - Hearing loss Skin and subcutaneous tissue disorders Not known - Burning sensation - Stinging - Itching (pruritus): - Dermatitis.

4) 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Long-term continuous topical therapy should be avoided. Prolonged use may lead to skin sensitisation and the emergence of resistant organisms. Cross sensitivity with other aminoglycoside antibiotics may occur. In severe infections, topical use of this medicine should be supplemented with appropriate systemic antibiotic treatment.

The condition of the ear drum must always be checked before this medicinal product is prescribed. The medicinal product must not be used if the integrity of the ear drum cannot be guaranteed. Gentamicin 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 and/or hepatic impairment and is more likely in the elderly. Irreversible toxic effects may result from direct contact of gentamicin with the middle and inner ear. The benefits of gentamicin therapy should be considered against the risk of infection itself causing hearing loss.

Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic gentamicin therapy. Although these effects have not been reported following topical optic use of gentamicin, caution is advised when used concomitantly with systemic aminoglycosides.

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. Mitochondrial mutations are rare, and the penetrance of this observed effect is unknown.

This medicine contains benzalkonium chloride which may irritate the skin. Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

1. Myasthenia gravis. Known or suspected perforation of the ear drum.