Patient Product Information

Roche

Gentisone® HC Ear Drops

Gentamicin + hydrocortisone acetate

Please read this leaflet carefully before you start to take your medicine.If you have any questions or are not sure about anything, ask your doctor or pharmacist.

What are Gentisone HC Ear Drops?

Gentisone HC Ear Drops contain an antibacterial called gentamicin sulphate and an anti-inflammatory steroid called hydrocortisone acetate.

The drops are available in dropper bottles of 10ml containing gentamicin base (0.3% w/v) and hydrocortisone acetate (1.0% w/v). The drops also contain benzalkonium chloride (a preservative), povidone, polyethylene glycol 4000, sodium chloride, borax, disodium edetate and purified water.

What are Gentisone HC Ear Drops used for?

Gentisone HC Ear Drops are used for the following:

• the treatment of eczema and infection of the outer ear (otitis externa),
• the prevention of otitis externa in an injured ear,

EXCEPT where there is a known or suspected perforated ear drum.

• after an operation on infected bone cavities behind the ear (mastoid),

When must Gentisone HC Ear Drops not be used?

You must not use this product if you are allergic to Gentisone HC Ear Drops or any of the ingredients it contains.

You must not use the drops to treat an infection of the outer ear if your ear drum is or may be perforated.

When should you be extra careful when using Gentisone HC Ear Drops?

In infants, there is a theoretical risk that adrenal suppression (reduced steroid production) may occur if sufficient Gentisone HC Ear Drops is absorbed. Symptoms might include not taking food, vomiting, diarrhoea and general weakness.

Do not apply Gentisone HC Ear Drops to open wounds or the middle ear, as deafness may occur.

In addition, make sure your doctor knows if you are:

• pregnant or breast feeding.
• allergic to other (aminoglycoside) antibiotics.
• suffering from liver or kidney damage, especially if you are elderly, as accumulation of Gentisone may occur. This accumulation, or high doses, can cause hearing impairment.

May Gentisone HC Ear Drops be used during pregnancy or while breast feeding?

You may only use the ear drops during pregnancy or breast feeding as directed by your doctor. Using steroids for a long time may potentially affect your baby.

How should Gentisone HC Ear Drops be used?

Always use the drops as your doctor tells you to.

Shake the bottle before use.

Two to four drops are usually put in the ear three to four times a day and at night.

Alternatively, wicks medicated with Gentisone HC Ear Drops may be placed in the external ear or mastoid cavity.

If you or someone else accidentally takes your medicine by mouth, contact your doctor, pharmacist or nearest hospital straight away.

If you forget to use a dose then use your next dose when you remember and continue as normal.

Long term use in the ear should be avoided.

What are the possible unwanted effects of Gentisone HC Ear Drops?

The following unwanted effects may occur:

• irritation or allergic reaction. If this occurs, stop treatment and talk to your doctor.
• super-infection (a new, added infection).

If you are concerned about these or any other unwanted effects talk to your doctor.

How should Gentisone HC Ear Drops be stored?

• Keep this medicine out of the reach and sight of children.
• Store below 25°C. Do not freeze or mix with other liquids.
• Do not keep the drops for longer than 4 weeks after first opening.
• This medicine must not be used after the date (EXP) printed on the pack. Return any left over medicine to your pharmacist. Only keep it if your doctor tells you to.
• REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may not be suitable for them even if their symptoms are the same as yours.

Further information:

You can get more information on Gentisone HC Ear Drops from your doctor or pharmacist.