Patient Product Information

Roche

Genticin® Eye/Ear Drops

Gentamicin

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 Genticin Eye/Ear Drops?

Genticin Eye/Ear Drops contain an antibacterial called gentamicin sulphate.

The drops are available in 10ml dropper bottles containing gentamicin base (0.3% w/v). The drops also contain benzalkonium chloride (a preservative), borax, sodium chloride and purified water.

What are Genticin Eye/Ear Drops used for?

Genticin Eye/Ear Drops are used for:

• the treatment of eye or ear infections as identified by your doctor.
• the prevention of infection in an injured eye or ear.

When must Genticin Eye/Ear Drops not be used?

You must not use this product if you are allergic to Genticin Eye/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.

Do not apply to open wounds or the middle ear as deafness may occur

When should you be extra careful when using Genticin Eye/Ear Drops?

Make sure your doctor knows if you:

• are pregnant or breast feeding.
• are allergic to other (aminoglycoside) antibiotics.
• wear contact lenses. You should remove them during the period of treatment as the drops may discolour your lenses.
• are taking other medicines which may be nephrotoxic or ototoxic (cause kidney or ear problems). If you are unsure whether this applies to you, talk to your doctor or pharmacist.

May Genticin Eye/Ear Drops be used during pregnancy or while breast feeding?

You may only use the drops during pregnancy or breast feeding as directed by your doctor.

May Genticin Eye/Ear Drops be used during driving or operating machinery?

Blurring of vision is usually temporary but may affect your ability to drive a car or use machinery.

How should Genticin Eye/Ear Drops be used?

Always use the drops as your doctor tells you to.

For use in the eye: 1 or 2 drops are usually put in the eye up to six times a day. However, your doctor may advise you to use the drops more frequently than this. Contact lenses should be removed during use in the eye.

For use in the ear:The area should be cleaned and then 2 or 3 drops are usually put in the ear three to four times a day, and at night. However, your doctor may advise you to use the drops more frequently than this.

The drops should not be used continuously over a long period as this may cause the skin to become irritated and the drops to become ineffective.

If the infection is severe, your doctor may also give you antibiotics by injection.

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.

What are the possible unwanted effects of Genticin Eye/Ear Drops?

The following unwanted effects may occur:

• hearing loss.
• discolouration of soft contact lenses.
• irritation or allergic reaction. If this occurs, stop treatment and talk to your doctor.
• burning, stinging, itching or dermatitis.

Gentamicin may cause kidney problems when it is given by injection, but when the drops are given in the eye or ear, this is unlikely.

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

How should Genticin Eye/Ear Drops be stored?

• Keep this medicine out of the reach and sight of children.
• Store below 25°C. Do not freeze.
• 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 Genticin Eye/Ear Drops from your doctor or pharmacist.