Gentisone HC (Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v) Ear Drops

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v Ear Drops; it will be called Gentamicin and Hydrocortisone Ear Drops for ease here after.

1. What Gentamicin and Hydrocortisone Ear Drops are and what they are used for
2. What you need to know before you use Gentamicin and Hydrocortisone Ear Drops
3. How to use Gentamicin and Hydrocortisone Ear Drops
4. Possible side effects
5. How to store Gentamicin and Hydrocortisone Ear Drops
6. Contents of the pack and other information

• if you are allergic to gentamicin, hydrocortisone or similar medicine containing an aminoglycoside antibiotic or steroid or any of the other ingredients of this medicine (listed in section 6)
• if you have or suspect you have a burst ear drum, if you are being treated for a problem with your external ear
• if you suffer from myasthenia gravis, a disease causing muscle weakness.

Talk to your doctor or pharmacist before using Gentamicin and Hydrocortisone Ear Drops:

• if you know (or think you have) a mitochondrial disease (mutations in the parts of your cells which help make energy); certain mitochondrial diseases may increase your risk of hearing loss with this product
• if you have any problems with your kidneys or liver
• if you are using this medicine for a long period of time
• if you have open wounds or damaged skin.

Some medicines may increase the effects of Gentisone HC Ear Drops and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

If either of these applies to you or if you are not sure, tell your doctor.

Contact your doctor if you experience blurred vision or other visual disturbances.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Gentamicin and Hydrocortisone Ear Drops are not recommended for use in pregnancy or breastfeeding unless considered appropriate by your doctor.

This medicine should not affect your ability to drive or use machines.

Gentamicin and Hydrocortisone Ear Drops contains benzalkonium chloride which may irritate the skin.

If you or someone else, accidentally swallows some of this medicine, contact your doctor, pharmacist or nearest hospital emergency department immediately.

If you forget to use your drops, use your next dose as soon as you remember and continue as before. Do not apply a double dose to make up for a forgotten dose.

Not known (frequency cannot be estimated from the available data)

• Super infection (infection occurring after an earlier infection)
• Hearing loss
• Burning sensation
• Stinging sensation
• Itching at the site of administration
• Blurred vision.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substances are gentamicin sulfate equivalent to 0.3% w/v gentamicin base and 1.0% w/v hydrocortisone acetate.
• The other ingredients are benzalkonium chloride, povidone, polyethylene glycol 4000, sodium chloride, borax, disodium edetate and Water for Injections.

The ear drops are available as a white to pale yellow solution in 10ml dropper bottles.