Genticin (Gentamicin 0.3% w/v) Eye/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.

1. What Gentamicin 0.3% w/v Eye/Ear Drops are and what they are used for
2. What you need to know before you use Gentamicin 0.3% w/v Eye/Ear Drops
3. How to use Gentamicin 0.3% w/v Eye/Ear Drops
4. Possible side effects
5. How to store Gentamicin 0.3% w/v Eye/Ear Drops
6. Contents of the pack and other information

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

Talk to your doctor or pharmacist before using Gentamicin 0.3% w/v Eye/Ear Drops:

• if you have any problems with your kidneys, liver or hearing
• 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 open wounds or damaged skin
• if you are using this medicine for a long period of time.

Contact lenses should be removed when treating an eye infection with these drops.

If any of these apply to you, or if you are not sure, tell your doctor.

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

This is especially important if you are taking:

• Ethacrynic acid (used in the treatment of high blood pressure and swelling) and furosemide (used in the treatment of congestive heart failure and swelling)
• Antibiotics such as cephalosporins
• Ciclosporin (used to stop the body rejecting bone marrow or organ transplants)
• Amphotericin (used to treat fungal infections)
• Cisplatin (used in anti-cancer therapy)
• Muscle relaxants

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

Gentamicin 0.3% w/v Eye/Ear Drops are not recommended for use in pregnancy or breast-feeding unless considered appropriate by your doctor.

Gentamicin 0.3% w/v Eye/Ear Drops may cause temporary blurred vision when used in the eyes. If you are affected, do not drive or use machinery until the blurring has cleared.

This medicine contains 0.2mg of benzalkonium chloride in each 1 ml, which is equivalent to 0.2mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

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 take a double dose to make up for a forgotten dose.

• hearing loss when used in your ears
• symptoms like dizziness or vertigo (vestibular disorder)
• irritation, burning, stinging, and itching of the skin (at the application site)
• blurred vision
• super infection (infection occurring after an earlier infection)
• skin inflammation (dermatitis)
• problems with your kidney function.

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 substance is gentamicin sulfate 0.3% w/v gentamicin base.

The other ingredients are benzalkonium chloride BP, borax Ph.Eur, Sodium chloride Ph.Eur, water for injection Ph.Eur.

The eye/ear drops are available in 10ml dropper bottles.