Patient Information Leaflet 103070/LF/2

Gentamicin

0. 3. w/v Eye/Ear Drops

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Please 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 symptoms 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.

What is in this leaflet:

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.

1.    What Gentamicin 0.3% w/v Eye/Ear Drops are and what they are used for

The name of your medicine is Gentamicin 0.3% w/v Eye/Ear Drops. Gentamicin 0.3% w/v Eye/Ear Drops contain the active ingredient gentamicin which belongs to a group of medicines called antibiotics.

Gentamicin 0.3% w/v Eye/Ear Drops are used in adults and children to treat bacterial infections in the eye or ear and to prevent infections in an injured eye or ear.

2.    What you need to know before you use Gentamicin 0.3% w/v Eye/Ear Drops

Do not take this medicine if you:

•    Are allergic to gentamicin, any of the other ingredients of Gentamicin 0.3% w/v Eye/Ear Drops (listed in section 6), or a similar medicine containing an aminoglycoside antibiotic;

•    Have or suspect you have a burst ear drum, if you are being treated for a problem with your ear;

•    Suffer from myasthenia gravis, a disease causing muscle weakness.

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Warnings and precautions

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

•    Have any problems with your kidneys or liver;

•    Have open wounds or damaged skin;

•    Are using this medicine for a long period of time.

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

Other medicines and Gentamicin 0.3% w/v Eye/Ear Drops

Please tell your doctor if you are taking, or have recently taken, or might take any other medicines including those obtained without a prescription.

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.

Pregnancy and breastfeeding

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 taking this medicine. Gentamicin 0.3% w/v Eye/Ear Drops are not recommended for use in pregnancy or breastfeeding unless considered appropriate by your doctor.

Driving and using machinery

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.

Gentamicin 0.3% w/v Eye/Ear Drops contain Benzalkonium Chloride

May cause eye irritation.

Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses. Irritant, may cause skin reactions.

3.    How to use Gentamicin 0.3% w/v Eye/Ear Drops

Always use the drops as your doctor tells you to. Check with your doctor or pharmacist if you are not sure.

Eyes:

The recommended dose is 1-2 drops into the infected eye up to 6 times a day. For more severe infections your doctor may tell you to use the drops more often than this. Contact lenses should be removed when treating an eye infection with these drops.

Ears:

You should clean the area and then use 2-3 drops, three to four times a day and at night. Your doctor may tell you to use the drops more often than this.

The drops should not be used continuously for a long time as it may irritate your skin and the drops may stop working.

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

If you swallow your eye/ear drops

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

If you forget a dose

If you forget to use your drops, use your next dose as soon as you remember and continue as before.

4.    Possible side effects

Like all medicines, Gentamicin 0.3% w/v Eye/Ear Drops can cause side effects, although not everybody gets them.

If you notice:

•    itching or skin rashes;

•    swelling of the face, lips or throat;

•    difficulty in breathing or wheeziness. Stop using these drops and tell your doctor immediately. These may be signs of an allergic reaction.

Side effects may include:

•    Hearing loss when used in your ears;

•    Irritation, burning, stinging, and itching of the skin (at the application site);

•    Blurred vision;

•    Super infection (infection occurring after an earlier infection);

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• Problems with your kidney function.

Reporting of side effects

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.

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

5.    How to store Gentamicin 0.3% w/v Eye/Ear Drops

Keep this medicine out of the sight and reach of children.

Store your medicine in a safe place below 25°C and do not freeze.

This medicine must not be used after the expiry date printed on the pack.

Do not use for more than 4 weeks after opening.

Return any unused drops to the pharmacist.

6.    Contents of the pack and other information

What Gentamicin 0.3% w/v Eye/Ear Drops contain

The eye/ear drops contain the active ingredient gentamicin sulphate 0.3% w/v gentamicin base.

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

What Gentamicin 0.3% w/v Eye/Ear Drops look like and the contents of the pack

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

Marketing Authorisation Holder and Manufacturer responsible for release:

Amdipharm UK Limited,

Capital House,

85 King William Street,

London EC4N 7BL, UK

Manufacturer and Batch Release Site:

Famar S.A.,

Agiou Dimitriou 63,

Alimos Attiki,

17456,

Greece

This leaflet was last revised in September 2014.

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