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GENTISONE HC 0.3% W/V & 1.0% W/V EAR DROPS SUSPENSION

Active substance(s): GENTAMICIN / HYDROCORTISONE ACETATE / GENTAMICIN / HYDROCORTISONE ACETATE

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Gentisone® HC 0.3% w/v & 1.0% w/v Ear Drops, suspension
gentamicin sulphate and hydrocortisone acetate
The name of your medicine is Gentisone HC 0.3% w/v & 1.0% w/v Ear Drops, suspension but will be
referred to as Gentisone HC Ear Drops throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Gentisone HC Ear Drops are and what they are used for
2. What you need to know before you use Gentisone HC Ear Drops
3. How to use Gentisone HC Ear Drops
4. Possible side effects
5. How to store Gentisone HC Ear Drops
6. Contents of the pack and other information
1. WHAT GENTISONE HC EAR DROPS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Gentisone HC Ear Drops. Gentisone HC Ear Drops contain the active
ingredients gentamicin which belongs to a group of medicines called antibiotics and hydrocortisone acetate
which is a steroid.
Gentisone HC Ear Drops are used in adults and children to treat eczema and bacterial infections in the
external ear, to prevent infections in an injured ear and to treat infected bone cavities (mastoid) behind the
ear after an operation.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GENTISONE HC EAR DROPS
Do not use this Gentisone HC Ear Drops:
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before using Gentisone HC Ear Drops if you:
• Have any problems with your kidneys or liver
• Are using this medicine for a long period of time
• 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.
Other medicines and Gentisone HC Ear Drops
Tell your doctor if you are taking, have recently taken or might take any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
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.
Gentisone HC Ear Drops are not recommended for use in pregnancy or breast-feeding unless considered
appropriate by your doctor.
Driving and using machinery
This medicine should not affect your ability to drive or use machines.
Gentisone HC Ear Drops contain Benzalkonium chloride
Irritant, may cause skin reactions.
3. HOW TO USE GENTISONE HC EAR DROPS
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Shake the bottle before use. The recommended dose is 2-4 drops three to four times a day and at night.
Alternatively, wicks medicated with your medicine may be placed into the external ear or into the bone
cavity behind your ear (mastoid).
The drops should not be used continuously for a long time as it may irritate your skin. If your infection is
severe, your doctor may also give you antibiotics by injection.
If you swallow your 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 to use Gentisone HC Ear Drops
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.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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.
Other side effects include:
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 GENTISONE HC EAR DROPS
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not freeze or mix with other liquids.
Do not use for more than 4 weeks after opening.
This medicine must not be used after the expiry date printed on the pack.
Return any unused drops to the pharmacist.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Gentisone HC Ear Drops contains
The ear drops contain the active ingredients gentamicin sulphate = 0.3% w/v gentamicin base (3,000 units
per ml), and 1.0% w/v hydrocortisone acetate.
The other ingredients are: benzalkonium chloride (preservative), povidone (E1201), macrogol 4000, sodium
chloride, borax (E285), disodium edetate and water for injections.
What Gentisone HC Ear Drops look like and the contents of the pack
The ear drops are available as a white suspension available in a 10ml dropper bottle.
Manufactured by Amdipharm UK Limited, Capital House, 85 King William Street, London, EC4N 7BL, UK
or Famar S.A., Agiou Dimitriou 63, Alimos Attiki, 17456, Greece and procured from within the EU and
repackaged in the UK by the Parallel Import Product Licence holder: CD Pharma Ltd, Unit 3, Manor Point,
Manor Way, Borehamwood, Herts. WD6 1EE.
Gentisone HC 0.3% w/v & 1.0% w/v, Ear Drops, suspension

PL: 20492/0564

POM

Blind or partially sighted? Is this leaflet hard to see or
read?
Call 020 8236 3190 to obtain a leaflet in a format
suitable for you.
Date of Preparation: 15th July 2017
Gentisone is a registered trademark of Amdipharm International Limited.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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