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

Active Ingredient:
gentamicin sulfate, hydrocortisone acetate
Company:  
ADVANZ Pharma See contact details
ATC code: 
S03AA
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About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 20 Mar 2024

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 20072/0058.

Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v Ear Drops

Package leaflet: Information for the user

Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v Ear Drops

gentamicin and hydrocortisone

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 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.

What is in this leaflet

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

1. What Gentamicin and Hydrocortisone Ear Drops are and what they are used for

The name of your medicine is Gentamicin and Hydrocortisone Ear Drops. Gentamicin and Hydrocortisone Ear Drops contain the active ingredients gentamicin which belongs to a group of medicines called antibiotics and hydrocortisone acetate which is a steroid.

Gentamicin and Hydrocortisone 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 Gentamicin and Hydrocortisone Ear Drops
Do not use Gentamicin and Hydrocortisone 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 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.

Other medicines and Gentamicin and Hydrocortisone Ear Drops

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

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.

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

Driving and using machines

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.

3. How to use Gentamicin and Hydrocortisone 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 Gentamicin and Hydrocortisone 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 Gentamicin and Hydrocortisone 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 or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice following side effects, stop using these drops and tell your doctor immediately:

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 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.

5. How to store Gentamicin and Hydrocortisone Ear Drops

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

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

Store your medicine in a safe place below 25°C and do not freeze or mix with other liquids.

Do not use for more than 4 weeks after opening.

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 Gentamicin and Hydrocortisone Ear Drops contains
  • 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.

What Gentamicin and Hydrocortisone Ear Drops look like and contents of the pack

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

Marketing Authorisation Holder
Amdipharm UK Limited
Dashwood House
69 Old Broad Street
London
EC2M 1QS
United Kingdom

Manufacturer
Famar S.A.
Agiou Dimitriou 63
Alimos Attiki
17456
Greece

This leaflet was last revised in February 2024.

ADVANZ Pharma
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Address
Dashwood House, 69 Old Broad Street, London, EC2M 1QS, UK
Telephone
+44 (0)208 588 9131
Medical Information Direct Line
+44 (0)208 588 9131
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0)208 588 9273