Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Gentisone HC (Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v) Ear Drops
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Gentamicin sulfate, Hydrocortisone acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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.
What you need to know before you take it
e 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.
How to take it
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.
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.
How to store it
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.
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.
Frequently asked questions about Gentisone HC (Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v) Ear Drops
How do I take Gentisone HC (Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v) Ear Drops?
Gentisone HC (Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v) Ear Drops comes as ear drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Gentisone HC (Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v) Ear Drops?
The active substance in Gentisone HC (Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v) Ear Drops is gentamicin sulfate, hydrocortisone acetate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Gentisone HC (Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v) Ear Drops, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Gentisone HC (Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v) Ear Drops without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: gentamicin sulfate, hydrocortisone acetate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
This medicine is indicated in adults and children:
1. For the treatment of eczema and infection of the outer ear (otitis externa).
2. For prophylaxis against otitis externa following trauma.
3. For post-operative local use in surgery to infected mastoid cavities.
4.2. Posology and method of administration
Posology
Adults, the elderly and the paediatric population
The area should be cleaned and 2 - 4 drops instilled in the affected ear three to four times a day and at night. Alternatively, wicks medicated with this medicine may be placed in the external ear or mastoid cavity.
Method of administration
Auricular use only.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Myasthenia gravis.
Known or suspected perforation of the ear drum.
4.4. Special warnings and precautions for use
Long-term continuous topical therapy should be avoided. Prolonged use may lead to skin sensitisation and the emergence of resistant organisms. Cross sensitivity with other aminoglycoside antibiotics may occur.
In severe infections, topical use of this medicine should be supplemented with appropriate systemic antibiotic treatment.
The condition of the ear drum must always be checked before this medicinal product is prescribed. The medicinal product must not be used if the integrity of the ear drum cannot be guaranteed.
Gentamicin may cause irreversible partial or total deafness when given systemically or when applied topically to open wounds or damaged skin. This effect is dose-related and is enhanced by renal and/or hepatic impairment and is more likely in the elderly.
Irreversible toxic effects may result from direct contact of gentamicin with the middle and inner ear. The benefits of gentamicin therapy should be considered against the risk of infection itself causing hearing loss.
Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic gentamicin therapy. Although these effects have not been reported following topical optic use of gentamicin, caution is advised when used concomitantly with systemic aminoglycosides.
There have been observed cases of an increased risk of ototoxicity with aminoglycosides administered to patients with mitochondrial mutations, particularly the m.1555A>G mutation, including cases where the patient's aminoglycoside serum levels were within the recommended range. Some cases were associated with a maternal history of deafness and/or mitochondrial mutation. Mitochondrial mutations are rare, and the penetrance of this observed effect is unknown.
This medicine contains benzalkonium chloride which may irritate the skin.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Paediatric population
In infants there is a theoretical risk that sufficient steroid may be absorbed to cause adrenal suppression.
4.5. Interaction with other medicinal products and other forms of interaction
None relevant to topical use.
4.6. Fertility, pregnancy and lactation
Pregnancy
Safety for use in pregnancy has not been established. Topical administration of any corticosteroid to pregnant animals can cause abnormalities of foetal development. This medicine should only be used in pregnancy when considered essential by the physician, after careful assessment of the potential risks and benefits.
Breast-feeding
Safety for use in lactation has not been established. This medicine should only be used in lactation when considered essential by the physician, after careful assessment of the potential risks and benefits.
Fertility
No data available.
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
In the event of irritation, sensitisation or super-infection, treatment with Gentisone HC Ear drops should be discontinued and appropriate therapy instituted. The undesirable effects listed below have been reported at the following frequency:
Not known (cannot be estimated from available data)
System organ class
Frequency
Undesirable effects
Ear and labyrinth disorders
Not known
- Local sensitivity
- Ototoxicity
- Vestibular disorder:
- Hearing loss
Skin and subcutaneous tissue disorders
Not known
- Burning sensation
- Stinging
- Itching (pruritus):
- Dermatitis.
Eye disorders
Not known
- Vision blurred (see also section 4.4)
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
Not applicable.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Gentamicin sulfate, Hydrocortisone acetate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- SOFTACORT 3,35 mg/ml prescription partial — not the same combinationHYDROCORTISONUM · eye / ear / nose
- GENTAMICINA SULFAT EIPICO 3 mg/ml prescription partial — not the same combinationGENTAMICINUM · eye / ear / nose
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Gentamicin sulfate, Hydrocortisone acetate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Gentamicin WZF 0,3% partial — not the same combinationGentamicinum · eye / ear / nose
- Gentamicin WZF 0.3 % - vet partial — not the same combinationGentamicinum · eye / ear / nose
- Easotic partial — not the same combinationhydrocortisone aceponate / miconazole nitrate / gentamicin sulphate · eye / ear / nose
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Gentisone HC (Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v) Ear Drops. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.