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.
Sofradex Ear/Eye Drops, Solution
⚠ 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 Dexamethasone sodium metasulfobenzoate, Framycetin sulfate, Gramicidin 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 Sofradex Ear/Eye Drops, Solution (called Sofradex Drops in this leaflet) contains three medicines called Framycetin sulphate, Gramicidin and Dexamethasone sodium metasulphobenzoate.
- Framycetin sulphate and Gramicidin belong to a group of medicines called antibiotics. These work by killing the bacteria that is causing the infection.
- Dexamethasone sodium metasulphobenzoate. This belongs to a group of medicines called steroids. It works by lowering inflammation What Sofradex Drops are used for It is used in the eye(s) for: •
Inflammation in the eye when prevention of bacterial infection is also needed. Signs include sore, red or swollen eyes.
It is used in the ear(s) for: •
Inflammation of the ear canal (otitis externa)
What you need to know before you take it
e Sofradex Drops
Do not use Sofradex Drops and tell your doctor: •
• •
•
If you are allergic (hypersensitive) to framycetin sulphate, dexamethasone sodium metasulphobenzoate, gramicidin or any of the other ingredients of this medicine (listed in section 6 below). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, tongue and worsening of redness, itching or swelling of the eye or eyelid. Your eye or ear inflammation is due to an infection caused by a fungus or a virus. You have untreated eye or ear infections caused by microorganisms that may be masked or enhanced by the steroids. if you are using these drops in your eye and:
- your eye inflammation is due to an infection called tuberculosis (TB)
- you have pus in your eye(s)
- you have eye pain or eyelid swelling or a red eye, the cause of which has not been diagnosed. Inappropriate use is potentially blinding.
- you have glaucoma
- you have an ulcer in your eye(s) caused by the herpes simplex virus (herpetic keratitis).
•
if you are using these drops in your ear and:
- you have pus in your ear(s).
- you have a damaged (perforated) eardrum.
Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Sofradex Drops. Warnings and precautions Talk to your doctor or pharmacist before using Sofradex Drops if:
- You experience blurred vision or other visual disturbances.
- You have ototoxicity or family history of ototoxicity (harmful effects to ear) with signs and symptoms including ringing in ears, imbalance (associated with dizziness, nausea, and blurry vision), decreased hearing, hearing loss.
- You know (or think) you have a mitochondrial disease (mutations in the parts of your cells which help make energy). These diseases may increase your risk of hearing loss with this product. Prolonged use may lead to allergy and the emergence of non-susceptible (resistant) bacteria. Repeated and prolonged use (more than 7 days) requires monitoring of intraocular pressure due to the risk of glaucoma, cataract formation or unsuspected infections. Prolonged use in children and infants may lead to the risk of partial or total deafness. Other medicines and Sofradex Drops •
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
•
Some medicines may increase the effects of Sofradex Drops and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Pregnancy and breast-feeding Talk to your doctor or pharmacist before using this medicine if:
- You are pregnant, might become pregnant, or think you may be pregnant. •
You are breast-feeding or planning to breast-feed.
Driving and using machines You may have blurred eyesight straight after using Sofradex Drops. If this happens, do not drive or use any tools or machines until you can see clearly. 3. How to use Sofradex 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.
How to take it
this medicine • •
This medicine can be used in the eye and the ear Do not use this medicine for more than 7 days without talking to your doctor
Use in the eye • • • • • •
Wash your hands Remove the cap on the bottle Tilt your head back Squeeze one or two drops inside the lower lid without touching your eye with the bottle Close your eye Wipe away any excess drops with a clean tissue
•
Always put the cap back on the bottle as soon as you have used it
Use in the ear • • • • • •
Wash your hands Remove the cap on the bottle Tilt your head on one side Squeeze two or three drops into your ear Lie your head with your affected ear facing upwards for a few minutes Wipe away any excess drops with a clean tissue
•
Always put the cap back on the bottle as soon as you have used it
How much to use In the eye(s) •
One or two drops in the affected eye six times a day or more if advised by your doctor
•
Keep using Sofradex Drops as instructed by your doctor
In the ear(s) • •
Two or three drops in the ear three or four times a day Keep using Sofradex Drops as instructed by your doctor
If you forget to use Sofradex Drops If you forget a dose, put some in as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose. If you stop using Sofradex Drops Keep using these drops until your doctor tells you to stop. Otherwise, you could get an infection or the inflammation could get worse. 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 Stop using Sofradex Drops and see a doctor as soon as possible if; • • • •
You get any kind of skin problem, such as a rash or itching around your eyes or irritation, increased sweating, burning, stinging, itching or swelling or eczema of the eye or ear area. Your eyes have problems focussing or develop a blind spot. You may have increased pressure in the eye (glaucoma). You have difficulty seeing at night or notice that your eyesight is cloudy and fuzzy, or you see halos around lights. These could be signs of cataracts. This may occur after using the medicine for a long time. You experience 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 at: 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
Sofradex 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 label and carton after EXP. The expiry date refers to the last day of that month. Store below 25°C. Do not refrigerate.
Sofradex Drops are sterile when you buy them, so you must not keep them for more than 28 days after opening the bottle. Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Contents of the pack and other information
What Sofradex Drops contains • •
The eye drops contain the active substances: framycetin sulphate (0.5%w/v), dexamethasone sodium metasulphobenzoate (equivalent to 0.050% w/v of dexamethasone) and gramicidin (0.005%w/v) The other ingredients are citric acid monohydrate, sodium citrate, lithium chloride, phenylethyl alcohol, industrial methylated spirit, polysorbate 80 and water for injection. Sodium hydroxide and hydrochloric acid are used for pH adjustment.
What Sofradex Drops looks like and contents of the pack Sofradex Drops are clear colourless ear/ eye drops. The drops are also available in 5 ml, 8 ml and 10 ml dropper bottles. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Neon Healthcare Ltd. 8 The Chase, John Tate Road, Hertford, SG13 7NN United Kingdom Manufacturer Zentiva k.s., U Kabelovny 130 102 37 Prague 10, Czech Republic This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in May 2025.
Frequently asked questions about Sofradex Ear/Eye Drops, Solution
How do I take Sofradex Ear/Eye Drops, Solution?
Sofradex Ear/Eye Drops, Solution comes as eye 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 Sofradex Ear/Eye Drops, Solution?
The active substance in Sofradex Ear/Eye Drops, Solution is dexamethasone sodium metasulfobenzoate, framycetin sulfate, gramicidin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Sofradex Ear/Eye Drops, Solution, 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 Sofradex Ear/Eye Drops, Solution 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: dexamethasone sodium metasulfobenzoate, framycetin sulfate, gramicidin
- 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
In the Eye:
For the short term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral disease.
In the Ear:
Otitis Externa.
4.2. Posology and method of administration
Posology
Adults (including elderly) and paediatric population:
In the Eye:
One or two drops applied to each affected eye up to six times daily or more frequently if required.
In the Ear:
Two or three drops instilled into the ear three or four times daily.
Method of administration
Auricular and Ocular use.
Treatment duration should be short (not to exceed 7 days) (see section 4.4)
4.3. Contraindications
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
• Viral or fungal infections of the eye and ear.
• Untreated purulent infections of the eye and ear, which, like other diseases caused by micro-organisms, may be masked or enhanced by the presence of the steroid.
Use in the eye:
• Tuberculosis
• Glaucoma
• Herpes simplex and other viral diseases of the cornea and conjunctiva, including where herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Use of topical steroids in the latter condition can lead to extension of the ulcer and marked visual deterioration.
Use in the ear:
• Eardrum perforation because of the risk of ototoxicity.
4.4. Special warnings and precautions for use
Treatment should be discontinued if there are signs of sensitivity to any of its ingredients.
Treatment with corticosteroid/antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement, since prolonged use may lead to occult extension of infections due to the masking effect of the steroid. Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms.
Corticosteroids
Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding (see section 4.3).
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.
Treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular, pressure, cataract formation or unsuspected infections.
Antibiotics
Ototoxicty
Aminoglycosides antibiotics 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 or hepatic impairment. Although this effect has not been reported following ocular use, the possibility should be considered when high dose topical is given to small children or infants.
Mitochondrial disorders
There have been reported cases of ototoxicity with aminoglycosides administered to patients with mitochondrial mutations, particularly the m.1555A>G mutation, which suggests an increased risk of ototoxicity in these patients, 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.
Although no cases were identified with topical preparations of neomycin, framycetin or gentamicin, the potential for a similar effect with neomycin and other aminoglycosides administered topically cannot be ruled out.
Paediatric Population
Although it is unlikely that infants will be treated with Sofradex for prolonged periods, there is a risk of adrenal suppression, even without occlusive dressings, after prolonged treatment of these patients with topical steroids.
4.5. Interaction with other medicinal products and other forms of interaction
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.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is inadequate evidence of safety in human pregnancy. Sofradex should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human fetus.
There is a risk of foetal ototoxicity if aminoglycoside antibiotics preparations are administrated during pregnancy.
Breast-feeding
The product should be used during breast-feeding only if the potential benefits to the mother outweigh the potential risks, including those to the breast-fed child.
4.7. Effects on ability to drive and use machines
Sofradex Ear/eye drops solution may cause transient blurring of vision on instillation. Patients must not drive or operate hazardous machinery unless vision is clear.
4.8. Undesirable effects
The following CIOMS frequency rating is used: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data).
Eye disorders:
Not known: blurred vision, glaucoma (see also section 4.4)
Topical steroid use may result in increased intraocular pressure leading to optic nerve damage, reduced visual acuity and visual field defects.
Intensive or prolonged use of topical corticosteroids may lead to formation of posterior subcapsular cataracts.
In those diseases causing thinning of the cornea or sclera, corticosteroid therapy may result in the thinning of the globe leading to perforation.
Immune system disorders:
Not known: Hypersensitivity reactions, usually of the delayed type, may occur leading to irritation, burning, stinging, itching and dermatitis.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Long-term intensive topical use may lead to systemic effects.
Oral ingestion of the contents of one bottle (up to 10ml) is unlikely to lead to any serious adverse effects.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Dexamethasone sodium metasulfobenzoate, Framycetin sulfate, Gramicidin. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- DEXAMETAZONA ROMPHARM 1mg/ml prescription partial — not the same combinationDEXAMETHASONUM · eye / ear / nose
- ETACORTILEN 1,5 mg/ml prescription partial — not the same combinationDEXAMETHASONUM · eye / ear / nose
- MAXIDEX 1 mg/ml prescription partial — not the same combinationDEXAMETHASONUM · 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 Dexamethasone sodium metasulfobenzoate, Framycetin sulfate, Gramicidin. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Dexamethason WZF 0,1% partial — not the same combinationDexamethasonum · eye / ear / nose
- Dexafree partial — not the same combinationDexamethasoni phosphas · eye / ear / nose
- Dexaprotect partial — not the same combinationDexamethasoni phosphas · eye / ear / nose
- Darazur partial — not the same combinationDexamethasoni phosphas · 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 Sofradex Ear/Eye Drops, Solution. 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.