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.
Betnesol-N Eye, Ear and Nose 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 Neomycin sulfate, Betamethasone sodium phosphate 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 Betnesol-N Drops belongs to a group of medicines called topical corticosteroids ('steroids' for short).
Betnesol-N Drops work by reducing inflammation (redness, itching and soreness). Topical means that they are used on the outside of the body and not taken by mouth or injection. Betnesol-N Drops also contain neomycin sulphate, an aminoglycoside antibiotic, which prevents bacterial infection developing. Betnesol-N Drops is used to treat inflammation of the eye, ear or nose when there may also be a risk of bacterial infection. It is important to use this medicine to prevent any damage to the delicate tissues of your eyes, ear or nose and to prevent any infection developing.
What you need to know before you take it
e Betnesol-N Drops Important: Never use this medicine in your eye without first checking with your doctor. If it is used for the wrong condition, it could lead to blindness. Do not use Betnesol-N Drops if:
- You are allergic to betamethasone
- You are allergic to any of the other ingredients of Betnesol-N Drops (listed in section 6)
- You have not checked your eye condition with your doctor first. If this medicine is used in your eye, for the wrong condition, it could lead to blindness.
- You have an infection in the eye, or it is producing pus and is sticky
- You have an infection in the ear or nose
- You have ulcers in your eye (shingles)
- You have glaucoma (increased pressure in the eye)
- You wear soft contact lenses
- You have a perforated ear drum. If any of the above applies to you talk to your doctor or pharmacist. Warnings and precautions Talk to your doctor or pharmacist before using this medicine if:
- You know you have (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.
- You have been treated with Betnesol-N drops or similar corticosteroid medicine recently. You should not use corticosteroids for a long time without regular medical checkups from your doctor
- You have redness in your eyes for which you do not know the cause. Steroid treatment must not be given unless the cause of the redness is known
- You have an infection of the lining of your nose, which is not being treated
- You have recently had surgery on your nose which has not yet healed
- You have tuberculosis (TB)
- You have thinning of the cornea or sclera (the tissues which cover the outer surface of the eye) y ) Using these drops p could lead to a hole in
the eyeball
- You are giving this medicine to an infant. Prolonged use in babies may cause the adrenal gland to stop working properly
- You are applying these drops to open wounds or damaged skin. The antibiotic component can cause permanent, partial or total deafness if used on open wounds or damaged skin. This possibility should be borne in mind if high doses are given to small children or infants. If any of the above applies to you talk to your doctor or pharmacist. Other medicines and Betnesol-N Drops Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines may increase the effects of Betnesol-N 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 breastfeeding If you are pregnant, trying to become pregnant or breastfeeding ask your doctor or pharmacist for advice before using Betnesol-N Drops. If you use these drops while pregnant there may be small risk of damage to the ear, cleft palate or retarded growth in the foetus.
Driving and using machines Betnesol-N Drops may cause temporary blurred vision and lightheadedness. If this happens to you, do not drive or use machinery until you return to normal. Warnings about the ingredients in Betnesol-N Drops This medicine contains:
- 0.005% w/v benzalkonium chloride in each dose. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time
- 0.23% w/v phosphates in each dose. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment. Warnings about visual problems when using Betnesol-N Drops Contact your doctor if you experience blurred vision or other visual disturbances.
How to take it
Betnesol-N Drops Important:Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist. Things to remember about your dose:
- Always use Betnesol-N exactly as your doctor has told you
- How often you use the drops will depend on how your body responds to the treatment
- Use as few drops as possible for the shortest possible time. Getting ready to use your medicine Check that the seal on the bottle is not broken before using Betnesol-N Drops for the first time. Wash and dry your hands. Do not breathe on or touch the dropper nozzle and do not touch the eyes, ear or nose with the dropper nozzle. If there is no improvement in your symptoms after 7 days, stop using the drops and see your doctor again. Using your medicine Eyes
- The usual dose is 1 or 2 drops put into the eye up to 6 times each day
- Once the redness, itching and soreness starts to feel better, apply the drops less often.
1. Tilt the head back 2. Gently pull lower eyelid downwards and outwards 3. Place drops in the gap between the lid and eye (squeeze bottle very gently if necessary) 4. Blink a few times to spread out the drops 5. Repeat for the other eye if needed. Medical checkups If you are using this medicine for your eyes and you use it for a number of weeks, your doctor may ask you to have check-ups. These are to make sure that your medicine is working properly and that the dose you are taking is right for you. Your doctor will check your eyes for: 1. An increase in pressure 2. Cataracts 3. Infection. Ears
- The usual dose is 2 or 3 drops put into the ear three or four times each day
- Once the redness, itching and soreness starts to feel better, apply the drops less often. 1. Tilt the head to one side 2. Place drops in the ear canal (squeeze bottle gently if necessary) 3. Keep head tilted for a minute or two to let the drops soak in 4. Repeat for other ear if needed.
Nose The usual dose is 2 or 3 drops put into each nostril two or three times each day. 1. Tilt head backwards 2. Place drops in nostril (squeeze bottle gently if necessary) 3. Keep head tilted and sniff gently to let the drops soak in 4. Repeat for other nostril if needed. Medical checkups Your doctor will regularly check the growth of children who are taking Betnesol-N by nose over a long period of time. If you use more Betnesol-N Drops than you should If you accidentally use too much Betnesol-N Drops it is unlikely to lead to any serious side effects. However, if you are concerned, contact the nearest hospital casualty department or your doctor. Accidental swallowing of the contents of one bottle (up to 10 ml) is unlikely to lead to any serious adverse events. It is important that you take your dose as stated on the pharmacist's label or as advised by your doctor. You should use only as much as your doctor recommends; using more or less may make your symptons worse. If you forget to use Betnesol-N Do not use a double dose to make up for a missed dose. Simply use the next dose as planned.
How to stop using Betnesol-N Drops Do not stop using Betnesol-N Drops without first talking to your doctor. If you have been using Betnesol-N Drops for a long period of time (around 6 to 8 weeks), then you should stop using it gradually, to avoid the inflammation coming back. If you have any further questions about the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines Betnesol-N Drops can cause side effects, although not everybody gets them. These may include:
- Ulcers on the surface of the eye (cornea). Tell your doctor if your eye becomes painful and if you have blurred vision which does not improve after a few minutes
- Increased pressure in the eye (glaucoma) which can lead to problems with your sight
- A hole in the eyeball (if you have a disease which causes thinning of the surface of the eye)
- Cataracts (clouding of the lens of the eye)
- Enlarged pupils
- Drooping of the eyelid
- Swelling and redness of the outer surface of the eye
- Blurred vision and other alterations to your sight
- In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build- up during treatment.
- Itchy, red or irritated skin. This may not appear until sometime after you have started to use the medicine
- A burning or stinging sensation on your skin. This may not appear until sometime after you have started to use the medicine
- Bugs may become resistant to the anti-biotic if using the drops for a long time. If you are using Betnesol-N Drops for your nose, you may also experience some of the following side effects:
- If you are a child, Betnesol-N Drops may slow your growth
- Difficulty breathing
- A hole or ulcers of the tissue that divides the nose (nasal septum)
- Irritation and dryness in the nose
- Sneezing
- Headache
- Lightheadedness
- Itching
- Feeling sick
- Nosebleeds
- Blocked nose
- Changes in your senses of smell and taste. Using too much of this medicine for a long time can prevent your adrenal gland from working properly and producing your body's own natural steroids (known as adrenal suppression). This means that when you stop using Betnesol-N Drops, you could experience the following effects:
- Low blood pressure which may make you feel faint
- Fever
- A runny nose
- Painful itchy skin
- Redness of the eye (conjunctivitis)
- Muscle and joint pain
- Weight loss. 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
Possible side effects
directly via Yellow Card Scheme on the MHRA 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
Betnesol-N Drops Keep out of the sight and reach of children. Do not use Betnesol-N Drops after the expiry date on the label. The expiry date refers to the last day of that month. The bottle should be disposed of 28 days after first opening, even if there is solution remaining. Store Betnesol-N Drops below 25oC and in the original carton to protect it from light. Do not freeze. Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.
Contents of the pack and other information
What Betnesol-N Drops contains The active substance is betamethasone sodium phosphate at a concentration of 0.1% w/v. Betnesol-N Drops also contain neomycin sulphate at a concentration on 0.5% w/v. The other ingredients are benzalkonium chloride, disodium edetate, polyethylene glycol 300, sodium formate, anhydrous sodium sulphate, disodium hydrogen phosphate anhydrous, sodium acid phosphate, sodium hydroxide or phosphoric acid and water for injections. What Betnesol-N Drops looks like Betnesol-N Drops is a colourless to pale yellow liquid. Betnesol-N Drops comes in 5 ml or 10 ml plastic bottles with a built-in nozzle and a tamper evident plastic cap. Marketing Authorisation Holder RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden. Manufacturer Excelvision, 27, rue de la Lombardière, ZI La Lombardière, 07100 Annonay. This leaflet was last revised in January 2021. If this leaflet is difficult to see or read or you would like it in a different format, please contact RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden.
Frequently asked questions about Betnesol-N Eye, Ear and Nose Drops
How do I take Betnesol-N Eye, Ear and Nose Drops?
Betnesol-N Eye, Ear and Nose Drops comes as 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 Betnesol-N Eye, Ear and Nose Drops?
The active substance in Betnesol-N Eye, Ear and Nose Drops is neomycin sulfate, betamethasone sodium phosphate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Betnesol-N Eye, Ear and Nose 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 Betnesol-N Eye, Ear and Nose 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: neomycin sulfate, betamethasone sodium phosphate
- 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
Eye
Short-term treatment of steroid responsive inflammatory conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of viral and fungal disease.
Ear
Otitis externa or other steroid responsive conditions where prophylactic antibiotic treatment is also required.
Nose
Steroid responsive inflammatory conditions where prophylactic antibiotic treatment is also required.
4.2. Posology and method of administration
The frequency of dosing depends on the clinical response. If there is no clinical response within 7 days of treatment, the drops should be discontinued.
Treatment should be the lowest effective dose for the shortest possible time. Normally, Betnesol-N Drops should not be given for more than 7 days, unless under expert supervision. After more prolonged treatment (over 6 to 8 weeks), the drops should be withdrawn slowly to avoid relapse.
Eyes
1 or 2 drops applied to each affected eye up to six times daily depending on clinical response.
Ears
2 or 3 drops instilled into the ear three or four times daily.
Nose
2 or 3 drops instilled into each nostril two or three times daily.
4.3. Contraindications
Viral, fungal, tuberculous or purulent conditions of the eye. Fungal infections of the nose or ear. Use is contra-indicated if glaucoma is present or herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Use of topical steroids in the latter condition can lead to an extension of the ulcer and marked visual deterioration.
Otitis externa should not be treated when the eardrum is perforated because of the risk of ototoxicity.
Corticosteroids should not be used in patients with a perforated tympanic membrane.
Hypersensitivity to any component of the preparation.
4.4. Special warnings and precautions for use
A patient information leaflet should be supplied with this product.
Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding.
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 infection due to the masking effect of the steroid. Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms.
Ophthalmological treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.
Aminoglycoside 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 topical ocular use, the possibility should be considered when high dose topical treatment is given to small children or infants.
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. While no cases were identified with neomycin, based on a shared mechanism of action there is the potential for a similar effect with neomycin. These mitochondrial mutations are rare, and the penetrance of this observed effect is unknown.
Nasal administration of corticosteroids is not advised if an untreated nasal infection is present or if the patient has pulmonary tuberculosis or following nasal surgery (until healing has occurred).
Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
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.
Excipients with specified warnings
This medicine contains 0.005% w/v benzalkonium chloride in each dose. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Contact lenses should be removed before using this medicine and reinserted 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially in patients with dry eyes or disorders of the cornea. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
This medicine contains 0.23% w/v phosphates in each dose. In patients suffering from severe damage to the cornea, phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
4.5. Interaction with other medicinal products and other forms of interaction
Betnesol-N Drops contain benzalkonium chloride as a preservative and therefore should not be used as eye drops to treat patients who wear soft contact lenses.
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. Pregnancy and lactation
Safety for use in pregnancy and lactation has not been established. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.
There is a risk of foetal ototoxicity if aminoglycoside antibiotic preparations are administered during pregnancy.
4.7. Effects on ability to drive and use machines
May cause transient blurring of vision on instillation. Patients should be warned not to drive or operate hazardous machinery unless vision is clear.
4.8. Undesirable effects
Hypersensitivity reactions, usually of the delayed type, may occur leading to irritation, burning, stinging, itching and dermatitis.
Topical corticosteroid use may result in corneal ulceration, 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 thinning of the globe leading to perforation.
Mydriasis, ptosis, epithelial punctate keratitis and glaucoma have also been reported following ophthalmic use of corticosteroids.
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Following nasal administration, the most common effects are nasal irritation and dryness, although sneezing, headache, lightheadedness, urticaria, nausea, epistaxis, rebound congestion, bronchial asthma, perforation of the nasal septum, ulceration of the nasal septum, anosmia, parosmia and disturbance to sense of taste have also been reported.
Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses.
It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid, if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should also be given to referring the patient to a paediatric specialist.
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 on the MHRA website 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.
Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence of higher than recommended doses being used then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Neomycin sulfate, Betamethasone sodium phosphate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- OPHTAMESONE 1 mg/ml prescription partial — not the same combinationBETAMETHASONUM · 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 Neomycin sulfate, Betamethasone sodium phosphate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Neomycinum Jelfa partial — not the same combinationNeomycini sulfas · 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 Betnesol-N Eye, Ear and Nose 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.