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.
Betamethasone 0.1% w/v 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 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 .
Betamethasone Drops contain Betamethasone Sodium Phosphate which belongs to a group of medicines called corticosteroids. These are used to relieve redness and swelling. Betamethasone Drops are used to treat redness and swelling of the eyes, nose and ears. .
What you need to know before you take it
e Betamethasone Drops .
Do not use Betamethasone Drops if you are:
- allergic (hypersensitive) to Betamethasone Sodium Phosphate or to any of the other ingredients of this medicine (listed in section 6). Do not use in your eyes if you:
- have a viral infection of the eye
- have a fungal infection of the eye
- have tuberculosis of the eye
- have an eye infection that is producing pus
- suffer from raised pressure in your eye(s) (glaucoma)
- suffer from herpes in your eye(s)
- have undiagnosed red eye(s)
- are wearing soft contact lenses. These should be removed whilst you are using Betamethasone Drops. Do not use in your ears if you have:
- a hole in your ear drum If any of the above apply please tell your doctor or pharmacist. Take special care with Betamethasone Drops:
- Do not use Betamethasone Drops for a prolonged period of time (more than 7 days) as this may cause serious side effects, particularly in children. (see section 4 of this leaflet)
- You should be aware that if you are using Betamethasone Drops in your eyes your doctor may need to check your eyes frequently during your treatment
- if the patient has an untreated nasal infection, has pulmonary tuberculosis or after nasal surgery. .
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Other medicines and Betamethasone Drops Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, before you use this medicine. If you have any doubts about whether this medicine is suitable for you, consult your doctor or pharmacist. Pregnancy and breast-feeding This medicine should be avoided if you are pregnant, trying to become pregnant or breastfeeding, unless your doctor has recommended it. Driving and using machines Betamethasone Drops can cause temporary blurring of vision after application to the eye. Wait until your vision is clear whilst driving or using machines. Betamethasone Drops contains benzalkonium chloride 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. .
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3. How to use Betamethasone Drops .
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. How much to use For adults, the elderly and children For use in the eye: The usual starting dose is one or two drops to be put into the eye every two hours. Your doctor may reduce the dose once the condition of your eye has begun to improve. For use in the ear: The usual starting dose is two or three drops put into the ear every three to four hours. Your doctor may reduce the dose once the condition of your ear has begun to improve. .
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For use in the nose: The usual dose is two or three drops into each nostril twice daily or as required. Instructions for use Instructions for use in the eye: If you wear soft contact lenses these must be removed during treatment of the eyes with Betamethasone Drops. 1. Before opening a new bottle of Betamethasone Drops, please check that the safety strip on the bottom of the outer cap is unbroken. 2. Twist the outer cap to break the seal. 3. After cap is removed, if the tamper evident snap collar is loose, please remove before using the product. Take care not to touch the end of the nozzle. 4. Wash your hands well before use. 5. If you are putting in the drops yourself you should use a mirror. 6. Tilt your head back and look up at the ceiling. 7. Pull the lower lid of the eye out to form a small pocket between your eyelid and your eye. 8. Hold the container between the thumb and middle finger of the other hand, turn the bottle upside down near to your eye, try not to touch your eye with the nozzle. 9. Apply enough pressure to the container to release one to two drops, or as directed by your doctor. 10.Blink your eye a few times. 11.If you think that you have missed your eye, then insert another drop 12.Repeat steps 5-10 in the other eye, if you have been told to use BetamethasoneDrops in both eyes. 13.Replace the outer cap on the bottle, trying not to touch the applicator tip with anything, including the eye or your fingers 14.Wash your hands .
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Instructions for use in the ear 1. Wash your hands well before use 2. Remove the outer cap on the bottle 3. Insert the nozzle into the affected ear and apply drops as advised by your doctor 4. Repeat steps 1-3 in the other ear, if you have been told to use Betamethasone Drops in both ears 5. Replace the outer cap on the bottle, trying not to touch the applicator tip with anything, including your fingers 6. Wash your hands Instructions for use in the nose 1. Wash your hands well before use 2. Remove the outer cap on the bottle 3. Tilt your head back and pour into each nostril drop by drop 4. Replace the outer cap on the bottle, trying not to touch the applicator tip with anything, including your fingers 5. Wash your hands
- If there is no improvement in your symptoms after 7 days, stop using the drops and see your doctor again.
- Discard 4 weeks after opening If you are unsure about how to use Betamethasone Drops talk to your doctor or pharmacist. If you use more Betamethasone Drops than you should If you are at all concerned that you have used too much of this medicine contact your doctor or pharmacist. Betamethasone Drops are for external use only. If you have swallowed or you suspect someone else has swallowed any, contact your doctor or pharmacist. If you forget to use Betamethasone Drops If you have just missed using your dose and it is a long time until your next dose is due, put in the missed dose now and continue the course of treatment. If it is near the time for using your next dose wait and use this dose at the correct time. Do not take a double dose to make up for one you have missed. .
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If you stop using Betamethasone Drops You should keep using Betamethasone Drops for as long as your doctor has instructed. Your treatment is helping your condition, even if you have not noticed a difference in how you feel. Should you need to stop your treatment, your doctor will advise you how to do this.
How to take it
Betamethasone Drops 4. Possible side effects. 5. How to store Betamethasone Drops
Possible side effects
you should tell your doctor immediately. These are symptoms of an allergic reaction.
- difficulty in breathing with or without swelling of the face, lips, tongue and/or throat
- swelling of the face, lips tongue and/ or throat, which may cause difficulty in swallowing
- severe itching of the skin (with raised lumps). Other possible side effects include:
- irritation, burning, itching and stinging in the area. This may occur after treatment has stopped.
- raised pressure in the eye (only when used in the eye)
- pupil dilation, drooping of the eyelid, corneal inflammation, sneezing, headache, light headedness, nausea, nosebleeds, rebound congestion, nasal discomfort, disturbance to sense of smell, disturbance to sense of taste, stunted growth in children Where you suffer from a disease (other than that for which you are using Betamethasone Drops) that causes thinning of the surface of the eye, serious damage may be caused. Prolonged use of this medicine (for more than 7 days) can lead to cloudiness of the lens of the eye (cataracts), it is therefore advised that the lens of the eye is checked frequently during use of this medicine. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 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 on the MHRA website www.mhra.gov.uk/ yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine. .
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Continued overleaf
D06444
100mm Measurement Verification Bar
6444-B
DEVELOPMENT ARTWORK Component Code: D06444 Prod: Betamethasone Sodium Phosphate 0.1% w/v PIL UK PL 00156/0083 Eye drops Paper Size: 135 x 220mm Version Control
Date
By
Version A:
27/03/25
RP
Version B:
03/04/25
RP
Version C: Version D: Version E: Version F: Version G: Version H: Version I: Version K: Version L: Version M: Version N: Version O: me&you The Old Printworks, High Street, Otford, Sevenoaks, Kent. TN14 5PQ t: +44 (0) 1732 743 455 e: [email protected] www.meandyou.co.uk
How to store it
Betamethasone Drops Keep this medicine out of the sight and reach of children. Make sure the container is properly closed after each use. Store Betamethasone Drops in the original container away from direct light. Store below 25°C. Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Dispose of this medicine 4 weeks after opening 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. Content of the pack and other information. What Betamethasone Drops contain The active substance is betamethasone sodium phosphate 0.1%w/v The other ingredients are benzalkonium chloride solution, disodium edetate, sodium phosphate and purified water. What Betamethasone Drops look like and contents of the pack Betamethasone Drops are a clear, colourless and sterile solution supplied in a plastic dropper bottle with a cap. Each bottle contains 5 or 10ml of the solution. Marketing Authorisation Holder: Martindale Pharmaceuticals Ltd Bampton Road Harold Hill Romford RM3 8UG United Kingdom Manufacturers: Famar A.V.E Alimos Plant 63, Agiou Dimitriou str, Alimos, Attiki 17456, Greece If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address. This leaflet was last revised in April 2025 Product License Number: PL 00156/0083
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4. Possible side effects .
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following
Frequently asked questions about Betamethasone 0.1% w/v Drops
How do I take Betamethasone 0.1% w/v Drops?
Betamethasone 0.1% w/v 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 Betamethasone 0.1% w/v Drops?
The active substance in Betamethasone 0.1% w/v Drops is betamethasone sodium phosphate.
Are there equivalent medicines to Betamethasone 0.1% w/v Drops?
Medicines with the same active substance, strength and form include: Betnesol Eye, Ear and Nose Drops Solution 0.1% w/v. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Betamethasone 0.1% w/v 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 Betamethasone 0.1% w/v 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: 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
For the topical treatment of inflammatory non-infected conditions of the eye, ear or nose.
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. After more prolonged treatment (over 6 to 8 weeks), the drops should be withdrawn slowly to avoid relapse.
Dosage schedule:
Administration for topical ocular use.
Adults, Elderly and Children:
Initially one or two drops to be instilled into the affected eye(s) every two hours. Frequency of administration should be reduced once the condition is under control.
Administration for topical otic use.
Adults, Elderly and Children:
Initially two or three drops to be instilled into the affected ear(s) every three to four hours. Frequency of administration should be reduced once the condition is under control.
Administration for topical nasal use.
Adults, Elderly and Children:
Two or three drops to be instilled into each nostril twice daily as required.
4.3. Contraindications
Hypersensitivity to any of the preparations components. Bacterial, Viral, fungal, tuberculous or purulent conditions of the eye. Use is contraindicated if Glaucoma is present or Herpetic keratitis (e.g. dendritic ulcer), is considered a possibility. Use of topical steroids in this condition can lead to extension of the ulcer and marked visual deterioration. Otitis externa should not be treated when the eardrum is perforated due to the risk of ototoxicity.
4.4. Special warnings and precautions for use
Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding.
Prolonged use may lead to the risk of adrenal suppression in infants. Ophthalmological treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.
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.
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.
This medicine contains 0.02 % w/v benzalkonium chloride in each 10 ml of solution which is equivalent to 0.2 mg/ml.
4.5. Interaction with other medicinal products and other forms of interaction
Vistamethasone / Betamethasone drops contain benzalkonium chloride as a preservative and therefore, should not be used 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. Fertility, 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 abnormal foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such defects in the human foetus.
4.7. Effects on ability to drive and use machines
May cause transient blurring of vision on instillation into the eye.
Betamethasone Sodium Phosphate has moderate influence on the ability to drive and use machine.
4.8. Undesirable effects
Hypersensitivity reactions, usually of the delayed type, may occur leading to irritation, burning, stinging, itching and dermatitis.
Use of topical corticosteroids 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 the 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, light headedness, 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.
💬 Ask about this leaflet
Ask anything about Betamethasone 0.1% w/v 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.