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.
Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear 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 Prednisolone 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
Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear Drops, Solution (referred to as Prednisolone Sodium Phosphate drops in this leaflet) contains 0.5% w/v of Prednisolone Sodium Phosphate. It belongs to a group of medicines called corticosteroids ('steroids' for short). Prednisolone Sodium Phosphate Drops work by reducing inflammation (redness, itching and soreness). Prednisolone Sodium Phosphate Drops is used to treat inflammation of the eye or ear where there is no infection. 2.
What you need to know before you take it
e Prednisolone Sodium Phosphate Drops
Do not use Prednisolone Sodium Phosphate Drops: if you are allergic to Prednisolone Sodium Phosphate or any of the other ingredients of this medicine (listed in section 6) if you have an infection in the eye, or it is producing pus and is sticky if you have glaucoma (increased pressure in the eye) if you have ulcers in your eye (shingles) if you have a fungal disease in your ear if you have a perforated ear drum. Warnings and precautions 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. Talk to your doctor or pharmacist before using Prednisolone Sodium Phosphate Drops
- if you have been treated with Prednisolone Sodium Phosphate or similar corticosteroid drops recently. Do not have repeated or prolonged treatment without regular checkups from your doctor
- if you have tuberculosis (TB)
- if you wear soft contact lenses (see other medicines and Prednisolone Sodium Phosphate Drops below) Systemic effects of nasal corticosteroids: Prolonged use at high doses may cause: 1
–
Cushing's syndrome (a hormonal disorder caused by high levels of cortisol), Cushingoid features such as facial roundness or puffiness, adrenal suppression, cataract and glaucoma. Rarely, a range of psychological effects including psychomotor hyperactivity (a feeling of restlessness, muscle spasms, twitches), sleep disorders, anxiety.
Children
- prolonged use may lead to the risk of adrenal suppression in infants
- growth retardation in children and adolescents
- depression or aggression (particularly in children) Other medicines and Prednisolone Sodium Phosphate Drops Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription. This medicine contains benzalkonium chloride as a preservative which may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses. Some medicines may increase the effects of Prednisolone Sodium Phosphate Drops and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat) Pregnancy, breast-feeding and fertility 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 taking this medicine. There is a small risk of cleft palate or retarded growth in the foetus. Driving and using machines Prednisolone Sodium Phosphate Drops may cause temporary blurred vision. If this happens to you, do not drive or use machinery until your sight returns to normal. Warnings about visual problems when using Prednisolone Sodium Phosphate Drops Contact your doctor if you experience blurred vision or other visual disturbances. 3.
How to take it
Prednisolone Sodium Phosphate 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. 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 is not, or you are not sure, ask your doctor or pharmacist. Remember:
- Always use Prednisolone Sodium Phosphate 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.
- If there is no improvement in your symptoms after 7 days, stop using the drops and see your doctor again. Check that the seal on the bottle is not broken before using Prednisolone Sodium Phosphate Drops for the first time. Wash and dry your hands. Do not breathe on or touch the dropper nozzle. Eyes
- The recommended dose is 1 or 2 drops put into the eye every one or two hours
- Once the redness, itching and soreness starts to feel better, apply the drops less often. 2
1. Tilt your head back 2. Gently pull your lower eyelid downwards and outwards 3. Place drops in the gap between the eyelid 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. Ears
- The recommended dose is 2 or 3 drops put into the ear every two or three hours
- Once the redness, itching and soreness starts to feel better, apply the drops less often. 1. Tilt your 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. Medical check-ups 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:
- An increase in pressure
- Cataracts
- Infection. If you use more Prednisolone Sodium Phosphate Drops than you should If you accidentally use too much Prednisolone Sodium Phosphate Drops it is unlikely to lead to any serious side effects. However, if you are concerned, contact your doctor or the nearest hospital casualty department. 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 symptoms worse. If you forget to use Prednisolone Sodium Phosphate Drops Do not use a double dose to make up for a forgotten dose. Simply use the next dose as planned. If you stop using Prednisolone Sodium Phosphate Drops Do not stop using Prednisolone Sodium Phosphate Drops without first talking to your doctor. If you have been using Prednisolone Sodium Phosphate 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 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. Effects on your eyes Very rare: may affect up to 1 in 10,000 people 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. Frequency not known (cannot be estimated from the available data) –
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 3
–
Drooping of the eyelid Swelling and redness of the outer surface of the eye Blurred vision and other alterations to your sight.
Effects on the skin around your eyes Frequency not known (cannot be estimated from the available data) These may not appear until some time after you have started to use the medicine. –
Irritation Burning Stinging Itching Redness.
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 any side effects directly to the national reporting system 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 it
Prednisolone Sodium Phosphate 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. Do not use for longer than 28 days after the seal on the bottle has been broken. Store below 25°C. Do not Freeze. Store in the original package in order to protect from light. 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 Prednisolone Sodium Phosphate Drops contains
- The active substance is Prednisolone sodium phosphate (0.5 %)
- The other ingredients are benzalkonium chloride solution, sodium chloride, sodium acid phosphate, disodium edetate, sodium hydroxide, phosphoric acid, purified water. What Prednisolone Sodium Phosphate Drops looks like and contents of the pack Prednisolone Sodium Phosphate Drops is clear, colourless solution. It 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 11/2020. 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. 4
Frequently asked questions about Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear Drops, Solution
How do I take Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear Drops, Solution?
Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear Drops, Solution 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 Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear Drops, Solution?
The active substance in Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear Drops, Solution is prednisolone sodium phosphate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear 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 Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear 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: prednisolone 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
Prednisolone Sodium Phosphate Drops is indicated for short term treatment of steroid responsive inflammatory conditions of the eye after clinical exclusion of bacterial, viral and fungal infections and Non-infected inflammatory conditions of the ear.
4.2. Posology and method of administration
Adults and Children (including the Elderly)
Eyes
1 or 2 drops instilled into the eyes every one or two hours until control is achieved, when the frequency may be reduced.
Ears
2 or 3 drops instilled into the ear every two or three hours until control is achieved, when the frequency can be reduced.
Frequency of dosing depends on clinical response. If there is no clinical response within 7 days treatment, the drops should be discontinued. Treatment should be the lowest effective dose for the shortest possible time. After more prolonged treatment (over 6-8 weeks), the drops should be withdrawn slowly to avoid relapse.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Bacterial, viral, fungal tuberculous or purulent conditions of the eye. Use is contraindicated if glaucoma is present or where herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Inadvertent use of topical steroids in the latter condition can lead to the extension of the ulcer and marked visual deterioration.
In the ear, topical corticosteroids are contraindicated in patients with fungal diseases of the auricular structure, and in those with a perforated tympanic membrane.
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.
Ophthalmological treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.
The use of corticosteroids may reduce resistance to or mask the signs of infection. Appropriate anti-infective agents should be used if infection is present.
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, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders and anxiety.
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
Prolonged use may lead to the risk of adrenal suppression in infants. Potential systemic effects may include growth retardation in children and adolescents and more rarely a range of psychological or behavioural effects including depression or aggression (particularly in children).
4.5. Interaction with other medicinal products and other forms of interaction
Prednisolone Sodium Phosphate Drops contain benzalkonium chloride as a preservative and, therefore, should not be given 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
Pregnancy
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 be a very small risk of such effects in the human foetus.
Breastfeeding
There is insufficient information on the excretion of Prednisolone sodium phosphate / metabolites in human milk. A risk to the newborns / infants cannot be excluded.
Fertility
No fertility data is available.
4.7. Effects on ability to drive and use machines
Prednisolone Sodium Phosphate Drops has moderate influence on the ability to drive and use machines.
It may cause transient blurring of vision on instillation, warn patients not to drive or operate hazardous machinery until vision is clear.
4.8. Undesirable effects
Very rare (<1/10,000)
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.
Not known (frequency cannot be estimated from the available data)
Not known: Immune system disorders
Hypersensitivity reactions usually of the delayed type may occur leading to irritation, burning, stinging and itching.
Not known: Skin and subcutaneous tissue disorders
Dermatitis
Not known: Eye disorders
Topical corticosteroid use may result in increased intraocular pressure leading to optic nerve damage, reduced visual acuity and visual field defects. Other side effects include Chorioretinopathy, mydriasis, ptosis, epithelial punctate keratitis and possible corneal or scleral malacia. Within a few days after discontinuing topical ophthalmic corticosteroid therapy and occasionally during therapy, acute anterior uveitis has occurred in patients (mainly blacks) without pre-existing ocular inflammation or infection.
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.
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
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
- ULTRACORTENOL 5 mg/g prescriptionPREDNISOLONUM · eye / ear / nose
Same active substance. 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
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- EncortolonPrednisolonum · taken by mouth
- Cortico VeyxinPrednisoloni acetas · injection / infusion
- EquisolonPrednisolonum · taken by mouth
- DermipredPrednisolonum · taken by mouth
- PrednicortonePrednisolonum · taken by mouth
- HedylonPrednisolonum · taken by mouth
Same active substance. 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 Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear 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.