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 20 mg/dose Rectal Foam
⚠ 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 metasulphobenzoate 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 20 mg/dose Rectal Foam is a foam enema which is inserted into the rectum. Prednisolone 20 mg/dose Rectal Foam belongs to a group of medicines called corticosteroids which are used to reduce inflammation. This medicine is used to treat ulcerative colitis (inflammation of the bowels) and may be used to treat proctitis (inflammation of the rectum).
What you need to know before you take it
e Prednisolone 20 mg/dose Rectal Foam Do not use Prednisolone 20 mg/dose Rectal Foam:
- If you are allergic to prednisolone or any of the other ingredients of this medicine (listed in section 6).
- If you suffer from peritonitis (inflammation of the peritoneum – (abdominal lining)).
- If you suffer from bowel problems such as obstruction, perforation or rectal/colonic fistulae (abnormal connection between internal organs) or if you have a possible infection. If you think this may apply to you speak to your doctor. Warnings and precautions Talk to your doctor before using Prednisolone 20 mg/dose Rectal Foam:
- If you have scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15 mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. The doctor may advise that you have your blood pressure and urine regularly checked.
- If you suffer from severe ulcerative colitis this medicine may not be suitable for you and you should talk to your doctor before using it.
- The use of Prednisolone 20 mg/dose Rectal Foam may make diagnosing an infection more difficult, but your doctor should be aware of this. 130/L/s/8 1
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Contact your doctor if you experience blurred vision or other visual disturbances. This medicine is for application in the rectum only. It is not advisable to use Prednisolone 20 mg/dose Rectal Foam for a long period of time, but your doctor will be aware of this. Children and adolescents This medicine is not recommended for use in children (i.e. those under 18 years old). Other medicines and Prednisolone 20 mg/dose Rectal Foam You can use Prednisolone 20 mg/dose Rectal Foam whilst taking other medicines. Tell your doctor if you are taking, have recently taken or might take any other medicines. Some medicines may increase the effects of Prednisolone 20 mg/dose Rectal Foam 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 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. Prednisolone 20 mg/dose Rectal Foam contains cetostearyl alcohol and sorbic acid This may cause local skin reactions (e.g. contact dermatitis). Prednisolone 20 mg/dose Rectal Foam contains polysorbates Polysorbates can cause allergic reactions.
How to take it
Prednisolone 20 mg/dose Rectal Foam Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The recommended dose is: One metered-dose of Prednisolone 20 mg/dose Rectal Foam should be inserted rectally, using one of the applicator nozzles provided, once or twice daily for 2 weeks. Your doctor may decide to extend the treatment for a further 2 weeks. Administration This medicine has been designed for your maximum comfort and ease of use. Read these instructions carefully before using Prednisolone 20 mg/dose Rectal Foam for the first time. If you find it difficult to use Prednisolone 20 mg/dose Rectal Foam in a standing position an alternative is to administer while lying on your side with both legs bent up.
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Disposal The used nozzles should be disposed of in the plastic bag provided. If you forget to use Prednisolone 20 mg/dose Rectal Foam Do not worry if you miss a dose of Prednisolone 20 mg/dose Rectal Foam. Administer it as soon as you remember and then use your next dose at the usual time. Do not use more than 2 doses in one day. If you use more Prednisolone 20 mg/dose Rectal Foam than you should Overdosage by this route is unlikely, but if someone else takes your medicine or it is used incorrectly take the canister to your doctor and ask for advice. If you have any further questions on the use of this medicine, ask your doctor. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects
where the frequency is not known: Scleroderma renal crisis in patients already suffering from scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. Slow heart rate. 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
Prednisolone 20 mg/dose Rectal Foam 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 canister after 'EXP'. The expiry date refers to the last day of that month.
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Prednisolone 20 mg/dose Rectal Foam is supplied in a pressurised container containing a flammable propellant. Do not store above 25 ̊C. Protect from sunlight and do not expose to temperatures above 50 ̊C. Do not pierce or burn even after use. Do not spray on naked flame or any incandescent material. Do not store in a refrigerator. Discard after 14 doses have been used. 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 Prednisolone 20 mg/dose Rectal Foam contains The active substance is prednisolone metasulphobenzoate sodium. Each metered dose contains 31.4 mg of the active ingredient (equivalent to 20.0 mg of prednisolone). The other ingredients are cetomacrogol emulsifying wax, cetostearyl alcohol, oleyl alcohol, light liquid paraffin, phenoxyethanol, sorbic acid, polysorbate 20, disodium edetate, sodium hydroxide and purified water. (See end of Section 2 for further information on cetostearyl alcohol, sorbic acid and polysorbate 20). The propellant in Prednisolone 20 mg/dose Rectal Foam is Butane 48. What Prednisolone 20 mg/dose Rectal Foam looks like and contents of the pack Prednisolone 20 mg Rectal Foam is a white to pale cream coloured, metered-dose rectal foam supplied in a canister. Each canister contains enough product for 14 doses and comes supplied with disposable applicators and disposal bags. Marketing Authorisation Holder Essential Generics, 8a Crabtree Road, Egham, Surrey TW20 8RN, UK Manufacturer Copea Pharma Limited, 25 Compass West, Liverpool, Merseyside, L24 1YA, United Kingdom This leaflet was last revised in September 2025.
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Frequently asked questions about Prednisolone 20 mg/dose Rectal Foam
What is the active substance in Prednisolone 20 mg/dose Rectal Foam?
The active substance in Prednisolone 20 mg/dose Rectal Foam is prednisolone sodium metasulphobenzoate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Prednisolone 20 mg/dose Rectal Foam, 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 20 mg/dose Rectal Foam 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 metasulphobenzoate
- 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
Treatment of proctitis and ulcerative colitis.
4.2. Posology and method of administration
Posology
Adults and elderly patients:
One metered dose rectally once or twice daily for 2 weeks, extending treatment for a further 2 weeks when a good response is obtained. Use should be discontinued at the discretion of the physician once the disease is stable and under control.
Paediatric population:
Not recommended.
Method of administration:
For rectal use only.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Corticosteroids are contraindicated in local conditions where infection might be masked or healing impaired, e.g. peritonitis, fistulae, intestinal obstruction, perforation of the bowel.
4.4. Special warnings and precautions for use
This product should be used with extreme caution in the presence of severe ulcerative colitis. The possibility of masking local or systemic infection should be borne in mind when using this product.
Scleroderma renal crisis
Caution is required in patients with systemic sclerosis because of an increased incidence of (possibly fatal) scleroderma renal crisis with hypertension and decreased urinary output observed with a daily dose of 15 mg or more prednisolone. Blood pressure and renal function (s-creatinine) should therefore be routinely checked.
When renal crisis is suspected, blood pressure should be carefully controlled.
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.
Excipients
This medicinal product contains cetostearyl alcohol and sorbic acid which may cause local skin reactions, (e.g. contact dermatitis).
This medicinal product contains Polysorbates which can cause allergic reactions.
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
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities in foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
The consequences of systemic absorption should be considered if prednisolone rectal foam is used extensively over prolonged periods. As with all rectal corticosteroids, prolonged continuous use is undesirable.
Frequency 'not known': Scleroderma renal crisis*, bradycardia**, vision, blurred (see also section 4.4).
*see section c)
**following high doses
c) Scleroderma renal crisis
Amongst the different subpopulations the occurrence of scleroderma renal crisis varies. The highest risk has been reported in patients with diffuse systemic sclerosis. The lowest risk has been reported in patients with limited systemic sclerosis (2%) and juvenile onset systemic sclerosis (1%).
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Overdosage by this route is unlikely.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Prednisolone sodium metasulphobenzoate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- ULTRACORTENOL 5 mg/g prescription partial — not the same combinationPREDNISOLONUM · 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 Prednisolone sodium metasulphobenzoate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Encortolon partial — not the same combinationPrednisolonum · taken by mouth
- Cortico Veyxin partial — not the same combinationPrednisoloni acetas · injection / infusion
- Equisolon partial — not the same combinationPrednisolonum · taken by mouth
- Dermipred partial — not the same combinationPrednisolonum · taken by mouth
- Prednicortone partial — not the same combinationPrednisolonum · taken by mouth
- Hedylon partial — not the same combinationPrednisolonum · taken by mouth
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 Prednisolone 20 mg/dose Rectal Foam. 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.