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.
Entocort Enema
⚠ 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 Budesonide 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 Entocort Enema contains a medicine called budesonide. This belongs to a group of medicines called 'corticosteroids'. These are used to reduce inflammation. • •
An enema is a liquid that is inserted into the back passage (rectum). Entocort Enema is used to treat inflammation and ulcers in the large intestine (colon) and rectum. This is known as ulcerative colitis.
What you need to know before you take it
e Entocort Enema Do not use Entocort Enema: If you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using Entocort Enema:
- If you have recently had a bowel infection.
- If you have ever had liver problems.
- If you or a member of your family has ever had mental health problems. Contact your doctor if you experience blurred vision or other visual disturbances. Other medicines and Entocort Enema Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines.
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This is because Entocort Enema can affect the way some medicines work and some medicines can have an effect on Entocort Enema. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Steroid medicines, such as prednisolone or dexamethasone.
- Ketoconazole or itraconazole, used to treat infections caused by a fungus.
- Medicines that contain oestrogen, such as hormone replacement therapy (HRT) and some oral contraceptives.
- Some medicines may increase the effects of Entocort Enema and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). Diagnostic tests for pituitary glands activity may show false low values due to suppression of the adrenal function. 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. Driving and using machines Entocort Enema is not likely to affect you being able to drive or use any tools or machines. Entocort Enema contains propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218) and lactose Entocort Enema contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218), these may cause allergic reactions (possibly delayed). Entocort Enema also contains lactose, a type of sugar, which some people may be intolerant to. If you have been told by your doctor that you have an intolerance to some sugars, please talk to your doctor before using this medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
How to take it
Entocort Enema Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Entocort Enema should only be used in your back passage (rectum), as directed by your doctor. Use in children Entocort Enema is not recommended for use by children. When to use Entocort Enema and how long to use it for
- It is important to use each enema at the right time.
- Usually this will be once a day, just before bedtime.
- Normally, your treatment will last for 4 weeks. However, your doctor may decide that you need to use Entocort Enema for longer.
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Parts of Entocort Enema To prepare your enema for use, you need to be familiar with the following parts of the Entocort Enema carton:
Preparing Entocort Enema for use To prepare one enema, dissolve one tablet in one bottle of liquid. To do this, follow the instructions below: 1. Unscrew the cap of one of the plastic bottles.
2. Take one of the tablets from its foil strip and drop the tablet into the bottle.
3. Replace the cap back onto the bottle and screw the cap tightly.
4. Shake the bottle well for at least 15 seconds, or until you cannot see the tablet in the liquid any more.
5. Unscrew the cap. 6. Unpack the nozzle and screw the nozzle on the bottle.
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7. The enema is now ready and should be used immediately. The nozzle can be lubricated if use is uncomfortable. • •
You will find it more comfortable to use Entocort Enema if you empty your bowels and bladder before using it. Entocort Enema can stain your bedclothes or bedding.
Inserting the enema into your back passage To insert the enema into your back passage, follow the instructions below: 1. Shake the bottle again. Then only take off the protective cap. This will reveal the nozzle. 2. Undress from the waist down, then lie down on your side. Choose whichever side is most comfortable. Try to lie down so that your bottom is slightly higher than the rest of your body. For example, you can raise the bottom of the bed onto blocks or place one or two pillows under your bottom. This will help to keep the liquid in your back passage. 3. If you wish, hold the bottle using one of the plastic bags.
4. Gently ease the nozzle into your back passage as far as is comfortable. 5. Squeeze the bottle, this will push most of the liquid into your back passage. However, you will not be able to empty the whole bottle. It has been designed to keep some liquid after being used. 6. Then remove the nozzle from your back passage. 7. If you used a plastic bag, remove it from your hand by pulling it forward over the bottle. This will leave the bottle inside the bag, ready to be disposed of.
8. Now, roll over onto your stomach. Stay like this for 5 minutes to stop any liquid coming out of your back passage. 9. Then, find a comfortable position to sleep in that helps you to keep the liquid in your back passage for as long as possible.
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Entocort Enema is a 'retention enema'. This means that the liquid is meant to be held in the back passage for as long as possible. The longer it is kept there the more time it has to work and the better the results should be. If you use more Entocort Enema than you should If you use more enemas than prescribed by your doctor, talk to a doctor or pharmacist straight away. If you forget to use Entocort Enema
- If you forget a dose of Entocort Enema, use it 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 (two doses at the same time) to make up for a forgotten dose. If you stop using Entocort Enema Do not stop using Entocort Enema without talking to your doctor first. If you stop using your enema suddenly, it may make you ill.
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If you have an allergic reaction, see a doctor straight away. The signs may include raised lumps on your skin (weals), or swelling of your face, lips, mouth, tongue or throat. This may make it difficult to breathe. Other possible side effects: Common: may affect up to 1 in 10 people
- Depression.
- Upset stomach or gut such as stomach pains, wind, diarrhoea, heartburn and feeling sick.
- Skin reactions such as lumpy rash and skin rash. Uncommon: may affect up to 1 in 100 people
- Feeling agitated.
- Difficulty sleeping.
- Anxiety.
- Unintentional movements or extreme restlessness possibly accompanied by muscle spasms or twitching.
- Ulcers in the stomach or duodenum. Rare: may affect up to 1 in 1,000 people
- An effect on the adrenal gland (a small gland near the kidney).
- Glaucoma (increased pressure in the eye).
- Blurred vision
- Aggression.
- Clouding of the eye's natural lens including the back of the lens.
- Inflamed pancreas (associated with pain in upper abdomen and back and feeling sick).
- Skin discoloration resulting from bleeding beneath the skin.
- Death of bone tissue caused by loss of blood supply to the bone.
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Very rare: may affect up to 1 in 10,000 people
- A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing or shock. Not known (frequency cannot be estimated from the available data)
- Allergic reactions which can cause swelling of the face, particularly eyelids, lips, tongue or throat (angioedema). Medicines like Entocort Enema (corticosteroids) can affect the normal production of steroid hormones in your body. The effects include:
- Changes in bone mineral density (thinning of the bones).
- Glaucoma (increased pressure in the eye).
- A slowing of the rate of growth of children and adolescents.
- An effect on the adrenal gland (a small gland near the kidney). Most of the side effects mentioned in this list can also be expected with other glucocorticoids treatment. Mental health problems can happen while taking steroids like Entocort Enema. Talk to a doctor if you (or someone taking this medicine), show any signs of mental health problems. This is particularly important if you are depressed, or might be thinking about suicide. Very rarely mental health problems have happened when high doses have been taken for a long time. Do not be concerned by this list of possible side effects. You may not get any of them. 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, pharmacist or nurse. This includes any possible
Possible side effects
not listed in this leaflet. You can also report side effects directly 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.. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Entocort Enema
- Keep this medicine out of the sight and reach of children.
- Do not store this medicine above 30°C.
- Do not use this medicine after the expiry date which is stated on the bottle or foil after EXP. The expiry date relates to the last day of that month.
- 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 Entocort Enema contains The active substance is budesonide. Each bottle provides a dose of approximately 2 mg of budesonide at a concentration of 0.02 mg of budesonide per ml of solution.
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The other ingredients are lactose anhydrous, polyvidone, riboflavine sodium phosphate, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, sodium chloride, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and water purified. What Entocort Enema looks like and contents of the pack Entocort Enema, once prepared, is a whitish yellow liquid. Entocort Enema comes in a box containing the following: • • • •
7 tablets wrapped in foil, inside a small box. 7 plastic bottles containing solution. 7 nozzles (enema applicators) 7 plastic bags to be used when giving the enema.
Marketing Authorisation Holder and Manufacturer The Marketing Authorisation for Entocort Enema is held by Tillotts UK Ltd., The Stables, Wellingore Hall, Wellingore, Lincoln, UK LN5 0HX, Tel: +44 1522 813500, e-mail: [email protected] Entocort Enema is manufactured by Lusomedicamenta, Sociedade Técnica Farmacêutica, SA, Estrada Consiglieri Pedroso, 66, 69 B, Queluz de Baixo, 2730-055 Barcarena, Portugal Tillotts Pharma GmbH, Warmbacher Str. 80, 79618 Rheinfelden, Germany
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: Product name Entocort Enema Reference number 36633/0007 This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in March 2023. GI 14 0030
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Frequently asked questions about Entocort Enema
What is the active substance in Entocort Enema?
The active substance in Entocort Enema is budesonide.
Are there equivalent medicines to Entocort Enema?
Medicines with the same active substance, strength and form include: Pulmicort Turbohaler 100, Pulmicort Turbohaler 200, Pulmicort Turbohaler 400. 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 Entocort Enema, 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 Entocort Enema 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: budesonide
- 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
Ulcerative colitis involving rectal and recto-sigmoid disease.
4.2. Posology and method of administration
Posology
Adults:
One Entocort Enema nightly for 4 weeks. Full effect is usually achieved within 2–4 weeks. If the patient is not in remission after 4 weeks, the treatment period may be prolonged to 8 weeks.
Paediatric population
Children: Not recommended.
Elderly
Dosage as for adults.
No dosage reduction is necessary in patients with reduced liver function.
Method of administration
The route of administration is rectal.
Instructions for correct use of Entocort enema.
Entocort enema consists of a dispersible tablet, a vehicle in a bottle and an individually packed nozzle for the application of the enema.
Note: it is important to instruct the patient
• To carefully read the instructions for use in the patient information leaflet which are packed together with each product.
• To reconstitute the enema immediately before use, put one dispersible tablet into the vehicle bottle, then shake the bottle vigorously for at least 15 seconds or until the tablet is completely dissolved.
• To administer in the evening before going to bed.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Side effects typical of systemic corticosteroids may occur. Potential systemic effects include glaucoma.
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.
When patients are transferred from systemic glucocorticosteroid treatment with higher systemic effect to Entocort enema, they may have adrenocortical suppression. Therefore, monitoring of adrenocortical function may be considered in these patients and their dose of systemic steroid should be reduced cautiously.
Replacement of high systemic effect glucocorticosteroid treatment with Entocort enema sometimes unmasks allergies, e.g. rhinitis and eczema, which were previously controlled by the systemic drug.
Reduced liver function affects the elimination of glucocorticosteroids, causing lower elimination rate and higher systemic exposure. Be aware of possible systemic side effects. The pharmacokinetics after oral ingestion of budesonide was affected by compromised liver function as evidenced by increased systemic availability in patients with moderately severe hepatic cirrhosis.
Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis (See section 4.8). Systemic effects of steroids may occur, particularly when prescribed at high doses and for prolonged periods. Such effects may include Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and very rarely a wide range of psychiatric/ behavioural effects (see Section 4.8).
Co-treatment with CYP3A inhibitors, including ketoconazole and 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. If this is not possible, the period between treatments should as long as possible, and a reduction of the budesonide dose could also be considered (see section 4.5).
Entocort enema contains the excipients lactose and methyl-, propyl-parahydroxybenzoate, therefore caution should be taken in patients with hypersensitivity to these excipients.
Some patients may feel unwell in a non-specific way during the withdrawal phase, e.g. pain in muscles and joints. A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases a temporary increase in the dose of systemic glucocorticosteroids is sometimes necessary.
When Entocort Enema is used chronically in excessive doses, systemic glucocorticosteroid effects such as hypercorticism and adrenal suppression may appear. However, the dosage form and the route of administration make any prolonged overdosage unlikely.
4.5. Interaction with other medicinal products and other forms of interaction
Raised plasma concentrations of and enhanced effects of corticosteroids have been reported in women also treated with oestrogens and contraceptive steroids. However, a low-dose combination oral contraceptive that more than doubled the plasma concentration of prednisolone, had no significant effect on the plasma concentration of oral budesonide.
The metabolism of budesonide is primarily mediated by CYP3A4, one of the cytochrome P450 enzymes.
Inhibitors of this enzyme, e.g. ketoconazole, itraconazole and HIV protease inhibitors, can therefore increase systemic exposure to budesonide several times (see Sections 4.4 and 5.2). Since there is no data to support a dosage recommendation, the combination should be avoided. If this is not possible, the period between treatments should as long as possible, and a reduction of the budesonide dose could also be considered. Other potent inhibitors of CYP3A4 are also likely to markedly increase plasma levels of budesonide. Inhibition by budesonide on other drugs metabolism via CYP3A4 is unlikely, since budesonide has low affinity to the enzyme.
Concomitant treatment with CYP3A4 inducers such as carbamazepine probably reduces budesonide exposure, which may require a dose increase.
Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).
4.6. Fertility, pregnancy and lactation
Pregnancy
The ability of corticosteroids to cross the placenta varies between individual drugs, however, in mice, budesonide and/or its metabolites have been shown to cross the placenta.
In pregnant animals, administration of budesonide, like other glucocorticosteroids, is associated with abnormalities in foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate/lip in humans. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. When corticosteroids are essential however, patients with normal pregnancies may be treated as though they were in the non-gravid state.
As with other drugs the administration of Entocort enema during pregnancy requires that the benefits for the mother are weighed against the risk for the foetus.
Breast-feeding
Budesonide is excreted in breast milk.
Maintenance treatment with inhaled budesonide (200 or 400 micrograms twice daily) in asthmatic nursing women results in negligible systemic exposure to budesonide in breast-fed infants.
In a pharmacokinetic study the estimated daily infant dose was 0.3% of the daily maternal dose for both dose levels, and the average plasma concentration in infants was estimated to be 1/600th of the concentrations observed in maternal plasma, assuming complete infant oral bioavailability. Budesonide concentrations in infant plasma samples were all less than the limit of quantification.
Based on data from inhaled budesonide and the fact that budesonide exhibits linear PK properties within the therapeutic dosage intervals after inhaled, oral and rectal administrations, at therapeutic doses of budesonide, exposure to the suckling child is anticipated to be low.
Infants of mothers taking higher than recommended doses of budesonide may have a degree of adrenal suppression.
These data support continued use of budesonide, oral and rectal administrations during breast-feeding.
4.7. Effects on ability to drive and use machines
Entocort Enema has no influence on the ability to drive and operate machinery.
4.8. Undesirable effects
The following definitions apply to the incidence of undesirable effects: Very Common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000).
Adverse drug reactions by frequency and system organ class (SOC)
SOC
Frequency
Reaction
Immune system disorders
Very rare
Anaphylactic reaction
Unknown
Hypersensitivity reactions such as angioedema
Endocrine disorders
Rare
Signs or symptoms of systemic glucocorticosteroid effects, including hypofunction of the adrenal gland
Psychiatric disorders
Common
Depression
Uncommon
Agitation, insomnia, anxiety,
Rare
Aggression
Nervous system disorders
Uncommon
Psychomotor hyperactivity
Eye disorders
Rare
Glaucoma, cataract including subcapsular catarct, blurred vision (see also section 4.4)
Gastrointestinal disorders
Common
Gastrointestinal disturbances, e.g., flatulence, nausea, diarrhoea
Uncommon
Duodenal or gastric ulcer
Rare
Pancreatitis
Skin and subcutaneous tissue disorders
Common
Skin reactions (urticaria, exanthema)
Rare
Ecchymosis
Musculoskeletal and connective tissue disorders
Rare
Osteonecrosis
Most of the adverse events mentioned in this SmPC can also be expected for other treatments with glucocorticoids.
Description of selected adverse events
In rare cases signs or symptoms of systemic glucocorticosteroid effects, including hypofunction of the adrenal gland, may occur with rectally administered glucocorticosteroids, probably depending on dose, treatment time, concomitant and previous glucocorticosteroid intake, and individual sensitivity.
Very rarely a wide range of psychiatric/ behavioural effects may occur, when systemic steroids are prescribed at high doses and for prolonged periods. (See 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: https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App.
4.9. Overdose
Reports of acute toxicity and/or death following overdosage of glucocorticosteroids are rare. Thus, acute overdosage with Entocort Enema, even in excessive doses, is not expected to be a clinical problem. In the event of acute overdosage, no specific antidote is available. If, by mistake, high doses of Entocort dispersible tablet have been taken orally, treatment consists of immediate gastric lavage or emesis followed by supportive and symptomatic therapy.
💬 Ask about this leaflet
Ask anything about Entocort Enema. 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.
Medicines containing Budesonide
- Benacort 64 micrograms Nasal Spray
- Benacort Hayfever Relief for Adults 64 micrograms, nasal spray
- Budelin Novolizer 200 micrograms per actuation inhalation powder
- Budenofalk 2mg/dose rectal foam
- Budenofalk 3mg gastro-resistant capsules
- Budenofalk 4mg suppositories
- Budenofalk 9mg gastro-resistant granules
- Budesonide 0.5mg nebuliser suspension
- Budesonide 1mg nebuliser suspension
- Budesonide CR 3 mg Capsules
- Budesonide Dr. Falk Pharma 4 mg suppositories
- Cortiment 9 mg, prolonged release tablets
- Easyhaler Budesonide 100 mcg
- Easyhaler Budesonide 200 mcg