What it is and what it is used for

for Your doctor has decided that you or your child, need this medicine to help treat your, or their, condition. Prednisolone 10mg/ml Oral Solution (called Prednisolone Oral Solution throughout the rest of this leaflet) contains the active ingredient prednisolone. Prednisolone belongs to a group of medicines called steroids (the full name is corticosteroids). Corticosteroids occur naturally in the body and help to maintain health and wellbeing. Boosting your body with extra corticosteroid (such as prednisolone) is an effective way to treat various illnesses involving inflammation in the body. Prednisolone Oral Solution reduces this inflammation and lowers the body's immune response, which could otherwise go on making your condition worse. You must take this medicine regularly to get the maximum benefit from it. Prednisolone Oral Solution can be used: y to treat breathing difficulties associated with asthma; y to treat severe allergic reactions; y to treat illnesses which cause inflammation of the skin, small and medium sized arteries, muscles and joints (including rheumatoid arthritis); y to treat problems with your immune system, where the immune system attacks the cells in your body; y to treat certain kidney problems; y to treat certain illnesses resulting in inflammation of the bowels e.g. Bowel diseases such as ulcerative colitis or Crohn's disease; y to treat inflammation of the heart; y to treat problems with your blood including haemolytic anaemia (a disorder which breaks down red blood cells) and leukaemia; y to prevent rejection following an organ transplant.

What you need to know before you take it

e Prednisolone Oral Solution Do not use Prednisolone Oral Solution y if you are allergic to prednisolone or any of the other ingredients of this medicine (listed in section 6). Signs of a severe allergic reaction may include a red and lumpy skin rash, itching, difficulty breathing, swelling of face, mouth, lips , tongue, throat or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away; y if you have an infection which affects your entire body (unless you are receiving treatment for the infection); y if you have recently had any "live" vaccinations or have a vaccination planned; y if you have a viral infection such as measles, chicken pox or shingles or any other infection. Tell your doctor immediately if you have come into contact with anyone suffering with measles, chicken pox or shingles in the last three months. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Prednisolone Oral Solution: y if you have or ever had severe depression or manic depressive illness (bipolar disorder). This includes having had depression before or while taking steroid medicines like Prednisolone Oral Solution; y if any of your close family has had these illnesses; y if you have Scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15mg 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. Mental health problems while taking Prednisolone Oral Solution Mental health problems can happen while taking steroids like Prednisolone Oral Solution. y These illnesses can be serious. y Usually they start within a few days or weeks of starting the medicine. y They are more likely to happen at high doses. y Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen, they might need treatment. 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. In a few cases, mental health problems have happened when doses are being lowered or stopped altogether. Contact your doctor if you experience blurred vision or other visual disturbances. Children and adolescents The use of steroids can slow down normal growth of children and adolescents which may be irreversible. Chickenpox, shingles or measles y Tell your doctor if you have previously had chickenpox, shingles or measles or if you have been vaccinated against these infections. y It is important that whilst you are taking this medicine, you avoid contact with anybody who has chickenpox, shingles or measles

especially if you have not already had them. If you think you may have come into contact with a person who has chickenpox, shingles or measles, you should contact your doctor immediately. y If you catch chickenpox, shingles or measles, tell your doctor immediately. Your doctor will advise you on how to take prednisolone. Your doctor may want to change your dose of Prednisolone Oral Solution. Please also tell your doctor or pharmacist if any of the following apply to you: y if you have, or have ever had, tuberculosis (TB) or blood poisoning (septicaemia); y if you have liver or kidney problems; y if you have high blood pressure (or a family history of high blood pressure), heart disease or you have recently had a heart attack; y if you have or have a family history of the following:

• diabetes
• osteoporosis (thinning of the bones)
• glaucoma (raised eye pressure)
• epilepsy (fits); y if you have ever previously suffered from muscle weakness when using prednisolone or any other steroids, in the past; y if you have, or have had, a stomach ulcer; y if you have an underactive thyroid gland (hypothyroidism). If you have any of the above conditions, your doctor may monitor you carefully whilst you are taking this medicine. Other medicines and Prednisolone Oral Solution Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. y Some medicines may increase the effects of Prednisolone Oral Solution and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). y Rifampicin and rifabutin (antibiotics used to treat tuberculosis): taking these medicines with prednisolone may stop prednisolone from working properly. y Carbamazepine, phenytoin, primidone and phenobarbitone (for epilepsy): taking these medicines with prednisolone may stop prednisolone from working properly. y Ephedrine (a nasal decongestant): taking ephedrine with prednisolone may stop prednisolone from working properly. y Aminoglutethimide (anti-cancer treatment): taking this medicine with prednisolone may stop prednisolone from working properly. y Mifepristone (used for termination of pregnancy): taking mifepristone with prednisolone may stop prednisolone from working properly for several days. y Erythromycin (an antibiotic, used to treat infections): if taken with prednisolone, your doctor may need to change your dose of prednisolone or you may experience more side effects. y Ketoconazole (used to treat fungal infections): if taken with prednisolone, your doctor may need to change your dose of prednisolone or you may experience more side effects. y Ciclosporin (used to prevent rejection after transplants): if taken with prednisolone, your doctor may need to change your dose of prednisolone or you may experience more side effects. y Oestrogen hormones including the contraceptive pill: if taken with prednisolone, you may experience more side effects and your doctor may need to change your dose of prednisolone. y Medicines for diabetics such as insulin, glibenclamide or metformin: if taken with prednisolone, then these medicines may not work properly. y Medicines used to treat high blood pressure (e.g. hydralazine): if taken with prednisolone, then these types of medicines may not work properly. y Diuretics also known as water tablets (e.g. bendrofluazide): if taken with prednisolone, then these types of medicine may not work properly. y Somatotropin (a growth hormone): if taken with prednisolone, your medicine may no longer work properly. y Medicines used to treat myasthenia gravis (muscle weakness), such as neostigmine: if taken with prednisolone, these medicines may not work as well. y Medicines used to make x-rays clearer: if taken with prednisolone, these medicines may not work as well. y Anticoagulant medicines which thin the blood (e.g. warfarin and coumarin): if taken with prednisolone, you may be at an increased risk of bleeding, therefore your doctor is likely to monitor you more closely. y Aspirin and Non-Steroidal Anti-Inflammatory Drugs (e.g. ibuprofen): if taken with prednisolone you may be more likely to develop ulcers or bleeding from the stomach. y Salicylates (e.g. Aspirin): if taken with prednisolone you may experience an increase in side effects of the salicylate once you stop taking prednisolone. y Methotrexate (anti-cancer treatment): if taken with prednisolone you may experience more severe side effects. In addition, please tell your doctor or pharmacist if you are taking any of the following medicines, as taking these medicines with Prednisolone Oral Solution may cause you to have a lower level of potassium in your blood than normal (hypokalaemia): y Acetazolamide (used for glaucoma and epilepsy); y Diuretics also known as water tablets e.g. furosemide and bendroflumethiazide (used to treat high blood pressure); y Carbenoxolone (used in the treatment of stomach ulcers); y Medicines used to treat asthma (e.g. theophylline, bambuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline); y Amphotericin (used to treat fungal infections). Vaccinations If you have recently had or are planning to have any vaccinations, tell your doctor before taking Prednisolone Oral Solution. 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. Prednisolone Oral Solution contains sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate and sodium: y Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate. May cause allergic reactions (possibly delayed). y Sodium. This medicinal product contains 2.5mg of sodium per 1ml oral solution (10mg prednisolone) and 25mg of sodium per 10ml of oral solution (100mg prednisolone) daily. To be taken into consideration by patients on a controlled sodium diet. Driving and using machines This medicine should not affect your ability to drive or use machines. Carrying a Steroid card Your doctor or pharmacist will give you a Steroid Treatment Card with your prescription or medicine. Keep this card with you always as it must be shown to any of the following persons: y Doctor or Nurse – before having any surgery or emergency treatment or if any new treatment is prescribed. y Dentist – before having any dental surgery. y Pharmacist – before buying any medicine. y Optician – it is advisable to have regular eye tests. y Even after your treatment has finished, tell any doctor, dentist, nurse, midwife or anyone else who is giving you treatment that you have taken steroids.

How to take it

Prednisolone Oral Solution Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. These instructions will have been added to the dispensing label by your pharmacist.

Using the syringe A 5ml graduated syringe is provided with your medicine. Use the syringe to withdraw, from the bottle, the amount of Prednisolone Oral Solution that has been prescribed for you by your doctor. y Insert the syringe in the bottle and hold it in place. y Still holding the syringe in place, pull the plunger up until you withdraw the prescribed amount of oral solution. (refer to Figure 1 and Figure 2). y Remove the syringe from the bottle. y After use, close the bottle with its cap and wash the syringe with hot water. Let the syringe dry. Figure 1.

Each graduation of the syringe above the 0.5ml graduation is equivalent to 0.25ml of solution. The lowest dose that can be administered with this syringe is 0.25ml. If you need to take 0.25ml of solution, insert the syringe in the bottle and, holding it in place, pull the plunger up to the 0.75ml graduation. Then, place the syringe above a spoon and push the plunger until the graduation of 0.5 ml. The solution in the spoon corresponds to 0.25ml. Figure 2.

The recommended dose is: Adults y The usual starting dose is 1ml to 10ml per day. y Your doctor may reduce the dose, after a few days or weeks, depending on how well your condition is responding to the treatment. For Rheumatoid Arthritis y The usual starting dose is between 0.75ml and 1ml per day. Use in children and adolescents y Your doctor will decide the most appropriate dose to treat your child. y If Prednisolone Oral Solution has been prescribed for your child, for the treatment of acute asthma attacks the following dosing regime may be given for up to three days:

• For children over 5 years of age, 3 to 4ml may be prescribed;
• For children aged 2-5 years of age, 2ml may be prescribed;
• For children aged under 2 years, 1ml may be prescribed if your child is being treated in a hospital. Important: If you are unsure how much medicine to take, please contact your doctor or pharmacist for advice. Method of administration: For oral use only. If you take more Prednisolone Oral Solution than you should If you take more oral solution than your doctor has told you to, contact a doctor or your nearest hospital casualty department immediately and take this medicine with you to show the doctor what you have taken. If you forget to take Prednisolone Oral Solution y If you forget to take a dose, take it as soon as you remember unless it is almost time for the next dose. y Do not take a double dose to make up for a forgotten dose. If you stop taking Prednisolone Oral Solution Speak to your doctor before you stop taking Prednisolone Oral Solution. y Do not stop taking this medicine suddenly. Your doctor will tell you how to reduce your dose slowly over a number of weeks or months to help lower the chance of you getting withdrawal symptoms. y Stopping Prednisolone Oral Solution (particularly if stopped suddenly) can lead to withdrawal symptoms. The most common are:
• high temperature
• muscle and joint pain
• runny nose
• weight loss
• itchy skin
• red, sore and sticky eyes (conjunctivitis)
• headache
• being sick
• blurred vision
• low blood pressure. y If you get severe withdrawal symptoms tell your doctor straight away. He/she may ask you to start taking your medicine again and then to start coming off it again more slowly. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following side effects after you have been given your medicine, tell your doctor or pharmacist immediately: y Severe allergic reaction which may include itching or a red and lumpy skin rash, difficulty breathing, or wheeziness, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away. y Serious mental health problems. Steroids, including prednisolone, can cause serious mental health problems. These are common in both adults and children. They can affect about five in every 100 people using medicines like prednisolone. The symptoms include:

• feeling depressed, including thinking about suicide;
• feeling high (mania) or moods that can go up (euphoric mood) and down;
• feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory;
• feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or have feelings of being alone. y If you have epilepsy and you have more fits than normal. The following side effects may occur if prednisolone is given for a long period of time: Not known (frequency cannot be estimated from the available data). y generally feeling unwell y feeling or being sick (nausea) y hiccups y indigestion or stomach discomfort

y stomach ulcers (which can rupture and bleed) ulcers in the oesophagus (gullet) y diarrhoea y thrush y inflammation of the pancreas causing abdominal pain (pancreatitis) y muscle weakness y muscle pain y thinning of the bones with an increased risk of fractures (osteoporosis) y damage to tendons y joint stiffness causing limited movement, pain and muscle spasms y fluid retention causing swelling y feeling dehydrated y high blood pressure y slow healing of wounds, thinning of the skin, bruising, acne, marks which look like stretch marks y small red, purple or blue spots found along the surface of the skin (caused by blood vessels under the skin) y low adrenal gland function y slowed growth in infants, children and teenagers y irregular periods or your periods may stop altogether y excess hair growth y increased appetite and weight gain y increased sweating y intolerance to carbohydrates y loss of protein and calcium balance y dizziness y severe headaches with blurred vision or temporary visual problems in children (usually after stopping treatment) y worsening of epilepsy y increased pressure in the eye (glaucoma), swelling in the eye, cataracts, thinning and inflammation of the eye membranes, worsening of viral or fungal eye diseases y vertigo (sensation of spinning) y heart attack (sudden severe chest pains) y tearing of the heart muscle tissues, particularly if you have recently had a heart attack y slow heart rate y changes in body chemistry (salt imbalances: sodium and potassium salts) y raised level of white blood cells y formation of blood clots y blocked blood vessel (embolism) y blurred vision y detachment of the retina causing visual impairment y protrusion of the eyeballs y 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 y long term use of high dose steroids, may lead to a weakening of the immune system, which can increase the risk of malignancy. Kaposi's sarcoma (a type of cancer consisting of raised, red, purple or brown skin lesion) has also been reported to occur in patients receiving corticosteroids. Stopping treatment may alleviate these symptoms. Prednisolone Oral Solution can make it easier for you to pick up infections which may very rarely be fatal. Infections such as chicken pox and measles can be made worse, or TB (tuberculosis) may recur. Additional side effects in children and adolescents Children and teenagers taking this medicine may grow more slowly than normal. If you, as the patient or carer, are worried about the effects of taking this medicine, go back and discuss it with your doctor. Elderly If you are elderly, your doctor will monitor you closely whilst you are taking this medicine as you may be more likely to experience

Possible side effects

. 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 Oral Solution 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 label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Once opened, your medicine should be used within 3 months and stored in a refrigerator. Store in the original package in order to protect from light. Do not use this medicine if you notice any visible signs of damage to the bottle or deterioration in your medicine. Return it to your pharmacist. 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 to protect the environment.

Contents of the pack and other information

What Prednisolone Oral Solution contains The active substance is prednisolone. Each 1ml of oral solution contains 10mg prednisolone (as prednisolone sodium phosphate). The other ingredients are: glycerol, xylitol, sucralose, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, orange flavour, vanilla cream flavour, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), disodium edetate, sodium hydroxide and/or hydrochloric acid (as pH adjusters) and purified water. What Prednisolone Oral Solution looks like and contents of the pack Prednisolone 10mg/ml Oral Solution is a clear, colourless to yellowish oral solution with a characteristic odour of orange. It is available in an amber glass bottle containing 30ml of medicine. The pack also contains a 5ml plastic oral dosing syringe. Marketing Authorisation Holder Aspire Pharma Limited Unit 4, Rotherbrook Court Bedford Road, Petersfield Hampshire, GU32 3QG United Kingdom Manufacturer MEDICAIR BIOSCIENCE LABORATORIES S.A. 61st km National Road Athinon-Lamias Sximatari Viotias, 32009 Greece This leaflet was last revised in 12/2025.

To request a copy of this leaflet in Braille, large print or audio please call 0800 198 5000 (UK only). Please be ready to give the following information: Product name: Prednisolone 10mg/ml Oral Solution Reference number: PL 35533/0326

1010715 – P2.1

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Your doctor will decide on the most appropriate dose to treat you or your child.

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