Package leaflet: Information for the patient 22595246 LF-103472-01 Prednisolone acetate 25mg/ml Suspension for Injection Read all of this leaflet carefully before you start using this • If you have epilepsy; medicine because it contains important information for you. • If you have an eye disease caused by a rise of pressure • Keep this leaflet. You may need to read it again. within the eye (glaucoma); • If you have any further questions, ask your doctor or nurse. • If you have osteoporosis (thinning of the bones); • If you get any side effects, talk to your doctor or nurse. This • If you have muscle problems when steroids have been includes any possible side effects not listed in this leaflet. taken before; See section 4. • If you have stomach ulcers; The name of medicine is Prednisolone acetate 25mg/ml • If you have high blood pressure or heart failure; Suspension for Injection. It will be referred to as Prednisolone • If you have any liver or kidney problems; Injection for ease of use hereafter. • If you have an under-active thyroid (hypothyroidism); - Prednisolone Injection is a steroid medicine, prescribed • If you are elderly your doctor may need to monitor you closely; for many different conditions, including serious illnesses. • If you are going to receive an organ transplant; - You need to take it regularly to get the maximum benefit. • if you have Scleroderma (also known as systemic sclerosis, - Don’t stop receiving this medicine without talking to your an autoimmune disorder) because daily doses of 15 mg doctor - you may need to reduce the dose gradually. or more may increase the risk of a serious complication - Prednisolone Injection can cause side effects in some called scleroderma renal crisis. Signs of scleroderma renal people (read section 4 below). Some problems such as crisis include increased blood pressure and decreased mood changes (feeling depressed or ‘high’) or stomach urine production. The doctor may advise that you have your problems can happen straight away. If you feel unwell in blood pressure and urine regularly checked. any way, see your doctor straight away. Contact your doctor if you experience blurred vision or other - Some side effects only happen after weeks or months. visual disturbances. These include weakness of arms and legs, or developing a If any of the above applies to you or you are not sure please rounder face (read section 4 for more information). tell your doctor or nurse before you use this medicine. - If you take this medicine for more than three weeks, you will get a blue ‘steroid card’: always keep it with you Mental health problems while receiving prednisolone and show it to any doctor or nurse treating you. Mental health problems can occur while being given steroids - Keep away from people who have chickenpox or like prednisolone (see also section 4 Possible Side Effects). shingles, if you have never had them. They could affect • These illnesses can be severe. you severely. If you do come into contact with chickenpox • Usually they start within a few days or weeks of starting or shingles, see your doctor straight away. the medicine. Now read the rest of this leaflet. It includes other important • They are more likely to happen at high doses. information on the safe and effective use of this medicine that • Most of these problems go away if the dose is lowered or may be especially important for you. the medicine is stopped. However, if problems do occur they might need treatment. Prednisolone - benefit information Prednisolone belongs to a group of medicines called steroids. Their Talk to a doctor if you (or someone is given this medicine) full name is corticosteroids. These corticosteroids occur naturally show any signs of mental health problems. This is particularly in the body and help to maintain health and well-being. Boosting important if you are depressed, or might be thinking about your body with extra corticosteroid (such as prednisolone) is an suicide. In a few cases, mental health problems have effective way to treat various illnesses involving inflammation in happened when doses are being lowered or the medicine the body. Prednisolone reduces this inflammation, which could stopped altogether. otherwise go on making your condition worse. You must take this Other medicines and Prednisolone Injection medicine regularly to get maximum benefit from it. Please tell your doctor if you are taking or have recently taken any What is in this leaflet other medicines, including medicines obtained without a 1. What Prednisolone Injection is and what it is used for prescription. 2. What you need to know before you are given Prednisolone This is especially important if you are taking: Injection • Some medicines may increase the effects of Prednisolone 3. How Prednisolone Injection is given to you Injection and your doctor may wish to monitor you carefully 4. Possible side effects if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat); 5. How to store Prednisolone Injection • Medicines for epilepsy such as carbamazepine, 6. Contents of the pack and other information phenobarbitone, phenytoin or primidone; 1. WHAT PREDNISOLONE INJECTION IS AND WHAT IT IS • Antibiotics such as rifampicin, rifabutin; USED FOR • Mifepristone (used to terminate pregnancy); The name of your medicine is Prednisolone Injection. • Oral contraceptives; Prednisolone Injection contains the active ingredient • Somatropin (used to treat growth problems); prednisolone acetate which belongs to a group of medicines • Medicines for diabetes such as insulin, glibenclamide or called corticosteroids or ‘steroids’. Steroids work by reducing metformin; inflammation and lowering the body’s immune response. • Medicines to treat high blood pressure, such as diuretics Prednisolone Injection is used to treat adults. This medicine is (water tablets) like bendroflumethiazide and furosemide; used to treat swollen, painful joints and tendons in conditions • Warfarin or other medicines used to thin the blood; such as arthritis, tennis elbow and golfer’s elbow. • Non steroidal anti-inflammatory drugs (NSAIDs) or aspirin; Prednisolone Injection can also be used to treat conditions such • Theophylline (used to treat asthma); as asthma, severe allergic reactions, ulcerative colitis and • Medicines to treat fungal infections such as amphotericin, Crohn’s disease. ketoconazole; 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN • Acetazolamide (used to treat glaucoma); PREDNISOLONE INJECTION • Carbenoxolone (used to treat stomach ulcers); • Methotrexate (used for rheumatoid arthritis, psoriasis and Prednisolone Injection is not suitable for use in children. certain types of cancer); You should not be given Prednisolone Injection: • Etoposide (used to treat cancer); • if you are allergic to prednisolone or any of the other • Any medicine which belong to a group of medicines called ingredients of this medicine (listed in section 6) (allergic sympathomimetics. reactions include mild symptoms such as itching and/or rash. • Medicines used to treat myasthenia gravis; More severe symptoms include swelling of the face, lips, • Medicines used to make x-rays clearer; tongue and/or throat with difficulty in swallowing or breathing); • Ciclosporin (used to stop the body rejecting bone marrow • if you just had a vaccination or have a vaccination or organ transplants); planned; • Aminoglutethimide (used to treat Cushing's disease or • if you have a viral infection such as measles, chickenpox some breast cancers); or shingles or any other infection. Tell your doctor • Retinoids. immediately if you have come into contact with anyone suffering with measles, chickenpox or shingles in the last Pregnancy, breast-feeding and fertility three months. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for Warnings and precautions advice before you are given this medicine. Talk to your doctor or nurse before you are given Prednisolone Injection. Driving and using machines • If you have severe depression or manic-depressive illness This medicine should not affect your ability to drive or use (bipolar disorder). This includes having had depression before machines. while taking steroid medicines like Prednisolone Injection or Carrying a Steroid card if anyone in your family has suffered from these illnesses; Your doctor or pharmacist will have given you a Steroid • If you have TB (tuberculosis); Treatment Card with your prescription or medicine. • If you have diabetes; YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it must be • thrush; shown to any of the following persons: • inflammation of the pancreas causing abdominal pain Doctor or Nurse - before having any surgery or (pancreatitis); emergency treatment or if any new • muscle weakness; treatment is prescribed. • muscle pain; Dentist - before having any dental surgery. • thinning of bones which makes fractures more likely Pharmacist - before buying any medicine. (osteoporosis); Optician - it is advisable to have regular eye tests. • damage to tendons; Prednisolone Injection contains sodium and benzyl alcohol • joint stiffness causing limited motion, pain and muscle Sodium- This medicinal product contains less than 1 mmol (23 spasms; mg) sodium per dose, i.e. essentially ‘sodium-free’. • fluid retention causing swelling; Benzyl alcohol- Must not be given to premature babies or • feeling dehydrated; neonates. May cause toxic reactions and allergic reactions in • high blood pressure; infants and children up to 3 years old. • slow healing of wounds, thinning of the skin, bruising, marks which look like stretch marks and acne; 3. HOW PREDNISOLONE INJECTION IS GIVEN TO YOU • small red, purple or blue spots found along the surface of This medicine will be given to you by a doctor or nurse. The doctor the skin (caused by blood vessels under the skin); will decide upon the most suitable dose for you, but the • low adrenal gland function; recommended doses are: • irregular or stopped menstrual periods; Adults: • swollen, round face (Cushingoid facies); For joint injections: Between 5 mg and 25 mg depending on the • excess hair growth; size of the joint. Not more than 3 joints will be treated in one day. • increased appetite and weight gain; The injections may be repeated if needed. • intolerance to carbohydrates; For muscle (systemic) injections: Between 25 mg and 100 mg • mood changes, dependence, depression, difficulty once or twice a week, depending on your condition. sleeping, worsening of schizophrenia; Elderly: • worsening of epilepsy; Your doctor will use the lowest dose for the shortest period of time • raised pressure in the eyes (glaucoma), cataracts, thinning to treat your condition. This is important to reduce the possible and inflammation of the cornea (part of the eye), worsening side effects. of viral or fungal eye diseases and visual impairment; Method of administration: • heart attack; Prednisolone Injection will be injected into or around a joint or into • changes in blood chemistry; a muscle, depending on the condition being treated. • an increase in the number of white blood cells in the blood; If you think you have been given more Prednisolone • formation of blood clots; Injection than you should have • long term use of high dose steroids, may lead to a Overdosing is unlikely. If it does happen the doctor will treat any weakening of the immune system, which can increase the symptoms that follow. risk of malignancy; • blurred vision; If you stop taking Prednisolone Injection • scleroderma renal crisis in patients already suffering from If treatment is stopped too quickly it can lead to severe problems scleroderma (an autoimmune disorder). Signs of of the adrenal gland, low blood pressure and death. scleroderma renal crisis include increased blood pressure You may also experience ‘withdrawal symptoms’ which include and decreased urine production. fever, muscular pain, joint pain, runny nose, an eye infection (conjunctivitis), painful itchy skin lumps, loss of weight, increased Kaposi’s sarcoma (a type of cancer) has also been reported to pressure in the brain with headache and vomiting, reappearance occur in patients receiving corticosteroids. However, once the of your disease symptoms and swelling eye nerve. treatment has been stopped, this may go away. Children may also experience swelling of the nerves in the eyes Injections like these can make it easier for you to pick up due to increase in pressure in and around the brain. The normal infections which may very rarely be fatal. Infections such as growth of infants, children and adolescents can slow down. chickenpox and measles can be made worse or TB (tuberculosis) may recur. If you have any further questions on the use of this medicine, ask your doctor or nurse. Additional side effects in children and adolescents • slowed growth in infants, children and teenagers; 4. POSSIBLE SIDE EFFECTS • severe headaches with blurred vision or temporary visual Like all medicines, this medicine can cause side effects, problems in children (usually after stopping treatment). although not everybody gets them. Reporting of side effects Steroids including prednisolone can cause severe mental If you get any side effects, talk to your doctor or nurse. This health problems. includes any possible side effects not listed in this leaflet. You These are common in both adults and children. They can affect can also report side effects directly via the Yellow Card Scheme about five in every 100 people taking medicines like prednisolone. at: www.mhra.gov.uk/yellowcard. By reporting side effects you • Feeling depressed, including thinking about suicide. can help provide more information on the safety of this • Feeling high (mania) or having moods that go up and down. medicine. • Feeling anxious, having problems sleeping, having difficulty in thinking or being confused and losing your memory. 5. HOW TO STORE PREDNISOLONE INJECTION • Feeling, seeing or hearing things which do not exist. Keep this medicine out of the sight and reach of children. • Having strange and frightening thoughts, changing how Prednisolone Injection ampoules will be stored at the healthcare you act or having feelings of being alone. centre. If you notice any of these problems talk to a doctor immediately. They should be stored at 15°C -25°C and kept in the carton in order to protect from light. If you notice: The doctor or nurse will check that the expiry date on the label • itching or skin rashes; has not passed before you are given the injection. • swelling of the face, lips or throat; Do not throw away any medicines via wastewater or household • difficulty in breathing or wheeziness. waste. Ask your pharmacist how to throw away medicines you Tell your doctor immediately. These may be signs of an no longer use. These measures will help protect the environment. allergic reaction. If you are having injections into a joint, the most likely side 6. CONTENTS OF THE PACK AND OTHER INFORMATION effect is increased pain and swelling after the injection. This What Prednisolone Injection contains usually goes away after a few hours and you should rest the - The active substance is Prednisolone Acetate. Each 1ml joint as much as possible. Prednisolone Injection ampoule contains 25 mg of the If you are having muscle (systemic) injections the steroid will enter active ingredient Prednisolone Acetate. your system. - The other ingredients are water for injections, sodium The side effects which can occur if steroids are given in high doses chloride, benzyl alcohol, sodium carboxymethylcellulose, for a long time are: polysorbate 80, with sodium hydroxide and/or hydrochloric acid as pH adjusters. Not known: frequency cannot be estimated from the available data • generally feeling unwell; What Prednisolone Injection looks like and the contents • feeling sick (nausea); of the pack • hiccups; Prednisolone Injection is a white or almost white suspension. Prednisolone injection is available in 1 ml clear glass ampoules. • indigestion or stomach discomfort; It is available in packs containing 10 x 1 ml ampoules. • stomach ulcer (which can rupture and bleed) or ulcer in the oesophagus (gullet); The Marketing Authorisation Holder and Manufacturer: • small bowel perforation; Amdipharm UK Limited, Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom The information in this leaflet applies only to Prednisolone Injection. This leaflet was revised in September 2017.