Read all of this leaflet carefully before you start using thismedicine because it contains important information for you.• Keep this leaflet. You may need to read it again.• If you have any further questions, ask your doctor or nurse.• If you get any side effects, talk to your doctor or nurse. This

includes any possible side effects not listed in this leaflet.See section 4.

The name of medicine is Prednisolone acetate 25mg/mlSuspension for Injection. It will be referred to as PrednisoloneInjection for ease of use hereafter.- Prednisolone Injection is a steroid medicine, prescribed

for many different conditions, including serious illnesses.- You need to take it regularly to get the maximum benefit.- Don’t stop receiving this medicine without talking to your

doctor - you may need to reduce the dose gradually.- Prednisolone Injection can cause side effects in some

people (read section 4 below). Some problems such asmood changes (feeling depressed or ‘high’) or stomachproblems can happen straight away. If you feel unwell inany way, see your doctor straight away.

- Some side effects only happen after weeks or months.These include weakness of arms and legs, or developing arounder face (read section 4 for more information).

- If you take this medicine for more than three weeks,you will get a blue ‘steroid card’: always keep it with youand show it to any doctor or nurse treating you.

- Keep away from people who have chickenpox orshingles, if you have never had them. They could affectyou severely. If you do come into contact with chickenpoxor shingles, see your doctor straight away.

Now read the rest of this leaflet. It includes other importantinformation on the safe and effective use of this medicine thatmay be especially important for you.Prednisolone - benefit informationPrednisolone belongs to a group of medicines called steroids. Theirfull name is corticosteroids. These corticosteroids occur naturallyin the body and help to maintain health and well-being. Boostingyour body with extra corticosteroid (such as prednisolone) is aneffective way to treat various illnesses involving inflammation inthe body. Prednisolone reduces this inflammation, which couldotherwise go on making your condition worse. You must take thismedicine regularly to get maximum benefit from it.What is in this leaflet1. What Prednisolone Injection is and what it is used for 2. What you need to know before you are given Prednisolone

Injection3. How Prednisolone Injection is given to you4. Possible side effects5. How to store Prednisolone Injection6. Contents of the pack and other information

1. WHAT PREDNISOLONE INJECTION IS AND WHAT IT ISUSED FOR

The name of your medicine is Prednisolone Injection.Prednisolone Injection contains the active ingredientprednisolone acetate which belongs to a group of medicinescalled corticosteroids or ‘steroids’. Steroids work by reducinginflammation and lowering the body’s immune response.Prednisolone Injection is used to treat adults. This medicine isused to treat swollen, painful joints and tendons in conditionssuch as arthritis, tennis elbow and golfer’s elbow. Prednisolone Injection can also be used to treat conditions suchas asthma, severe allergic reactions, ulcerative colitis andCrohn’s disease.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVENPREDNISOLONE INJECTION

Prednisolone Injection is not suitable for use in children.You should not be given Prednisolone Injection:• if you are allergic to prednisolone or any of the other

ingredients of this medicine (listed in section 6) (allergicreactions include mild symptoms such as itching and/or rash.More severe symptoms include swelling of the face, lips,tongue and/or throat with difficulty in swallowing or breathing);

• if you just had a vaccination or have a vaccinationplanned;

• if you have a viral infection such as measles, chickenpoxor shingles or any other infection. Tell your doctorimmediately if you have come into contact with anyonesuffering with measles, chickenpox or shingles in the lastthree months.

Warnings and precautionsTalk to your doctor or nurse before you are given PrednisoloneInjection.• If you have severe depression or manic-depressive illness

(bipolar disorder). This includes having had depression beforewhile taking steroid medicines like Prednisolone Injection orif anyone in your family has suffered from these illnesses;

• If you have TB (tuberculosis);• If you have diabetes;

• If you have epilepsy;• If you have an eye disease caused by a rise of pressure

within the eye (glaucoma);• If you have osteoporosis (thinning of the bones);• If you have muscle problems when steroids have been

taken before;• If you have stomach ulcers;• If you have high blood pressure or heart failure;• If you have any liver or kidney problems;• If you have an under-active thyroid (hypothyroidism);• If you are elderly your doctor may need to monitor you closely;• If you are going to receive an organ transplant;• if you have Scleroderma (also known as systemic sclerosis,

an autoimmune disorder) because daily doses of 15 mgor more may increase the risk of a serious complicationcalled scleroderma renal crisis. Signs of scleroderma renalcrisis include increased blood pressure and decreasedurine production. The doctor may advise that you have yourblood pressure and urine regularly checked.

Contact your doctor if you experience blurred vision or othervisual disturbances. If any of the above applies to you or you are not sure pleasetell your doctor or nurse before you use this medicine.Mental health problems while receiving prednisoloneMental health problems can occur while being given steroidslike prednisolone (see also section 4 Possible Side Effects).• These illnesses can be severe.• Usually they start within a few days or weeks of starting

the medicine.• They are more likely to happen at high doses.• Most of these problems go away if the dose is lowered or

the medicine is stopped. However, if problems do occurthey might need treatment.

Talk to a doctor if you (or someone is given this medicine)show any signs of mental health problems. This is particularlyimportant if you are depressed, or might be thinking aboutsuicide. In a few cases, mental health problems havehappened when doses are being lowered or the medicinestopped altogether.Other medicines and Prednisolone InjectionPlease tell your doctor if you are taking or have recently taken anyother medicines, including medicines obtained without aprescription.This is especially important if you are taking:• Some medicines may increase the effects of Prednisolone

Injection and your doctor may wish to monitor you carefullyif you are taking these medicines (including somemedicines for HIV: ritonavir, cobicistat);

• Medicines for epilepsy such as carbamazepine,phenobarbitone, phenytoin or primidone;

• Antibiotics such as rifampicin, rifabutin;• Mifepristone (used to terminate pregnancy);• Oral contraceptives;• Somatropin (used to treat growth problems);• Medicines for diabetes such as insulin, glibenclamide or

metformin;• Medicines to treat high blood pressure, such as diuretics

(water tablets) like bendroflumethiazide and furosemide;• Warfarin or other medicines used to thin the blood;• Non steroidal anti-inflammatory drugs (NSAIDs) or aspirin;• Theophylline (used to treat asthma);• Medicines to treat fungal infections such as amphotericin,

ketoconazole;• Acetazolamide (used to treat glaucoma);• Carbenoxolone (used to treat stomach ulcers);• Methotrexate (used for rheumatoid arthritis, psoriasis and

certain types of cancer);• Etoposide (used to treat cancer);• Any medicine which belong to a group of medicines called

sympathomimetics.• Medicines used to treat myasthenia gravis;• Medicines used to make x-rays clearer;• Ciclosporin (used to stop the body rejecting bone marrow

or organ transplants);• Aminoglutethimide (used to treat Cushing's disease or

some breast cancers);• Retinoids.Pregnancy, breast-feeding and fertilityIf you are pregnant or breast-feeding, think you may bepregnant or are planning to have a baby, ask your doctor foradvice before you are given this medicine. Driving and using machinesThis medicine should not affect your ability to drive or usemachines.Carrying a Steroid cardYour doctor or pharmacist will have given you a SteroidTreatment Card with your prescription or medicine.

Package leaflet: Information for the patientLF-103472-01

Prednisolone acetate 25mg/mlSuspension for Injection

22595246

YOU SHOULD ALWAYS CARRY THIS CARD WITH YOU as it must beshown to any of the following persons:Doctor or Nurse - before having any surgery or

emergency treatment or if any newtreatment is prescribed.

Dentist - before having any dental surgery.Pharmacist - before buying any medicine.Optician - it is advisable to have regular eye tests.Prednisolone Injection contains sodium and benzyl alcoholSodium- This medicinal product contains less than 1 mmol (23mg) sodium per dose, i.e. essentially ‘sodium-free’.Benzyl alcohol- Must not be given to premature babies orneonates. May cause toxic reactions and allergic reactions ininfants and children up to 3 years old.

3. HOW PREDNISOLONE INJECTION IS GIVEN TO YOUThis medicine will be given to you by a doctor or nurse. The doctorwill decide upon the most suitable dose for you, but therecommended doses are:Adults:For joint injections: Between 5 mg and 25 mg depending on thesize of the joint. Not more than 3 joints will be treated in one day.The injections may be repeated if needed.For muscle (systemic) injections: Between 25 mg and 100 mgonce or twice a week, depending on your condition.Elderly:Your doctor will use the lowest dose for the shortest period of timeto treat your condition. This is important to reduce the possibleside effects.Method of administration:Prednisolone Injection will be injected into or around a joint or intoa muscle, depending on the condition being treated.If you think you have been given more PrednisoloneInjection than you should haveOverdosing is unlikely. If it does happen the doctor will treat anysymptoms that follow.If you stop taking Prednisolone Injection If treatment is stopped too quickly it can lead to severe problemsof the adrenal gland, low blood pressure and death. You may also experience ‘withdrawal symptoms’ which includefever, muscular pain, joint pain, runny nose, an eye infection(conjunctivitis), painful itchy skin lumps, loss of weight, increasedpressure in the brain with headache and vomiting, reappearanceof your disease symptoms and swelling eye nerve. Children may also experience swelling of the nerves in the eyesdue to increase in pressure in and around the brain. The normalgrowth of infants, children and adolescents can slow down.If you have any further questions on the use of this medicine, askyour doctor or nurse.

4. POSSIBLE SIDE EFFECTSLike all medicines, this medicine can cause side effects,although not everybody gets them. Steroids including prednisolone can cause severe mentalhealth problems.These are common in both adults and children. They can affectabout five in every 100 people taking medicines like prednisolone.• Feeling depressed, including thinking about suicide.• Feeling high (mania) or having moods that go up and down.• Feeling anxious, having problems sleeping, having 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 having feelings of being alone.If you notice any of these problems talk to a doctor immediately.If you notice:• itching or skin rashes;• swelling of the face, lips or throat;• difficulty in breathing or wheeziness.Tell your doctor immediately. These may be signs of anallergic reaction.If you are having injections into a joint, the most likely sideeffect is increased pain and swelling after the injection. Thisusually goes away after a few hours and you should rest thejoint as much as possible.If you are having muscle (systemic) injections the steroid will enteryour system.The side effects which can occur if steroids are given in high dosesfor a long time are:Not known: frequency cannot be estimated from the available data• generally feeling unwell;• feeling sick (nausea);• hiccups;• indigestion or stomach discomfort;• stomach ulcer (which can rupture and bleed) or ulcer in the

oesophagus (gullet);• small bowel perforation;

• thrush;• inflammation of the pancreas causing abdominal pain

(pancreatitis);• muscle weakness;• muscle pain;• thinning of bones which makes fractures more likely

(osteoporosis);• damage to tendons;• joint stiffness causing limited motion, pain and muscle

spasms;• fluid retention causing swelling;• feeling dehydrated;• high blood pressure;• slow healing of wounds, thinning of the skin, bruising,

marks which look like stretch marks and acne;• small red, purple or blue spots found along the surface of

the skin (caused by blood vessels under the skin);• low adrenal gland function;• irregular or stopped menstrual periods;• swollen, round face (Cushingoid facies);• excess hair growth;• increased appetite and weight gain;• intolerance to carbohydrates;• mood changes, dependence, depression, difficulty

sleeping, worsening of schizophrenia;• worsening of epilepsy;• raised pressure in the eyes (glaucoma), cataracts, thinning

and inflammation of the cornea (part of the eye), worseningof viral or fungal eye diseases and visual impairment;

• heart attack;• changes in blood chemistry; • an increase in the number of white blood cells in the blood;• formation of blood clots;• long term use of high dose steroids, may lead to a

weakening of the immune system, which can increase therisk of malignancy;

• blurred vision;• scleroderma renal crisis in patients already suffering from

scleroderma (an autoimmune disorder). Signs ofscleroderma renal crisis include increased blood pressureand decreased urine production.

Kaposi’s sarcoma (a type of cancer) has also been reported tooccur in patients receiving corticosteroids. However, once thetreatment has been stopped, this may go away.Injections like these can make it easier for you to pick upinfections which may very rarely be fatal. Infections such aschickenpox and measles can be made worse or TB(tuberculosis) may recur.Additional side effects in children and adolescents• slowed growth in infants, children and teenagers;• severe headaches with blurred vision or temporary visual

problems in children (usually after stopping treatment).Reporting of side effectsIf you get any side effects, talk to your doctor or nurse. Thisincludes any possible side effects not listed in this leaflet. Youcan also report side effects directly via the Yellow Card Schemeat: www.mhra.gov.uk/yellowcard. By reporting side effects youcan help provide more information on the safety of thismedicine.

5. HOW TO STORE PREDNISOLONE INJECTIONKeep this medicine out of the sight and reach of children.Prednisolone Injection ampoules will be stored at the healthcarecentre. They should be stored at 15°C -25°C and kept in the carton inorder to protect from light.The doctor or nurse will check that the expiry date on the labelhas not passed before you are given the injection.Do not throw away any medicines via wastewater or householdwaste. Ask your pharmacist how to throw away medicines youno longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATIONWhat Prednisolone Injection contains- The active substance is Prednisolone Acetate. Each 1ml

Prednisolone Injection ampoule contains 25 mg of theactive ingredient Prednisolone Acetate.

- The other ingredients are water for injections, sodiumchloride, benzyl alcohol, sodium carboxymethylcellulose,polysorbate 80, with sodium hydroxide and/or hydrochloricacid as pH adjusters.

What Prednisolone Injection looks like and the contentsof the packPrednisolone Injection is a white or almost white suspension.Prednisolone injection is available in 1 ml clear glass ampoules.It is available in packs containing 10 x 1 ml ampoules.The Marketing Authorisation Holder and Manufacturer:Amdipharm UK Limited, Capital House, 85 King William Street,London, EC4N 7BL, United Kingdom

The information in this leaflet applies only to PrednisoloneInjection.

This leaflet was revised in September 2017.