Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Prednisolone
Almus Pharmaceuticals Ltd
H02AB06
Prednisolone
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 05060057401422
PACKAGE LEAFLET: INFORMATION FOR THE USER PREDNISOLONE 5 MG SOLUBLE TABLETS (Prednisolone sodium phosphate) • PREDNISOLONE 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 TAKING THIS MEDICINE without talking to your doctor • you may need to reduce the dose gradually. • PREDNISOLONE CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read section 4 below). Some problems such as mood changes (feeling depressed or ‘high’) or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but SEE YOUR DOCTOR STRAIGHT AWAY. • SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS. These include weakness of arms and legs or developing a rounder 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 you and show it to any doctor or nurse treating you. • KEEP AWAY FROM PEOPLE WHO HAVE CHICKENPOX OR SHINGLES, if you have never had them. They could affect you severely. If you do come into contact with chickenpox or shingles, SEE YOUR DOCTOR STRAIGHT AWAY. Read all of this leaflet carefully before you start using this medicine 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, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Prednisolone Soluble Tablets are and what they are used for 2. What you need to know before you take Prednisolone Soluble Tablets 3. How to take Prednisolone Soluble Tablets 4. Possible side effects 5. How to store Prednisolo Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prednisolone 5mg Tablets BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5mg of prednisolone. Excipients with known effect: Also contains 72.30mg of Lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round tablets scored on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A wide variety of diseases may sometimes require corticosteroid therapy. Some of the principal indications are: • Bronchial asthma, severe hypersensitivity reactions, anaphylaxis, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease (excluding systemic sclerosis), polyarteritis nodosa; • inflammatory skin disorders, including pemphigus vulgaris, bullous pemphigoid and pyoderma gangrenosum; • minimal change nephrotic syndrome, acute interstitial nephritis; • ulcerative colitis, Crohn's disease; sarcoidosis; • rheumatic carditis; • haemolytic anaemia (autoimmune), acute lymphoblastic and chronic lymphocytic leukaemia, malignant lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura; • immunosuppression in transplantation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The lowest dosage that will produce an acceptable result should be used (See precautions sections); when it is possible to reduce the dosage, this must be accomplished by stages. During prolonged therapy any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage; if corticosteroids have been stopped following prolonged therapy they may need to be temporarily re-introduced. _Adult:_ The dose used will depend upon the disease, its severity, and the clinical response obtained. The following regimens are for guidance only. Divided dosage is usually employed. _Short-term treatment:_ 20 to 30 mg daily for the first few days, subsequently reducing the daily dosage by 2.5 or 5 mg every two to five days, depending upon the respo Read the complete document