Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Prednisolone sodium phosphate
Accord-UK Ltd
H02AB06
Prednisolone sodium phosphate
5mg
Soluble tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 5012617026996
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. EU-Artwork-Support@accord-healthcare.com PREDNISOLONE 5MG SOLUBLE TABLETS PIL - UK Black Profile BBBB1122 NM 13/04/2021 13/04/2021 NM 210x297mm 9pts Wasdell Packaging Ltd N/A 02 Version 7 12.02.2020 Cartons and label leaflets only (labels only when specified) 02970210X01480035L00-M050UWASS FRONT HEAD LAST BAR LAST BAR >> READ DIRECTION >> READ DIRECTION 1ST BAR 1ST BAR • 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 IT FOR MORE THAN 3 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 TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prednisolone 5mg Soluble Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg prednisolone as prednisolone sodium phosphate Excipient with known effect Each tablet contains: 1.18 mmol (27.22 mg) sodium Sodium benzoate (E211) 7 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Soluble Tablet White, 7mm, round, with a score line on one side, imprinted with “A” and “615” respectively on each side of the score. The tablet can be divided into equal doses. 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 section); 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 emp Preberite celoten dokument