Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Prednisolone
A A H Pharmaceuticals Ltd
H02AB06
Prednisolone
30mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200
296x210 Leaflet Reel Fed Bi Fold Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Prednisolone Tablets 2.5,5,10, 20,25 & 30mg x 28 & 56’s (UK) 296x210 (Reel Fed) 50963374 Leaflet for Blisters 4123 R.Wrey 06/12/18 page 4 page 1 * 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 UK-Eire-Artwork-Support@accord-healthcare.com 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. FMD info NA (not a carton) No Yes Details PREDNISOLONE 2.5MG, 5MG, 10MG, 20MG, 25MG, 30MG TABLETS PIL - UK Black Profile BBBA3552 T. Hull 11.12.2018 24/10/2019 G. Worth 296x210 8.5pt Accord UK n/a n/a 7 Version 2 01.11.2017 50963374 BBBA3552 PREDNISOLONE 2.5MG, 5MG, 10MG, 20MG, 25MG AND 30MG TABLETS PACKAGE LEAFLET: INFORMATION FOR THE USER • 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 Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prednisolone 30mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg prednisolone. Excipient with known affect Each 30mg tablet contains 153.4mg of Lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets 30mg tablet Yellow, 9mm, round, flat, tablet, with a score line on one side, imprinted with “A670” on one side and “30” on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ALLERGY AND ANAPHYLAXIS: bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema, anaphylaxis, incapacitating allergies unresponsive to conventional treatment. ARTERITIS/COLLAGENOSIS: giant cell arteritis/polymyalgia rheumatica, mixed connective tissue disease, polyarteritis nodosa, polymyositis. BLOOD DISORDERS: haemolytic anaemia (auto-immune), leukaemia (acute and chronic lymphocytic), lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura. CARDIOVASCULAR DISORDERS: post-myocardial infarction syndrome, rheumatic fever with severe carditis. ENDOCRINE DISORDERS: primary and secondary adrenal insufficiency, congenital adrenal hyperplasia. GASTRO-INTESTINAL DISORDERS: regional ileitis (Crohn's disease), ulcerative colitis, persistent coeliac syndrome (coeliac disease unresponsive to gluten withdrawal), auto-immune chronic active hepatitis, multisystem disease affecting liver, biliary peritonitis. HYPERCALCAEMIA: sarcoidosis, vitamin D excess. INFECTIONS (WITH APPROPRIATE CHEMOTHERAPY): helminthic infestations, Herxheimer reaction, infectious mononucleosis, miliary tuberculosis, mumps orchitis (adult), tuberculous meningitis, rickettsial disease. MUSCULAR DISORDERS: polymyositis, dermatomyositis. NEUROLOGICAL DISORDERS: infantile spasms, Shy-Drager syndrome, sub-acute demyelinating polyneuropathy. OCULAR DISEASE: scleritis, posterior uveitis, retinal vasculitis, pseudo-tumours of the orbit, giant cell arteritis, malignant ophthalmic Graves disease. R Lees het volledige document