Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Prednisolone
Accord-UK Ltd
H02AB06
Prednisolone
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 5012617026279
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, 28s, 56s - UK 296x210 (Reel Fed) 50999609 Leaflet for Blisters 3695 RH 24-03-21 * 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 BBBB1052 C.Grant 29/03/2021 30/03/2021 C.Grant 296x210 8.5pt Accord Barnstaple n/a n/a 02 Version 2 01.11.2017 page 4 page 1 BBBB1052 50999609 RARE (may affect up to 1 in 1,000 people): • Depression • Mania in patients without a history of psychiatric illness • Benign pressure increase in the skull • Breakdown of bone tissue, tendon rupture. NOT KNOWN (frequency cannot be estimated from the available data): • Increased number of white blood cells (leukocytosis) • Withdrawal syndrome when reducing the dose (see section 3) • Lowered blood pH, decreased blood potassium, elevated blood fats, impaired sugar tolerance, accumulation of fatty tissue at secluded places in the body, increased appetite (which can lead to weight gain) • Emotional symptoms (such as elation, emotional instability, drug dependence), mental disorder (such as delusions, hallucinations and schizophrenia), personality change, confusion, anxiety, mood swings, abnormal behaviour, sleep problems, irritability • Seizures, problems with memory, intellectual disturbance, dizziness, headache, increased amount of fat around the spinal cord • Acid reduction (central ser Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prednisolone 20mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg prednisolone. Excipient with known affect Each 20mg tablet contains 163.4mg of Lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets 20mg tablet Red, 9mm, round, flat, tablet, with a score line on one side, imprinted with “A640” on one side and “20” 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. RENA Pročitajte cijeli dokument