Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Prednisolone
Accord-UK Ltd
H02AB06
Prednisolone
1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 5012617004093
296x210 Leaflet Reel Fed Bi Fold Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Prednisolone Tablets 1mg x 28 (UK) 296x210 (Reel Fed) 51009531 Leaflet for Blisters 4397 T. Hull 08/12/21 * 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 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 1MG AND 5MG TABLETS, PIL UNITED KINGDOM Black Profile BBBB3581 R.Paul 23.12.2021 17.02.2022 R.Paul 296x210 8pts Accord Barnstaple NA 5 Version 7 12.02.2020 German GTIN 14 (incorporating PZN): Cartons and label leaflets only (labels only when specified) page 4 page 1 51009531 BBBB3581 • PREDNISOLONE IS A STEROID MEDICINE, prescribed for many different conditions, including serious illnesses. • YOU NEED TO TAKE IT REGULARLY to get the maximum benefit. • DO NOT 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 for more information). Some side effects 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 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 affe Pročitajte cijeli dokument
1. NAME OF THE MEDICINAL PRODUCT PREDNISOLONE 1mg TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1mg of Prednisolone. Excipient with known effect Each 1mg tablet contains 50.00mg of Lactose Monohydrate PhEur. For the full list of excipients, see section 6.1. _3 _ _PHARMACEUTICAL FORM _ White, circular, flat bevelled edge tablets, 5.56mm in diameter, embossed ‘C’ on one side and the identifying letters ‘PJ on the reverse. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Prednisolone is indicated in the management of all conditions deemed likely to benefit from short or long term glucocorticoid therapy. These include: _ALLERGIC STATES _ Severe, incapacitating allergies unresponsive to conventional treatment; asthma serum sickness; drug hypersensitivity reactions. _COLLAGEN DISORDERS _ Eg systemic lupus erythematosus, polymyositis, polymyalgia rheumatica and temporal (giant cell) arteritis, mixed connective tissue disease syndrome, acute rheumatic carditis. _RHEUMATIC DISORDERS _ Usually given as an adjunctive therapy for short term administration during an acute episode or exacerbation of rheumatoid arthritis, psoriatic arthritis. _SKIN CONDITIONS _ Life-threatening or incapacitating skin conditions such as pemphigus and exfoliative dermatitis. _NEOPLASTIC DISEASE _ Leukaemias and lymphomas in adults, acute leukaemia of childhood. _GASTRO-INTESTINAL DISEASE _ During acute exacerbation in ulcerative colitis and regional ileitis (Crohn's Disease). _RESPIRATORY DISEASE _ Sarcoidosis (especially with hypercalcaemia), fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy. _HAEMATOLOGICAL DISORDERS _ Various blood dyscrasias eg selected cases of haemolytic anaemia, thrombocytopenic purpura. _MISCELLANEOUS _ Nephrotic syndrome. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY In adults and the elderly: The lowest effective dose should be used for the minimum period in order to minimise side effects. Paediatric populat Pročitajte cijeli dokument