Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Prednisolone
Phoenix Labs
H02AB; H02AB06
Prednisolone
5 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Glucocorticoids; prednisolone
Marketed
1978-10-27
PACKAGE LEAFLET: INFORMATION FOR THE USER PREDNESOL 5MG TABLETS Active Ingredient: Prednisolone sodium phosphate 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. PREDNESOL TABLETS 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. PREDNESOL TABLETS CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read section 4 “Possible side effects” 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 “Possible side effects” 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. NOW READ THE REST OF THIS LEAFLET. It includes other important information on the safe and effective use of this medicine that might be especially important for you. IN THIS LEAFLET : 1. WHAT PREDNESOL 5MG TABLETS A Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 08 July 2021 CRN00CCSK Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prednesol 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of prednisolone as Prednisolone Sodium Phosphate. Excipients: - Contains Sodium Benzoate (E211) 7.5mg, Sodium Acid Citrate 99.17mg, Sodium Bicarbonate 31.7mg and Saccarin Sodium 0.5mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. Pink, circular, flat, bevel-edged tablets engraved ‘PRED 5’ on one face and a breakline on the other. The scoreline allows the tablet to be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A wide variety of diseases may sometimes require corticosteroid therapy. Prednisolone is used principally for its anti-inflammatory and immunosuppressant action or anti-neoplastic properties. Prednisolone may also be used as a replacement therapy but cortisone is usually preferred. The major indications are listed below. This list of indications is not exhaustive but represents the major established disease states with evidence of an established and current role in their management. Prednisolone may be used in a wide variety of other inflammatory and immune disorders according to local guidelines and according to the assessment of the benefit risk in individual patients. Inflammatory and immunological disorders Pemphigus Asthma Sarcoid disease Rheumatoid arthritis, polymyalgia rheumatica and giant cell (temporal) arteritis and polyarteritis nodosa Systemic lupus erythematosus, Polymyositis Inflammatory bowel disease: ulcerative colitis and Crohn's disease Renal disease: minimal change nephrotic syndrome, acute interstitial nephritis; renal lupus Autoimmune hepatitis, Thrombocytopenic purpura and acquired haemolytic anaemia Immunosuppression – in organ transplantation Health Products Regulatory Authority 08 July 2021 CRN00CCSK Page 2 of 12 Neoplasms Treated with Cortic Lesen Sie das vollständige Dokument