Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Prednisolone
Phoenix Labs
H02AB; H02AB06
Prednisolone
2.5 milligram(s)
Gastro-resistant tablet
Product subject to prescription which may not be renewed (A)
Glucocorticoids; prednisolone
Marketed
1977-03-01
PATIENT INFORMATION LEAFLET DELTACORTRIL® ENTERIC 2.5MG GASTRO-RESISTANT TABLETS DELTACORTRIL® ENTERIC 5MG GASTRO-RESISTANT TABLETS Active Ingredient: Prednisolone DELTACORTRIL ENTERIC 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. DELTACORTRIL ENTERIC CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read Section 4 “Possible Side Effects”). Some problems such as mode 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 the 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 CHICKEN-POX OR SHINGLES, if you have never had them. They could affect you severely. If you come into contact with chicken-pox 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. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Deltacortril Enteric is and what it is tak Прочитајте комплетан документ
Health Products Regulatory Authority 17 June 2021 CRN00CCYT Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DELTACORTRIL ENTERIC 2.5 mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg of prednisolone. Also contains 33mg of lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet Smooth, uniformly coloured brown tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ALLERGY AND ANAPHYLAXIS_: Bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema, anaphylaxis. _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. _GASTROINTESTINAL DISORDERS: _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. _RENAL DISORDERS: _Lupus nephritis, acute interstitial nephritis, minimal change glomerulonephritis Прочитајте комплетан документ