Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Prednisolone
Teva UK Ltd
H02AB06
Prednisolone
1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 5017007240143
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PREDNISOLONE 1 MG AND 5 MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. PREDNISOLONE TABLETS LEAFLET - HEADLINES PREDNISOLONE TABLETS ARE 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 TABLETS CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (see 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 (see 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 WHO HAVE CHICKEN-POX OR SHINGLES, if you have never had them. They could affect you severely. If you do 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. WHAT IS IN THIS LEAFLET 1. What Prednisolone tablets are and what they are used for 2. What you need Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Prednisolone 1mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg of the active ingredient prednisolone. Excipient with known effect Each tablet contains 47.4 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White biconvex tablets. Engraved: ‘APS’ over ‘2401’ on one side and plain on the reverse. 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 _GASTRO-INTESTINAL _ _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, millary 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 glomeru Baca dokumen lengkapnya