País: Malta
Língua: inglês
Origem: Medicines Authority
PREDNISOLONE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
H02AB06
PREDNISOLONE 30 mg
TABLET
PREDNISOLONE 30 mg
POM
CORTICOSTEROIDS FOR SYSTEMIC USE
Withdrawn
2016-04-29
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER PREDNISOLONE 2.5 MG TABLETS PREDNISOLONE 5 MG TABLETS PREDNISOLONE 10 MG TABLETS PREDNISOLONE 20 MG TABLETS PREDNISOLONE 25 MG TABLETS PREDNISOLONE 30 MG TABLETS Prednisolone - PREDNISOLONE 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. - PREDNISOLONE CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read 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 (read 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. 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 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. WHAT IS IN THIS LEAFLET 1. What Prednisolone is and what it is used for 2. What you need to know before you take Prednisolone 3. How to take Prednisolone 4. Possible side effects Leia o documento completo
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Prednisolone 2.5 mg tablets Prednisolone 5 mg tablets Prednisolone 10 mg tablets Prednisolone 20 mg tablets Prednisolone 25 mg tablets Prednisolone 30 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg prednisolone. Each tablet contains 5 mg prednisolone. Each tablet contains 10 mg prednisolone. Each tablet contains 20 mg prednisolone. Each tablet contains 25 mg prednisolone. Each tablet contains 30 mg prednisolone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets 2.5mg tablet Yellow, 7mm, round, flat, tablet, with a score line on one side, imprinted with “A610” on one side and “2.5” on the other. 5mg tablet White, 7mm, round, flat, tablet, with a score line on one side, imprinted with “A620” on one side and “5” on the other. 10mg tablet Red, 7mm, round, flat, tablet, with a score line on one side, imprinted with “A630” on one side and “10” on the other. 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. 25mg tablet White, 9mm, round, flat, tablet, with a score line on one side, imprinted with “A650” on one side and “25” on the other. 30mg tablet Yellow, 9mm, round, flat, tablet, with a score line on one side, imprinted with “A670” on one side and “30” on the other. 4. CLINICAL PARTICULARS 2 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 infar Leia o documento completo