Krajina: Malta
Jazyk: angličtina
Zdroj: Malta Medicines Authority
HYDROCORTISONE
Novelgenix Therapeutics Limited 20, Oliver Business Park, Oliver Road, Park Royal, London, NW10 7JB, United Kingdom
H02AB09
HYDROCORTISONE 20 mg
TABLET
HYDROCORTISONE 20 mg
POM
CORTICOSTEROIDS FOR SYSTEMIC USE
Withdrawn
2017-08-11
Page 1 of 11 _PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ HYDROCORTISONE 10MG AND 20MG TABLETS Hydrocortisone 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. It includes any possible side effects not listed in this leaflet. See section 4. HYDROCORTISONE 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. HYDROCORTISONE 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 TREATMENT 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, even if you had them previously (see section 2 for further information). 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. WHAT IS IN THIS LEAFLET 1. What Hydrocortisone Tablets are and what th Prečítajte si celý dokument
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone 20mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg hydrocortisone Excipients with known effect: Each tablet contains 75 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. White, round, biconvex tablet with a break-line and embossment “20” on one side Diameter 8.0 - 8.2 mm. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Corticosteroid For use as replacement therapy in congenital adrenal hyperplasia in children. Treatment of adrenal insufficiency in children and adolescents < 18 years of age Emergency treatment of severe bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema and anaphylaxis in adults and children Hydrocortisone tablets are indicated in adults and children aged from 1 month to 18 years where the dose of 10 mg and 20 mg tablet formulation is considered appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dosage must be individualised according to the response of the individual patient. The lowest possible dosage should be used. In patients requiring replacement therapy, the first dose in the morning should be higher than the other doses, to simulate the normal diurnal rhythm of cortisol secretion. Page 2 of 12 Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g. surgery, infection, and trauma). During stress it may be necessary to increase the dosage temporarily. To avoid hypoadrenalism and/or a relapse of the underlying disease, it may be necessary to withdraw the drug gradually (see section 4.4). _Replacement therapy _ PAEDIATRIC POPULATION In congenital adrenal hyperplasia, 9–15 mg/m 2 /day divided in 3 doses, adjusted accord Prečítajte si celý dokument