País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Kent Pharma (UK) Ltd
H02AB09
Hydrocortisone
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200
Size: 165 x 420 mm 1:1 PACKAGE LEAFLET: INFORMATION FOR THE USER HYDROCORTISONE 20 MG TABLETS GB 674-8172-APIL SAMPLE SAMPLE SAMPLE SAMPLE 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 further questions, ask your doctor or your 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 become severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. • HYDROCORTISONE IS A STEROID MEDICINE prescribed for many different conditions including serious illnesses. • YOU NEED TO TAKE IT REGULARLY to get the maximum benefit. • DO NOT 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 AS SOON AS POSSIBLE. • 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 THIS MEDICINE 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 have had them previously (read Section 2 for further information). 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. HYDROCORTISONE - BENEFIT INFORMATION. Hydrocortisone belongs to a group of medicines called steroids. Their Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 mg tablet contains 20 mg hydrocortisone. Excipients with known effect: Each 20 mg tablet contains 196.72 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets 20 mg White to off white, oval, flat faced beveled edge, uncoated tablets debossed with ‘G361’ on one side and break line on the other with approx. 3.3mm thickness, 10.9mm length and 7.1mm breadth The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • 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. 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. 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/m2/day divided in 3 doses, adjusted according to response. In adrenocortical insufficiency, 8–10 mg/ m2/day divided in 3 doses (approximately 0.4 to 0. Leer el documento completo