País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Teva UK Ltd
H02AB09
Hydrocortisone
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 5017007014522
HYDROCORTISONE 10 MG AND 20 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. • 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 ‘Possible side effects’ section 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 ‘Possible side effects’ section 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 CHICKENPOX OR SHINGLES, if you have never had them. They could affect you severely. If you do come into contact with chickenpox 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. 1. WHAT HYDROCORTISONE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYDROCORTISONE 3. HOW TO TAKE HYDROCORTISONE Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg hydrocortisone Excipient(s) with known effect Each tablet contains 284.8 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, oval shaped tablet, engraved “H20” on one side and bisect breakline on the other. Dimensions: Approx. 9 mm x 14 mm. 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. • 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 doses of 10 mg and 20 mg and tablet formulation are considered appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dose must be individualised according to the response of the individual patient. The lowest possible dose 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 dose 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 dose 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 according to response. In adrenocortical insuffici Leer el documento completo