Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Bristol Laboratories Ltd
H02AB09
Hydrocortisone
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 5060013945519
SAME SIZE ARTWORK 560 x 170 MM Front XXXXXXX PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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. It includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Hydrocortisone Tablets are and what they are used for 2. What you need to know before you take Hydrocortisone Tablets 3. How to take Hydrocortisone Tablets 4. Possible side effects 5. How to store Hydrocortisone Tablets 6. Contents of the pack and other information • 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 yo Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone 20mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20mg hydrocortisone Excipients with known effect: Each tablet contains 146.75 mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. White to off white, elliptical shape, flat, bevelled edge tablet with “BL 20” on one side and a breakline on other side. 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, 20mg and 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. The lowest possible dosage should be used. Doses should be multiples of 10 (i.e. 10mg, 20mg, 30mg, etc.). In patients requiring replacement therapy, the daily dose should be given when practicable, in two doses. The first dose in the morning should be larger than the second dose in the evening, thus simulating 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, 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 wit Aqra d-dokument sħiħ