Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
HYDROCORTISONE
Auden Mckenzie (Pharma Division) Ltd
H02AB09
HYDROCORTISONE
10 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Glucocorticoids
Authorised
2010-02-12
HYDROCORTONE® 10 MG 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. 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). • 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. WHAT IS IN THIS LEAFLET 1. What Hydrocortone is and what it is used for 2. What you need to know before you take Hydrocortone 3. How to take Hydrocortone 4. Possible side effects 5. How to store Hydrocortone 6. Contents of the pack and other information 1. WHAT HYDROCORTONE IS AND WHAT Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortone 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg Hydrocortisone. Excipient: Contains 191.1mg Lactose Monohydrate per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, oval-shaped tablets quartersected on one side and imprinted with 'HYD 10' on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Corticosteroid. For use as replacement therapy in primary, secondary or acute adrenocortical insufficiency. Pre-operatively, and during serious trauma or illness in patients with known adrenal insufficiency or doubtful adrenocortical reserve. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage must be individualized according to the response of the individual patient. The lowest possible dosage should be used. 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. If the drug is to be stopped after more than a few days of treatment, it should be withdrawn gradually. _In chronic adrenocortical insufficiency,_ a dosage of 20-30 mg a day is usually recommended, sometimes together with 4-6 g of sodium chloride or 50-300 micrograms of fludrocortisone daily. When immediate support is mandatory, one of the soluble adrenocortical corticosteroid preparations (e.g., dexamethasone sodium phosphate), which may be effective within minutes after parenteral administration, can be life-saving. _Paediatric population_: in chronic adrenocortical insufficiency, the dosage should be approximately 0.4 to 0.8 mg/kg/day in two or three divided doses, adjusted to the needs of the individual chil Đọc toàn bộ tài liệu