Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
HYDROCORTISONE
Resolution Chemicals Limited
H02AB09
HYDROCORTISONE
TABLET
HYDROCORTISONE 20 mg
POM
CORTICOSTEROIDS FOR SYSTEMIC USE
Authorised
PACKAGE LEAFLET – INFORMATION FOR THE PATIENT HYDROCORTISONE 10 MG TABLETS HYDROCORTISONE 20 MG TABLETS THIS LEAFLET CONTAINS IMPORTANT INFORMATION ABOUT HYDROCORTISONE TABLETS. READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • This medicine has been prescribed for you personally and you should 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. • HYDROCORTISONE TABLETS ARE 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 TABLETS CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read ‘Possible side effects’ 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 ‘Possible side effects’ section 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 have had them previously (See Section 2 for additional 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 Đọc toàn bộ tài liệu
1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Hydrocortisone 20 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 20mg - Each tablet contains 20 mg of hydrocortisone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 20mg – A white oval, half scored tablet marked ‘F2’ on one side and ’20’ on reverse. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Corticosteroid Hydrocortisone Tablets are indicated for replacement therapy in congenital adrenal hyperplasia in children. Hydrocortisone Tablets are also used for the 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 For oral administration: _Replacement therapy _ Children: 10-30 mg in divided doses is the normal daily requirement (see also section 4.4, Special Warnings and Precautions for Use). 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. _Acute emergencies _ 60-80 mg every 4-6 hours for 24 hours then gradually reduce the dose over several days. 2 of 9 Steroids should be used cautiously in the elderly, since adverse effects are enhanced in old age (see section 4.4, Special Warnings and Precautions for Use). When long term treatment is to be discontinued, the dose should be gradually reduced over a period of weeks or months, depending on dosage and duration of therapy (see section 4.4, Special Warnings and Precautions for Use). Undesirable effects may be minimised by using the lowest effective dose for the minimum period, and by administering the daily requirement as a single morning dose, or whenever possible, as a single morning dose on alternative days. Frequent patient review is required to Đọc toàn bộ tài liệu