Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Advanz Pharma
H02AB09
Hydrocortisone
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 05021691035329
PATIENT INFORMATION LEAFLET HITODEN ® 10 MG AND 20 MG TABLETS (HYDROCORTISONE) THIS LEAFLET CONTAINS IMPORTANT INFORMATION ABOUT HITODEN 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. • HITODEN TABLETS ARE 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 • HITODEN TABLETS 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 CHICKEN-POX OR SHINGLES, if you have never had them. They could affect you severely. 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. IN THIS LEAFLET 1. WHAT HITODEN TABLETS ARE AND WHAT ARE THEY USED FOR Прочетете целия документ
OBJECT 1 HYDROCORTISONE 10 MG TABLETS Summary of Product Characteristics Updated 14-Aug-2017 | Concordia International - formerly AMCo 1. Name of the medicinal product Hydrocortisone 10 mg Tablets 2. Qualitative and quantitative composition Each tablet contains 10 mg hydrocortisone. Excipient(s) with known effect: Contains lactose monohydrate (199.94 mg per tablet). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. A white, round, biconvex tablet. 4. Clinical particulars 4.1 Therapeutic indications 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 Posology _Replacement therapy_ _Paediatric population _10-30 mg in divided doses is the normal daily requirement (see section 4.4). 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. _Elderly _ Steroids should be used cautiously in the elderly, since adverse effects are enhanced in old age (see section 4.4). 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). 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 titrate the dose against disease activity. Method of administration For oral adminis Прочетете целия документ