Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
NorthStar Healthcare Unlimited Company
H02AB09
Hydrocortisone
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 05051089990138
PATIENT INFORMATION L E AFL E T HITODEN ® 10MG AND 20MG TABL E T S (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 Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg 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 10” on one side and crossed break lines 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. • Pre-operatively, and during serious trauma or illness in children with known adrenal insufficiency or doubtful adrenocortical reserve. 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. 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 under Διαβάστε το πλήρες έγγραφο