Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Hydrocortisone
Amdipharm Limited
H02AB; H02AB09
Hydrocortisone
10 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Glucocorticoids; hydrocortisone
Not marketed
2016-10-28
PACKAGE LEAFLET: INFORMATION FOR THE USER HYDROCORTISONE 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, pharmacist or nurse. 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, pharmacist or nurse. It includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Hydrocortisone 10 mg Tablets. It will be referred to as Hydrocortisone Tablets for ease hereafter. 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 1. WHAT HYDROCORTISONE TABLETS ARE AND WHAT THEY ARE USED FOR Hydrocortisone belongs to a group of medicines called steroids. Their full name is _corticosteroids_. These corticosteroids occur naturally in the body and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Hydrocortisone) is an effective way to treat various illnesses involving inflammation in the body. Hydrocortisone reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it. It is indicated for use as replacement therapy for children with congenital adrenal hyperplasia which affects your body’s natural production of steroids. pre-operatively and during serious trauma or illness in children with known adrenal insufficiency or doubtful adrenocortical reserve. Hydrocortisone which is contained in this product is also authorised to treat other sub- group Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg hydrocortisone. Excipient with known effect Each tablet contains 191 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. A white, 10.8 mm x 7.0 mm, oval, tablet, engraved with ‘HC 10’ on one side and break-marked on both sides. 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. Pre-operatively and during serious trauma or illness in children with known adrenal insufficiency or doubtful adrenocortical reserve. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dosage must be individualised according to the response of the individual patient. _Replacement therapy_ _Paediatric_ _population_: In chronic adrenocortical insufficiency, the dosage should be approximately 0.4 to 0.8mg/kg/day in two or three divided doses, adjusted to the needs of the individual child. 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. _Use in serious trauma or illness with known adrenal insufficiency or doubtful adrenocortical reserve_ _Paediatric population_: Doses are generally higher than that used for chronic adrenocortical insufficiency and should be selected as appropriate for the clinical situation. 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. H E A L T H P R O D U C T S R E G U L A T O R Lesen Sie das vollständige Dokument