Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Sigma Pharmaceuticals Plc
H02AB09
Hydrocortisone
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200
500MM 170MM 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. This 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-groups of patients which are not mentioned in this leaflet. Ask your do Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrocortisone 10mg Excipients: Hydrocortisone 10mg Tablets contain 64.3mg lactose monohydrate per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Round, white tablet, with ‘H10’ imprinted on one side and a breakline on the other. 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 individualised according to the response of the individual patient. The lowest possible dosage should be used. Doses should be multiples of 10 (ie 10mg, 20mg, 30mg, etc). 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 (eg surgery, infection, trauma). During stress it may be necessary to increase the dosage temporarily. To avoid hypoadrenalism and/or a relapse of the underlying disease, it may be necessary to withdraw the drug gradually (see 4.4 'Special warnings and precautions for use'). In chronic adrenocortical insufficiency, a dosage of 20 to 30mg a day is usually recommended, sometimes together with 4-6g of sodium chloride or 50-300micrograms of fludrocortisone daily. When immediate support is mandatory, one of the soluble adrenocortical hormone preparations (eg dexamethasone sodium phosphate), which may be effective within minutes after parenteral administration, can be life-saving. _Use _ _in _ _children_: 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 Preberite celoten dokument