Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Auden McKenzie (Pharma Division) Ltd
H02AB09
Hydrocortisone
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200
continued....please turn over 1. What Hydrocortisone Accord Tablets are and what are they used for Hydrocortisone Accord Tablets contain a medicine called hydrocortisone. This 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 Accord Tablets) is an effective way to treat various illnesses involving inflammation in the body. Hydrocortisone Accord Tablets reduce this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it. Hydrocortisone Accord Tablets are used for: • adding hydrocortisone usually made naturally in the body because part of the adrenal gland is not working properly • adding hydrocortisone after injuries, surgery or other stressful events • some other types of illness. Ask your doctor to explain why you have been given Hydrocortisone Accord Tablets if you are unsure. 2. Before taking Hydrocortisone Accord Tablets Before you take Hydrocortisone Accord Tablets Check with your doctor first if • You have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before or while taking steroid medicines like Hydrocortisone Accord Tablets. • any of your close family has had these illnesses. If either of these applies to you, talk to a doctor before taking Hydrocortisone Accord Tablets. Do not take Hydrocortisone Accord Tablets if you: • are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of Hydrocortisone Accord Tablets • have thrush, candida or any other fungal infection. If you are not sure talk to your doctor or pharmacist before taking Hydrocortisone Accord Tablets. Take special care with Hydrocortisone Accord Tablets Check with your doctor before taking your medicine if: • you have recently had a heart attack • you have a heart co Les hele dokumentet
OBJECT 1 HYDROCORTISONE 20MG TABLETS Summary of Product Characteristics Updated 21-May-2018 | Auden Mckenzie (Pharma Division) Ltd (a subsidiary of Actavis PLC) 1. Name of the medicinal product Hydrocortisone 20mg Tablets Hydrocortone 20mg Tablets Hydrocortisone Accord 20mg Tablets Hitoden 20mg Tablets 2. Qualitative and quantitative composition 20mg tablet: 20mg hydrocortisone 3. Pharmaceutical form Tablets 20mg tablets: white, half-scored tablets, marked 'HYD 20'. The tablet can be divided into equal doses. 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 (i.e. 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 (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 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 4-6 g of sodium chloride or 50-300 micrograms 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 ap Les hele dokumentet