Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Sigma Pharmaceuticals Plc
H02AB09
Hydrocortisone
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200
Package leaflet: Information for the user Hydrocortisone 20mg Soluble Tablets Hydrocortisone Important things you need to know about Hydrocortisone ■ Hydrocortisone is a steroid medicine, prescribed for many different conditions, including replacement therapy, emergency treatment of asthma, the treatment of drug reactions, serum sickness and severe allergic reactions in adults and children. ■ You will need to take it as prescribed, to get the maximum benefit. ■ Do not stop taking this medicine without first talking to your doctor - you may need to reduce the dose gradually. ■ Hydrocortisone can cause side effects in some people (read section 4 below). Some side effects may happen straight away. If you feel unwell in any way, see your doctor as soon as possible. ■ Some side effects only happen after weeks or months. (Read section 4 below for more information). ■ If you take this medicine for more than 3 weeks, you will get a blue ‘Steroid Treatment Card’: always keep this 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, consult 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 may be especially important for you. 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 or 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 this medicine is Hydrocorti Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone 20mg Soluble Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Hydrocortisone 20 mg Soluble Tablet contains 20 mg hydrocortisone (as hydrocortisone sodium phosphate ester). Excipient with known effect Each Hydrocortisone 20 mg Soluble Tablet contains 37.08 mg sodium and 5.06 mg sodium benzoate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Soluble Tablets Hydrocortisone 20 mg Soluble Tablets: Pink, biconvex, oblong tablets marked with “HS 20” with length of approx. 11 mm. SUMMARY OF PRODUCT CHARACTERISTICS 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Replacement therapy in congenital adrenal hyperplasia in children. • Emergency treatment of severe bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema and anaphylaxis in adults and children. • Treatment of adrenal insufficiency in children and adolescents < 18 years of age. Hydrocortisone 20 mg Soluble Tablets are indicated in adults and children aged from 1 month to 18 years where the dose of 20 mg and soluble tablet formulation is considered appropriate. SUMMARY OF PRODUCT CHARACTERISTICS 4 CLINICAL PARTICULARS 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 Soma hati kamili