Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Hydrocortisone
Renata Pharmaceuticals (Ireland) Limited
H02AB; H02AB09
Hydrocortisone
20 milligram(s)
Tablet
Glucocorticoids; hydrocortisone
Not marketed
2017-10-20
1 PACKAGE LEAFLET: INFORMATION FOR THE USER HYDROCORTISONE 10 MG TABLETS HYDROCORTISONE 20 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - - HYDROCORTISONE IS A STEROID MEDICINE , prescribed for many different conditions, including serious illnesses. - YOU NEED TO TAKE IT REGULARLY to get the maximum benefit. - DO NOT STOP TAKING THIS MEDICINE without talking to your doctor - you may need to reduce the dose gradually. - HYDROCORTISONE 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). - 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 chickenpox 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. 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 Belgenin tamamını okuyun
Health Products Regulatory Authority 08 June 2023 CRN00D8S3 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg Hydrocortisone Excipient(s) with known effect: Each tablet contains 157.6 mg lactose monohydrate (equivalent to 149.7mg lactose anhydrous) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet 10.9 x 7.1 mm white, oval, flat, bevelled tablets with a single break line on one side and imprinted “H” on the other side. 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 Posology Dosage must be individualized according to the response of the individual patient. The lowest possible dosage for the minimum period of time should be used. 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. If the drug is to be stopped after more than a few days of treatment, the dose should be reduced gradually over a period of weeks to months, depending on dosage and duration of therapy _In chronic adrenocortical insufficiency_, a dosage of 20-30 mg 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 corticosteroid preparations (e.g., dexamethasone sodium phosphate), which may be effective within minutes after parenter Belgenin tamamını okuyun