Country: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Resolution Chemicals Ltd
H02AB09
Hydrocortisone
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 5060301920112
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, please ask your doctor or your 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. • HYDVENTIA ® TABLETS ARE 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. • HYDVENTIA ® CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read section 4 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 as soon as possible. • SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information). • IF YOU TAKE THIS MEDICINE FOR MORE THAN 3 WEEKS, YOU WILL GET A BLUE ‘STEROID TREATMENT CARD’: always keep it with you and show it to any doctor or nurse treating you. • KEEP AWAY FROM PEOPLE WHO HAVE CHICKEN-POX OR SHINGLES, even if you have had them previously (read Section 2 for additional information). If you do come into contact with chicken pox 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 HYDVENTIA ® TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYDVENTIA ® TABLETS 3. HOW TO Lestu allt skjalið
1. NAME OF THE MEDICINAL PRODUCT Hydventia 10 mg Tablets Hydrocortisone 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 10mg - Each tablet contains 10 mg of hydrocortisone. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. 10mg - A white, oval, quarter scored tablet marked ‘F2’ on one side ‘10’ on the reverse. The tablet can be divided into equal halves or quarters. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Corticosteroid Hydrocortisone Tablets are indicated 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. • replacement therapy in congenital adrenal hyperplasia in children. • the emergency treatment of severe bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema and anaphylaxis in adults and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of Administration For oral administration. Posology Dosage must be individualised according to the response of the individual patient. The lowest possible dosage should be used. Undesirable effects may be minimised by using the lowest effective dose for the minimum period, and by administering the daily requirement as a single morning dose, or whenever possible, as a single morning dose on alternative days. Frequent patient review is required to titrate the dose against disease activity. To avoid hypoadrenalism and/or a relapse of the underlying disease, it may be necessary to withdraw the drug gradually (see section 4.4). _Replacement therapy _ 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 (e.g. dexamethasone sodium phosphate), which may be effective within min Lestu allt skjalið