国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dexamethasone
Aspire Pharma Ltd
H02AB02
Dexamethasone
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 5060378600016 5060209732824
DEXAMETHASONE - HEADLINES • DEXAMETHASONE IS A STEROID MEDICINE, prescribed for many different conditions, including serious illnesses. • YOU NEED TO TAKE IT REGULARLY to get the maximum benefit. • DON’T STOP TAKING THIS MEDICINE without talking to your doctor – you may need to reduce the dose gradually. • DEXAMETHASONE 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 STRAIGHT AWAY. • 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 IT FOR MORE THAN 3 WEEKS, YOU WILL GET A BLUE ‘STEROID CARD’: always keep it with you and show it to any doctor or nurse treating you. • KEEP AWAY FROM PEOPLE WHO HAVE CHICKENPOX 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 to you. THIS LEAFLET WAS LAST UPDATED IN MARCH 2017. PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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 symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. IN THIS LEAFLET: 1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE DEXAMETHASONE TABLETS 3. HOW TO TAKE DEXAMETHASONE TABLE 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexamethasone 2mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 milligrams dexamethasone Ph Eur. Excipient with known effect: Contains lactose monohydrate, see section 4.4. Each tablet contains 70 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Round, white, flat tablets, 6 mm in diameter, debossed with D2 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dexamethasone is indicated as a treatment for certain endocrine and non endocrine disorders, in certain cases of cerebral oedema, and for diagnostic testing of adrenocortical hyperfunction. Endocrine disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia. Non-endocrine disorders: Dexamethasone may be used in the treatment of non endocrine corticosteroid responsive conditions, including: Allergy and anaphylaxis: Angioneurotic oedema, anaphylaxis. Arteritis collagenosis: Polymyalgia rheumatica, polyarteritis nodosa. Blood disorders: Haemolytic anaemia, leukaemia, myeloma. Cardiovascular disorders: Post-myocardial infarction syndrome. Gastro-intestinal: Crohn’s disease, ulcerative colitis. Hypercalcaemia: Sarcoidosis. Infections (with appropriate chemotherapy): Miliary tuberculosis. Muscular disorders: Polymyositis. Neurological disorders: Raised intra-cranial pressure secondary to cerebral tumours. Ocular disorders: Anterior and posterior uveitis, optic neuritis. Renal disorders: Lupus nephritis. Respiratory disease: Bronchial asthma, aspiration pneumonitis. Rheumatic disorders: Rheumatoid arthritis. Skin disorders: Pemphigus vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _General considerations_: Dosage must be individualised on the basis of the disease and the response of the patient. In order to minimise side effects, the lowest possible dosage adequate to control the disease process should be used (see section 4.8). The initial dosage varies from 0. 阅读完整的文件