国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dexamethasone
DE Pharmaceuticals
H02AB02
Dexamethasone
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200
DEXAMETHASONE 2MG TABLETS Your medicine is known by the above name, but will be referred to as Dexamethasone throughout this: • 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: POSSIBLE SIDE EFFECTS). 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 MEDICINE, 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, IN THE UK, 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 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, 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. PATIENT INFORMATION LEAFLET 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. WHAT IS IN THIS LEAFLET 1) What Dexamethasone is a 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexamethasone 2 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2mg dexamethasone. _Excipient with known effect: _ Each tablet contains 78.74mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets White to off-white tablet, round, flat with “D2” engraved on one side, about 6.3mm in diameter and 3.6mm in thickness. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NEUROLOGY Cerebral oedema (only with symptoms of intracranial pressure evidenced by computerised tomography) caused by a brain tumour, neuro-surgical intervention, cerebral abscess. PULMONARY AND RESPIRATORY DISEASES Acute asthma exacerbations when use of an oral corticosteroid (OCS) is appropriate, croup. DERMATOLOGY Initial treatment of extensive, severe, acute, skin diseases responding to glucocorticoids, e.g. erythroderma, pemphigus vulgaris. AUTOIMMUNE DISORDERS/RHEUMATOLOGY Initial treatment of autoimmune disorders like systemic lupus erythematodes. Active phases of systemic vasculitides like panarteritis nodosa (treatment duration should be limited to two weeks in cases of concomitant positive hepatitis B serology). Severe progressive course of active rheumatoid arthritis, e.g. fast proceeding destructive forms and/or extraarticular manifestations. Severe systemic course of juvenile idiopathic arthritis (Still’s disease). HAEMATOLOGICAL DISORDER Idiopathic thrombocytopenic purpura in adults. INFECTOLOGY Tuberculous meningitis only in conjunction with anti-infective therapy. Dexamethasone is indicated in the treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) who require supplemental oxygen therapy. ONCOLOGY Palliative treatment of neoplastic diseases. Prophylaxis and treatment of emesis induced by cytostatics, emetogenic chemotherapy within antiemetic treatment. Treatment of symptomatic multiple myelom 阅读完整的文件