Dexamethasone 2mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

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下载 资料单张 (PIL)
22-02-2018
下载 产品特点 (SPC)
26-10-2022
下载 公众评估报告 (PAR)
20-04-2020

有效成分:

Dexamethasone

可用日期:

DE Pharmaceuticals

ATC代码:

H02AB02

INN(国际名称):

Dexamethasone

剂量:

2mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 06030200

资料单张

                                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
                                
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产品特点

                                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
                                
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