Dexamethasone 4mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Dexamethasone

MAH:

DE Pharmaceuticals

ATC_code:

H02AB02

INN:

Dexamethasone

dosage:

4mg

pharmaceutical_form:

Oral tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 06030200

PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER
DECADRON
® 4MG TABLETS
(DEXAMETHASONE)
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.
•
The name of your medicine is Decadron
®
4mg tablets but will be referred
to as Decadron throughout the remainder of this leaflet.
•
Decadron is also available in other strengths.
WHAT IS IN THIS LEAFLET
1. What Decadron is and what it is used for
2. What you need to know before you take Decadron
3. How to take Decadron
4. Possible side effects
5. How to store Decadron
6. Contents of the pack and other information
1. WHAT DECADRON IS AND WHAT IT IS USED FOR
Decadron is a synthetic glucocorticoid. Glucocorticoids are hormones
produced by the cortex of adrenal glands. The medicine has
anti-inflammatory, analgesic and anti-allergic effects, and suppresses
the
immune system.
Decadron is recommended for the treatment of rheumatic and autoimmune
diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis,
juvenile
idiopathic arthritis, polyarthritis nodosa), diseases of respiratory
tract (e.g.
bronchial asthma, croup), skin (e.g. erythroderma, pemphigus
vulgaris),
tuberculous meningitis only in conjunction with anti-infective
therapy,
diseases of blood (e.g. idiopathic thrombocytopenic purpura in
adults),
cerebral oedema, treatment of symptomatic multiple myeloma, acute
lymphoblastic leukemia, Hodgkin’s disease and non-Hodgkin’s
lymphoma in
combination with other medicinal products, palliative treatment of
neoplastic
diseases, prophylaxis and treatment of nausea and vomiting caused

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dexamethasone 4 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg of Dexamethasone.
Excipient with known effect
Each tablet contains approximately 141 mg Lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Each tablet contains 4 mg of Dexamethasone.
Excipient with known effect
Each tablet contains approximately 141 mg Lactose monohydrate.
For the full list of excipients, see section 6.1.
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.
ONCOLOGY
Palliative treatment of neoplastic diseases.
Prophylaxis and treatment of emesis induced by cytostatics, emetogenic
chemotherapy within antiemetic treatment.
Treatment of symptomatic multiple myeloma, acute lymphoblastic
leukemia,
Hodgkin's disease and non-Hodgkin's lymphoma in combination with other
medicinal
products.
VARIOUS
Prevention and treatment of pos