Dexamethasone 2mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Dexamethasone

Beschikbaar vanaf:

Martindale Pharmaceuticals Ltd

ATC-code:

H02AB02

INN (Algemene Internationale Benaming):

Dexamethasone

Dosering:

2mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 06030200; GTIN: 5060378600016

Bijsluiter

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

Productkenmerken

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.