Dexamethasone 2mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Dexamethasone

Disponível em:

Aspen Pharma Trading Ltd

Código ATC:

H02AB02

DCI (Denominação Comum Internacional):

Dexamethasone

Dosagem:

2mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 06030200; GTIN: 5013257001213 5013257000711 5013257000728

Folheto informativo - Bula

Package leaflet: Important information for the patient
Dexamethasone
2mg Tablets
Dexamethasone
•
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.
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 and what it is used for
2. What you need to know before you take Dex

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dexamethasone Tablets BP 2.0mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.0mg dexamethasone PhEur.
Excipient with known effect
Each tablet contains approximately 116mg lactose monohydrate Ph.Eur.
For the full list of excipients, see section 6.1
.
3
PHARMACEUTICAL FORM
Tablet
White, round and flat tablets with bevelled edges and a diameter of 6
mm, coded XC
above, and 8 below on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indicated in a wide variety of disorders amenable to glucocorticoid
therapy, as well as an
adjunct in the control of cerebral oedema.
Dexamthasone 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In general, glucocorticoid dosage depends on the severity of the
condition and
response of the patient. Under certain circumstances, for instance in
stress and
changed clinical picture, extra dosage adjustments may be necessary.
If no favourable
response
is
noted
within
a
couple
of
days,
glucocorticoid
therapy
should
be
discontinued.
_Adults_
Usually, daily oral dosages of 0.5 - 10 mg are sufficient. In some
patients higher
dosages may be temporarily required to control the disease. Once the
disease is under
control the dosage should be reduced or tapered off to the lowest
suitable level under
continuous monitoring and observation of the patient. (SEE SECTION
4.4)
For a short dexamethasone suppression test, 1mg dexamethasone is given
at 11 p.m.
and plasma cortisol measured the next morning. Patients who do not
show a decrease
in cortisol can be exposed to a longer test: 500 micrograms
dexamethasone is given at
6 hourly intervals for 48 hours followed by 2mg every 6 hours for a
further 48 hours.
24 hour-urine collections are made before, during and at the end of
the test fo