Hydrocortisone 10mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Hydrocortisone

Tilgængelig fra:

Genesis Pharmaceuticals Ltd

ATC-kode:

H02AB09

INN (International Name):

Hydrocortisone

Dosering:

10mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 06030200; GTIN: 5060014444370

Indlægsseddel

Package leaflet: Information for the user
Hydrocortisone 10mg Soluble
Tablets
Hydrocortisone
Important things you need to know about
Hydrocortisone
■ Hydrocortisone is a steroid medicine,
prescribed for many different conditions,
including replacement therapy,
emergency treatment of asthma, the
treatment of drug reactions, serum
sickness and severe allergic reactions in
adults and children.
■ You will need to take it as prescribed, to
get the maximum benefit.
■ Do not stop taking this medicine without
first talking to your doctor - you may
need to reduce the dose gradually.
■ Hydrocortisone can cause side effects in
some people (read section 4 below).
Some side effects may happen straight
away. If you feel unwell in any way, see
your doctor as soon as possible.
■ Some side effects only happen after
weeks or months. (Read section 4 below
for more information).
■ If you take this medicine for more than 3
weeks, you will get a blue ‘Steroid
Treatment Card’: always keep this 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, consult 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 may 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 or nurse.
■ 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, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
■ The name of this medicine is
Hydrocorti

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone 10mg
Excipients:
Hydrocortisone 10mg Tablets contain 64.3mg lactose monohydrate per
tablet.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
Round, white tablet, with ‘H10’ imprinted on one side and a
breakline on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Corticosteroid.
For
use
as
replacement
therapy
in
primary,
secondary,
or
acute
adrenocortical
insufficiency.
Pre-operatively, and during serious trauma or illness in patients with
known adrenal
insufficiency or doubtful adrenocortical reserve.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage must be individualised according to the response of the
individual patient.
The lowest possible dosage should be used. Doses should be multiples
of 10 (ie
10mg, 20mg, 30mg, etc).
Patients should be observed closely for signs that might require
dosage adjustment,
including changes in clinical status resulting from remissions or
exacerbations of the
disease, individual drug responsiveness, and the effect of stress (eg
surgery, infection,
trauma). During stress it may be necessary to increase the dosage
temporarily.
To avoid hypoadrenalism and/or a relapse of the underlying disease, it
may be
necessary to withdraw the drug gradually (see 4.4 'Special warnings
and precautions
for use').
In chronic adrenocortical insufficiency, a dosage of 20 to 30mg a day
is usually
recommended,
sometimes
together
with
4-6g
of
sodium
chloride
or
50-300micrograms of fludrocortisone daily. When immediate support is
mandatory,
one of the soluble adrenocortical hormone preparations (eg
dexamethasone sodium
phosphate), which may be effective within minutes after parenteral
administration,
can be life-saving.
_Use _
_in _
_children_:
In
chronic
adrenocortical
insufficiency,
the
dosage
should
be
approximately 0.4 to 0.8mg/kg/day in two or three divided doses,
adjusted to the
needs of the individual