Hydrocortisone 10mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Hydrocortisone

제공처:

Sigma Pharmaceuticals Plc

ATC 코드:

H02AB09

INN (International Name):

Hydrocortisone

복용량:

10mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 06030200

환자 정보 전단

500MM
170MM
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, 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
your
medicine
is
Hydrocortisone
10
mg
Tablets.
It
will
be
referred
to
as
Hydrocortisone Tablets for ease hereafter.
WHAT IS IN THIS LEAFLET:
1. What Hydrocortisone Tablets are and what they
are used for
2. What
you
need
to
know
before
you
take
Hydrocortisone Tablets
3. How to take Hydrocortisone Tablets
4. Possible side effects
5. How to store Hydrocortisone Tablets
6. Contents of the pack and other information.
1. WHAT HYDROCORTISONE TABLETS ARE AND WHAT THEY
ARE USED FOR
Hydrocortisone belongs to a group of medicines
called steroids. Their full name is corticosteroids.
These corticosteroids occur naturally in the body
and help to maintain health and well-being. Boosting
your
body
with
extra
corticosteroid
(such
as
Hydrocortisone) is an effective way to treat various
illnesses
involving
inflammation
in
the
body.
Hydrocortisone
reduces
this
inflammation,
which
could otherwise go on making your condition worse.
You
must
take
this
medicine
regularly
to
get
maximum benefit from it.
It is indicated
• for use as replacement therapy for children with
congenital adrenal hyperplasia which affects your
body’s natural production of steroids.
• pre-operatively
and
during
serious
trauma
or
illness in children with known adrenal insufficiency
or doubtful adrenocortical reserve.
Hydrocortisone which is contained in this product is
also authorised to treat other sub-groups of patients
which are not mentioned in this leaflet. Ask your
do

제품 특성 요약

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