Hydrocortisone 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone

Available from:

Almus Pharmaceuticals Ltd

ATC code:

H02AB09

INN (International Name):

Hydrocortisone

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200; GTIN: 05060057404553

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 10mg Tablets
Hydrocortone 10mg Tablets
Hydrocortisone Accord 10mg Tablets
Hitoden 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
10mg tablet: 10mg hydrocortisone
3
PHARMACEUTICAL FORM
Tablets
10mg tablets: white, quarter-scored tablets, marked ‘HYD 10’. The
tablet can
be divided into equal halves or quarters
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 (i.e. 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 (e.g. 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 4-6 g of sodium chloride
or
50-300 micrograms 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 chil