Hydrocortone 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone

Available from:

Auden McKenzie (Pharma Division) 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

Patient Information leaflet

Package Leaflet: Information for the User
HITODEN
®
10MG TABLETS
(HYDROCORTISONE)
THIS LEAFLET CONTAINS IMPORTANT INFORMATION ABOUT HITODEN 10MG
TABLETS.
READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

This medicine has been prescribed for you personally and you
should 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 get serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.

The name of this medicine is Hitoden 10mg Tablets but it will be
referred to as Hitoden Tablets throughout the remainder of this
leaflet.

Hitoden Tablets are also available in other strengths.
 HITODEN TABLETS ARE 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
 HITODEN TABLETS CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read
‘Possible side effects’ section 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 ‘Possible side effects’ section 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 LEAF

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
Posology
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).
Undesirable effects may be minimised by using the lowest effective
dose for
the minimum period and by administering the daily requirement as a
single
morning dose or whenever possible, as a single morning dose on
alternate
days. Frequent patient review is required to titrate the dose against
disease
activity.
To avoid hypoadrenalism and/or a relapse of the underlying disease, it
may
be necessary to withdraw the drug gradually (see section 4.4).
_Replacement therapy_
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 (e.g. dexamethasone sodium phosphate), which may
be effective within minutes after parenteral administration, can be
life-saving.
_ _
_Paediatric population_:
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 child.
_ _
_Elderly_:
Treatment