Hydrocortisone 10 mg Tablets

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Hydrocortisone

Inapatikana kutoka:

Amdipharm Limited

ATC kanuni:

H02AB; H02AB09

INN (Jina la Kimataifa):

Hydrocortisone

Kipimo:

10 milligram(s)

Dawa fomu:

Tablet

Dawa ya aina:

Product subject to prescription which may not be renewed (A)

Eneo la matibabu:

Glucocorticoids; hydrocortisone

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2016-10-28

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
HYDROCORTISONE 10 MG TABLETS
HYDROCORTISONE
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.
It 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-
group

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg hydrocortisone.
Excipient with known effect
Each tablet contains 191 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A white, 10.8 mm x 7.0 mm, oval, tablet, engraved with ‘HC 10’ on
one side and break-marked on both sides.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Corticosteroid
For use as replacement therapy in congenital adrenal hyperplasia in
children.
Pre-operatively and during serious trauma or illness in children 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.
_Replacement therapy_
_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.
In patients requiring replacement therapy, the daily dose should be
given when practicable, in two doses. The first dose
in the morning should be larger than the second dose in the evening,
thus simulating the normal
diurnal
rhythm of
cortisol secretion.
_Use in serious trauma or illness with known adrenal insufficiency or
doubtful adrenocortical reserve_
_Paediatric population_: Doses are generally higher than that used for
chronic adrenocortical insufficiency and should be
selected as appropriate for the clinical situation. 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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R