Hydrocortisone 20 mg Tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Hydrocortisone

Dostupné s:

Amdipharm Limited

ATC kód:

H02AB; H02AB09

INN (Mezinárodní Name):

Hydrocortisone

Dávkování:

20 milligram(s)

Léková forma:

Tablet

Druh předpisu:

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

Terapeutické oblasti:

Glucocorticoids; hydrocortisone

Stav Autorizace:

Not marketed

Datum autorizace:

2016-10-28

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE USER
HYDROCORTISONE 20 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 20 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

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg hydrocortisone.
Excipient with known effect
Each tablet contains 191mg 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 20’ 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_
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