HYDROCORTONE 10 Milligram Tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

HYDROCORTISONE

Dostupné z:

Auden Mckenzie (Pharma Division) Ltd

ATC kód:

H02AB09

INN (Medzinárodný Name):

HYDROCORTISONE

Dávkovanie:

10 Milligram

Forma lieku:

Tablets

Typ predpisu:

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

Terapeutické oblasti:

Glucocorticoids

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2010-02-12

Príbalový leták

HYDROCORTONE® 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 or pharmacist.

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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
• HYDROCORTISONE IS A STEROID MEDICINE, prescribed for many
different conditions, including serious
illnesses.
• YOU NEED TO TAKE IT REGULARLY to get the maximum benefit.
• DO NOT STOP TAKING THIS MEDICINE without talking to your doctor -
you may need to reduce the dose
gradually.
• HYDROCORTISONE 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).
• 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 LEAFLET. It includes other important
information on the safe and effective use of
this medicine that might be especially important for you.
WHAT IS IN THIS LEAFLET
1.
What Hydrocortone is and what it is used for
2.
What you need to know before you take Hydrocortone
3.
How to take Hydrocortone
4.
Possible side effects
5.
How to store Hydrocortone
6.
Contents of the pack and other information
1.
WHAT HYDROCORTONE IS AND WHAT

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydrocortone 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg Hydrocortisone.
Excipient: Contains 191.1mg Lactose Monohydrate per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, oval-shaped tablets quartersected on one side and imprinted
with 'HYD 10'
on the other side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
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 individualized according to the response of the
individual patient. The lowest possible dosage should
be used.
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.
If the drug is to be stopped after more than a few days of treatment,
it should be withdrawn gradually.
_In chronic adrenocortical insufficiency,_ a dosage of 20-30 mg 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 corticosteroid 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 0.8
mg/kg/day in two or three divided doses, adjusted to the needs of the
individual chil