HYDROCORTISONE 10 Milligram Tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

HYDROCORTISONE

Beszerezhető a:

Bristol Laboratories Limited

ATC-kód:

H02AB02

INN (nemzetközi neve):

HYDROCORTISONE

Adagolás:

10 Milligram

Gyógyszerészeti forma:

Tablets

Recept típusa:

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

Terápiás terület:

Glucocorticoids

Engedélyezési státusz:

Authorised

Engedély dátuma:

2016-01-29

Betegtájékoztató

SAME SIZE ARTWORK
430  x 130 MM
Front
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HYDROCORTISONE 10 MG AND 20 MG TABLETS
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. It
includes any possible side effects
not listed in this leaflet. See section 4.
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
• HYDROCORTISONE IS 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.
• HYDROCORTISONE CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read
section 4 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 section 4 for more
information).
• IF YOU TAKE IT FOR MORE THAN 3 WEEKS, YOU WILL GET A BLUE
‘STEROID TREATMENT  CARD’: always keep
it with you and show it to any doctor or nurse treating you.
• KEEP AWAY FROM PEOPLE WHO HAVE CHICKEN-POX OR SHINGLES, even if
you had them previously
(see section 2 for further information). 

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg hydrocortisone
Excipients with known effect:
Each tablet contains 146.75 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
White to off white, elliptical shape, flat, bevelled edge tablet with “BL 10” on one side and crossed break lines on
other side.
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_
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 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_
Children: 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