Hydrocortisone 10mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Hydrocortisone

Dostupné z:

Accord-UK Ltd

ATC kód:

H02AB09

INN (Medzinárodný Name):

Hydrocortisone

Dávkovanie:

10mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 06030200; GTIN: 5060032242132

Príbalový leták

Package leaflet: Information for the patient
HYDROCORTISONE 10MG AND 20MG
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 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 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 HYDROCORTISONE TABLETS CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read
section 4:
‘Possible side effects’ 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:
‘Possible side effects’ 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 CHICKEN-POX OR SHINGLEs, if you have
never
had them. They could affect you severely. If you do come into contact
with chicken
pox 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 HYDROCORTISONE TABLETS ARE AND WHAT ARE THEY USED FOR
2. WHAT YOU NEE

Súhrn charakteristických

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
Excipient with known effect
Each tablet contains 191.0mg of lactose.
For the full list of excipients, see section 6.1.
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