Hydrocortisone 20mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Hydrocortisone

Предлага се от:

Accord-UK Ltd

АТС код:

H02AB09

INN (Международно Name):

Hydrocortisone

дозиране:

20mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 06030200; GTIN: 5060032242149

Листовка

Package leaflet: Information for the patient
HYDROCORTONE® 10 MG AND 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 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.
HYDROCORTONE 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.
HYDROCORTONE 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 SHINGLE
s, 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 HYDROCORTONE TABLETS ARE AND WHAT ARE THEY USED FO

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 20mg Tablets
Hydrocortone 20mg Tablets
Hydrocortisone Accord 20mg Tablets
Hitoden 20mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
20mg tablet: 20mg hydrocortisone
Excipient with known effect
Each tablet contains 182.7mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
20mg tablets: white, half-scored tablets, marked ‘HYD 20’. The
tablet can be
divided 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
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
0.4 to 0.8mg/kg/