Hydrocortisone 10mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Hydrocortisone

Предлага се от:

NorthStar Healthcare Unlimited Company

АТС код:

H02AB09

INN (Международно Name):

Hydrocortisone

дозиране:

10mg

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: 05051089990138

Листовка

PATIENT INFORMATION
L
E
AFL
E
T
HITODEN
®
10MG AND 20MG TABL
E
T
S
(HYDROCORTISONE)
THIS LEAFLET CONTAINS IMPORTANT INFORMATION ABOUT HITODEN TABLETS.
READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your
pharmacist.
• This medicine has been prescribed for you personally and you
should not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
• HITODEN 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.
• HITODEN TABLETS 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).
• 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.
IN THIS LEAFLET
1.
WHAT HITODEN TABLETS ARE AND WHAT ARE THEY

Данни за продукта

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.
•
Treatment of adrenal insufficiency in children and adolescents < 18
years of
age.
•
Emergency treatment of severe bronchial asthma, drug hypersensitivity
reactions, serum sickness, angioneurotic oedema and anaphylaxis in
adults
and children.
•
Pre-operatively, and during serious trauma or illness in children with
known adrenal insufficiency or doubtful adrenocortical reserve.
Hydrocortisone tablets are indicated in adults and children aged from
1 month
to 18 years where the dose of 10 mg, 20mg and tablet formulation is
considered appropriate
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.
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.
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
To avoid hypoadrenalism and/or a relapse of the under