Hydrocortisone 20mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Hydrocortisone

Beschikbaar vanaf:

Sovereign Medical Ltd

ATC-code:

H02AB09

INN (Algemene Internationale Benaming):

Hydrocortisone

Dosering:

20mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 06030200; GTIN: 5021730026851

Bijsluiter

Size:
165 x 420 mm
1:1
PACKAGE LEAFLET:
INFORMATION FOR THE USER
HYDROCORTISONE 20 MG TABLETS
GB 674-8172-APIL
SAMPLE
SAMPLE
SAMPLE
SAMPLE READ
ALL
OF
THIS
LEAFLET
CAREFULLY
BEFORE
YOU
START TAKING THIS MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor or your
pharmacist.
•
This medicine has been prescribed for you. Do 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 become severe, or if you
notice
any
side
effects
not
listed
in
this
leaflet,
please tell your doctor or pharmacist.
•
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 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 AS SOON AS POSSIBLE.
•
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 THIS MEDICINE 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 have had them previously
(read Section 2 for further information). 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.
HYDROCORTISONE - BENEFIT INFORMATION.
Hydrocortisone belongs to a group of medicines called
steroids.
Their

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 20 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Hydrocortisone 20 mg Tablet contains 20 mg Hydrocortisone EP.
3
PHARMACEUTICAL FORM
A white, round, biconvex tablet scored on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hydrocortisone Tablets are indicated for replacement therapy in
primary and
secondary adrenal insufficiency, Addison’s disease and congenital
adrenal
hyperplasia.
Hydrocortisone Tablets are also used for the emergency treatment of
severe
bronchial asthma, drug hypersensitivity reactions, serum sickness,
angioneurotic oedema and anaphylaxis.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
_Replacement therapy _
Adults: 20-30 mg in divided doses is the normal daily requirement.
Children: 10-30 mg in divided doses is the normal daily requirement
(see also
section 4.4, Special Warnings and Precautions for Use).
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.
_Acute emergencies _
_ _
60-80 mg every 4-6 hours for 24 hours then gradually reduce the dose
over
several days. Steroids should be used cautiously in the elderly, since
adverse
effects are enhanced in old age (see section 4.4, Special Warnings and
Precautions for Use).
When long term treatment is to be discontinued, the dose should be
gradually
reduced over a period of weeks or months, depending on dosage and
duration
of therapy (see section 4.4, Special Warnings and Precautions for
Use).
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
alternative
days. Frequent patient review is required to titrate the dose against
disease
activity.
4.3
CONTRAINDIC