Hydrocortisone 20mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Hydrocortisone

Commercializzato da:

Kent Pharma (UK) Ltd

Codice ATC:

H02AB09

INN (Nome Internazionale):

Hydrocortisone

Dosaggio:

20mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 06030200

Foglio illustrativo

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

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 20 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mg tablet contains 20 mg hydrocortisone.
Excipients with known effect:
Each 20 mg tablet contains 196.72 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
20 mg
White to off white, oval, flat faced beveled edge, uncoated tablets
debossed with
‘G361’ on one side and break line on the other with approx. 3.3mm
thickness,
10.9mm length and 7.1mm breadth
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
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.
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 first dose in the
morning should be
higher than the other doses, to simulate 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, and trauma). During stress it may be necessary to increase
the dosage
temporarily.
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
_Paediatric population _
In congenital adrenal hyperplasia, 9–15 mg/m2/day divided in 3
doses, adjusted
according to response.
In adrenocortical insufficiency, 8–10 mg/ m2/day divided in 3 doses
(approximately
0.4 to 0.