Hydrocortisone 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone

Available from:

Sigma Pharmaceuticals Plc

ATC code:

H02AB09

INN (International Name):

Hydrocortisone

Dosage:

20mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200

Patient Information leaflet

Package leaflet: Information for the user
Hydrocortisone 20mg Soluble
Tablets
Hydrocortisone
Important things you need to know about
Hydrocortisone
■ Hydrocortisone is a steroid medicine,
prescribed for many different conditions,
including replacement therapy,
emergency treatment of asthma, the
treatment of drug reactions, serum
sickness and severe allergic reactions in
adults and children.
■ You will need to take it as prescribed, to
get the maximum benefit.
■ Do not stop taking this medicine without
first 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 side effects may happen straight
away. If you feel unwell in any way, see
your doctor as soon as possible.
■ Some side effects only happen after
weeks or months. (Read section 4 below
for more information).
■ If you take this medicine for more than 3
weeks, you will get a blue ‘Steroid
Treatment Card’: always keep this 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, consult 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 may be
especially important for you.
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 any further questions, ask
your doctor or pharmacist or nurse.
■ 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, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
■ The name of this medicine is
Hydrocorti

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 20mg Soluble Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Hydrocortisone 20 mg Soluble Tablet contains 20 mg hydrocortisone
(as
hydrocortisone sodium phosphate ester).
Excipient with known effect
Each Hydrocortisone 20 mg Soluble Tablet contains 37.08 mg sodium and
5.06 mg
sodium benzoate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Soluble Tablets
Hydrocortisone 20 mg Soluble Tablets: Pink, biconvex, oblong tablets
marked with
“HS 20” with length of approx. 11 mm.
SUMMARY OF PRODUCT CHARACTERISTICS
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Replacement therapy in congenital adrenal hyperplasia in children.
•
Emergency treatment of severe bronchial asthma, drug hypersensitivity
reactions,
serum sickness, angioneurotic oedema and anaphylaxis in adults and
children.
•
Treatment of adrenal insufficiency in children and adolescents < 18
years of age.
Hydrocortisone 20 mg Soluble Tablets are indicated in adults and
children aged from
1 month to 18 years where the dose of 20 mg and soluble tablet
formulation is
considered appropriate.
SUMMARY OF PRODUCT CHARACTERISTICS
4
CLINICAL PARTICULARS
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