Hydrocortisone 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone

Available from:

Phoenix Healthcare Distribution Ltd

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

PATIENT INFORMATION LEAFLET
HITODEN
® 10 MG AND 20 MG TABLETS
(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 USED FOR

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