Hydrocortisone 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone

Available from:

Alliance 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

SAME SIZE ARTWORK
430 x 160 MM
Front
XXXXXXX
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HYDROCORTISONE 10 MG AND 20 MG TABLETS
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.
-
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 or pharmacist. It
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Hydrocortisone Tablets are and what they are used for
2.
What you need to know before you take Hydrocortisone Tablets
3.
How to take Hydrocortisone Tablets
4.
Possible side effects
5.
How to store Hydrocortisone Tablets
6.
Contents of the pack and other information
•
HYDROCORTISONE IS 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.
•
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 STRAIGHT AWAY.
•
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 IT 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
had them previously
(see section 2 for further information). They could affect you
severely. If yo

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