Hydrocortisone 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

H02AB09

INN (International Name):

Hydrocortisone

Dosage:

10mg

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

HYDROCORTISONE
10MG TABLETS
Your medicine is known by the above name but will be referred to as
Hydrocortisone
Tablets
throughout
this
leaflet.
Please
note
that
this
medicine is also available in other strengths.
PATIENT INFORMATION LEAFLET
• HYDROCORTISONE 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.
• HYDROCORTISONE 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 CHICKENPOX 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.
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
1) WHAT HYDROCORTISONE TABLETS ARE AND WHAT THEY ARE USED
FOR
Hydrocortisone
Tablets
contain
a
medicine
called
hydrocortisone.
Hydrocortisone belongs to a group of me

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg hydrocortisone
Excipients with known effect:
Each tablet contains 146.75 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
White to off white, elliptical shape, flat, bevelled edge tablet with
“BL 10” on one
side and crossed break lines on other side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Corticosteroid
•
For use as 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.
•
Pre-operatively, and during serious trauma or illness in children with
known adrenal insufficiency or doubtful adrenocortical reserve.
Hydrocortisone tablets are indicated in adults and children aged from
1 month
to 18 years where the dose of 10 mg, 20mg and tablet formulation is
considered appropriate
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 a relapse of the under