Hydrocortisone 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone

Available from:

Mibe Pharma UK 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; GTIN: 5060608410002

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HYDROCORTISONE 10 MG TABLETS
Hydrocortisone
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. This
includes any possible side effects
not listed in this leaflet. See section 4.
j
HYDROCORTISONE IS A STEROID MEDICINE, prescribed for many different
conditions, including serious ill-
nesses.
j
YOU NEED TO TAKE IT REGULARLY to get the maximum benefit.
j
DO NOT STOP TAKING THIS MEDICINE without talking to your doctor - you
may need to reduce the dose
gradually.
j
HYDROCORTISONE CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read section 4:
‘Possible side effects‘ 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.
j
SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS. These include
weakness of arms and legs or
developing a rounder face (read section 4 ‘Possible side effects‘
for more information).
j
IF YOU TAKE THIS MEDICINE 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.
j
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.
WHAT IS IN THIS LEAFLET
1. What Hydrocortisone 10 mg Tablets are and what they

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg hydrocortisone.
Excipient with known effect:
Each tablet contains 76 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
White, round, flat tablet with a breakline on one side and ‘H’
imprinted on other side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Corticosteroid
o
As replacement therapy in congenital adrenal hyperplasia in children.
o
For the 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.
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 underlying disease, it
may be
necessary to withdraw the drug gradually (see 4.4 ‘Special warnings
and precautions
for use’).
_Replacement therapy in congenital hyperplasia_
Children: 10-30 mg in divided doses is the normal daily requirement
(see also
section 4.4, Special Warnings and Precautions for Use).
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.
_Acute emergencies_
60-80 mg every 4-6 hours for 24 hours then gradually reduce the dose
over
several days.
Steroids should be used cau