Hydrocortisone 20mg Tablets

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

HYDROCORTISONE

Disponibbli minn:

Novelgenix Therapeutics Limited 20, Oliver Business Park, Oliver Road, Park Royal, London, NW10 7JB, United Kingdom

Kodiċi ATC:

H02AB09

INN (Isem Internazzjonali):

HYDROCORTISONE 20 mg

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

HYDROCORTISONE 20 mg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

CORTICOSTEROIDS FOR SYSTEMIC USE

L-istatus ta 'awtorizzazzjoni:

Withdrawn

Data ta 'l-awtorizzazzjoni:

2017-08-11

Fuljett ta 'informazzjoni

Page 1 of 11
_PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _
HYDROCORTISONE 10MG AND 20MG 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. It
includes any possible side
effects not listed in this leaflet. See section 4.

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
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.
WHAT IS IN THIS LEAFLET
1. What Hydrocortisone Tablets are and what th

Karatteristiċi tal-prodott

Page
1
of
12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 20mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg hydrocortisone
Excipients with known effect:
Each tablet contains 75 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
White, round, biconvex tablet with a break-line and embossment
“20” on one side
Diameter 8.0 - 8.2 mm. 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
Hydrocortisone tablets are indicated in adults and children aged from
1 month to 18
years
where
the
dose
of
10
mg
and
20
mg
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 first dose in the
morning should be
higher than the other doses, to simulate the normal diurnal rhythm of
cortisol
secretion.
Page
2
of
12
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, and 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 section 4.4).
_Replacement therapy _
PAEDIATRIC POPULATION
In congenital adrenal hyperplasia, 9–15 mg/m
2
/day divided in 3 doses, adjusted
accord