Hydrocortisone 20mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Hydrocortisone

Commercializzato da:

Flynn Pharma Ltd

Codice ATC:

H02AB09

INN (Nome Internazionale):

Hydrocortisone

Dosaggio:

20mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 06030200; GTIN: 5060106551573

Foglio illustrativo

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.
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 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
imp

Scheda tecnica

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