Hydrocortisone 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone

Available from:

DE Pharmaceuticals

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

continued....please turn over
1.
What Hydrocortisone Accord Tablets are
and what are they used for
Hydrocortisone Accord Tablets contain a medicine
called hydrocortisone. This belongs to a group of
medicines called ‘steroids’. Their full name is
corticosteroids. These corticosteroids occur naturally
in the body, and help to maintain health and
well-being. Boosting your body with extra corticosteroid
(such as Hydrocortisone Accord Tablets) is an effective
way to treat various illnesses involving inflammation in
the body.
Hydrocortisone Accord Tablets reduce this
inflammation, which could otherwise go on making
your condition worse. You must take this medicine
regularly to get maximum benefit from it.
Hydrocortisone Accord Tablets are used for:
•
adding hydrocortisone usually made naturally in the
body because part of the adrenal gland is not
working properly
•
adding hydrocortisone after injuries, surgery or other
stressful events
• some other types of illness.
Ask your doctor to explain why you have been given
Hydrocortisone Accord Tablets if you are unsure.
2. Before taking Hydrocortisone Accord Tablets
Before you take Hydrocortisone Accord Tablets
Check with your doctor first if
• You have ever had severe depression or manic
depression (bipolar disorder). This includes having
had depression before or while taking steroid
medicines like Hydrocortisone Accord Tablets.
• any of your close family has had these illnesses.
If either of these applies to you, talk to a doctor
before taking Hydrocortisone Accord Tablets.
Do not take Hydrocortisone Accord Tablets if you:
• are allergic (hypersensitive) to hydrocortisone or any
of the other ingredients of Hydrocortisone Accord
Tablets
• have thrush, candida or any other fungal infection.
If you are not sure talk to your doctor or pharmacist
before taking Hydrocortisone Accord Tablets.
Take special care with Hydrocortisone Accord
Tablets
Check with your doctor before taking your medicine if:
• you have recently had a heart attack
•
you have a heart co

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