Hydrocortisone 20 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hydrocortisone

Available from:

Renata Pharmaceuticals (Ireland) Limited

ATC code:

H02AB; H02AB09

INN (International Name):

Hydrocortisone

Dosage:

20 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Glucocorticoids; hydrocortisone

Authorization status:

Not marketed

Authorization date:

2017-10-20

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
HYDROCORTISONE 10 MG TABLETS
HYDROCORTISONE 20 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.
-
-
HYDROCORTISONE IS A STEROID MEDICINE
, prescribed for many different conditions, including serious
illnesses.
-
YOU NEED TO TAKE IT REGULARLY
to get the maximum benefit.
-
DO NOT 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 ‘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).
-
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 chickenpox 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

Summary of Product characteristics

Health Products Regulatory Authority
08 June 2023
CRN00D8S3
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg Hydrocortisone
Excipient(s) with known effect:
Each tablet contains 157.6 mg lactose monohydrate (equivalent to
149.7mg lactose anhydrous)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
10.9 x 7.1 mm white, oval, flat, bevelled tablets with a single break
line on one side and imprinted “H” on the other side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Corticosteroid

For use as replacement therapy in primary, secondary or acute
adrenocortical insufficiency. .

Pre-operatively, and during serious trauma or illness in patients with
known adrenal insufficiency or doubtful
adrenocortical reserve.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage must be individualized according to the response of the
individual patient. The lowest possible dosage for the
minimum period of time 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.
If the drug is to be stopped after more than a few days of treatment,
the dose should be reduced gradually over a period of
weeks to months, depending on dosage and duration of therapy
_In chronic adrenocortical insufficiency_, a dosage of 20-30 mg a day
is usually recommended, sometimes together with 4-6 g of
sodium chloride or 50-300 micrograms of fludrocortisone daily. When
immediate support is mandatory, one of the soluble
adrenocortical corticosteroid preparations (e.g., dexamethasone sodium
phosphate), which may be effective within minutes
after parenter