Hydrocortisone 10mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYDROCORTISONE

Available from:

Elara Pharmaservices Europe 239 Blanchardstown Corporate Park, Ballycoolin, Dublin, D15 KV21, Ireland

ATC code:

H02AB09

INN (International Name):

HYDROCORTISONE 10 mg

Pharmaceutical form:

TABLET

Composition:

HYDROCORTISONE 10 mg

Prescription type:

POM

Therapeutic area:

CORTICOSTEROIDS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2016-03-24

Patient Information leaflet

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PACKAGE LEAFLET – INFORMATION FOR THE PATIENT
HYDROCORTISONE
10 MG TABLETS
HYDROCORTISONE 20 MG TABLETS
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 any have further questions, please ask your doctor or your
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 TABLETS ARE 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 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 as soon as possible.
•
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 THIS MEDICINEFOR 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 have had
them previously (read Section 2 for additional information). 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. WHA

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 10 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
10mg - Each tablet contains 10 mg of hydrocortisone.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
10mg - A white, oval, quarter scored tablet marked ‘F2’ on one
side ‘10’ on the reverse. The tablet
can be divided into equal halves or quarters.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Corticosteroid
Hydrocortisone Tablets are indicated for replacement therapy in
congenital adrenal hyperplasia in
children.
Hydrocortisone Tablets are also used 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
Method of Administration
For oral administration.
Posology
_Replacement therapy _
Paediatric population: 10-30 mg in divided doses is the normal daily
requirement (see also section
4.4).
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 _
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60-80 mg every 4-6 hours for 24 hours then gradually reduce the dose
over several days.
Elderly
Steroids should be used cautiously in the elderly, since adverse
effects are enhanced in old age (see
section 4.4).
When long term treatment is to be discontinued, the dose should be
gradually reduced over a period of
weeks or months, depending on dosage and duration of therapy (see
section 4.4).
Undesirable effects may be minimised by using the lowest effective
dose for the minimum period, and
by administering the daily requirement as a single morning dose, or
whenever possible, as a single
morning dose on alternative days. Frequent patient review is required
to titrate the dose against
disease activity.
4.3 CONTRAI