Hydrocortisone Tablets 20mg

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

HYDROCORTISONE

Διαθέσιμο από:

Resolution Chemicals Limited

Φαρμακολογική κατηγορία (ATC):

H02AB09

INN (Διεθνής Όνομα):

HYDROCORTISONE

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

HYDROCORTISONE 20 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

CORTICOSTEROIDS FOR SYSTEMIC USE

Καθεστώς αδειοδότησης:

Authorised

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET – INFORMATION FOR THE PATIENT
HYDROCORTISONE
10 MG TABLETS
HYDROCORTISONE 20 MG TABLETS
THIS LEAFLET CONTAINS IMPORTANT INFORMATION ABOUT HYDROCORTISONE
TABLETS. READ THIS
LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your
pharmacist.
• This medicine has been prescribed for you personally and you
should not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
• 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 TABLETS CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read
‘Possible side
effects’ 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 ‘Possible side
effects’ section 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 have had them
previously (See 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

Αρχείο Π.Χ.Π.

1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 20 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
20mg - Each tablet contains 20 mg of hydrocortisone.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
20mg – A white oval, half scored tablet marked ‘F2’ on one side
and ’20’ on reverse. The tablet can
be divided into equal halves.
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
For oral administration:
_Replacement therapy _
Children: 10-30 mg in divided doses is the normal daily requirement
(see also section 4.4, Special
Warnings and Precautions for Use).
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 _
60-80 mg every 4-6 hours for 24 hours then gradually reduce the dose
over several days.
2 of 9
Steroids should be used cautiously in the elderly, since adverse
effects are enhanced in old age (see
section 4.4, Special Warnings and Precautions for Use).
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, Special Warnings
and Precautions for Use).
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