Hydrocortisone 10mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Hydrocortisone

Beschikbaar vanaf:

Bristol Laboratories Ltd

ATC-code:

H02AB09

INN (Algemene Internationale Benaming):

Hydrocortisone

Dosering:

10mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 06030200; GTIN: 5060013945502

Bijsluiter

SAME SIZE ARTWORK
560 x 170 MM
Front
XXXXXXX
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HYDROCORTISONE 10 MG AND 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 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. It
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 yo

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg hydrocortisone
Excipients with known effect:
Each tablet contains 146.75 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
White to off white, elliptical shape, flat, bevelled edge tablet with
“BL 10” on one
side and crossed break lines on other side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Corticosteroid
•
For use as replacement therapy in congenital adrenal hyperplasia in
children.
•
Treatment of adrenal insufficiency in children and adolescents < 18
years of age.
•
Emergency treatment of severe bronchial asthma, drug hypersensitivity
reactions, serum sickness, angioneurotic oedema and anaphylaxis in
adults and children.
Hydrocortisone tablets are indicated in adults and children aged from
1 month
to 18 years where the dose of 10 mg, 20mg and tablet formulation is
considered appropriate
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.
The lowest possible dosage should be
used. Doses should be multiples of 10 (i.e. 10mg, 20mg, 30mg, etc.).
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 a relapse of the underlying disease, it
may be
necessar